tag:blogger.com,1999:blog-5391989360501465452024-03-10T20:22:51.522-07:00Millie Kieve's Adverse Psychiatric Reactions APRIL_charity blogAdverse drug reactions (ADRs) caused by everyday medicines, or anaesthetics can include depression, anxiety, insomnia, suicidal feelings. Pharmaceutical drugs for pain, infections, acne, anxiety, depression, may cause immediate or withdrawal reactions. Genetic differences may put individuals at risk
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APRIL (Adverse Psychiatric Reactions Information Link) www.april.org.ukAdverse Reactions APRILcharity bloghttp://www.blogger.com/profile/10938026980225981583noreply@blogger.comBlogger88125tag:blogger.com,1999:blog-539198936050146545.post-26000842377948149872023-07-14T12:14:00.001-07:002023-07-14T12:17:01.617-07:00<p><br /></p><h1 class="gem-c-title__text govuk-heading-l" style="-webkit-font-smoothing: antialiased; background-color: white; color: #0b0c0c; font-family: "GDS Transport", arial, sans-serif; line-height: 1.11111; margin: 0px;"><span style="font-size: large;">Isotretinoin: an expert UK review of suspected psychiatric and sexual side effects- Review from 2021 with results in 2023</span></h1><p><a href="https://www.gov.uk/guidance/isotretinoin-an-expert-review-of-suspected-psychiatric-and-sexual-side-effects#contributions-from-patients-and-the-public">https://www.gov.uk/guidance/isotretinoin-an-expert-review-of-suspected-psychiatric-and-sexual-side-effects#contributions-from-patients-and-the-public</a></p><p><span style="background-color: white; color: #0b0c0c; font-family: "GDS Transport", arial, sans-serif;"><span style="font-size: medium;">The review of the safety of isotretinoin/Roaccutane has concluded.</span></span></p><p><span style="background-color: white; color: #0b0c0c; font-family: "GDS Transport", arial, sans-serif;"><span style="font-size: medium;">A great deal of thought and anguish for those bereaved or harmed they believed was after or during the use Roaccutane/ isotretinoin, prescribed for acne, before they sent in written evidence or / and spoke in meetings with some of the Istotretinoin Expert Working Group (IEWG).</span></span></p><p><span style="background-color: white; color: #0b0c0c; font-family: "GDS Transport", arial, sans-serif;"><span style="font-size: medium;">The three meetings videos of the evidence from patients, bereaved family members and doctors are on the .Gov site</span></span></p><p><span style="background-color: white; color: #0b0c0c; font-family: "GDS Transport", arial, sans-serif;"><span style="font-size: medium;">The final discussion on findings following evidence sessions is here: </span></span></p><p><span style="background-color: white; font-size: 24px;"><span style="color: #0b0c0c; font-family: GDS Transport, arial, sans-serif;"><a href="https://www.youtube.com/watch?v=jOX6hASHdTM" target="_blank">https://www.youtube.com/watch?v=jOX6hASHdTM </a></span></span></p><p><span style="background-color: white;"><span style="font-size: medium;"><i>it may be of interest that the manufacturer Roche have ceased being responsible for the sale of isotretinoin/ Accutane in the USA - the amount of litigation linking the adverse effects to Inflammatory Bowel Disease in the US was not said to be the reason. However I spoke to a generic provider of the drug in the UK and was told Roche provides them with the drugs.</i></span></span></p><p><span style="background-color: white;"><span style="font-size: medium;"><i>Before this the evidence sessions on Zoom occurred and we had all sent in written evidence too.</i></span></span></p><p><span style="background-color: white; color: #0b0c0c; font-family: "GDS Transport", arial, sans-serif; font-size: 1.6875rem;">Contributions from patients and the public</span></p><p style="-webkit-font-smoothing: antialiased; background-color: white; color: #0b0c0c; font-family: "GDS Transport", arial, sans-serif; font-size: 1.1875rem; line-height: 1.31579; margin-bottom: 20px; margin-top: 20px;">A call for information was held for 14 weeks (10 November 2020 to 16 February 2021). A total of 710 complete responses were received. These included 659 responses that provided views. We have assessed each one and shared the responses with the IEWG.</p><p style="-webkit-font-smoothing: antialiased; background-color: white; color: #0b0c0c; font-family: "GDS Transport", arial, sans-serif; font-size: 1.1875rem; line-height: 1.31579; margin-bottom: 20px; margin-top: 20px;">Patients and other stakeholders presented information about their experience of isotretinoin and what aspect of treatment has had the greatest impact as well as how the risks associated with isotretinoin should be managed.</p><p style="-webkit-font-smoothing: antialiased; background-color: white; color: #0b0c0c; font-family: "GDS Transport", arial, sans-serif; font-size: 1.1875rem; line-height: 1.31579; margin-bottom: 20px; margin-top: 20px;">Three sessions were held to allow the IEWG to hear from everyone who registered and wished to present.</p><p style="-webkit-font-smoothing: antialiased; background-color: white; color: #0b0c0c; font-family: "GDS Transport", arial, sans-serif; font-size: 1.1875rem; line-height: 1.31579; margin-bottom: 20px; margin-top: 20px;">See recordings of the 3 IEWG sessions with stakeholders. These videos have been edited to only show the views of those who consented to being recorded. The videos contain content that some people may find upsetting:</p><ul style="-webkit-font-smoothing: antialiased; background-color: white; line-height: 1.31579; list-style-image: initial; list-style-position: initial; margin-bottom: 20px; margin-left: 20px; margin-top: 20px; padding: 0px;"><li style="color: #0b0c0c; font-family: "GDS Transport", arial, sans-serif; font-size: 1.1875rem; margin: 0px 0px 5px; padding: 0px;"><a class="govuk-link" href="https://youtu.be/xTlvBr4QstI" rel="external" style="-webkit-font-smoothing: antialiased; color: #1d70b8; text-decoration-thickness: max(1px, 0.0625rem); text-underline-offset: 0.1578em;">IEWG Meeting 16 July 2021</a> <a href="https://www.youtube.com/watch?v=xTlvBr4QstI">https://www.youtube.com/watch?v=xTlvBr4QstI</a></li><li style="color: #0b0c0c; font-family: "GDS Transport", arial, sans-serif; font-size: 1.1875rem; margin: 0px 0px 5px; padding: 0px;"><a class="govuk-link" href="https://www.youtube.com/watch?v=OxUOo5DK_zg" rel="external" style="-webkit-font-smoothing: antialiased; color: #1d70b8; text-decoration-thickness: max(1px, 0.0625rem); text-underline-offset: 0.1578em;">IEWG Meeting 21 July Meeting (morning session)</a></li><li style="margin: 0px 0px 5px; padding: 0px;"><span style="color: #0b0c0c; font-family: GDS Transport, arial, sans-serif;"><span style="font-size: 19px;"><a href="https://www.youtube.com/watch?v=OxUOo5DK_zg">https://www.youtube.com/watch?v=OxUOo5DK_zg</a></span></span></li><li style="color: #0b0c0c; font-family: "GDS Transport", arial, sans-serif; font-size: 1.1875rem; margin: 0px 0px 5px; padding: 0px;"><a class="govuk-link" href="https://youtu.be/KA2xlhmYr_o" rel="external" style="-webkit-font-smoothing: antialiased; color: #1d70b8; text-decoration-thickness: max(1px, 0.0625rem); text-underline-offset: 0.1578em;">IEWG Meeting 21 July 2021 Afternoon Session</a></li><li style="margin: 0px 0px 5px; padding: 0px;"><span style="color: #0b0c0c; font-family: GDS Transport, arial, sans-serif;"><span style="font-size: 19px;"><a href="https://www.youtube.com/watch?v=KA2xlhmYr_o">https://www.youtube.com/watch?v=KA2xlhmYr_o</a></span></span></li></ul><p><span style="background-color: white;"><span style="color: #0b0c0c; font-family: GDS Transport, arial, sans-serif; font-size: medium;"><i>It is worth hearing the above sessions for real patient experiences. There are generic versions of isotretinoin and it should only be prescribed by consultant dermatologists, not by GPs or obtained from the Internet.</i></span></span></p><p><i><span style="background-color: white; color: #202124; font-family: "Google Sans", arial, sans-serif; font-size: 20px;">isotretinoin is marketed as </span><span style="background-color: rgba(80, 151, 255, 0.18); color: #040c28; font-family: "Google Sans", arial, sans-serif; font-size: 20px;">Absorica, Absorica LD, Claravis, Amnesteem, Myorisan, and Zenatane</span><span style="background-color: white; color: #202124; font-family: "Google Sans", arial, sans-serif; font-size: 20px;">, and is sometimes referred to by its former brand name, Accutane</span></i></p><p><i><span style="background-color: rgba(80, 151, 255, 0.18); color: #040c28; font-family: "Google Sans", arial, sans-serif; font-size: 20px;">Rizuderm, Reticutan</span><span style="background-color: white; font-family: "Google Sans", arial, sans-serif; font-size: 20px;"><span style="color: #202124;"> in the UK</span></span></i></p><p><br /></p>Adverse Reactions APRILcharity bloghttp://www.blogger.com/profile/10938026980225981583noreply@blogger.com0tag:blogger.com,1999:blog-539198936050146545.post-7691647452344302892023-07-14T10:02:00.003-07:002023-07-14T10:04:21.281-07:00Antidepressant Withdrawal Official Advice from UK's Royal College of Psychiatrists<p> <strong style="background-color: white; color: #565656; font-family: Arial, Helvetica, sans-serif; font-size: 14px;"><a href="https://www.rcpsych.ac.uk/mental-health/treatments-and-wellbeing/stopping-antidepressants" style="color: #0066cc; text-decoration-line: none;" target="_blank">For antidepressant withdrawal</a> and safe, slow reduction in dosage, a huge breakthrough is the Royal College of Psychiatrists have included, on their web site, detailed information about titrating the dosage, the use of liquid medication and other advice. They also warn about possibe withdrawal effects. This is a vital contribution towards patient safety, we have been begging for during the past 20 years. </strong></p><p style="background-color: white; color: #565656; font-family: "Open Sans", Arial, sans-serif; font-size: 17px !important; line-height: 1.5; margin: 0px; padding-bottom: 11.4766px;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;"><strong><a href="https://www.rcpsych.ac.uk/mental-health/treatments-and-wellbeing/stopping-antidepressants" style="color: #0066cc; text-decoration-line: none;" target="_blank">https://www.rcpsych.ac.uk/mental-health/treatments-and-wellbeing/stopping-antidepressants</a></strong></span></p>Adverse Reactions APRILcharity bloghttp://www.blogger.com/profile/10938026980225981583noreply@blogger.com0tag:blogger.com,1999:blog-539198936050146545.post-85379878195293900892023-01-04T09:45:00.002-08:002023-01-04T10:04:16.425-08:00<p> BREAKING NEWS</p><div class="update-components-actor display-flex
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" style="align-items: center; background-color: white; border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; color: rgba(0, 0, 0, 0.9); display: flex !important; flex-wrap: nowrap; font-family: -apple-system, system-ui, "system-ui", "Segoe UI", Roboto, "Helvetica Neue", "Fira Sans", Ubuntu, Oxygen, "Oxygen Sans", Cantarell, "Droid Sans", "Apple Color Emoji", "Segoe UI Emoji", "Segoe UI Emoji", "Segoe UI Symbol", "Lucida Grande", Helvetica, Arial, sans-serif; font-size: 16px; margin-bottom: 0.8rem; padding: 1.2rem calc(4rem) 0px 1.6rem; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><a aria-label="View: Ron H.N. van Schaik Full Professor Pharmacogenetics / Head Dept Clinical Chemistry / Past-President European Society Pharmacogenomics &amp; Personalised Therapy (ESPT) 5 days ago" class="app-aware-link update-components-actor__container-link relative display-flex flex-grow-1" data-test-app-aware-link="" href="https://www.linkedin.com/in/rhnvanschaik?miniProfileUrn=urn%3Ali%3Afs_miniProfile%3AACoAAAFYsfMB0InMrlHYC9hNm1KGnR-lc7HMxOs" style="background-color: var(--artdeco-reset-link-background-color-transparent); border: var(--artdeco-reset-link-border-zero); box-sizing: inherit; display: flex !important; flex-grow: 1 !important; font-size: var(--artdeco-reset-base-font-size-hundred-percent); font-weight: var(--font-weight-bold); margin-right: 1.2rem; overflow: hidden; padding: var(--artdeco-reset-base-padding-zero); position: relative !important; text-decoration: var(--artdeco-reset-link-text-decoration-none); touch-action: manipulation; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);" target="_self"><div class="update-components-actor__image relative" style="background: var(--artdeco-reset-base-background-transparent); border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; flex-shrink: 0; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: var(--artdeco-reset-base-margin-zero); padding: var(--artdeco-reset-base-padding-zero); position: relative !important; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span class="js-update-components-actor__avatar" data-entity-hovercard-id="urn:li:fs_miniProfile:ACoAAAFYsfMB0InMrlHYC9hNm1KGnR-lc7HMxOs" style="background: var(--artdeco-reset-base-background-transparent); border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><div class="ivm-image-view-model update-components-actor__avatar" style="background: var(--artdeco-reset-base-background-transparent); border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: var(--artdeco-reset-base-margin-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><div class="ivm-view-attr__img-wrapper ivm-view-attr__img-wrapper--use-img-tag display-flex
" style="background: var(--artdeco-reset-base-background-transparent); border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; display: flex !important; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: var(--artdeco-reset-base-margin-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><div class="presence-entity presence-entity--size-3" style="background: var(--artdeco-reset-base-background-transparent); border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; display: flex; font-size: var(--artdeco-reset-base-font-size-hundred-percent); height: 48px; margin: var(--artdeco-reset-base-margin-zero); padding: var(--artdeco-reset-base-padding-zero); position: relative; vertical-align: var(--artdeco-reset-base-vertical-align-baseline); width: 48px;"><img alt="Ron H.N. van Schaik" class="presence-entity__image ivm-view-attr__img--centered EntityPhoto-circle-3 update-components-actor__avatar-image EntityPhoto-circle-3 lazy-image ember-view" id="ember2256" loading="lazy" src="https://media.licdn.com/dms/image/C4E03AQGcnocitpc01w/profile-displayphoto-shrink_100_100/0/1595409862187?e=1678320000&v=beta&t=Z5uuz8Rlrh5_0RQZzcd-Qs3da2ThejiewLCPPhq8WcM" style="background-clip: content-box; background-color: var(--color-background-container); background-position: 50% center; background-repeat: no-repeat; background-size: contain; border-radius: var(--corner-radius-full) !important; border: none; box-shadow: none; box-sizing: border-box; color: var(--color-text); font-size: var(--artdeco-reset-base-font-size-hundred-percent); height: 48px; margin: var(--artdeco-reset-base-margin-zero); object-fit: contain; object-position: center center; outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline); width: 48px;" /></div></div></div></span></div><div class="update-components-actor__meta relative" style="background: var(--artdeco-reset-base-background-transparent); border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; flex-basis: 0px; flex-grow: 1; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin-left: 0.8rem; overflow: hidden; padding: var(--artdeco-reset-base-padding-zero); position: relative !important; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span class="update-components-actor__title" style="background: var(--artdeco-reset-base-background-transparent); border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; display: flex; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span class="update-components-actor__name t-14 t-bold hoverable-link-text
t-black" data-entity-hovercard-id="urn:li:fs_miniProfile:ACoAAAFYsfMB0InMrlHYC9hNm1KGnR-lc7HMxOs" style="--artdeco-reset-typography_getfontsize: 1.4rem; --artdeco-reset-typography_getlineheight: 1.42857; background: var(--artdeco-reset-base-background-transparent); border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; color: var(--color-text); display: inline-block; font-size: var(--artdeco-reset-typography_getFontSize); font-weight: var(--artdeco-reset-typography-font-weight-bold); line-height: var(--artdeco-reset-typography_getLineHeight); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); overflow: hidden; padding: var(--artdeco-reset-base-padding-zero); text-overflow: ellipsis; vertical-align: top; white-space: nowrap;"><span dir="ltr" style="background: var(--artdeco-reset-base-background-transparent); border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">Ron H.N. van Schaik</span></span><span class="update-components-actor__supplementary-actor-info t-14 t-normal ml1
t-black--light" style="--artdeco-reset-typography_getfontsize: 1.4rem; --artdeco-reset-typography_getlineheight: 1.42857; background: var(--artdeco-reset-base-background-transparent); border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; color: var(--color-text-low-emphasis); flex-shrink: 0; font-size: var(--artdeco-reset-typography_getFontSize); font-weight: var(--artdeco-reset-typography-font-weight-normal); line-height: var(--artdeco-reset-typography_getLineHeight); margin-left: 4px !important; outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: top; white-space: nowrap;">• Posted this - APRIL is Following on Linkedin.</span></span><span class="update-components-actor__description t-12 t-normal
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" style="--artdeco-reset-typography_getfontsize: 1.2rem; --artdeco-reset-typography_getlineheight: 1.33333; background: var(--artdeco-reset-base-background-transparent); border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; color: var(--color-text-low-emphasis); display: block; font-size: var(--artdeco-reset-typography_getFontSize); font-weight: var(--artdeco-reset-typography-font-weight-normal); line-height: var(--artdeco-reset-typography_getLineHeight); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); overflow: hidden; padding: var(--artdeco-reset-base-padding-zero); text-overflow: ellipsis; vertical-align: var(--artdeco-reset-base-vertical-align-baseline); white-space: nowrap;">Full Professor Pharmacogenetics / Head Dept Clinical Chemistry / Past-President European Society Pharmacogenomics & Personalised Therapy (ESPT)</span><span class="update-components-actor__sub-description t-12 t-normal
t-black--light" style="--artdeco-reset-typography_getfontsize: 1.2rem; --artdeco-reset-typography_getlineheight: 1.33333; background: var(--artdeco-reset-base-background-transparent); border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; color: var(--color-text-low-emphasis); display: block; font-size: var(--artdeco-reset-typography_getFontSize); font-weight: var(--artdeco-reset-typography-font-weight-normal); line-height: var(--artdeco-reset-typography_getLineHeight); margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); overflow: hidden; padding: var(--artdeco-reset-base-padding-zero); text-overflow: ellipsis; vertical-align: var(--artdeco-reset-base-vertical-align-baseline); white-space: nowrap;"><div class="update-components-text-view white-space-pre-wrap break-words
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" style="--artdeco-reset-typography_getlineheight: 1.42857; -webkit-line-clamp: initial; background: var(--artdeco-reset-base-background-transparent); border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); line-height: 2rem !important; margin: 0px 1.6rem; max-height: none; max-width: 928px; overflow: hidden; padding: var(--artdeco-reset-base-padding-zero); position: relative; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);" tabindex="-1"><div class="update-components-text relative feed-shared-update-v2__commentary " dir="ltr" style="--artdeco-reset-typography_getfontsize: 1.4rem; --artdeco-reset-typography_getlineheight: 1.42857; background: var(--artdeco-reset-base-background-transparent); border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; color: var(--color-text); font-size: var(--artdeco-reset-typography_getFontSize); line-height: var(--artdeco-reset-typography_getLineHeight); margin: var(--artdeco-reset-base-margin-zero); padding: var(--artdeco-reset-base-padding-zero); position: relative !important; vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span class="break-words" style="background: var(--artdeco-reset-base-background-transparent); border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); line-height: inherit !important; margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); overflow-wrap: break-word !important; padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline); word-break: break-word !important;"><span style="background: var(--artdeco-reset-base-background-transparent); border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); line-height: inherit !important; margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);"><span dir="ltr" style="background: var(--artdeco-reset-base-background-transparent); border: var(--artdeco-reset-base-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); line-height: inherit !important; margin: var(--artdeco-reset-base-margin-zero); outline: var(--artdeco-reset-base-outline-zero); padding: var(--artdeco-reset-base-padding-zero); vertical-align: var(--artdeco-reset-base-vertical-align-baseline);">First-ever NHS pilot of routine pharmacogenetic testing to guide drug choice in primary care will begin in early 2023 in north-west England, with plans for it to become a national programme if successful. Drugs include antidepressants, statins and proton pump inhibitors (PPIs).<br style="box-sizing: inherit; line-height: inherit !important;" /><br style="box-sizing: inherit; line-height: inherit !important;" />Great move forward!<br style="box-sizing: inherit; line-height: inherit !important;" /><br style="box-sizing: inherit; line-height: inherit !important;" />There are also plans to expand pharmacogenomic testing in Scotland, where health board NHS Tayside has begun a routine clopidogrel genotype testing service in secondary care after acute stroke, and there are also plans in development to use pharmacogenomic testing pilots more broadly using gene panels.<br style="box-sizing: inherit; line-height: inherit !important;" /><br style="box-sizing: inherit; line-height: inherit !important;" /><a data-attribute-index="0" href="https://www.linkedin.com/feed/hashtag/?keywords=pharmacogenetics&highlightedUpdateUrns=urn%3Ali%3Aactivity%3A7014306306530361344" style="background-color: var(--artdeco-reset-link-background-color-transparent); border: var(--artdeco-reset-link-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); font-weight: var(--font-weight-bold); line-height: inherit !important; margin: var(--artdeco-reset-base-margin-zero); overflow-wrap: normal; padding: var(--artdeco-reset-base-padding-zero); position: relative; text-decoration: var(--artdeco-reset-link-text-decoration-none); touch-action: manipulation; vertical-align: var(--artdeco-reset-base-vertical-align-baseline); word-break: normal;">#pharmacogenetics</a> <a data-attribute-index="1" href="https://www.linkedin.com/feed/hashtag/?keywords=cyp2d6&highlightedUpdateUrns=urn%3Ali%3Aactivity%3A7014306306530361344" style="background-color: var(--artdeco-reset-link-background-color-transparent); border: var(--artdeco-reset-link-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); font-weight: var(--font-weight-bold); line-height: inherit !important; margin: var(--artdeco-reset-base-margin-zero); overflow-wrap: normal; padding: var(--artdeco-reset-base-padding-zero); position: relative; text-decoration: var(--artdeco-reset-link-text-decoration-none); touch-action: manipulation; vertical-align: var(--artdeco-reset-base-vertical-align-baseline); word-break: normal;">#CYP2D6</a> <a data-attribute-index="2" href="https://www.linkedin.com/feed/hashtag/?keywords=cyp2c19&highlightedUpdateUrns=urn%3Ali%3Aactivity%3A7014306306530361344" style="background-color: var(--artdeco-reset-link-background-color-transparent); border: var(--artdeco-reset-link-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); font-weight: var(--font-weight-bold); line-height: inherit !important; margin: var(--artdeco-reset-base-margin-zero); overflow-wrap: normal; padding: var(--artdeco-reset-base-padding-zero); position: relative; text-decoration: var(--artdeco-reset-link-text-decoration-none); touch-action: manipulation; vertical-align: var(--artdeco-reset-base-vertical-align-baseline); word-break: normal;">#CYP2C19</a> <a data-attribute-index="3" href="https://www.linkedin.com/feed/hashtag/?keywords=slco1b1&highlightedUpdateUrns=urn%3Ali%3Aactivity%3A7014306306530361344" style="background-color: var(--artdeco-reset-link-background-color-transparent); border: var(--artdeco-reset-link-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); font-weight: var(--font-weight-bold); line-height: inherit !important; margin: var(--artdeco-reset-base-margin-zero); overflow-wrap: normal; padding: var(--artdeco-reset-base-padding-zero); position: relative; text-decoration: var(--artdeco-reset-link-text-decoration-none); touch-action: manipulation; vertical-align: var(--artdeco-reset-base-vertical-align-baseline); word-break: normal;">#SLCO1B1</a><br style="box-sizing: inherit; line-height: inherit !important;" /><a data-attribute-index="4" data-entity-hovercard-id="urn:li:fs_miniProfile:ACoAAALrQvUBWZhHVbDQFPQNTBR9lCGfjDZMCso" data-entity-type="MINI_PROFILE" href="https://www.linkedin.com/in/ACoAAALrQvUBWZhHVbDQFPQNTBR9lCGfjDZMCso" style="background-color: var(--artdeco-reset-link-background-color-transparent); border: var(--artdeco-reset-link-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); font-weight: var(--font-weight-bold); line-height: inherit !important; margin: var(--artdeco-reset-base-margin-zero); overflow-wrap: normal; padding: var(--artdeco-reset-base-padding-zero); position: relative; text-decoration: var(--artdeco-reset-link-text-decoration-none); touch-action: manipulation; vertical-align: var(--artdeco-reset-base-vertical-align-baseline); word-break: normal;">Joba van den Berg</a> <a data-attribute-index="6" data-entity-hovercard-id="urn:li:fs_miniProfile:ACoAABXHRXMBa1oMiVlRrgnEynR_vpqp6fU-g4k" data-entity-type="MINI_PROFILE" href="https://www.linkedin.com/in/ACoAABXHRXMBa1oMiVlRrgnEynR_vpqp6fU-g4k" style="background-color: var(--artdeco-reset-link-background-color-transparent); border: var(--artdeco-reset-link-border-zero); box-sizing: inherit; font-size: var(--artdeco-reset-base-font-size-hundred-percent); font-weight: var(--font-weight-bold); line-height: inherit !important; margin: var(--artdeco-reset-base-margin-zero); overflow-wrap: normal; padding: var(--artdeco-reset-base-padding-zero); position: relative; text-decoration: var(--artdeco-reset-link-text-decoration-none); touch-action: manipulation; vertical-align: var(--artdeco-reset-base-vertical-align-baseline); word-break: normal;">Ernst Kuipers</a></span></span></span></div></div></div>Adverse Reactions APRILcharity bloghttp://www.blogger.com/profile/10938026980225981583noreply@blogger.com0tag:blogger.com,1999:blog-539198936050146545.post-52989317409125058822022-04-10T07:57:00.002-07:002022-04-10T07:57:26.473-07:00Personalised Medicine promise - to prevent high rate of adverse drug reactions (ADRs)<p> </p><h1 style="background-color: white; color: #1d5a9b; font-family: Ubuntu, Arial, Helvetica, sans-serif !important; font-size: 26px; font-weight: normal; letter-spacing: -1px; margin: 31.5625px 0px 11.4766px; padding: 2.86719px 0px 5.16406px;"><span style="font-family: "Comic Sans MS"; font-size: 14px;"><span style="font-family: "Open Sans", Arial, sans-serif; font-size: 22px;"><strong>BREAKING NEWS </strong></span></span></h1><h2 style="background-color: white; color: #00a2af; font-family: Ubuntu, Arial, Helvetica, sans-serif !important; font-size: 22px; font-weight: 300; margin: 17.2188px 0px 11.4766px;"><span style="font-family: "Open Sans", Arial, sans-serif;"><strong>Personalised Medicine </strong></span></h2><p style="background-color: white; color: #565656; font-family: "Open Sans", Arial, sans-serif; font-size: 17px !important; line-height: 1.5; margin: 0px; padding-bottom: 11.4766px;"><span style="font-size: 18px;"><strong> At last in March 2022 a promise for Personalised Medication Prescribing. This should dramatically reduce harm done to many by using medication they cannot tolerate, or does nothing to improve their condition.</strong></span></p><p style="background-color: white; color: #565656; font-family: "Open Sans", Arial, sans-serif; font-size: 17px !important; line-height: 1.5; margin: 0px; padding-bottom: 11.4766px;"><span style="font-size: 18px;"><strong>A Detailed report just published March 2022 by the <br />Royal College of Physicians & British Pharmacological Society -</strong></span><br /><strong><span style="font-size: 18px;">Click Here for the Report: <a href="https://april.org.uk/content/pages/documents/personalised-prescribing.pdf" style="color: #0066cc; text-decoration-line: none;" target="_blank">PERSONALISED PRESCRIBING</a></span></strong></p><p style="background-color: white; color: #565656; font-family: "Open Sans", Arial, sans-serif; font-size: 17px !important; line-height: 1.5; margin: 0px; padding-bottom: 11.4766px;"><span style="font-size: 16px;"><strong>An article in The Guardian </strong></span><span style="font-size: 18px;"><strong><em style="padding-right: 1em; vertical-align: top;">Experts push for genetic testing to personalise drug prescriptions</em></strong></span><span style="font-size: 16px;"><strong> explains the benefits, as About 6.5% of UK hospital admissions are caused by adverse drug reactions</strong>, <strong>while most prescription medicines only work on 30% to 50% of people.</strong></span><br /><span style="font-size: 16px;"><strong><a href="https://www.theguardian.com/science/2022/mar/29/experts-push-for-genetic-testing-to-personalise-drug-prescriptions" style="color: #0066cc; text-decoration-line: none;" target="_blank">Click here for the Guardian article by Linda Geddes:</a></strong></span></p><p style="background-color: white; color: #565656; font-family: "Open Sans", Arial, sans-serif; font-size: 17px !important; line-height: 1.5; margin: 0px; padding-bottom: 11.4766px;"><span style="font-size: 18px;"><strong>APRIL has been promoting the use of genetic testing for many years - <a href="https://vimeo.com/15987982" style="color: #0066cc; text-decoration-line: none;" target="_blank">Click here for a talk by Professor Sir Munir Pirmohamed,</a> Chair of the Working Group on Personalised Prescribing, speaking at our conference</strong></span></p><p style="background-color: white; color: #565656; font-family: "Open Sans", Arial, sans-serif; font-size: 17px !important; line-height: 1.5; margin: 0px; padding-bottom: 11.4766px;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;"><strong>The aim of this web site is to share information about psychiatric adverse effects of prescribed medicines and anaesthetics.</strong></span><span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;"><strong>However many who suffer adverse reactions are then prescribed psychotropic drugs, some cause dependence.</strong></span></p><p style="background-color: white; color: #565656; font-family: "Open Sans", Arial, sans-serif; font-size: 17px !important; line-height: 1.5; margin: 0px; padding-bottom: 11.4766px;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;"><strong>Read below about an online conference on issues of dependence and withdrawal from antidepressants, benzodiasepines and other drugs causing serious withdrawal reactions.</strong></span> With Professor Joanna Moncrieff and Robert Whitaker</p><h2 style="background-color: white; color: #00a2af; font-family: Ubuntu, Arial, Helvetica, sans-serif !important; font-size: 22px; font-weight: 300; margin: 17.2188px 0px 11.4766px;"><span style="font-family: "Open Sans", Arial, sans-serif;"><strong>Withdrawal from Medication</strong></span><br /><span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;"><strong><span style="font-family: "Open Sans", Arial, sans-serif; font-size: 16px;">CONFERENCE - May 6/7 2022 </span> <br />Click for flyer: </strong></span><strong><span style="font-family: "Open Sans", Arial, sans-serif;"><a href="https://april.org.uk/content/pages/documents/withdrawal-from-psychiatric-drugs.pdf" style="color: #0066cc; text-decoration-line: none;" target="_blank">Withdrawal from Psychiatric Drugs</a></span></strong></h2><h3 style="background-color: white; color: #00a2af; font-family: Ubuntu, Arial, Helvetica, sans-serif !important; font-size: 15px; margin: 17.2188px 0px 11.4766px;"><span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;"><strong><a href="https://iipdw.org/" style="color: #0066cc; text-decoration-line: none;" target="_blank">https://iipdw.org/</a></strong></span></h3><div><span style="font-family: Arial, Helvetica, sans-serif; font-size: 14px;"><br /></span></div>Adverse Reactions APRILcharity bloghttp://www.blogger.com/profile/10938026980225981583noreply@blogger.com0tag:blogger.com,1999:blog-539198936050146545.post-35242643991094617582022-03-03T04:16:00.005-08:002022-03-03T04:16:30.612-08:00The MHRA Roaccutane / isotretinoin Inquiry into harms some people suffer, is still ongoing. Plus link to Millie Kieve's newest video.<p><b> Re the MHRA Isotretinoin expert working Group (IEWG) conclusions following submission of evidence from Millie Kieve for APRIL charity, together with many parents tragically bereaved by the suicide of their child.</b></p><p>The outcome of our written and face to face (via Zoom) submissions of evidence, is very slow to emerge and more will be posted about this at a later date.</p><p>For my part (Millie) - News of the work for APRIL which is ongoing, even though my age tells me to slow down!</p><p>I have now given up the office as I had rarely been into the space since the Covid lockdown, so am working on books about the history of APRIL and my life in fact!</p><p>In the meantime I have updated some videos on the Vimeo web site and this one is the newest:</p><p><a data-saferedirecturl="https://www.google.com/url?q=https://vimeo.com/683984803&source=gmail&ust=1646390212625000&usg=AOvVaw1CIiDB4zLs1XuFbnlHKiJY" href="https://vimeo.com/683984803" style="color: #1155cc; font-family: Arial, Helvetica, sans-serif; text-size-adjust: auto;" target="_blank">https://vimeo.com/683984803</a></p><p>It is a talk that started as a conversation between me and my long time volunteer and friend Kathy.</p><p>I decided as I was explaining some of the history of the efforts I have made to help towards greater patient safety, I may as well record this. So I added still pictures to help illustrate the information. This covers the early years around the time of the first conference I organised.</p><p>This includes when Dr David Healy (now Professor) was rejected after having his post as Professor in Toronto, following his talk to a few doctors, I believe, about the risk of suicide for some people taking antidepressant SSRI and similar drugs. You will hear he did agree to speak at that first conference, which led to the amazing work by the BBC Panorama team in highlighting the issues around dependence and harm caused by the SSRI antidepressant Seroxat. </p><p>The fact that dosage was licensed too high and how the CEO of MIND charity actually resigned from and committee of people working for the Medicines regulator at the time, for reasons of failure to disclose or act on harm they knew about.</p><p>Please listen to the 11 minute 'conversation' in which I do actually include Kath's contribution, but not all as it may have been unsuitable for sharing! </p><p>There are many videos of interest I have edited and included on Vimeo and the link to them all is on the Home Page of APRIL's web site<a href="https://www.april.org.uk " target="_blank"> https://www.april.org.uk</a> Talks by leading experts in adverse drug reactions (ADRs) and how clinical trials have been rigged in favour of benefits from medicines with cover up of harms. Testimonials of suffering and recovery from people who have been sectioned for psychiatric issues, some due to the ADRs they suffered.</p><p>I will do more on the blog if I can be sure some people are still reading my posts. Please enter your email to be informed of new posts. I have no access to that data so have no idea how many of you may have signed up.</p><p>Kind regards to all and stay safe from Covid - with heartfelt concern for those in Ukraine who have far more than Covid to worry about.</p>Adverse Reactions APRILcharity bloghttp://www.blogger.com/profile/10938026980225981583noreply@blogger.com0tag:blogger.com,1999:blog-539198936050146545.post-57148590511847909682021-02-03T04:27:00.010-08:002021-02-03T04:40:10.798-08:00Inquiry invites your views as concern about psychiatric and physical harm from acne drug isotretinoin / Ro - Accutane / Reticutan / Rizuderm<p><span style="font-size: medium;"> I<strong style="color: #565656; font-family: "Open Sans", Arial, sans-serif;">sotretinoin / Roaccutane / Reticutan / Rizuderm / Accutane </strong></span></p><p><span style="caret-color: rgb(86, 86, 86); color: #565656; font-family: "Open Sans", Arial, sans-serif; font-size: 17px;"><b><a href="https://www.gov.uk/government/consultations/isotretinoin-call-for-information-to-be-considered-as-part-of-an-expert-review " target="_blank">Please submit your views for an Expert Review</a> of your experience or your relative or friend's as to the safety or otherwise of this acne medication.</b></span></p><p><a href="https://www.gov.uk/government/consultations/isotretinoin-call-for-information-to-be-considered-as-part-of-an-expert-review" style="color: #0066cc; font-family: "Open Sans", Arial, sans-serif; font-size: 17px; text-decoration: none;" target="_blank">https://www.gov.uk/government/consultations/isotretinoin-call-for-information-to-be-considered-as-part-of-an-expert-review</a><span style="caret-color: rgb(86, 86, 86); color: #565656; font-family: "Open Sans", Arial, sans-serif; font-size: 17px;"> </span></p><p><b><span style="caret-color: rgb(86, 86, 86); color: #565656; font-family: "Open Sans", Arial, sans-serif; font-size: 17px;">Closing date for submission </span><span style="color: #565656; font-family: Open Sans, Arial, sans-serif;"><span style="font-size: 17px;">extend to 16th February 2021 </span></span></b></p><p><span style="color: #565656; font-family: Open Sans, Arial, sans-serif;"><span style="font-size: 17px;">UK and non UK submissions welcome</span></span></p><p><b><span style="color: #565656; font-family: Open Sans, Arial, sans-serif;"><span style="caret-color: rgb(86, 86, 86); font-size: 17px;">Concerns about suicide, depression and physical harm linked to using this acne medication are worldwide. </span></span></b></p><p><b><span style="color: #565656; font-family: Open Sans, Arial, sans-serif;"><span style="caret-color: rgb(86, 86, 86); font-size: 17px;">EU ADR database records psychiatric Adverse Drug Reactions (ADRs) 30,295 </span></span></b><b><span style="color: #565656; font-family: Open Sans, Arial, sans-serif;"><span style="font-size: 17px;">with reported cases of completed suicide by people using the acne drug 440 by 01/02/21</span></span></b></p><p><b><span style="color: #565656; font-family: Open Sans, Arial, sans-serif;"><span style="font-size: 17px;">The original manufacturer Roche withdrew the drug from the US market following extensive amount of litigation. The US litigation was also about the drug causing Inflammatory Bowel Disease such as Ulcerative Colitis.</span></span></b></p><p><strong style="color: #565656; font-family: "Open Sans", Arial, sans-serif;">Only licensed for for severe acne, yet has been given to people with mild acne. One young medical student with a few spots on his back died by suicide - you can hear his father's account here:</strong><span style="color: #565656; font-family: "Open Sans", Arial, sans-serif;"> </span><a href="https://vimeo.com/16759077">https://vimeo.com/16759077</a> </p><p><strong style="color: #565656; font-family: "Open Sans", Arial, sans-serif;"> Roaccutane / isotretinoin and generic versions can cause serious adverse reactions for some people . </strong></p><p style="color: #565656; font-family: "Open Sans", Arial, sans-serif; font-size: 17px !important; line-height: 1.5; margin: 0px; padding-bottom: 11.46875px;">Please submit your views for the Expert Review due to concerns about suicide, depression and physical harm linked to usage - date has been extended until February 16 2021.</p><p style="color: #565656; font-family: "Open Sans", Arial, sans-serif; font-size: 17px !important; line-height: 1.5; margin: 0px; padding-bottom: 11.46875px;">Worldwide - not just the UK - so please if you have any views, if you or a family member has concerns about adverse effects you may not expect, such as on libido or mood changes or if you were bereaved suddenly and the victim was using or had stopped using the acne drug, please access via the link below and submit your views by Feb 16 2021</p><p style="color: #565656; font-family: "Open Sans", Arial, sans-serif; font-size: 17px !important; line-height: 1.5; margin: 0px; padding-bottom: 11.46875px;"><a href="https://www.gov.uk/government/consultations/isotretinoin-call-for-information-to-be-considered-as-part-of-an-expert-review" style="color: #0066cc; text-decoration: none;" target="_blank">https://www.gov.uk/government/consultations/isotretinoin-call-for-information-to-be-considered-as-part-of-an-expert-review</a> </p>Adverse Reactions APRILcharity bloghttp://www.blogger.com/profile/10938026980225981583noreply@blogger.com0tag:blogger.com,1999:blog-539198936050146545.post-41207004335235651512020-06-29T08:51:00.005-07:002020-06-29T08:55:57.990-07:00Benzo Belle is about preventing Harm from Medicines by Calista Cazuko Calista Cazuko is a remarkable young and lovely singer songwriter. <div>Her first meeting with me (Millie) was when I was thinking of having piano lessons and</div><div>we both lived near a piano shop.</div><div><br /></div><div>So from music we got on to the subject of medicines, in particular Dianette.</div><div>Hear what Calista says about the years (contrary to the licensing) she took this acne drug as a contraceptive pill.</div><div><br /></div><div>The blog post is so delightful to listen to and has some very good advice both from Calista and from her </div><div>guest Melanie Davis. Melanie use to work with MIND and she talks about her project to help people with their benzodiazepine issues, either to reduce or withdraw. </div><div><br /></div><div>Many support activities involving music were set up for the victims of Benzo addiction. Many were unaware the drugs cause dependence.</div><div><br /></div><div>So please listen to the latest blog "Benzo Belle"and there are links on the page too. This is part of the Empress Diaries project. <a href="https://empressdiaries.buzzsprout.com">https://empressdiaries.buzzsprout.com</a></div><div><br /></div><div><br /></div>Adverse Reactions APRILcharity bloghttp://www.blogger.com/profile/10938026980225981583noreply@blogger.com0tag:blogger.com,1999:blog-539198936050146545.post-56884023685186113922020-06-29T08:25:00.001-07:002020-06-29T08:30:59.733-07:00Analysis of FDA Antidepressant suicide risk in RCTrials<div><br /></div><div><br /></div>New Generation_Antidepressants_and_Suicide_Risk_in_Randomized_Controlled_Trials_A_Re-Analysis_of_the_FDA_Databaseer-<div><br /></div><div>The full paper is available from the link <a href="https://www.karger.com/Article/FullText/501215" target="_blank">https://www.karger.com/Article/FullText/501215</a></div><div><br /></div><div>Or google as it is freely available.</div>Adverse Reactions APRILcharity bloghttp://www.blogger.com/profile/10938026980225981583noreply@blogger.com0tag:blogger.com,1999:blog-539198936050146545.post-44266829992207287672019-06-12T09:53:00.000-07:002019-06-12T09:56:55.688-07:00Antidepressants withdrawal effects<!--[if gte mso 9]><xml>
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<b style="mso-bidi-font-weight: normal;">AVOIDABLE DEATHS DUE
TO MEDICINES ADVERSE SIDE-EFFECTS AND WITHDRAWAL REACTIONS.</b></div>
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<br /></div>
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<b style="mso-bidi-font-weight: normal;">May 2019</b></div>
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<b style="mso-bidi-font-weight: normal;"> </b>The UK <b>Royal College of
Psychiatrists</b> have finally agreed, after years of denial.</div>
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Withdrawal from antidepressants and benzodiazepine drugs at
last being recognised as sometimes causing serious adverse effects<span style="mso-spacerun: yes;"> </span>harming many people.</div>
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<br /></div>
<b>National clinical guidelines are currently being updated</b>.<br />
<br />
Wendy Burn, president of the Royal College of Psychiatrists, said she wanted
to see the guidelines "more in keeping with what we're hearing from some
patients - and GPs - about the range of experiences of coming off
antidepressants".<br />
<br />
The number of prescriptions for antidepressants in the UK nearly doubled
between 2007 and 2017, from around 40 million to more than 82 million, <a href="https://www.rcpsych.ac.uk/improving-care/campaigning-for-better-mental-health-policy/position-statements/position-statements-2019">a
report by the College shows.</a><br />
<br />
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The Royal College of Psychiatrists now accepts that it has <a data-link-name="in body link" href="https://www.bbc.co.uk/news/health-48457980" title="">not paid enough attention</a> to patients
suffering from severe withdrawal symptoms when coming off antidepressants.</div>
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<br /></div>
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The new stance by the Royal College follows a <a data-link-name="in body link" href="https://www.thelancet.com/journals/lanpsy/article/PIIS2215-0366(19)30032-X/fulltext?fbclid=IwAR1eBoF7LwWyOD9Nq6IWDk9-CY77GkDA1wjgLZae2TxCWxc_UMdTMpH8Nq4" title="">Lancet Psychiatry paper</a> co-authored
by David Taylor, the director of pharmacy and pathology at the Maudsley
Hospital in London, who has himself experienced withdrawal, describing it in a
recent <a data-link-name="in body link" href="https://www.newyorker.com/magazine/2019/04/08/the-challenge-of-going-off-psychiatric-drugs" title="">New Yorker article</a> as a “strange and
frightening and torturous” experience that lasted six weeks. “Although the
withdrawal syndrome can be differentiated from recurrence of the underlying
disorder, it might also be mistaken for recurrence, leading to long-term
unnecessary medication,” reads the paper.</div>
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<br /></div>
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Despite current guidelines
recommending a taper of two to four weeks, “tapers over a period of months and down
to doses much lower than minimum therapeutic doses have shown greater success
in reducing withdrawal symptoms”.</div>
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<br /></div>
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Back in 2014 APRIL_charity was contacted by a desperate
relative, trying to convince the psychiatrists it was withdrawal causing the
problems. The psychiatrists only wanted to prescribe more and more medication.</div>
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They told us:</div>
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<i style="mso-bidi-font-style: normal;">“I was saying that it was a result of withdrawal in the end it slightly
registered but they will only treat on the basis of diagnosis and relapse and
it's always more medication. I think you're right it is the way they are
trained. You're website is really helpful and a gem to find when such
information is so valuable and rare. Thanks once again for taking the time out
of your busy day and I will continue to visit your site and support where I
can.”</i></div>
</div>
<div class="MsoNoSpacing">
<br /></div>
<div class="MsoNoSpacing">
<br /></div>
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<br /></div>
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<span style="font-size: 12.0pt;">In 2018 the headline in
the British Medical Journal was:</span></div>
<div style="border-top: none; border: solid windowtext 1.0pt; mso-border-bottom-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-right-alt: solid windowtext .5pt; mso-element: para-border-div; padding: 0cm 4.0pt 1.0pt 4.0pt;">
<h1 style="border: none; mso-border-bottom-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-right-alt: solid windowtext .5pt; mso-padding-alt: 0cm 4.0pt 1.0pt 4.0pt; padding: 0cm;">
<i><span lang="EN" style="font-size: 20.0pt; mso-ansi-language: EN;">Government must investigate rising excess deaths in
England and Wales, experts warn</span></i><span style="font-size: 20.0pt;"></span></h1>
<div class="MsoNormal" style="border: none; mso-border-bottom-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-right-alt: solid windowtext .5pt; mso-padding-alt: 0cm 4.0pt 1.0pt 4.0pt; padding: 0cm;">
<span class="highwire-cite-journal"><i><span lang="EN" style="mso-ansi-language: EN;">BMJ</span></i></span><cite><span lang="EN" style="font-family: "calibri" , "sans-serif"; mso-ansi-language: EN; mso-ascii-theme-font: minor-latin; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi; mso-hansi-theme-font: minor-latin;"> </span></cite><span class="highwire-cite-published-year"><i><span lang="EN" style="mso-ansi-language: EN;">2018</span></i></span><cite><span lang="EN" style="font-family: "calibri" , "sans-serif"; mso-ansi-language: EN; mso-ascii-theme-font: minor-latin; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi; mso-hansi-theme-font: minor-latin;">; </span></cite><span class="highwire-cite-volume-issue"><i><span lang="EN" style="mso-ansi-language: EN;">361</span></i></span><cite><span lang="EN" style="font-family: "calibri" , "sans-serif"; mso-ansi-language: EN; mso-ascii-theme-font: minor-latin; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi; mso-hansi-theme-font: minor-latin;"> </span></cite><span class="highwire-cite-doi"><i><span lang="EN" style="mso-ansi-language: EN;">doi: <a href="https://doi.org/10.1136/bmj.k2127">https://doi.org/10.1136/bmj.k2127</a></span></i></span><cite><span lang="EN" style="font-family: "calibri" , "sans-serif"; mso-ansi-language: EN; mso-ascii-theme-font: minor-latin; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi; mso-hansi-theme-font: minor-latin;"> </span></cite><span class="highwire-cite-date"><i><span lang="EN" style="mso-ansi-language: EN;">(Published
11 May 2018)</span></i></span><cite><span lang="EN" style="font-family: "calibri" , "sans-serif"; mso-ansi-language: EN; mso-ascii-theme-font: minor-latin; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi; mso-hansi-theme-font: minor-latin;"> </span></cite><span class="highwire-cite-article-as"><i><span lang="EN" style="mso-ansi-language: EN;">Cite
this as: </span></i></span><span class="italic"><i><span lang="EN" style="mso-ansi-language: EN;">BMJ</span></i></span><span class="highwire-cite-article-as"><i><span lang="EN" style="mso-ansi-language: EN;">
2018;361:k2127 </span></i></span></div>
<div style="border: none; mso-border-bottom-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-right-alt: solid windowtext .5pt; mso-padding-alt: 0cm 4.0pt 1.0pt 4.0pt; padding: 0cm;">
<span lang="EN" style="mso-ansi-language: EN;">Research experts have urged the government and MPs to investigate rising
numbers of deaths in England
and Wales,
after new figures showed over 20 000 “excess deaths” so far in 2018.</span></div>
<div style="border: none; mso-border-bottom-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-right-alt: solid windowtext .5pt; mso-padding-alt: 0cm 4.0pt 1.0pt 4.0pt; padding: 0cm;">
<span lang="EN" style="mso-ansi-language: EN;">Earlier this year an analysis of the Office for National Statistics’ data
on weekly provisional deaths in England
and Wales,
published in <i>The BMJ</i>,<span class="xref-bibr">1</span> found that by week
seven of 2018 (ending 16 February) 10 000 more people had died than the average
from the past five years.</span></div>
</div>
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<br /></div>
Adverse Reactions APRILcharity bloghttp://www.blogger.com/profile/10938026980225981583noreply@blogger.com1tag:blogger.com,1999:blog-539198936050146545.post-72364685048439169022019-04-27T01:32:00.002-07:002019-04-27T01:37:06.136-07:00Doctors in the dark about how medicines workDo Doctors have to prove they know how drugs work and can recognise Adverse Drug Reactions (ADRs) before - or even after they qualify?<br />
<br />
The newly established Prescribing Safetly Assessment has been available for medical students across the UK only for the past 3 years.<br />
<a href="https://www.medschools.ac.uk/our-work/assessment/prescribing-safety-assessment">https://www.medschools.ac.uk/our-work/assessment/prescribing-safety-assessment</a><br />
<br />
This is a step forward and follows the campaign 19 years ago, we participated in to persuade the General Medical Council (GMC) to re- introduce Clinical Pharmacology into the medical schools curriculum for medical education, as in the GMC guidline manual called ' Tomorrow's Doctors'.<br />
<br />
The subject of Clinical Pharmacology and Therapeutics had been withdrawn as an essential subject for medical students in the early 90's due to the GMC preferring 'Integrated Medicine'. As one Medical Consultant friend said to me " They will learn as the coffins are driven past the surgery windows!".Adverse Reactions APRILcharity bloghttp://www.blogger.com/profile/10938026980225981583noreply@blogger.com1tag:blogger.com,1999:blog-539198936050146545.post-29222410760014279122018-07-17T12:55:00.000-07:002018-07-17T12:57:03.334-07:00Many U.S. adults take medicines that can cause depression<br />
<h1 style="background: white; margin: 18pt 0cm 0.67em;">
<span lang="EN" style="color: #3f3f40; font-family: "arial"; font-size: 14pt;"><a href="https://abcnews.go.com/GMA/Wellness/american-adults-prescription-drugs-depression-study/story?id=55846725" target="_blank">Many U.S. adults take medicines that can cause depression</a></span></h1>
<h1 style="background: white; margin: 18pt 0cm 0.67em;">
<span lang="EN" style="color: #3f3f40; font-family: "arial"; font-size: 14pt;"><a href="https://jamanetwork.com/journals/jama/article-abstract/2684607" target="_blank">Details of study in Journal of American Medical Association</a> June 2018 repeats what we at APRIL have been warning for the past 20 years.<o:p></o:p></span></h1>
<span lang="EN" style="font-family: "arial"; mso-ansi-language: EN;">The researchers, from the <st1:placetype w:st="on">University</st1:placetype> of <st1:placename w:st="on">Illinois</st1:placename>
at <st1:city w:st="on"><st1:place w:st="on">Chicago</st1:place></st1:city>,
looked at how more than 26,000 people from 2005 to 2014 used medications.</span><br />
<span lang="EN" style="font-family: "arial"; mso-ansi-language: EN;"></span><br />
<span lang="EN" style="font-family: "arial"; mso-ansi-language: EN;">They found one third of Americans at risk of depression as a potential adverse effect. The medicines include those for acid reflux, birth control, allergies, high blood pressure, and we know of course drugs for acne and anti-malarial are also high risk for possibly causing depression and suicidal thoughts and actions..</span><br />
<span lang="EN" style="font-family: "arial"; mso-ansi-language: EN;"></span><br />
The news of this study spread through the world but for some reason not picked up in the UK as far as we know. There is a video of interview with a doctor on ABC news<br />
<h1 style="background: white; margin: 18pt 0cm 0.67em;">
<span lang="EN" style="color: #3f3f40; font-family: "arial"; font-size: 14pt;"><a href="https://abcnews.go.com/GMA/Wellness/american-adults-prescription-drugs-depression-study/story?id=55846725"><span style="color: blue;">https://abcnews.go.com/GMA/Wellness/american-adults-prescription-drugs-depression-study/story?id=55846725</span></a><o:p></o:p></span></h1>
Adverse Reactions APRILcharity bloghttp://www.blogger.com/profile/10938026980225981583noreply@blogger.com1tag:blogger.com,1999:blog-539198936050146545.post-56095640877373402492018-01-19T10:21:00.000-08:002018-01-19T10:21:09.558-08:00Regulation of medicines safetyAn excellent talk by Professor John Abraham is well worth listening to<br />
<br />
<a href="https://www.youtube.com/watch?v=0qBd4KRbXNc">https://www.youtube.com/watch?v=0qBd4KRbXNc</a><br />
<br />
Please also sign up to receive notification of new blog posts, you will not be inundated with<br />
emails from us. We do not share this information with any other organisation.<br />
Adverse Reactions APRILcharity bloghttp://www.blogger.com/profile/10938026980225981583noreply@blogger.com0tag:blogger.com,1999:blog-539198936050146545.post-84502481718480362332017-10-23T05:06:00.000-07:002017-10-23T05:06:12.240-07:00Keep your own medical records
<br />
<h1 style="margin: 0.67em 0cm;">
<i><span lang="EN" style="mso-ansi-language: EN;">NHS boss reveals loss of
further 162 000 pieces of medical correspondence</span></i></h1>
<br />
<div class="MsoNormal" style="margin: 0cm 0cm 0pt;">
<span class="highwire-cite-journal"><i><span lang="EN" style="mso-ansi-language: EN;">BMJ</span></i></span><cite><span lang="EN" style="mso-ansi-language: EN;"> </span></cite><span class="highwire-cite-published-year"><i><span lang="EN" style="mso-ansi-language: EN;">2017</span></i></span><cite><span lang="EN" style="mso-ansi-language: EN;">; </span></cite><span class="highwire-cite-volume-issue"><i><span lang="EN" style="mso-ansi-language: EN;">359</span></i></span><cite><span lang="EN" style="mso-ansi-language: EN;"> </span></cite><span class="highwire-cite-doi"><i><span lang="EN" style="mso-ansi-language: EN;">doi: <a href="https://doi.org/10.1136/bmj.j4822"><span style="color: blue;">https://doi.org/10.1136/bmj.j4822</span></a></span></i></span><cite><span lang="EN" style="mso-ansi-language: EN;"> </span></cite><span class="highwire-cite-date"><i><span lang="EN" style="mso-ansi-language: EN;">(Published
17 October 2017)</span></i></span><cite><span lang="EN" style="mso-ansi-language: EN;"> </span></cite><span class="highwire-cite-article-as"><i><span lang="EN" style="mso-ansi-language: EN;">Cite this as: </span></i></span><span class="italic"><i><span lang="EN" style="mso-ansi-language: EN;">BMJ</span></i></span><span class="highwire-cite-article-as"><i><span lang="EN" style="mso-ansi-language: EN;">
2017;359:j4822 </span></i></span><span lang="EN" style="mso-ansi-language: EN;"><o:p></o:p></span></div>
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<!--[if !supportLists]--><b><span lang="EN" style="mso-ansi-language: EN;"><span style="mso-list: Ignore;">1.<span style="font-size-adjust: none; font-stretch: normal; font: 7pt/normal "Times New Roman";">
</span></span></span></b><!--[endif]--><span class="name"><b><span lang="EN" style="mso-ansi-language: EN;">Gareth Iacobucci</span></b></span><b><span lang="EN" style="mso-ansi-language: EN;"><o:p></o:p></span></b></div>
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<address style="display: none; margin-left: 36pt; mso-list: l0 level1 lfo2; tab-stops: list 36.0pt; text-indent: -18pt;">
<!--[if !supportLists]--><span lang="EN" style="display: none; mso-ansi-language: EN; mso-hide: all;"><span style="mso-list: Ignore;">1.</span></span><!--[endif]--><em><span lang="EN" style="display: none; mso-ansi-language: EN; mso-hide: all;">The BMJ</span></em><span lang="EN" style="display: none; mso-ansi-language: EN; mso-hide: all;"><o:p></o:p></span></address>
<br />
<span lang="EN" style="mso-ansi-language: EN;">The loss of more than 700 000
items of NHS clinical correspondence, reported earlier this year, has been compounded after officials admitted that a
further 162 000 patient files went missing over five years.<o:p></o:p></span><br />
<span lang="EN" style="font-family: "Times New Roman"; font-size: 12pt; mso-ansi-language: EN; mso-bidi-language: AR-SA; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-GB;">The scandal first emerged in March 2016, when it was discovered that
hundreds of thousands of files, including test results and diagnoses, were
misplaced between 2011 and 2016 before they were delivered to hospitals and GPs
in England by NHS Shared Business Services, an agency co-owned by the
Department of Health and the IT company Sopra Steria. In June this year a
National Audit Office inquiry identified around 1700 cases where patients could
have been harmed as a result </span>Adverse Reactions APRILcharity bloghttp://www.blogger.com/profile/10938026980225981583noreply@blogger.com1tag:blogger.com,1999:blog-539198936050146545.post-3637003624422069862017-09-27T10:10:00.006-07:002017-09-29T04:44:14.897-07:00APRIL charity web site now back on line at www.april.org.uk<br />
<strong><span style="font-size: large;">APRIL - Adverse Psychiatric Reactions Information Link</span></strong><br />
<br />
<br />
<span style="font-size: x-large;"><strong>Our web site is back on line now click here to access </strong></span> <strong><u><span style="color: #0066cc; font-size: x-large;"><a href="http://www.april.org.uk/">www.april.org.uk</a> </span></u></strong><span style="font-size: large;">for information about many medicines linked to neuro-psychiatric adverse reactions, support groups, articles, videos of doctor's advice, personal experiences and much more.</span><br />
<strong><u><br /></u></strong>
<strong><i>If you previously found the url <a href="http://www.april.org.uk/">www.april.org.uk</a> redirected you to this blog site, that was just during the time the new web site was being created. You may need to 'clear Internet History' to access the new web site.</i></strong><br />
<strong><u><br /></u></strong><strong>Please continue reviewing this <a href="https://aprilcharity.blogspot.co.uk/" target="_blank">APRIL charity blog</a> from time to time for updates on latest research or news by inserting</strong><b> <a href="https://aprilcharity.blogspot.co.uk/">https://aprilcharity.blogspot.co.uk</a> </b>into the url box.<br />
<br />
<span style="font-size: large;"><b>Our new web site at </b><a href="http://www.april.org.uk/" style="font-weight: bold;">www.april.org.uk</a> will continue being updated with content, so please refer back on a regular basis for added content. </span><br />
<strong></strong><br />
<strong>
<span style="font-size: large;">Adverse Drug Reactions (ADRs) and withdrawal effects changing mood and behaviour, need to be studied and understood.</span></strong><br />
<br />
<span style="font-size: large;">We hope the information will be valuable for doctors and prescribers and those of us who rely on them to stay well.</span><br />
<span style="font-size: large;"></span><br />
<span style="font-size: large;">Informed choice is the key, as awareness saves lives.</span><br />
<br />
<span style="font-size: large;"></span>
<span style="font-size: large;"> How many more stories like the </span><a href="https://www.theguardian.com/society/2017/sep/26/sodium-valproate-birth-defect-risks-known-40-years-ago-campaigners" target="_blank"><span style="font-size: large;"><strong>Sodium Valproate</strong></span></a><span style="font-size: large;"> tragedy, of harm from medicines, will we have to hear before the medical profession have the kind of education we believe they are deprived of? Not only were women not informed, some prescribers played down the risks. </span><br />
<span style="font-size: large;"><br /></span>
<span style="font-size: large;">We all have a right to know about even so called rare adverse drug reactions (ADRs) . Who knows how rare, when less than 10% of serious ADRs are reported? (MHRA statistic)</span><br />
<span style="font-size: large;"></span><br />
<span style="font-size: large;">The warnings are often overlooked by prescribers and informed choice denied to patients. The voices of those who suffer, or are bereaved, often fall on deaf ears.</span><br />
<br />
<h3>
<span style="font-size: large;"> APRIL, the charity that believes Awareness Saves Lives</span></h3>
posted by Millie Kieve<br />
<a href="http://www.april.org.uk/" target="_blank">www.april.org.uk</a><a href="http://www.april.org.uk/" target="_blank">www.april.org.uk</a>Adverse Reactions APRILcharity bloghttp://www.blogger.com/profile/10938026980225981583noreply@blogger.com0tag:blogger.com,1999:blog-539198936050146545.post-92065481142207178952017-05-31T15:16:00.002-07:002017-05-31T15:19:15.321-07:00Please donate to APRIL the charity acting on behalf of victims of adverse drug reactions<br />
<br />
Please donate to help APRIL as we rely on supporters, friends and family<br />
to continue our efforts to improve patient safety. <a href="http://www.charitychoice.co.uk/april" target="_blank">http://www.charitychoice.co.uk/april</a>Adverse Reactions APRILcharity bloghttp://www.blogger.com/profile/10938026980225981583noreply@blogger.com0tag:blogger.com,1999:blog-539198936050146545.post-63554986598331312852017-05-08T07:29:00.002-07:002017-05-08T07:41:03.008-07:00Another tragic suicide linked to acne drug Roaccutane<a href="http://www.eadt.co.uk/news/our-happy-go-lucky-luke-changed-after-taking-acne-drug-colchester-family-say-after-son-s-suicide-1-5005927" target="_blank">http://www.eadt.co.uk/news/our-happy-go-lucky-luke-changed-after-taking-acne-drug-colchester-family-say-after-son-s-suicide-1-5005927</a><br />
<br />
The tragic suicide in May 2017 of 21 year old Luke Reeves is so sad and one wonders if the consultant who prescribed the drug Roaccutane (isotretinoin) was taken in by the manufacturer's claim that suicides linked to the drug are 'rare'. The need to monitor patients on some drugs know to have psychiatric adverse effects is often not followed.<br />
<br />
isotretinoin called Accutane in the USA and Roaccutane in the UK is a drug derived from Vitamin A with known serious adverse side effects, works for some people to reduce their acne - but for others it can lead to tragic ill health, long term depression and in some cases suicide.<br />
<br />
I just sent the following information to a journalist:<br />
<br />
<div class="MsoNormal">
<span style="font-family: "arial"; font-size: x-small;"><span style="font-family: "arial"; font-size: 10pt;">My main comment is that parents
should look a the pharmaceutical company data sheet</span></span></div>
<div class="MsoNormal">
<span style="font-family: "arial"; font-size: x-small;"><span style="font-family: "arial"; font-size: 10pt;"><a href="http://www.medicines.org.uk/emc/medicine/32477" title="blocked::http://www.medicines.org.uk/emc/medicine/32477"><span style="color: blue;">http://www.medicines.org.uk/emc/medicine/32477</span></a><o:p></o:p></span></span></div>
<br />
<div class="MsoNormal">
<span style="font-family: "arial"; font-size: x-small;"><span style="font-family: "arial"; font-size: 10pt;"> which
states under the heading</span></span><br />
<span style="font-family: "arial"; font-size: x-small;"><span style="font-family: "arial"; font-size: 10pt;"> <span style="font-family: "times new roman"; font-size: small;"><strong>4.4 Special warnings and precautions for use:</strong></span></span></span></div>
<br />
<table border="1" cellpadding="0" cellspacing="0" class="MsoTableGrid" style="border-collapse: collapse; border: currentColor;">
<tbody>
<tr>
<td style="border: 1pt solid windowtext; padding: 0cm 5.4pt; width: 426.1pt;" valign="top" width="710"><div class="MsoNormal" style="background: white;">
<b><i><span style="color: black; font-family: "arial"; font-size: x-small;"><span lang="EN" style="color: black; font-family: "arial"; font-size: 10.5pt; font-style: italic; font-weight: bold;">Psychiatric
disorders</span></span></i></b><b><span style="color: black; font-family: "arial"; font-size: x-small;"><span lang="EN" style="color: black; font-family: "arial"; font-size: 10.5pt; font-weight: bold;">
</span></span></b><span style="color: black; font-family: "arial"; font-size: x-small;"><span lang="EN" style="color: black; font-family: "arial"; font-size: 10.5pt;"><o:p></o:p></span></span></div>
</td></tr>
<tr>
<td style="border-color: currentColor windowtext windowtext; border-style: none solid solid; border-width: medium 1pt 1pt; padding: 0cm 5.4pt; width: 426.1pt;" valign="top" width="710"><div class="MsoNormal" style="background: white;">
<span style="color: black; font-family: "arial"; font-size: x-small;"><span lang="EN" style="color: black; font-family: "arial"; font-size: 10.5pt;">Depression,
depression aggravated, anxiety, aggressive tendencies, mood alterations,
psychotic symptoms, and very rarely, suicidal ideation, suicide attempts and
suicide have been reported in patients treated with isotretinoin (see section
4.8). Particular care needs to be taken in patients with a history of depression
and all patients should be monitored for signs of depression and referred for
appropriate treatment if necessary. However, discontinuation of isotretinoin may
be insufficient to alleviate symptoms and therefore further psychiatric or
psychological evaluation may be
necessary<o:p></o:p></span></span></div>
</td></tr>
</tbody></table>
<br />
<div class="MsoNormal">
<span style="font-family: "arial"; font-size: x-small;"><span style="font-family: "arial"; font-size: 10pt;">And further, what they
found in the original clinical trials is nothing to go by as the clinical trials can be rigged (talks on
APRIL’ Vimeo site by Dr BenGoldacre <a href="https://vimeo.com/15986864">https://vimeo.com/15986864</a></span></span></div>
<div class="MsoNormal">
<span style="font-family: "arial"; font-size: x-small;"><span style="font-family: "arial"; font-size: 10pt;"></span></span> </div>
<div class="MsoNormal">
<span style="font-family: "arial"; font-size: x-small;"><span style="font-family: "arial"; font-size: 10pt;">and Prof David Healy explain how this is
done! Even if they reccon 1 in 10,000 dies by suicide how many millions are
given the drug and how many hundred or thousands of families lose their lovely
kids. – oh and the MHRA admit less than 10% of serious ADRs (Adverse drug
reactions) are reported!</span></span></div>
<br />
The data sheet also contains the following information for istotretinoin /Ro-Accutane under the heading: <br />
<br />
<strong>4.8 Undesirable effects</strong><br />
<strong></strong><br />
<table border="1" cellpadding="0" cellspacing="0" class="MsoNormalTable" style="border-collapse: collapse; width: 691px;">
<tbody>
<tr>
<td style="padding: 1.2pt; width: 37%;" valign="top" width="37%"><div class="MsoNormal">
<i><span style="color: black; font-family: "arial"; font-size: x-small;"><span style="color: black; font-family: "arial"; font-size: 10.5pt; font-style: italic;">Psychiatric
disorders:</span></span></i><span style="color: black; font-family: "arial"; font-size: x-small;"><span style="color: black; font-family: "arial"; font-size: 10.5pt;">
<o:p></o:p></span></span></div>
<div class="MsoNormal">
<span style="color: black; font-family: "arial"; font-size: x-small;"><span style="color: black; font-family: "arial"; font-size: 10.5pt;">Rare (≥ 1/10
000,<1 o:p=""></1></span></span></div>
</td></tr>
</tbody></table>
<div class="MsoNormal">
<span style="color: black; font-family: "arial"; font-size: x-small;"><span style="color: black; font-family: "arial"; font-size: 10.5pt;">Very Rare (≤ 1/10
000)<o:p></o:p></span></span></div>
<div class="MsoNormal">
<span style="color: black; font-family: "arial"; font-size: x-small;"><span style="color: black; font-family: "arial"; font-size: 10.5pt;">Depression,
depression aggravated, aggressive tendencies, anxiety, mood
alterations<o:p></o:p></span></span></div>
<div class="MsoNormal">
<span style="color: black; font-family: "arial"; font-size: x-small;"><span style="color: black; font-family: "arial"; font-size: 10.5pt;">Abnormal behaviour,
psychotic disorder, suicidal ideation, suicide attempt,
suicide<o:p></o:p></span></span></div>
<div class="MsoNormal">
<i><span style="color: black; font-family: "arial"; font-size: x-small;"><span style="color: black; font-family: "arial"; font-size: 10.5pt; font-style: italic;">Nervous
system disorders:</span></span></i><span style="color: black; font-family: "arial"; font-size: x-small;"><span style="color: black; font-family: "arial"; font-size: 10.5pt;">
<o:p></o:p></span></span></div>
<div class="MsoNormal">
<span style="color: black; font-family: "arial"; font-size: x-small;"><span style="color: black; font-family: "arial"; font-size: 10.5pt;">Common (≥1/100,
<1 o:p=""></1></span></span></div>
<br />
<div class="MsoNormal">
<span style="color: black; font-family: "arial"; font-size: x-small;"><span style="color: black; font-family: "arial"; font-size: 10.5pt;">Very Rare (≤ 1/10
000)<o:p></o:p></span></span></div>
<div class="MsoNormal">
<span style="color: black; font-family: "arial"; font-size: x-small;"><span style="color: black; font-family: "arial"; font-size: 10.5pt;">Headache<o:p></o:p></span></span></div>
<div class="MsoNormal">
<span style="color: black; font-family: "arial"; font-size: x-small;"><span style="color: black; font-family: "arial"; font-size: 10.5pt;">Benign intracranial
hypertension, convulsions, drowsiness,
dizziness</span></span><br />
<span style="color: black; font-family: "arial"; font-size: x-small;"><span style="color: black; font-family: "arial"; font-size: 10.5pt;"></span></span><br />
<a name='more'></a><span style="color: black; font-family: "arial"; font-size: x-small;"><span style="color: black; font-family: "arial"; font-size: 10.5pt;"><o:p></o:p></span></span><br /></div>
<br />
<br />
<div class="MsoNormal">
<span style="font-family: "arial"; font-size: x-small;"><span style="font-family: "arial"; font-size: 10pt;">Another tragedy I know of and was at
the inquest for was Angela Lee – no report was put in about the drugs as the
Coroner said she jumped under a train. I sat next to the driver who told the
jury Angela ‘staggered and fell’<o:p></o:p></span></span></div>
<br />
<div class="MsoNormal">
<span style="font-family: "arial"; font-size: x-small;"><span style="font-family: "arial"; font-size: 10pt;">The poor girl was convinced
Roaccutane had destroyed her skin but was put on another 3 drugs linked to
suicide and none of her doctors had communicated with each other onhow to
protect a vulnerable girl…her brother had contacted me 3 months prior to her
tragic death and I warned him of the risk of suicide not knowing she was also on
Prozac, Zopiclone and Dianette – Dianette being a drug I have spent years
campaigning about.</span></span></div>
<br />
<div class="MsoNormal">
<span style="font-family: "arial"; font-size: x-small;"><span style="font-family: "arial"; font-size: 10pt;">Important to note in the
manufacturers data sheet they state stopping the drug may not alleviate symptoms
as many of the suicides happen after the drug is stopped. Could this be like the
antidepressants another drug with serious withdrawal
complications?</span></span></div>
<div class="MsoNormal">
<span style="font-family: "arial"; font-size: x-small;"><span style="font-family: "arial"; font-size: 10pt;"><o:p></o:p></span></span> </div>
<u>This information below will appear on the new APRIL web site which is still being edited:</u><br />
<br />
<table border="0" cellpadding="0" cellspacing="0" class="MsoNormalTable" style="width: 100%px;">
<tbody>
<tr>
<td style="padding: 0cm;" valign="top"><strong><b><span style="font-family: "times new roman"; font-size: large;">Roaccutane </span></b></strong><span style="color: black; font-family: "open sans";"><span style="color: black; font-family: "open sans";"><o:p></o:p></span></span><br />
<span style="font-size: large;">
</span><strong><b><span style="font-family: "times new roman"; font-size: large;">Also known as Accutane Sotoret Amnesteem
Claravis</span></b></strong><o:p></o:p><br />
<span style="font-size: large;">
</span><strong><b><span style="font-family: "times new roman"; font-size: small;"><span style="font-size: large;">Active ingredient isotretinoin</span> </span></b></strong><br />
<strong><b><span style="font-family: "times new roman"; font-size: small;">
</span></b></strong><o:p></o:p><br />
<strong><b><span style="font-family: "times new roman"; font-size: small;"><span style="font-size: 12pt;">Indication:</span></span></b></strong><br />
Severe forms
of acne (such as nodular or conglobate acne or acne at risk of permanent
scarring) resistant to adequate courses of standard therapy with systemic
antibacterials and topical therapy.<o:p></o:p><br />
<strong><b><span style="font-family: "times new roman"; font-size: small;"><span style="font-size: 12pt;">Our mission</span></span></b></strong><o:p></o:p><br />
<span style="font-family: "times new roman"; font-size: small;"><span style="font-size: 12pt;">Roaccutane
is a treatment for acne that can cause serious psychiatric side effects, such as
depression and suicidal ideation. APRIL would like all patients, and ideally
their families, to be aware of the severe nature of these side effects before
choosing or whilst taking this medication.<o:p></o:p></span></span><br />
<span style="font-family: "times new roman"; font-size: small;"><span style="font-size: 12pt;">APRIL has
been informed of many cases from people who are suffering from long-term
neurological and psychological adverse effects, including suicide attempts,
apparently since taking roaccutane.<o:p></o:p></span></span><br />
<span style="font-family: "times new roman"; font-size: small;"><span style="font-size: 12pt;">This
article on David Healy’s Rxisk site blog discusses the history and extent of the
pharmaceutical industry protecting this drug’s
existence:<o:p></o:p></span></span><br />
<span style="font-family: "times new roman"; font-size: small;"><span style="font-size: 12pt;"><a href="https://rxisk.org/roche-and-the-perfect-circle/" title="blocked::https://rxisk.org/roche-and-the-perfect-circle/"><span style="color: blue;">https://rxisk.org/roche-and-the-perfect-circle/</span></a><o:p></o:p></span></span><br />
<b><span style="font-family: "times new roman"; font-size: small;"><span style="font-size: 12pt; font-weight: bold;"> </span></span></b><b><span style="font-size: medium;"><span style="font-size: 14pt; font-weight: bold;">“Dying to have clear
skin” is a BBC documentary on the extent of Roaccutane’s adverse effects on the
lives of its patients. Please watch it here:<o:p></o:p></span></span></b><br />
<b><span style="font-family: "times new roman"; font-size: medium;"><span style="font-size: 14pt; font-weight: bold;"><a href="https://www.youtube.com/watch?v=PgpYS33kMVc" title="blocked::https://www.youtube.com/watch?v=PgpYS33kMVc"><span style="color: blue;">https://www.youtube.com/watch?v=PgpYS33kMVc</span></a><o:p></o:p></span></span></b><br />
<span style="font-family: "times new roman"; font-size: small;"><span style="font-size: 12pt;">Please
watch the APRIL interview with Jon Medland speaking about his son, a medical
student, and his subsequent mood change and suicide whilst on Roaccutane for
acne: <a href="http://vimeo.com/groups/aprilcharity/videos/16759077" title="blocked::http://vimeo.com/groups/aprilcharity/videos/16759077"><span style="color: blue;">http://vimeo.com/groups/aprilcharity/videos/16759077</span></a><o:p></o:p></span></span><br />
<strong><b><span style="font-family: "times new roman"; font-size: small;"><span style="font-size: 12pt;">Psychiatric Side
Effects:</span></span></b></strong><o:p></o:p><br />
<span style="font-family: "times new roman"; font-size: small;"><span style="font-size: 12pt;">Depression,
depression aggravated, anxiety, aggressive tendencies, mood alterations,
psychotic symptoms, and very rarely, suicidal ideation, suicide attempts and
suicide have been reported in patients treated with isotretinoin (see section
4.8). Particular care needs to be taken in patients with a history of depression
and all patients should be monitored for signs of depression and referred for
appropriate treatment if necessary. However, discontinuation of isotretinoin may
be insufficient to alleviate symptoms and therefore further psychiatric or
psychological evaluation may be necessary.<o:p></o:p></span></span><br />
<span style="font-family: "times new roman"; font-size: small;"><span style="font-size: 12pt;"><a href="http://www.medicines.org.uk/emc/medicine/32486" title="blocked::http://www.medicines.org.uk/emc/medicine/32486"><span style="color: blue;">http://www.medicines.org.uk/emc/medicine/32486</span></a><o:p></o:p></span></span><br />
<span style="font-family: "times new roman"; font-size: small;"><span style="font-size: 12pt;">5% of all
reported ADRs to Roaccutane are psychiatric reactions including depression,
suicide and attempted suicide.<o:p></o:p></span></span><br />
<span style="font-family: "times new roman"; font-size: small;"><span style="font-size: 12pt;">Product
information for Roaccutane has been amended to strengthen warnings about
depression and the possibility of suicide. Doctors are advised to monitor
patients for signs of depression.<o:p></o:p></span></span><br />
<span style="font-family: "times new roman"; font-size: small;"><span style="font-size: 12pt;">Bereaved
father Liam Grant, was determined to take Roche to the High Court over the death
of his son, he believed was due to Roaccutane: <o:p></o:p></span></span><br />
<span style="font-family: "times new roman"; font-size: small;"><span style="font-size: 12pt;"><a href="http://www.independent.ie/irish-news/13-years-after-my-son-died-its-great-to-get-my-day-in-court-26663138.html" title="blocked::http://www.independent.ie/irish-news/13-years-after-my-son-died-its-great-to-get-my-day-in-court-26663138.html"><span style="color: blue;">http://www.independent.ie/irish-news/13-years-after-my-son-died-its-great-to-get-my-day-in-court-26663138.html</span></a></span></span><span style="font-family: "times new roman"; font-size: small;"><span style="font-size: 12pt;"><br /> <o:p></o:p></span></span><br />
<strong><b><span style="font-family: "times new roman"; font-size: small;"><span style="font-size: 12pt;">Patient Warnings and Advice
</span></span></b></strong><o:p></o:p><br />
<span style="font-family: "times new roman"; font-size: small;"><span style="font-size: 12pt;">All
patients treated with isotretinoin should be observed closely for symptoms of
depression or suicidal thoughts, such as sad mood, irritability, acting on
dangerous impulses, anger, loss of pleasure or interest in social or sports
activities, sleeping too much or too little, changes in weight or appetite,
school or work performance going down, or trouble concentrating, or for mood
disturbance, psychosis, or aggression.<o:p></o:p></span></span><br />
<span style="font-family: "times new roman"; font-size: small;"><span style="font-size: 12pt;">Patients
should stop isotretinoin and they or their caregiver should contact their
healthcare professional right away if the patient has any of the previously
mentioned symptoms. Discontinuation of treatment may be insufficient and further
evaluation may be necessary. [Action taken 08/12/05 Labeling
revision] <o:p></o:p></span></span><br />
<span style="font-family: "times new roman"; font-size: small;"><span style="font-size: 12pt;">Due to the
excellent research and publicity regarding Roaccutane, the Committee on Safety
of Medicines in their bulletin entitled Current Problems in Pharmacovigilance
Volume 24 August 1998, issued a warning to doctors headed Isotretinoin
(Roaccutane)<o:p></o:p></span></span><br />
<span style="font-family: "times new roman"; font-size: small;"><span style="font-size: 12pt;">"Product
information for Roaccutane has been amended to strengthen warnings about
depression and the possibility of suicide. Doctors are advised to monitor
patients for signs of depression"<o:p></o:p></span></span><br />
<span style="font-family: "times new roman"; font-size: small;"><span style="font-size: 12pt;">The results
of the above research will surely save lives – APRIL will raise funds to further
the excellent work which would not have taken place but for the support of a
bereaved parent.<o:p></o:p></span></span><br />
<span style="font-family: "times new roman"; font-size: small;"><span style="font-size: 12pt;">For the
latest research results see the Roaccutane Action web site <a href="http://www.accutaneaction.com/" title="blocked::http://www.accutaneaction.com/"><span style="color: blue;">www.accutaneaction.com</span></a><o:p></o:p></span></span><br />
<strong><b><span style="font-family: "times new roman"; font-size: small;"><span style="font-size: 12pt;">Evidence</span></span></b></strong> <strong><b><span style="font-family: "times new roman";">of side effects</span></b></strong><o:p></o:p><br />
<span style="font-family: "times new roman"; font-size: small;"><span style="font-size: 12pt;">The
<st1:country-region w:st="on"><st1:place w:st="on">UK</st1:place></st1:country-region> regulator is the Medicines and
Healthcare Products Regulatory Agency (MHRA) received 1,588 reports of suspected
adverse events experienced by people taking the drug between licensing in 1983
and September 2006. In 38 cases, people died and 25 of those were suicide. The
MHRA says the safety of Roaccutane is under constant scrutiny. In June last year
an expert working group recommended patients be monitored for signs of
depression.<o:p></o:p></span></span><br />
<strong><b><span style="font-family: "times new roman"; font-size: small;"><span style="font-size: 12pt;">Further
information</span></span></b></strong><o:p></o:p><br />
<span style="font-family: "times new roman"; font-size: small;"><span style="font-size: 12pt;"><a href="http://www.medicines.org.uk/EMC/searchresults.aspx?term=isotretinoin&searchtype=QuickSearch" title="blocked::http://www.medicines.org.uk/EMC/searchresults.aspx?term=isotretinoin&searchtype=QuickSearch"><span style="color: blue;">http://www.medicines.org.uk/EMC/searchresults.aspx?term=isotretinoin&searchtype=QuickSearch</span></a><o:p></o:p></span></span><br />
<span style="font-family: "times new roman"; font-size: small;"><span style="font-size: 12pt;">If you have
suffered a psychiatric adverse reaction please report them via the <a href="https://yellowcard.mhra.gov.uk/" title="blocked::https://yellowcard.mhra.gov.uk/"><span style="color: blue;">Yellow Card</span></a> in the
<st1:country-region w:st="on"><st1:place w:st="on">UK</st1:place></st1:country-region> or to the <a href="https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home" title="blocked::https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home"><span style="color: blue;">FDA</span></a><o:p></o:p></span></span></td></tr>
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Adverse Reactions APRILcharity bloghttp://www.blogger.com/profile/10938026980225981583noreply@blogger.com12tag:blogger.com,1999:blog-539198936050146545.post-55333148027750826892017-05-01T09:22:00.001-07:002017-05-01T09:22:32.802-07:00Clinical Trial Study 329 Ghostwritten by GSK - reanalysis of review of Seroxat Paxil<br />
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<b style="mso-bidi-font-weight: normal;"><u><span style="font-family: "verdana"; font-size: 10pt;">Restoring Study 329 - The study that disproved anti-depressants’ efficacy<o:p></o:p></span></u></b></div>
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<span style="font-family: "verdana"; font-size: 10pt;"><strong>A major reanalysis of the infamous clinical trial, Study 329, has shown Paroxetine (also known as Paxil or Seroxat), one of the most commonly prescribed antidepressants, to be unsafe and no more effective than a placebo.<o:p></o:p></strong></span></div>
<span style="font-family: "verdana"; font-size: 10pt;"><o:p></o:p></span><br />
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<span style="font-family: "verdana"; font-size: 10pt;">This new assessment directly contradicts the results of the clinical trial that claimed Seroxat to be “generally well tolerated and effective”, which was sponsored by and ghostwritten for GlaxoSmithKline, despite using the same original data. <o:p></o:p></span></div>
<span style="font-family: "verdana"; font-size: 10pt;"><o:p></o:p></span><br />
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<span style="font-family: "verdana"; font-size: 10pt;">The latest paper was published under the restoring invisible and abandoned trials (RIAT) initiative, in order to re-evaluate any conclusions drawn from evidence that had previously been hidden from public view. <o:p></o:p></span></div>
<span style="font-family: "verdana"; font-size: 10pt;"><o:p></o:p></span><br />
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<span style="font-family: "verdana"; font-size: 10pt;"><strong>Published in 2001, Study 329 generated a high level of controversy</strong> from patients and doctors after lawsuits were filed stating the side-effects were much more serious than those documented in the clinical trials.<o:p></o:p></span></div>
<span style="font-family: "verdana"; font-size: 10pt;"><o:p></o:p></span><br />
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<span style="font-family: "verdana"; font-size: 10pt;">Restoring Study 329, showed Paroxetine (Seroxat or Paxil) to have no significant reduction of depressive symptoms more than a placebo or previous anti-depressants, and gave users a higher chance of psychiatric side effects.<o:p></o:p></span></div>
<span style="font-family: "verdana"; font-size: 10pt;"><o:p></o:p></span><br />
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<span style="font-family: "verdana"; font-size: 10pt;"><strong>The original study came under intense scrutiny following revelations that it was ghost written by GSK authors and not those named on the study, and the primary data was not made publically available.</strong> </span></div>
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<span style="font-family: "verdana"; font-size: 10pt;">The findings of Study 329, originally published in 2001, was the first double blind patient study to report the efficacy of anti-depressants on adolescents. <o:p></o:p></span></div>
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<span style="font-family: "verdana"; font-size: 10pt;">It has allowed Seroxat to gain widespread approval by the healthcare industry, becoming the most widely prescribed anti-depressant in the <st1:country-region w:st="on"><st1:place w:st="on">US</st1:place></st1:country-region>, with over 14 billion dolllars worth of sales between 1997 and 2004. <o:p></o:p></span></div>
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<span style="font-family: "verdana"; font-size: 10pt;">Following a decade of public and legal pressure, GSK finally released the original data to the public, making its reanalysis possible. <o:p></o:p></span></div>
<span style="font-family: "verdana"; font-size: 10pt;"><o:p></o:p></span><br />
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<span style="font-family: "verdana"; font-size: 10pt;">These devastating results overturning the original paper may come as no surprise to many who have already suffered loss and harm from the drug. In<span style="mso-spacerun: yes;"> </span>2012 GSK were successfully sued $3 billion for fraudulently promoting Paroxetine to the public, and hiding key data in its study, such as reclassifying suicidal acts so that they would not count in the final analysis.<o:p></o:p></span></div>
<span style="font-family: "verdana"; font-size: 10pt;"><o:p></o:p></span><br />
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<span style="font-family: "verdana"; font-size: 10pt;">To this day however, GSK remain silent on the issue and continue to promote the drug to its customers, without any attempt to acknowledge the restoration of the study.<o:p></o:p></span></div>
<span style="font-family: "verdana"; font-size: 10pt;"><o:p></o:p></span><br />
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<b style="mso-bidi-font-weight: normal;"><i style="mso-bidi-font-style: normal;"><u><span style="font-family: "verdana"; font-size: 10pt;">A personal note to our readers:<o:p></o:p></span></u></i></b></div>
<b style="mso-bidi-font-weight: normal;"><i style="mso-bidi-font-style: normal;"><u><span style="font-family: "verdana"; font-size: 10pt;"><o:p><span style="text-decoration: none;"></span></o:p></span></u></i></b><br />
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<span style="font-family: "verdana"; font-size: 10pt;">As we reveal these facts about Seroxat, we do not wish to condemn all use of anti-depressants nor encourage the immediate withdrawal from the medication. <span style="mso-spacerun: yes;"> </span>It is important to obtain advice from responsible health professionals who can help to plan any reduction in drugs that may cause dependence. It is also important to inform those close to you when you plan to start, reduce or stop taking antidepressants and to obtain professional medical or support group assistance and advice. </span></div>
<span style="font-family: "verdana"; font-size: 10pt;"><o:p></o:p></span><br />
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<span style="font-family: "verdana"; font-size: 10pt;">We wish to highlight the potential dangers and risks of Paroxetine and similar medication, and let readers understand that medical information to support the drug can be unreliable or biased.<o:p></o:p></span></div>
<span style="font-family: "verdana"; font-size: 10pt;"><o:p></o:p></span><br />
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<span style="font-family: "verdana"; font-size: 10pt;">Both starting and coming off anti-depressants is a serious undertaking and we strongly advise that users seek professional medical help as well as inform either close friends or family when doing so, as it can be a tough process which needs careful monitoring and support.<o:p></o:p></span></div>
<span style="font-family: "verdana"; font-size: 10pt;"><o:p></o:p></span><br />
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<span style="font-family: "verdana"; font-size: 10pt;">Dealing with life events can cause anxiety but may not be depression. We recommend considering talking therapy, possible CBT- cognitive behavioural therapy for those who have access to these services, as these have been shown to provide beneficial reductions of depression and anxiety with fewer and less serious side effects.</span><br />
<span style="font-family: "verdana"; font-size: 10pt;"></span><br />
<span style="font-family: "verdana"; font-size: 10pt;">Specialised bereavement counselling is also of benefit as it is more difficult for some people to express grief when blocked by drug effects.</span></div>
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<span style="font-family: "verdana"; font-size: 10pt;">©JBforAPRIL<o:p></o:p></span></div>
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<span style="font-family: "verdana"; font-size: 10pt;"><o:p> </o:p></span></div>
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<a href="https://www.blogger.com/null" name="_GoBack"></a><b style="mso-bidi-font-weight: normal;"><span style="font-family: "verdana"; font-size: 10pt;">Further <st1:city w:st="on"><st1:place w:st="on">Reading</st1:place></st1:city> <o:p></o:p></span></b></div>
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<span style="font-family: "verdana"; font-size: 10pt;">Article on Study 329<o:p></o:p></span></div>
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<span style="font-family: "verdana"; font-size: 10pt;"><a href="https://www.theatlantic.com/health/archive/2015/09/paxil-safety-bmj-depression-suicide/406105/"><span style="color: blue; font-family: "times new roman";">https://www.theatlantic.com/health/archive/2015/09/paxil-safety-bmj-depression-suicide/406105/</span></a><o:p></o:p></span></div>
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<span style="font-family: "verdana"; font-size: 10pt;">British Medical Journal Analysis of Study 329 <o:p></o:p></span></div>
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<span style="font-family: "verdana"; font-size: 10pt;"><a href="http://www.bmj.com/content/bmj/351/bmj.h4629.full.pdf"><span style="color: blue; font-family: "times new roman";">http://www.bmj.com/content/bmj/351/bmj.h4629.full.pdf</span></a><o:p></o:p></span></div>
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<span style="font-family: "verdana"; font-size: 10pt;">David Healy’s website on the controversy of Study 329<o:p></o:p></span></div>
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<span style="font-family: "verdana"; font-size: 10pt;"><a href="https://study329.org/"><span style="color: blue; font-family: "times new roman";">https://study329.org/</span></a><o:p></o:p></span></div>
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<span style="font-family: "verdana"; font-size: 10pt;">Restored Study 329 <o:p></o:p></span></div>
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<span style="font-family: "verdana"; font-size: 10pt;"><a href="http://www.bmj.com/content/351/bmj.h4320"><span style="color: blue; font-family: "times new roman";">http://www.bmj.com/content/351/bmj.h4320</span></a><o:p></o:p></span></div>
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<span style="font-family: "verdana"; font-size: 10pt;">Original Study 329 <a href="https://www.justice.gov/sites/default/files/opa/legacy/2012/07/02/complaint-ex2.pdf"><span style="color: blue; font-family: "times new roman";">https://www.justice.gov/sites/default/files/opa/legacy/2012/07/02/complaint-ex2.pdf</span></a><o:p></o:p></span></div>
Adverse Reactions APRILcharity bloghttp://www.blogger.com/profile/10938026980225981583noreply@blogger.com1tag:blogger.com,1999:blog-539198936050146545.post-28348233374535217472017-04-12T04:33:00.002-07:002017-04-12T04:56:47.140-07:00<iframe allowfullscreen="" frameborder="0" height="315" src="https://www.youtube.com/embed/fi2k80vEQUU" width="560"></iframe>
well worth watching and hearing psychiatrist Dr Joanna Moncrieff speak at the end of the video - her comments about 'Disease Awareness' campaigns and the fact there is no scientific evidence for the promotion by the pharmaceutical industry in their campaigns of a 'chemical imbalance' as a cause of mental distress should he heard by all medical students. Together with reading her book 'The Myth of the Chemical Cure' - if on the medical curriculum we may in the future see a reduction in iatrogenic illness. That is the ill health actually caused by the treatment. The rise in iatrogenesis is a public health crisis which the Department of Health would be wise to take into account when looking at the cost of emergency admissions to hospital.<br />
<br />
The increase in emergency admissions to A & E caused by adverse drug reactions (ADRs) was highlighted in the<a href="https://www.ncbi.nlm.nih.gov/pubmed/20513902" target="_blank"> Imperial College review of 10 years of hospital statistics.</a> The increase by 76.8% was the fastest increase of any cause of admission. The human and financial cost is massive.Adverse Reactions APRILcharity bloghttp://www.blogger.com/profile/10938026980225981583noreply@blogger.com0tag:blogger.com,1999:blog-539198936050146545.post-6165759806826832692016-08-11T02:47:00.000-07:002017-04-12T04:45:53.030-07:00Our web site is being updated<b><br /></b>
<b><span style="font-family: Verdana, sans-serif;">Blog post - latest update 15 December 2016</span></b><br />
<span style="font-family: Verdana, sans-serif;"><strong></strong><br /></span>
<span style="font-family: Verdana, sans-serif;">You will have been re-directed to our blog while our web site is in the process of being upgraded and edited, for which we apologise.</span><br />
<span style="font-family: Verdana, sans-serif;"><span style="color: #333333;"><span lang="EN" style="color: #333333;"></span></span><br /></span>
<span style="color: #333333;"><span lang="EN" style="color: #333333; font-family: Verdana, sans-serif;">Please read here :</span></span><br />
<span style="color: #333333;"><span lang="EN" style="color: #333333; font-family: Verdana, sans-serif;"><a href="http://data.parliament.uk/writtenevidence/committeeevidence.svc/evidencedocument/health-committee/suicide-prevention/written/37700.pdf" target="_blank">our submission to the Parliamentary Health Select Committee Inquiry into Suicide Prevention</a></span></span><br />
<span style="font-family: Verdana, sans-serif;"><br /></span>
<span style="color: #333333; font-family: Verdana, sans-serif;">The final report by the committee totally ignored the medication links to suicides, stating the view of those who gave oral evidence was that treatment with drugs is better than no treatment. How sad they could not discuss the fact there are suicide warnings for many psychotropic and everyday medicines.</span><br />
<span style="font-family: Verdana, sans-serif;"><b><br /></b>
<b>APRIL charity has had a web site for over 15 years - this is currently being upgraded.</b></span><br />
<b><span style="font-family: Verdana, sans-serif;">By early 2017 we should have an improved site up and running - In the meantime please read articles on this blog and <a href="https://vimeo.com/user1816628" target="_blank"> view our videos</a> from our groundbreaking conferences.</span></b><br />
<span style="font-family: Verdana, sans-serif;"><b><br /></b>
<b>Leading experts in clinical pharmacology, genetics and medical education. speak and answer questions about adverse drug reactions (ADRs), and dependence issues.</b></span><br />
<span style="font-family: Verdana, sans-serif;"><b><br /></b><b>Hear about the way clinical trials may be manipulated explained by Dr Ben Goldacre and Professor David Healy. The wonderful Professor Heather Ashton's wise words and many other experts in the field of medicine. A coroner's view and the stories of people, some bereaved, who kindly agreed to sharing their experiences with us.</b></span><br />
<span style="font-family: Verdana, sans-serif;"><b><br /></b>
<a href="https://vimeo.com/user1816628" target="_blank">https://vimeo.com/user1816628 </a></span><br />
<span style="font-family: Verdana, sans-serif;"><br /></span>
<span style="font-family: Verdana, sans-serif;">We also have a Youtube channel to which over 40,000 people have seen and some have commented. Well worth reading those comments to hear how people have suffered and how valuable our work of creating awareness is. Please find information about specific drugs on the pharma web site <a href="http://www.medicines.org.uk/">www.medicines.org.uk</a> and review the data on the SPC (summary of product characteristics) for full information about some of the possible side effects.</span><br />
<span style="font-family: Verdana, sans-serif;"><br /></span>
<b><span style="font-family: Verdana, sans-serif;">Please follow us on Twitter <a href="https://twitter.com/april_charity?lang=en" target="_blank">@APRIL_charity </a></span></b><br />
<span style="font-family: Verdana, sans-serif;"><br /></span>
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<span style="color: #333333; font-family: "verdana" , "helvetica" , sans-serif;"><span style="font-family: Verdana, sans-serif; font-size: 17px;"><b>Our submission to the Government Suicide Prevention Inquiry can be viewed on the <a href="https://www.parliament.uk/business/committees/committees-a-z/commons-select/health-committee/inquiries/parliament-2015/suicide-prevention-inquiry/publications/" target="_blank">Parliamentary web site:</a> </b></span></span><br />
<span style="color: #333333; font-family: "verdana" , "helvetica" , sans-serif;"><span style="font-family: Verdana, sans-serif; font-size: 17px;"><a href="http://data.parliament.uk/writtenevidence/committeeevidence.svc/evidencedocument/health-committee/suicide-prevention/written/37700.pdf">http://data.parliament.uk/writtenevidence/committeeevidence.svc/evidencedocument/health-committee/suicide-prevention/written/37700.pdf</a></span></span><br />
<b style="color: #333333;"><span style="font-family: Verdana, sans-serif;"><br /></span></b>
<b style="color: #333333;"><span style="font-family: Verdana, sans-serif;"> We take the opportunity to request if you may please consider a <a href="https://www.charitychoice.co.uk/april/appeals/psychiatric-side-effects-major-resource-upgrade-of-web-site/626" target="_blank">contribution to help us continue in our work</a>.</span></b></div>
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<b><span style="font-family: Verdana, sans-serif;">Donations towards the upgrade of the web site will be appreciated - please read our Fundraising Appeal here:</span></b><br />
<span style="font-family: Verdana, sans-serif;"><br /></span>
<span style="font-family: Verdana, sans-serif;">Link to Charity Choice Fundraising site, click on 'Our Appeals : <a href="https://www.charitychoice.co.uk/april">https://www.charitychoice.co.uk/april</a></span><br />
<span style="font-family: Verdana, sans-serif;"><br /></span>
<span style="font-family: Verdana, sans-serif;">Direct link to the Appeal:</span><br />
<a href="https://www.charitychoice.co.uk/april/appeals/psychiatric-side-effects-major-resource-upgrade-of-web-site/626"><span style="font-family: Verdana, sans-serif;">https://www.charitychoice.co.uk/april/appeals/psychiatric-side-effects-major-resource-upgrade-of-web-site/626</span></a><br />
<span style="font-family: Verdana, sans-serif;"><span style="color: #333333; text-align: center;"><b><br /></b></span>
<span style="color: #333333; text-align: center;"><b>Latest news on activities of APRIL</b></span></span><br />
<span style="font-family: Verdana, sans-serif;"><br /></span>
<span style="font-family: Verdana, sans-serif;">Please share the link for this remarkable new video documentary by Katinka Newman but can only be viewed on a computer - not on mobile devices unfortunately!</span><br />
<a href="https://www.youtube.com/watch?v=eEeJtRB5hqg" rel="noreferrer" style="-webkit-box-shadow: none; border-bottom-left-radius: 0px; border-bottom-right-radius: 0px; border-top-left-radius: 0px; border-top-right-radius: 0px; box-shadow: none; color: #005797; text-shadow: none;" target="_blank"><span style="font-family: Verdana, sans-serif;">https://www.youtube.<wbr style="-webkit-box-shadow: none; border-radius: 0px; box-shadow: none; text-shadow: none;"></wbr>com/watch?v=eEeJtRB5hqg</span></a><br />
<span style="font-family: Verdana, sans-serif;"><br /></span>
<span style="font-family: Verdana, sans-serif;"><br /></span>
<span style="font-family: Verdana, sans-serif;">Oxford University Press International Journal of Neuropsychopharmacology</span><br />
<span style="font-family: Verdana, sans-serif;"><br /></span>
<span style="font-family: Verdana, sans-serif;">A newly published paper = October 2016 referring to rigged clinical trials covering up suicides and other ADRs caused by antidepressants is also worth reviewing:</span><br />
<span style="font-family: Verdana, sans-serif;"><br /></span>
<a href="http://ijnp.oxfordjournals.org/content/early/2016/10/25/ijnp.pyw092"><span style="font-family: Verdana, sans-serif;">http://ijnp.oxfordjournals.org/content/early/2016/10/25/ijnp.pyw092</span></a><br />
<br />
<span style="font-family: Verdana, sans-serif;"><br /></span>
<b><span style="font-family: Verdana, sans-serif; font-size: medium;">Please scroll down this blog for important information about antidepressants, Dianette, Non psychiatric drugs linked to suicidal behaviour and depression in a recent study by Professor Munir Pirmohamed and others.</span></b><br />
<span style="font-family: Verdana, sans-serif;"><br /></span>
<span style="font-family: Verdana, sans-serif;">Until the revised web site is available, it is still possible to research the information about medicines or other data on our web site archived by Wayback Machine - just go to the web site :<a href="http://web.archive.org/web/*/www.april.org.uk" target="_blank"> http://web.archive.org/web/*/www.april.org.uk</a></span><br />
<span style="font-family: Verdana, sans-serif;"><br /></span>
<span style="font-family: Verdana, sans-serif;">waybackmachine.org is a great resource and they state for www.april.org.uk it has been</span><br />
<div class="wbUrl" style="box-sizing: border-box; color: #333333; margin-bottom: 2px; padding: 0px; text-align: center; text-decoration: underline;">
<span style="font-family: Verdana, sans-serif; font-size: xx-small;">Saved <strong style="box-sizing: border-box;">158 times</strong> between <a href="http://web.archive.org/web/20000824072920/http://www.april.org.uk/" style="box-sizing: border-box; color: #428bca; text-decoration: none;">August 24, 2000</a> and <a href="http://web.archive.org/web/20160426143710/http://www.april.org.uk/" style="box-sizing: border-box; color: #428bca; text-decoration: none;">April 26, 2016</a>.</span></div>
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<b><span style="font-family: Verdana, sans-serif;">Antimalarial drug</span></b></div>
<div style="font-size: 17px;">
<span style="font-family: Verdana, sans-serif;">31 August 2016 on BBC TV Victoria Derbyshire programme focus was partly on the #psychiatric adverse reactions to <b>#Lariam #Mefloquine</b> the drug recommended for prevention of #malaria</span></div>
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<span style="font-family: Verdana, sans-serif;"><br /></span></div>
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<a href="http://www.bbc.co.uk/iplayer/episode/b07rgvhh/victoria-derbyshire-31082016"><span style="font-family: Verdana, sans-serif;">http://www.bbc.co.uk/iplayer/episode/b07rgvhh/victoria-derbyshire-31082016</span></a></div>
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<span style="font-family: Verdana, sans-serif;"><br /></span></div>
<div style="text-align: left;">
<span style="font-family: Verdana, sans-serif;">Follow her on twitter too: <a href="https://twitter.com/hashtag/VictoriaLIVE?src=hash&lang=en-gb" target="_blank">@VictoriaLive</a> </span></div>
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<span style="font-family: Verdana, sans-serif;"><br /></span></div>
<div style="text-align: left;">
<span style="font-family: Verdana, sans-serif;">After hearing the evidence in the programme one may wonder why nothing was done to protect the public and our troops from the long term mental health issues triggered by this drug, there are suicides and homicides linked to the adverse effects too. </span></div>
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<span style="font-family: Verdana, sans-serif;"><br /></span></div>
<div style="text-align: left;">
<span style="font-family: Verdana, sans-serif;">The answer is the pharmaceutical company threatened that if any kind of campaigning were to continue in the UK the cost would be too great.</span></div>
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<span style="font-family: Verdana, sans-serif;">details are here:</span></div>
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<a href="http://www.lariaminfo.org/about/lariam-uk/"><span style="font-family: Verdana, sans-serif;">http://www.lariaminfo.org/about/lariam-uk/</span></a></div>
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<span style="font-family: Verdana, sans-serif;"><br /></span></div>
<div style="text-align: left;">
<span style="font-family: Verdana, sans-serif;">APRIL has a dossier of testaments from the public about the dreadful effects of the drug. It may be of use for 'curing' malaria but as a preventative the harm seems to outweigh the benefit.</span></div>
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<span style="font-family: Verdana, sans-serif;">_____________________________________________________________</span></div>
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<div style="box-sizing: border-box; color: #333333; margin-bottom: 2px; padding: 0px; text-align: left;">
<span style="font-family: Verdana, sans-serif;">Apart from editing and revising the web site, Millie Kieve the founder of APRIL Tweets to doctors and others - Please follow us on Twitter @APRIL_charity</span><br />
<span style="font-family: Verdana, sans-serif;"><br /></span>
<span style="font-family: Verdana, sans-serif;">This week a good result was when Dr Mark Porter mention Millie Kieve had tweeted to ask why he did not promote patient reporting of ADRs:</span></div>
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</div>
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<span style="font-family: Verdana, sans-serif;"><span style="font-size: 17px;"><a href="http://www.bbc.co.uk/programmes/b07mxk4g" rel="noreferrer" style="-webkit-box-shadow: none; border-bottom-left-radius: 0px; border-bottom-right-radius: 0px; border-top-left-radius: 0px; border-top-right-radius: 0px; box-shadow: none; color: #005797; text-shadow: none;" target="_blank">http://www.bbc.co.uk/programmes/b07mxk4g</a> BBC </span><span style="font-size: 17px;">broadcast </span>9th & 10th August 2016</span></div>
<div style="text-align: justify;">
<span style="font-family: Verdana, sans-serif;"><br /></span></div>
<div style="color: #333333; text-align: justify;">
<span style="-webkit-box-shadow: none; border-radius: 0px; box-shadow: none; font-family: Verdana, sans-serif; text-shadow: none;">After radio 4 programme 'Inside Health' prog last week (2nd & 3rd August), item on statins, when they discussed the conflicting evidence re benefits and harms. I tweeted direct to Dr Mark Porter how important to balance the misinformation and why did he not promote the Yellow Card reporting system for patients as doctors so seldom report ADRS. (more than one tweet of course as words so limited in tweets!) - I believe the incidents of memory loss, depression and muscle weakness caused by statins is under reported!</span></div>
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</span>
</span><br />
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<span style="-webkit-box-shadow: none; border-radius: 0px; box-shadow: none; text-shadow: none;"><span style="color: #333333; font-family: Verdana, sans-serif; font-size: 13px;"><br /></span></span></div>
<span style="font-family: Verdana, sans-serif;"><span style="-webkit-box-shadow: none; border-radius: 0px; box-shadow: none; text-shadow: none;">
<span style="color: #333333; font-family: "verdana" , "geneva" , sans-serif; font-size: 13px;"></span></span>
</span><br />
<div style="text-align: justify;">
<span style="-webkit-box-shadow: none; border-radius: 0px; box-shadow: none; text-shadow: none;"><span style="color: #333333; font-family: Verdana, sans-serif; font-size: 13px;">And Dr Porter quoted my tweet to instigate a discussion on Yellow Card reporting in this week's prog and even mentioned my name!</span></span></div>
<span style="font-family: Verdana, sans-serif;"><span style="-webkit-box-shadow: none; border-radius: 0px; box-shadow: none; text-shadow: none;"><span style="color: #333333; font-family: "verdana" , "geneva" , sans-serif; font-size: 13px;">
</span></span>
</span><br />
<div style="box-sizing: border-box; color: #333333; margin-bottom: 2px; padding: 0px; text-align: justify;">
<span style="-webkit-box-shadow: none; border-bottom-left-radius: 0px; border-bottom-right-radius: 0px; border-top-left-radius: 0px; border-top-right-radius: 0px; box-shadow: none; font-family: Verdana, sans-serif; text-shadow: none;">This is about 15 mins into the programme after the hip treatment discussion. </span></div>
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</div>
<div style="text-align: justify;">
<span style="color: #333333; font-family: Verdana, sans-serif; font-size: 13px;"><br /></span></div>
<span style="font-family: Verdana, sans-serif;"><span style="-webkit-box-shadow: none; border-bottom-left-radius: 0px; border-bottom-right-radius: 0px; border-top-left-radius: 0px; border-top-right-radius: 0px; box-shadow: none; color: #333333; text-shadow: none;"></span><br /></span>
<div style="text-align: justify;">
<span style="-webkit-box-shadow: none; border-bottom-left-radius: 0px; border-bottom-right-radius: 0px; border-top-left-radius: 0px; border-top-right-radius: 0px; box-shadow: none; color: #333333; font-family: Verdana, sans-serif; text-shadow: none;">I hope the MHRA will be pleased but still wonder why they don't do more to publicise the Yellow Card system. This lack of effort to promote the scheme to the public re-enforces the Health Committee Inquiry finding:</span><br />
<span style="-webkit-box-shadow: none; border-bottom-left-radius: 0px; border-bottom-right-radius: 0px; border-top-left-radius: 0px; border-top-right-radius: 0px; box-shadow: none; color: #333333; font-family: Verdana, sans-serif; text-shadow: none;">The MHRA have a conflict of interest in trying to manage safety of medicines while they are supported by and have to promote the pharmaceutical industry. </span></div>
<span style="-webkit-box-shadow: none; border-radius: 0px; box-shadow: none; color: #333333; font-family: "verdana" , "geneva" , sans-serif; font-size: 13px; text-shadow: none;">
</span>Adverse Reactions APRILcharity bloghttp://www.blogger.com/profile/10938026980225981583noreply@blogger.com0tag:blogger.com,1999:blog-539198936050146545.post-77487655574639117262016-01-29T06:37:00.006-08:002017-02-27T07:53:44.431-08:00Antidepressants double risk of aggression & suicide for young, according to meta analysis of dataChildren and adolescents have a doubled risk of aggression and suicide when
taking one of the five most commonly prescribed antidepressants, according to
findings of a study published in The BMJ today. (The following is taken from the email sent to APRIL by the BMJ.)<br />
<br />
<b>However, the true risk for all associated serious harms, such as deaths,
aggression, akathisia and suicidal thoughts and attempts, remains unknown for
children, adolescents and adults, say experts.</b><br />
This is because of the poor design of clinical trials that assess these
antidepressants, and the misreporting of findings in published articles.<br />
<br />
Selective serotonin reuptake inhibitors antidepressants (SSRIs) and
serotonin-norepinephrine reuptake inhibitors (SNRIs) are the most commonly
prescribed drugs for depression.<br />
A team of researchers from Denmark carried out a systematic review and
meta-analysis of 68 clinical study reports of 70 trials with 18,526 patients to
examine use of antidepressants and associated serious harms.<br />
These included deaths, suicidal thoughts and attempts as well as aggression
and akathisia, a form of restlessness that may increase suicide and violence.<br />
<br />
They examined double blind placebo controlled trials that contained patient
narratives or individual patient listings of associated harms.<br />
<br />
<b>Harms associated with antidepressants are often not included in published
trial reports,</b> explain the authors. This is why they analysed clinical study
reports, prepared by pharmaceutical companies for market authorisation, and
summary trial reports, both of which usually include more information.<br />
In adults, they found no significant associations between antidepressants and
suicide and aggression. However, a novel finding showed there was a doubling of
risk for aggression and suicides in children and adolescents.<br />
<br />
<b>This study has shown limitations in trials, not only in design, but also in
reporting</b> of clinical study reports, which may have lead to "serious
under-estimation of the harms," write the authors.<br />
They compared the results from the clinical study reports with data from
individual patient listings or narratives of adverse effects. This revealed
misclassification of deaths and suicidal events in people taking
antidepressants.<br />
<br />
<b>For example, four deaths were misreported by a pharmaceutical company, in all
cases favouring the antidepressant, and more than half of the suicide attempts
and suicidal ideation, for example, were coded as "emotional lability" or
"worsening of depression."</b><br />
In the Eli Lilly summary trial reports, almost all deaths were noted, but <b>
suicidal attempts were missing in 90% of instances,</b> and information on other
outcomes was incomplete. These were "even more unreliable than we previously
suspected," write the authors.<br />
<br />
Clinical study reports for antidepressants duloxetine, fluoxetine,
paroxetine, sertraline and venlafaxine were obtained from regulatory agencies in
the UK and Europe. Summary trial reports for duloxetine and fluoxetine were
taken from the drug company Eli Lilly's website.<br />
<br />
However, clinical study reports could not be obtained for all trials and all
antidepressants, and <b>individual listings of adverse outcomes for all patients
were available for only 32 trials.</b><br />
"The true risk for serious harms is still unknown [because] the low incidence
of these rare events, and the poor design and reporting of the trials, makes it
difficult to get accurate effect estimates," they explain.<br />
<br />
They recommend "minimal use of antidepressants in children, adolescents, and
young adults, as the serious harms seem to be greater, and as their effect seems
to be below what is clinically relevant," and suggest alternative treatments
such as exercise or psychotherapy.<br />
They also call for the need to identify "hidden information in clinical study
reports to form a more accurate view of the benefits and harms of drugs."<br />
<br />
In an accompanying editorial, Joanna Moncrieff from University College
London, agrees that "regulators and the public need access to more comprehensive
and reliable data", and that clinical study reports "are likely to underestimate
the extent of drug related harms."<br />
Over half the clinical study reports had no individual patient listings and
"this begs the question of how many more adverse events would have been revealed
if [these] were available for all trials, and raises concerns why this
information is allowed to be withheld."<br />
<a href="http://www.bmj.com/cgi/doi/10.1136/bmj.i65" title="blocked::http://www.bmj.com/cgi/doi/10.1136/bmj.i65">Link to research</a><br />
<a href="http://www.bmj.com/cgi/doi/10.1136/bmj.i217" title="blocked::http://www.bmj.com/cgi/doi/10.1136/bmj.i217">Link to editorial</a><br />
<h3>
</h3>
<h3>
Additional information about antidepressant trial data added to this blog February 2017</h3>
<br />
<div class="MsoNormal" style="margin: 0cm 0cm 0pt;">
<b style="mso-bidi-font-weight: normal;"><u><span style="font-family: Verdana; font-size: 10pt;">Restoring Study 329 - The study
that disproved anti-depressants’ efficacy<o:p></o:p></span></u></b></div>
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<span style="font-family: Verdana; font-size: 10pt;"><o:p> </o:p></span></div>
<br />
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<span style="font-family: Verdana; font-size: 10pt;">A major
reanalysis of the infamous clinical trial, Study 329, has shown Paroxetine
(also known as Paxil or Seroxat), one of the most commonly prescribed
antidepressants, to be unsafe and no more effective than a placebo.<o:p></o:p></span></div>
<br />
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<span style="font-family: Verdana; font-size: 10pt;"><o:p> </o:p></span></div>
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<span style="font-family: Verdana; font-size: 10pt;">This new
assessment directly contradicts the results of the clinical trial that claimed
Seroxat to be “generally well tolerated and effective”, which was sponsored by
and ghostwritten for GlaxoSmithKline, despite using the same original data. <o:p></o:p></span></div>
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<span style="font-family: Verdana; font-size: 10pt;"><o:p> </o:p></span></div>
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<span style="font-family: Verdana; font-size: 10pt;">The
latest paper was published under the restoring invisible and abandoned trials
(RIAT) initiative, in order to re-evaluate any conclusions drawn from evidence
that had previously been hidden from public view. <o:p></o:p></span></div>
<br />
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<span style="font-family: Verdana; font-size: 10pt;"><o:p> </o:p></span></div>
<br />
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<span style="font-family: Verdana; font-size: 10pt;">Published
in 2001, Study 329 generated a high level of controversy from patients and
doctors after lawsuits were filed stating the side-effects were much more
serious than those documented in the clinical trials.<o:p></o:p></span></div>
<br />
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<span style="font-family: Verdana; font-size: 10pt;"><o:p> </o:p></span></div>
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<span style="font-family: Verdana; font-size: 10pt;">Restoring
Study 329, showed Paroxetine (Seroxat or Paxil) to have no significant
reduction of depressive symptoms more than a placebo or previous
anti-depressants, and gave users a higher chance of psychiatric side effects.<o:p></o:p></span></div>
<br />
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<span style="font-family: Verdana; font-size: 10pt;"><o:p> </o:p></span></div>
<br />
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<span style="font-family: Verdana; font-size: 10pt;">The
original study came under intense scrutiny following revelations that it was
ghost written by GSK authors and not those named on the study, and the primary
data was not made publically available. <o:p></o:p></span></div>
<br />
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<span style="font-family: Verdana; font-size: 10pt;"><o:p> </o:p></span></div>
<br />
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<span style="font-family: Verdana; font-size: 10pt;">The
findings of Study 329, originally published in 2001, was the first double blind
patient study to report the efficacy of anti-depressants on adolescents. <o:p></o:p></span></div>
<br />
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<span style="font-family: Verdana; font-size: 10pt;"><o:p> </o:p></span></div>
<br />
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<span style="font-family: Verdana; font-size: 10pt;">It has
allowed Seroxat to gain widespread approval by the healthcare industry,
becoming the most widely prescribed anti-depressant in the <st1:country-region w:st="on"><st1:place w:st="on">US</st1:place></st1:country-region>, with over
14 billion dolllars worth of sales between 1997 and 2004. <o:p></o:p></span></div>
<br />
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<span style="font-family: Verdana; font-size: 10pt;"><o:p> </o:p></span></div>
<br />
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<span style="font-family: Verdana; font-size: 10pt;">Following
a decade of public and legal pressure, GSK finally released the original data
to the public, making its reanalysis possible. <o:p></o:p></span></div>
<br />
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<span style="font-family: Verdana; font-size: 10pt;"><o:p> </o:p></span></div>
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<span style="font-family: Verdana; font-size: 10pt;">These
devastating results overturning the original paper may come as no surprise to
many who have already suffered loss and harm from the drug. In<span style="mso-spacerun: yes;"> </span>2012 GSK were successfully sued $3 billion
for fraudulently promoting Paroxetine to the public, and hiding key data in its
study, such as reclassifying suicidal acts so that they would not count in the
final analysis.<o:p></o:p></span></div>
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<span style="font-family: Verdana; font-size: 10pt;"><o:p> </o:p></span></div>
<br />
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<span style="font-family: Verdana; font-size: 10pt;">To this
day however, GSK remain silent on the issue and continue to promote the drug to
its customers, without any attempt to acknowledge the restoration of the study.<o:p></o:p></span></div>
<br />
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<span style="font-family: Verdana; font-size: 10pt;"><o:p> </o:p></span></div>
<br />
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<b style="mso-bidi-font-weight: normal;"><i style="mso-bidi-font-style: normal;"><u><span style="font-family: Verdana; font-size: 10pt;">A personal note
to our readers:<o:p></o:p></span></u></i></b></div>
<br />
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<b style="mso-bidi-font-weight: normal;"><i style="mso-bidi-font-style: normal;"><u><span style="font-family: Verdana; font-size: 10pt;"><o:p><span style="text-decoration: none;"> </span></o:p></span></u></i></b></div>
<br />
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<span style="font-family: Verdana; font-size: 10pt;">As we
reveal these facts about Seroxat, we do not wish to condemn all use of
anti-depressants nor encourage the immediate withdrawal from the medication. <span style="mso-spacerun: yes;"> </span>It is important to obtain advice from
responsible health professionals who can help to plan any reduction in drugs
that may cause dependence. It is also important to inform those close to you
when you plan to start, reduce or stop taking antidepressants.<o:p></o:p></span></div>
<br />
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<span style="font-family: Verdana; font-size: 10pt;"><o:p> </o:p></span></div>
<br />
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<span style="font-family: Verdana; font-size: 10pt;">We wish
to highlight the potential dangers and risks of Paroxetine and similar
medication, and let readers understand that medical information to support the
drug can be unreliable or biased.<o:p></o:p></span></div>
<br />
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<span style="font-family: Verdana; font-size: 10pt;"><o:p> </o:p></span></div>
<br />
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<span style="font-family: Verdana; font-size: 10pt;">Both
starting and coming off anti-depressants is a serious undertaking and we
strongly advise that users seek professional medical help as well as inform
either close friends or family when doing so, as it can be a tough process
which needs careful monitoring and support.<o:p></o:p></span></div>
<br />
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<span style="font-family: Verdana; font-size: 10pt;"><o:p> </o:p></span></div>
<br />
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<span style="font-family: Verdana; font-size: 10pt;">We
recommend considering talking therapy and CBT to those who have access to these
services, as these have been shown to provide beneficial reductions of
depression and anxiety with fewer and less serious side effects.<o:p></o:p></span></div>
<br />
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<span style="font-family: Verdana; font-size: 10pt;"><o:p> </o:p></span></div>
<br />
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<span style="font-family: Verdana; font-size: 10pt;">©JBforAPRIL<o:p></o:p></span></div>
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<span style="font-family: Verdana; font-size: 10pt;"><o:p> </o:p></span></div>
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<a href="https://www.blogger.com/null" name="_GoBack"></a><b style="mso-bidi-font-weight: normal;"><span style="font-family: Verdana; font-size: 10pt;">Further <st1:city w:st="on"><st1:place w:st="on">Reading</st1:place></st1:city> <o:p></o:p></span></b></div>
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<span style="font-family: Verdana; font-size: 10pt;">Article
on Study 329<o:p></o:p></span></div>
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<span style="font-family: Verdana; font-size: 10pt;"><a href="https://www.theatlantic.com/health/archive/2015/09/paxil-safety-bmj-depression-suicide/406105/"><span style="color: blue; font-family: Times New Roman;">https://www.theatlantic.com/health/archive/2015/09/paxil-safety-bmj-depression-suicide/406105/</span></a><o:p></o:p></span></div>
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<span style="font-family: Verdana; font-size: 10pt;">British
Medical Journal Analysis of Study 329 <o:p></o:p></span></div>
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<span style="font-family: Verdana; font-size: 10pt;"><a href="http://www.bmj.com/content/bmj/351/bmj.h4629.full.pdf"><span style="color: blue; font-family: Times New Roman;">http://www.bmj.com/content/bmj/351/bmj.h4629.full.pdf</span></a><o:p></o:p></span></div>
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<span style="font-family: Verdana; font-size: 10pt;">David
Healy’s website on the controversy of Study 329<o:p></o:p></span></div>
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<span style="font-family: Verdana; font-size: 10pt;"><a href="https://study329.org/"><span style="color: blue; font-family: Times New Roman;">https://study329.org/</span></a><o:p></o:p></span></div>
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<span style="font-family: Verdana; font-size: 10pt;">Restored
Study 329 <o:p></o:p></span></div>
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<span style="font-family: Verdana; font-size: 10pt;"><a href="http://www.bmj.com/content/351/bmj.h4320"><span style="color: blue; font-family: Times New Roman;">http://www.bmj.com/content/351/bmj.h4320</span></a><o:p></o:p></span></div>
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<span style="font-family: Verdana; font-size: 10pt;">Original
Study 329 <a href="https://www.justice.gov/sites/default/files/opa/legacy/2012/07/02/complaint-ex2.pdf"><span style="color: blue; font-family: Times New Roman;">https://www.justice.gov/sites/default/files/opa/legacy/2012/07/02/complaint-ex2.pdf</span></a><o:p></o:p></span></div>
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<span style="font-family: Verdana; font-size: 10pt;"><o:p> </o:p></span></div>
Adverse Reactions APRILcharity bloghttp://www.blogger.com/profile/10938026980225981583noreply@blogger.com0tag:blogger.com,1999:blog-539198936050146545.post-61650573005909197992015-01-12T07:57:00.000-08:002015-02-05T16:49:49.967-08:00Acne drug Dianette (Diane-35) obtains new depression and suicide risk warning<div style="border-bottom: solid windowtext 1.0pt; border: none; mso-border-bottom-alt: solid windowtext .75pt; mso-element: para-border-div; padding: 0cm 0cm 1.0pt 0cm;">
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<b><i><span lang="EN-US">Foreword to readers:<o:p></o:p></span></i></b></div>
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<i><span lang="EN-US">Thanks to women who
contacted APRIL and those who have heeded our request to report side-effects
for Dianette (Diane-35).<o:p></o:p></span></i></div>
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<i><span lang="EN-US">It is due to the efforts of
</span></i><span lang="EN-US"><a href="http://www.theguardian.com/society/2006/may/08/health.medicineandhealth"><i>APRIL
for many years requesting the Medicines & Healthcare Products Regulatory
Agency</i></a><i> to review the emails
we received from women, with detailed explanations of the way Dianette affected
them, that eventually the MHRA reviewed the drug for safety issues. This review,
started in 2006, led to the manufacturers adding an additional warning about
depression which previously had been listed under MILD side effects.<o:p></o:p></i></span></div>
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<i><span lang="EN-US">The MHRA requested APRIL to
urge these women to report using the Yellow Card system. Compliance with this
request has led to reports of psychiatric adverse drug reactions (ADRs) soaring
in a few years from 3% of all reports to 33% of all reports by 2011. Due to the
increased number of reports recorded on Drug Analysis Prints by the MHRA the
manufacturer has added the warning as mentioned below in this post.<o:p></o:p></span></i></div>
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<b><span lang="EN-US">Dianette,</span></b><span lang="EN-US"> the hormonal acne treatment manufactured by the German
pharmaceutical company Bayer, has had a </span><span lang="EN-US"><a href="http://www.medicines.org.uk/emc/history/1814">label change in the UK</a></span><span lang="EN-US">,
following a number of reports of depression and suicidal thoughts. <o:p></o:p></span></div>
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<span lang="EN-US">Patient Information Leaflets should now include this warning
in each box of Dianette:<o:p></o:p></span></div>
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<b><i><span lang="EN-US">“Post-marketing reports of severe depression (including very
rare reports of suicidal ideation or behaviour) in patients using Dianette have
been received. However, a causal relationship between clinical depression
and Dianette has not been established.” <o:p></o:p></span></i></b></div>
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<span lang="EN-US">The drug is prescribed to 62,000 British women and millions
of women worldwide each year for acne and excessive body hair (hirsutism).
Hundreds of adverse drug reactions and some fatalities have been reporting for
people taking Dianette, also known as Diane-35 and other generic names.<o:p></o:p></span></div>
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<span lang="EN-US">In the <st1:country-region w:st="on">USA</st1:country-region>
the medication has </span><span lang="EN-US"><a href="http://graftonmedical.ie/france-bans-dianette/">not been approved</a></span><span lang="EN-US">
by the Food and Drug Administration (FDA), and </span><span lang="EN-US"><a href="http://www.telegraph.co.uk/news/worldnews/europe/france/9830519/French-acne-and-contraceptive-drug-to-be-investigated-over-deaths.html">France banned the drug
altogether</a> in 2013**</span><span lang="EN-US"> </span><span lang="EN-US" style="color: windowtext; mso-bidi-font-family: "Times New Roman"; mso-hansi-font-family: "Times New Roman";">after its links to at least four French deaths from blood
clots and 125 patients suffering serious side effects. <span style="background: white;">The European medicines agency </span></span><span lang="EN-US" style="background: white; mso-bidi-font-family: "Times New Roman"; mso-hansi-font-family: "Times New Roman";">released a statement</span><span lang="EN-US"> <a href="http://www.bbc.co.uk/news/uk-england-kent-21591654">reported on BBC News</a>
(27 February 2013)</span><span lang="EN-US" style="background: white; color: windowtext; mso-bidi-font-family: "Times New Roman"; mso-hansi-font-family: "Times New Roman";">
about the decision of the French medicines agency <a href="http://www.ansm.sante.fr/"><span style="color: black;">ANSM</span></a> to
stop distribution:<o:p></o:p></span></div>
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<span lang="EN-US" style="background: white; color: windowtext; mso-bidi-font-family: "Times New Roman"; mso-hansi-font-family: "Times New Roman";">“ANSM considered that
Diane-35 and its generics carry a risk of thromboembolism which has been well
known for many years, while their effectiveness in treating acne was only
moderate and alternative treatments for acne are available.”</span><span lang="EN-US" style="color: windowtext; mso-bidi-font-family: "Times New Roman"; mso-hansi-font-family: "Times New Roman";"><o:p></o:p></span></div>
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<span lang="EN-US">Dianette can be taken off-label as a contraceptive pill, but
is unlicensed for this purpose due to its </span><span lang="EN-US"><a href="http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON287002">significantly higher risk of
blood clots</a></span><span lang="EN-US"> compared to other
pills. Professor Dominique Maraninchi, director-general of the ANSM, believes doctors</span><span lang="EN-US"> are</span><span lang="EN-US"> giving women the drug as a
contraceptive off-label too often, <a href="http://www.theguardian.com/world/2013/jan/27/france-diane-acne-drug-deaths">saying</a>:<o:p></o:p></span></div>
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<span lang="EN">"Diane-35 is an acne treatment that
also blocks ovulation. We have several inquiries going on that show that this
non-authorised use is significant."</span><span lang="EN-US"><o:p></o:p></span></div>
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<span lang="EN-US">Between 2010 and 2013, the MHRA revealed that</span><span lang="EN-US"><a href="http://www.dailymail.co.uk/news/article-2283560/Dianette-Acne-pill-banned-parts-Europe-linked-deaths-seven-British-women-years.html"> seven women in the United
Kingdom</a> have died whilst taking the drug</span><span lang="EN-US">,
with 83 reports of side effects such as thrombosis and depression. </span></div>
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<span lang="EN-US">Last year, a Dutch report revealed up to 27 women, most of
whom under 30, died from blood clots believed to be caused by Dianette.<o:p></o:p></span></div>
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<span lang="EN-US">Despite being listed as a </span><span lang="EN-US"><a href="http://www.yccscotland.scot.nhs.uk/reporting/Pages/BlackTriangleDrugs.aspx">Black Triangle Drug</a></span><span lang="EN-US"> under further review by the medicine’s regulator, Dianette and
its generic counterparts remain on license in the <st1:country-region w:st="on"><st1:place w:st="on">UK</st1:place></st1:country-region>.<o:p></o:p></span></div>
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<span lang="EN-US">Earlier this year Jessica Eales, a young sailing champion,
took her life after her 17th birthday, </span><span lang="EN-US"><a href="http://www.thetimes.co.uk/tto/news/uk/article4245053.ece">following 4 months of using
Dianette</a></span><span lang="EN-US"> as an acne treatment. The coroner
Graham Short </span><span lang="EN-US"><a href="http://www.mirror.co.uk/news/uk-news/young-sailing-star-hanged-herself-4482153">could not conclude any links
between her suicide and the drug</a></span><span lang="EN-US">
as she had not presented any noticeable signs of depression before this. The
coroner quoted the European Medicines Agency review of Dianette in his report,
which had concluded the benefits of the drug outweigh its risks. However, the
EU report only took into account the risks in respect of thrombosis; the risk
of depression and suicidal thoughts and actions was not considered in this
review.<o:p></o:p></span></div>
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<span lang="EN-US">Following the death of Charlotte Porter, who </span><span lang="EN-US"><a href="http://www.dailymail.co.uk/news/article-2283560/Dianette-Acne-pill-banned-parts-Europe-linked-deaths-seven-British-women-years.html">died of a blood clot in 2010</a></span><span lang="EN-US"> whilst on Dianette, an MHRA spokesman announced: ‘Dianette
is an effective medicine for treating the distressing conditions of severe acne
and excessive hair […] Despite recent developments in <st1:country-region w:st="on"><st1:place w:st="on">France</st1:place></st1:country-region>, we have
no new concerns.’ German manufacturer Bayer said: ‘Bayer believes that Dianette
has a favourable benefit-risk profile when used in accordance with the label.’<o:p></o:p></span></div>
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<span lang="EN-US"><a href="http://www.theguardian.com/society/2006/may/08/health.medicineandhealth">Prior to the publicity
instigated by APRIL</a></span><span lang="EN-US">, we were told of
many instances where antidepressants were prescribed to women who complained of
depression, and left uninformed of the link or told to stop taking Dianette.
APRIL’s research on patient safety collated 102 adverse drug reaction reports
sent in by 2011 by women on their use of Dianette. Several personal accounts
document that once removing themselves from the drug, their mood clears,
following severe depression in some instances.
One patient described how “The cloud lifted when I stopped taking Dianette”.
Woman’s hour described similar stories in their programme about <a href="http://www.bbc.co.uk/programmes/b04cbv9g">contraceptive pills and mood</a>.<o:p></o:p></span></div>
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<span lang="EN-US">This change in patient information is one step forward to
informing the patient of the risks to their mental health when taking Dianette.
Once a change in a patient leaflet is made, however, the GP may not be aware of
the new information. However, we are hopeful that following this change in
labelling, there may be further consideration of Dianette’s psychiatric side
effects taken by prescribers as well as by coroners.<o:p></o:p></span></div>
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<span lang="EN-US">Crucially we urge those affected to report adverse
side-effects using the </span><span lang="EN-US"><a href="https://yellowcard.mhra.gov.uk/">Yellow
Card reporting system</a></span><span lang="EN-US"> in the <st1:country-region w:st="on"><st1:place w:st="on">UK</st1:place></st1:country-region>. From this,
we can build a stronger and more accurate profile of this drug for both
prescribers and the prescribed to be aware of its risks.<o:p></o:p></span></div>
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<span lang="EN-US">Jacqueline
Bond <o:p></o:p></span><br />
<span lang="EN-US"><br /></span>
<span lang="EN-US">** Edit: T</span>he ANSM's decision to suspend Dianette was overruled as t<span lang="EN-US">he European Commission's decision to maintain marketing authorisation was implemented in all EU Member states.</span></div>
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Adverse Reactions APRILcharity bloghttp://www.blogger.com/profile/10938026980225981583noreply@blogger.com2tag:blogger.com,1999:blog-539198936050146545.post-81200563387443244162014-10-16T08:43:00.001-07:002014-10-28T13:42:53.093-07:00Non-psychiatric drugs linked to suicidal behaviour and depression in new study<div align="center" class="MsoNormal" style="text-align: center;">
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<span style="font-family: Arial; font-size: 11pt;">Adverse side effects of medicines can be underestimated and often not
recognised as such. 110 drugs prescribed on the NHS have been linked to depression,
self-harm and suicidal behaviour in a scientific study of patient Yellow Cards drug
reaction reports sent to the </span><a href="http://www.mhra.gov.uk/" style="font-family: Arial; font-size: 11pt;">Medicine’s
Regulatory agency, the MHRA</a><span style="font-family: Arial; font-size: 11pt;">.</span></div>
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<span style="font-family: Arial; font-size: 11.0pt; mso-ansi-language: EN-GB;"><a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4184159/">The paper
published this September 2014</a> in the journal BMC Pharmacology &
Toxicology is believed to be the first <st1:country-region w:st="on"><st1:place w:st="on">UK</st1:place></st1:country-region> systematic review of psychiatric
side-effects. Researchers found reports of 11,000 cases of depression, self
injurious and suicidal behaviour following prescribed drug use between 1964 and
2011. This number covered 1.65% of all reports received in this time period. <o:p></o:p></span></div>
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<span style="font-family: Arial; font-size: 11.0pt; mso-ansi-language: EN-GB;">Anti-depressants, acne, smoking cessation and weight-loss drugs were most
frequently linked with serious psychiatric adverse drug reactions (ADRs).
Clozapine, the anti-psychotic drug, had the highest reporting rate of suicide,
with 78 reports between 1998 and 2011 linking the fatality to the drug.<o:p></o:p></span></div>
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<span style="font-family: Arial; font-size: 11.0pt; mso-ansi-language: EN-GB;">Both nervous system and non-nervous system drugs met the study’s
thresholds of at least 20 reports for depression, 10 for non-fatal suicide and
5 for fatal suicide between 1998 and 2011. Topping the charts with most
frequent reports of depression were smoking cessation medicine, varenicline (Champix
/ Chantix) and bupriopion (Wellbutrin / Zyban), followed by paroxetine (Seroxat
or Paxil), the SSRI antidepressant. Also high on the list of drugs linked to
depression were the acne treatment, isotretinoin (Roaccutane / Accutane), and
rimonabant (Acomplia), a drug for weight loss. For suicidal and self injurious
behaviour, SSRIs, varenicline and clozapine occurred most often. <o:p></o:p></span></div>
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<span style="font-family: Arial; font-size: 11.0pt; mso-ansi-language: EN-GB;">Figures found in the study are likely to underrepresent the true count
of iatrogenic effects (drug-induced side effects) as the <a href="https://yellowcard.mhra.gov.uk/">Yellow Card reporting system</a> remains
relatively underused by both patients and healthcare professionals. <o:p></o:p></span></div>
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<span style="font-family: Arial; font-size: 11.0pt; mso-ansi-language: EN-GB;">The paper recommends the drugs most commonly arising in patient reports
for grave psychiatric conditions need further analysis to understand the
reasons why these drugs might be causing undue harm.<o:p></o:p></span></div>
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<span style="font-family: Arial; font-size: 11.0pt; mso-ansi-language: EN-GB;">When a drug is licensed for prescription, pre-market trials <a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1669038/pdf/bmj00110-0043.pdf">do
not undergo full powered studies</a> into adverse drug reactions (ADRs) as this
would require larger numbers of participants. Post-marketing pharmacovigilance
using the Yellow Card reporting system and its careful analysis is therefore
one of the main ways we can achieve a fuller picture into the neglected area of
patient experience with medication.<o:p></o:p></span></div>
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<span style="font-family: Arial; font-size: 11.0pt; mso-ansi-language: EN-GB;">Due to poor
publicity and the underpowered studies of iatrogenic effects, psychiatric drug
reactions and withdrawal effects are neither sufficiently well recognised nor analysed
in the medical community. <a href="http://www.ncbi.nlm.nih.gov/pubmed/14748895">A
study</a> published in 2004 found that fewer than half of pharmacy programmes
and medical schools provided students with a guide to reporting ADRs. Yet NHS
Education for Scotland (NES), in <a href="http://www.nes.scot.nhs.uk/media-centre/press-releases/adverse-drug-reactions-e-modules.aspx">a
press release</a> published in June 2014, stated that 7% of acute hospital
admissions were due to ADRs. The NES have thus launched six new e-learning
modules to support healthcare professionals identifying and reporting
iatrogenic symptoms. <a href="http://vimeo.com/16359896">Clinical pharmacologist
Dr Simon Maxwell</a> published an article reporting that <a href="http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2125.2008.03197.x/pdf">undergraduate
study is in urgent need of review</a> to improve the safe and effective use of
drugs in patients. </span><span style="font-family: Arial; font-size: 11.0pt; mso-ansi-language: EN-GB; mso-fareast-language: EN-GB;">74% of medical students felt
the amount of teaching in this area of safe prescribing was ‘too little’ or ‘far too little’, and most
disagreed that their assessment ‘thoroughly tested knowledge and skills’.<o:p></o:p></span></div>
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<span style="font-family: Arial; font-size: 11.0pt; mso-ansi-language: EN-GB;">If we are to reduce the effect of ADRs on the population, and their
economic impact that costs the <a href="http://www.theguardian.com/society/2008/apr/03/nhs.drugsandalcohol">NHS
an estimated £2 billion each year</a>, healthcare professionals and
pharmaceutical companies need to make best use of new information made
available by patient reporting.<o:p></o:p></span></div>
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<i><span style="font-family: Arial; font-size: 11.0pt; mso-ansi-language: EN-GB;">Jacqueline
Bond blogging for APRIL<o:p></o:p></span></i></div>
Adverse Reactions APRILcharity bloghttp://www.blogger.com/profile/10938026980225981583noreply@blogger.com0tag:blogger.com,1999:blog-539198936050146545.post-50027485894462291502014-10-02T10:19:00.000-07:002017-09-09T05:58:00.156-07:00 Study of Children Harmed by Medicines finds Doctors Fail to Listen<br />
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<span style="color: #66b446; font-family: "verdana"; font-size: 10pt;">Report on Adverse Drug Reactions in Children reveals </span></h3>
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<span style="color: #66b446; font-family: "verdana"; font-size: 10pt;">better
communication needed between doctors and patients<o:p></o:p></span></h3>
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<span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;"><span style="font-family: "verdana"; font-size: x-small;"><span style="font-family: "times new roman"; font-size: small;">
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<span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;"><span style="font-family: "verdana"; font-size: x-small;"><span style="font-family: "verdana"; font-size: 10pt;">Of 5118 children
admitted to <st1:place w:st="on">Europe</st1:place>'s largest
children's hospital between 1 October 2009 and 30 September 2010, 17.7%
experienced at least one adverse drug reaction (ADR), according to a new
report.</span></span></span></span></div>
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<span style="font-family: "verdana"; font-size: 10pt;">The Adverse Drug Reactions
in Children (ADRIC) report, was funded by the National Institute for Health
Research and is the first large-scale and long-term study of its kind to report
on the </span><span style="font-family: "verdana"; font-size: 10pt;">ADRs of children</span><span style="font-family: "verdana"; font-size: 10pt;"> under hospital care. </span></div>
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<span style="font-family: "verdana"; font-size: 10pt;">The aim of the
research that took place in the largest children’s hospital in <st1:place w:st="on">Europe</st1:place>, Alder Hey Children’s Hospital, is to improve the
safety of medicines administered to those under 16. Many common medicines are
licensed without being tested on children thoroughly, if at all, yet are used
regularly in paediatric healthcare. </span></div>
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<span style="font-family: "verdana"; font-size: 10pt;">Drug safety in
paediatric care is a neglected area of research. Most medicines go through drug
trials using primarily adult samples. In 2006, 75% of all 317 European
centrally licensed drugs were relevant and used for children yet only half of
these had indications, or validated medical reasons, for child use. This means
a large proportion of drugs used for children are ‘off-label and/or unlicensed’
(OLUL). These have not undergone thorough trials to gain evidence for
calculating appropriate dosage and efficacy in children of different ages. It
is therefore difficult to evaluate the risk-benefit ratio for the children
taking OLUL drugs, therefore increasing the risk of ADRs.</span></div>
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<span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">Simple extrapolation of pharmaceutical data for adult to
child use is inappropriate, given the size differences in children that would
alter optimal dosages</span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;"> as well </span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">as</span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">
the</span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">
developmental changes in a child’s physiology that could </span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">affect</span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;"> </span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">responsiveness
to a drug</span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">.
</span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;"><span class="msoIns"><ins cite="mailto:Millie" datetime="2014-10-02T13:30"><o:p></o:p></ins></span></span></span><br />
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<span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">Th</span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">e
ADRIC </span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">study
discovered 31% of acute children’s</span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;"> emergency</span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">
admissions to hospital were attributable to OLUL drugs. </span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">Perhaps
unsurprisingly these drugs were also found significantly more likely to be
implicated in ADRs than for drugs licensed for children. </span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;"><o:p></o:p></span></span></div>
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<span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">Drugs most commonly implicated in
admissions were </span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">cytotoxic
agents, corticosteroids, non-steroidal anti-in</span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">fl</span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">ammatory drugs (NSAID</span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">s)</span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;"> </span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">vaccines and
immunosuppressant</span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">
</span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">drugs</span></span><span style="font-family: "verdana"; font-size: 10pt;">. </span><span style="font-family: "verdana"; font-size: 10pt;">Adverse
side-effects from medication taken at home accounted for 3% of admissions to
the Alder Hey Children’s Hospital, where the reaction was the main reason or
contributed to the reason of their visit. Of the reactions, one-fifth was found
to be either definitely or possibly avoidable. In most cases, it was found
these would have been prevented if not for oversights by the doctor of previous
ADRs to the same drug, insufficient patient education of possible ADRs, and
prescribing that could have been more rational, with possible use of alternative
drugs<span style="mso-prop-change: Millie 20141002T1511;">.</span><span style="mso-prop-change: Millie 20141002T1511;"><span class="msoIns"><ins cite="mailto:Millie" datetime="2014-10-02T14:46"><o:p></o:p></ins></span></span></span></div>
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<span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">Nearly 20% of children and young people who had been
inpatients at the hospital for over two days suffered at least one ADR</span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">
from treatment during their stay</span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">. Opiate analgesics and general
anaesthetic (GA) drugs were found responsible for over half the cases of ADRs
in this group</span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">.</span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;"> G</span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">eneral anaesthetic drugs</span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;"> </span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">present</span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">ed</span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;"> </span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">a
hazard to patients six times as high as any other drug administered to
patients. Of the ADRs reported, 1% of these resulted in permanent harm or a
higher level of care being required for the patient.</span></span></div>
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<span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">With few exceptions, parents reported poor management and
communication from their clinicians about suspected ADRs. Reports described
parents receiving inadequate or contradictory information from doctors about
their child’s medical assessments. One parent described how “no-one actually
said why </span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">it
</span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">[the
hallucination] was happening, the nurses just thought it was a bit funny”;
others felt “fobbed off” by clinicians or even “lied to” when doctors could not
explain their child’s ADR to them.</span></span></div>
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<span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">When there was an improvement in communication, it was when
parents were more anxious. At these points parents reported a greater level of
information from clinicians as compared to other times</span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">.
W</span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">hen
less anxious and therefore better placed to absorb facts, </span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">information
received was </span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">“little or none”.<span style="mso-spacerun: yes;"> </span></span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">Reports</span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">
from parents gave a sense information was conveyed only when it was pushed for.</span></span></div>
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<span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">The study </span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">observed</span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">
a</span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">
consequence of poor </span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">doctor</span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">-</span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">patient </span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">communication is the potential for missing out certain
symptoms, such as hallucinations, anxiety, nausea and pain which can be described
</span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">only
</span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">by
the patient verbally. It is possible that this explains the
under-representation of ADRs of this type reported in </span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">younger
children</span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">
and</span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">
those</span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">
mentally disabled, than in adults.</span></span></div>
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<span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">The study looked at current methods of </span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">ADR
</span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">identification
and reporting. At present, the Yellow Card reporting scheme allows patients and
relatives to report suspected or confirmed ADRs. These are sent to the MHRA, a
regulatory board for pharmaceutical use in the <st1:country-region w:st="on"><st1:place w:st="on">UK</st1:place></st1:country-region>. This scheme was reported to be
relatively unheard of by patients, however when </span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">informed</span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">,
the idea was much favoured by the parent and patient population as an essential
tool for reporting ADRs.</span></span></div>
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<span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">Positively, the report found that parents, children and
young people work on the same principles as doctors when evaluating the
possibility of an ADR over an unrelated symptom, recommending them as equally
reliable sources of detection. So, rather than being “ignored” and “dismissed”,
the report’s findings recommend that patient and parental concerns ought to be
taken more seriously by clinicians, </span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">with
greater</span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">
trust and emphasis put </span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">o</span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">n </span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">patient </span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">self-evaluation</span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">.</span></span></div>
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<span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">With these changes taken on board, the ADRIC report
believes the greater recognition and improved recording of ADRs could reduce
the incidence of avoidable harm to patients from prescribed medicines and
anaesthetics. </span></span><span style="color: red;"><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;"><span class="msoDel"><del cite="mailto:Millie" datetime="2014-10-02T15:05"><span style="mso-spacerun: yes;"> </span></del></span></span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;"><o:p></o:p></span></span></span></div>
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<span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">References:
</span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">Smyth
RL, Peak M, Turner MA, Nunn AJ, Williamson PR, Young B, </span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">et al. </span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">ADRIC: Adverse Drug</span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;"> </span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">Reactions In Children
</span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">–
</span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">a
programme of research using mixed methods. </span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">Programme Grants Appl</span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;"> </span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">Res </span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">2014;</span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">2</span></span><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1511;">(3)</span></span><span style="font-family: "verdana"; font-size: 10pt;"><o:p></o:p></span></div>
<br />
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<span style="font-family: "verdana"; font-size: 10pt;">Jacqueline Bond
02/10/14<a href="https://www.blogger.com/null" name="_GoBack"></a> <o:p></o:p></span></div>
<br />
<div class="MsoNormal" style="line-height: normal; margin: 0cm 0cm 10pt; mso-prop-change: Millie 20141002T1513;">
<i style="mso-bidi-font-style: normal;"><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1508;">Jacqueline is a graduate from Oxford
University having</span></span></i><i style="mso-bidi-font-style: normal;"><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1508;"> read</span></span></i><i style="mso-bidi-font-style: normal;"><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1508;"> Psychology, </span></span></i><i style="mso-bidi-font-style: normal;"><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1508;">Philosophy & Physiology, and </span></span></i><i style="mso-bidi-font-style: normal;"><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1508;">a </span></span></i><i style="mso-bidi-font-style: normal;"><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1508;">M</span></span></i><i style="mso-bidi-font-style: normal;"><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1508;">asters in </span></span></i><i style="mso-bidi-font-style: normal;"><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1508;">Neuroscience </span></span></i><i style="mso-bidi-font-style: normal;"><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1508;">from</span></span></i><i style="mso-bidi-font-style: normal;"><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1508;"> </span></span></i><st1:placename w:st="on"><i style="mso-bidi-font-style: normal;"><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1508;">Imperial</span></span></i></st1:placename><i style="mso-bidi-font-style: normal;"><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1508;"> </span></span></i><st1:placetype w:st="on"><i style="mso-bidi-font-style: normal;"><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1508;">College</span></span></i></st1:placetype><i style="mso-bidi-font-style: normal;"><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1508;"> </span></span></i><st1:city w:st="on"><st1:place w:st="on"><i style="mso-bidi-font-style: normal;"><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1508;">London</span></span></i></st1:place></st1:city><i style="mso-bidi-font-style: normal;"><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1508;">.</span></span></i><i style="mso-bidi-font-style: normal;"><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1508;"> </span></span></i><i style="mso-bidi-font-style: normal;"><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1508;">She is doing research</span></span></i><i style="mso-bidi-font-style: normal;"><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1508;"> for</span></span></i><i style="mso-bidi-font-style: normal;"><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1508;"> APRIL</span></span></i><i style="mso-bidi-font-style: normal;"><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1508;"> and contribut</span></span></i><i style="mso-bidi-font-style: normal;"><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1508;">es</span></span></i><i style="mso-bidi-font-style: normal;"><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1508;"> to </span></span></i><i style="mso-bidi-font-style: normal;"><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1508;">the </span></span></i><i style="mso-bidi-font-style: normal;"><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1508;">APRIL </span></span></i><i style="mso-bidi-font-style: normal;"><span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1508;">blog</span></span></i><i style="mso-bidi-font-style: normal;"><span style="font-family: "verdana"; font-size: 10pt;">.</span></i></div>
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<span style="font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Millie 20141002T1507;">Added note from Millie Kieve</span></span><span style="font-family: "verdana"; font-size: 10pt;">,<span style="mso-prop-change: Millie 20141002T1507;"> formerly
chair of Advisory Group to Evaluation of Patient Yellow Card Repo</span><span style="mso-prop-change: Millie 20141002T1507;">rting</span>:<span class="msoIns"> </span><o:p></o:p></span></h4>
<br />
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<i style="mso-bidi-font-style: normal;"><span style="font-family: "verdana"; font-size: 10pt;">I wish to thank Jacqueline Bond for her
careful review of the 200-page ADRIC report about the adverse drug reactions of
children in hospital. The full report can be found here:</span></i><span style="font-family: "verdana"; font-size: 8pt;"> <a href="http://www.journalslibrary.nihr.ac.uk/__data/assets/pdf_file/0013/121414/FullReport-pgfar02030.pdf"><span style="color: blue;">http://www.journalslibrary.nihr.ac.uk/__data/assets/pdf_file/0013/121414/FullReport-pgfar02030.pdf</span></a>
</span><i style="mso-bidi-font-style: normal;"><span style="font-family: "verdana"; font-size: 10pt;"><o:p></o:p></span></i></div>
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<i style="mso-bidi-font-style: normal;"><span style="font-family: "verdana"; font-size: 10pt;">I was involved with a study to evaluate the
value of patient reporting in 2011, also funded by the The National Institute
for Health Research (2). The researchers concluded <span style="mso-spacerun: yes;"> </span>“patient reporting of suspected ADRs has the
potential to add value to pharmacovigilance by reporting types of drugs and
reactions different from those reported by Health Care Professionals.”</span></i></div>
<div class="MsoNormal" style="line-height: normal; margin: 0cm 0cm 10pt; mso-prop-change: Millie 20141002T1513;">
<i style="mso-bidi-font-style: normal;"><span style="font-family: "verdana"; font-size: 10pt;">In regards to the low awareness of Yellow Card
reporting of adverse drug reactions (ADRs), we have made multiple requests to the Medicines Healthcare Products Regulatory Agency (MHRA)
to increase publicity and their availability. APRIL believes Yellow Cards and
awareness of the Yellow Card system of pharmacovigilance is not well
publicised.</span></i></div>
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<i style="mso-bidi-font-style: normal;"><span style="font-family: "verdana"; font-size: 10pt;">Healthcare Professionals do not have a good record for reporting ADRs and those other than doctors have had to persuade, in the past, the regulatory body to accept their reports as valid. The official assessment of less than 10% of serious ADRs reports is a reflection of the poor awareness and promotion of the scheme.</span></i></div>
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<i style="mso-bidi-font-style: normal;"><span style="font-family: "verdana"; font-size: 10pt;">We have requested that posters and YC cards be displayed in
hospitals, doctors’ surgeries and in community and supermarket pharmacies. The
lack of visible encouragement for patients, pharmacists, nurses and doctors to report ADRs raises the question
of why this essential method of monitoring the safety of medicines is currently
under-publicised.</span></i></div>
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<i style="mso-bidi-font-style: normal;"><span style="font-family: "verdana"; font-size: 10pt;">Pharmacovigilance in the <st1:country-region w:st="on"><st1:place w:st="on">UK</st1:place></st1:country-region> should be
improved to increase awareness of the extent of iatrogenic (treatment-induced)
injuries to mental and physical health. Hospital admissions caused by ADRs has
been estimated to cost the NHS £466 million annually (1).</span></i></div>
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<i style="mso-bidi-font-style: normal;"><u><span style="font-family: "verdana"; font-size: 10pt;">References<span style="mso-prop-change: Millie 20141002T1509;"> </span><span style="mso-prop-change: Millie 20141002T1509;">to
note</span><span style="mso-prop-change: Millie 20141002T1509;"><o:p></o:p></span></span></u></i></div>
<br />
<div class="MsoNormal" style="line-height: normal; margin: 0cm 0cm 10pt 36pt; mso-list: l0 level1 lfo1; mso-prop-change: Millie 20141002T1513; tab-stops: list 36.0pt; text-indent: -18pt;">
<!--[if !supportLists]--><i style="mso-bidi-font-style: normal;"><span style="font-family: "verdana"; font-size: 9pt;"><span style="mso-list: Ignore;">1)<span style="font-size-adjust: none; font-stretch: normal; font: 7pt/normal "Times New Roman";">
</span></span></span></i><!--[endif]--><i style="mso-bidi-font-style: normal;"><span style="font-family: "verdana"; font-size: 10pt;">Stage Three: Directive. Improving medication, error
incident reporting and learning - 20 March 2014 MHRA Study NHS/PSA/D/2014/005<br />
</span></i><i style="mso-bidi-font-style: normal;"><span style="font-family: "verdana"; font-size: 9pt;"><a href="http://www.england.nhs.uk/wp-content/uploads/2014/03/psa-sup-info-med-error.pdf"><span style="color: blue;">http://www.england.nhs.uk/wp-content/uploads/2014/03/psa-sup-info-med-error.pdf</span></a><o:p></o:p></span></i></div>
<br />
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<!--[if !supportLists]--><span lang="EN" style="color: #0066cc; font-family: "verdana"; font-size: 10pt;"><span style="mso-list: Ignore;">2)<span style="font-size-adjust: none; font-stretch: normal; font: 7pt/normal "Times New Roman";">
</span></span></span><!--[endif]--><span lang="EN" style="font-family: "verdana"; font-size: 10pt;">Evaluation
of patient reporting of adverse drug reactions to the UK Yellow Card Scheme<span style="color: #0066cc;"> </span></span><i style="mso-bidi-font-style: normal;"><span lang="EN" style="font-family: "verdana"; font-size: 10pt;"><span style="mso-spacerun: yes;"> </span></span></i><i style="mso-bidi-font-style: normal;"><span style="font-family: "verdana"; font-size: 9pt;"><a href="http://www.journalslibrary.nihr.ac.uk/hta/volume-15/issue-20"><span style="color: blue;">http://www.journalslibrary.nihr.ac.uk/hta/volume-15/issue-20</span></a></span></i><i style="mso-bidi-font-style: normal;"><span style="font-family: "verdana"; font-size: 10pt;"> </span></i><span lang="EN" style="color: #0066cc; font-family: "verdana"; font-size: 10pt;"><span style="mso-prop-change: Unknown 19000000T0000;"><o:p></o:p></span></span></div>
<h2>
</h2>
Adverse Reactions APRILcharity bloghttp://www.blogger.com/profile/10938026980225981583noreply@blogger.com0tag:blogger.com,1999:blog-539198936050146545.post-54635409210488530902014-09-05T07:29:00.001-07:002015-02-05T16:50:14.896-08:00BLACK TRIANGLE DRUGS under High Scrutiny <div class="MsoNormal">
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<b>Black Triangle</b> classification on drugs your doctor may
prescribe should be carefully monitored and ANY suspected adverse reactions
reported to <a href="http://www.yellowcard.gov.uk/">www.yellowcard.gov.uk</a> a pharmacovigilance system we have to support as it is the only 'official' one. Please also report to the web site monitored by doctors <a href="https://www.rxisk.org/" target="_blank">https://www.rxisk.org </a> as they may take more active efforts to create awareness of newly discovered adverse drug reactions (ADRs) also please report all psychiatric ADRs to any medicine or following anaesthetics to APRIL <a href="http://www.april.org.uk/">www.april.org.uk</a> </div>
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<h1 style="background: white; mso-line-height-alt: 18.0pt;">
<span lang="EN-US" style="color: #222222; font-family: Helvetica; font-size: 19.5pt; mso-ansi-language: EN-US;">Black Triangle Drugs now include Dianette (cyproterone acetate &
ethinylestradiol)and Champix (Verenicline) the drug prescribed to help smokers also known as Chantix.</span></h1>
<div class="wp-caption-text" style="background: white;">
<span lang="EN-US" style="font-family: Helvetica; font-size: 11.5pt;"><b>“The Black Triangle”</b><span style="color: #373737;"><o:p></o:p></span></span></div>
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<span lang="EN-US" style="font-family: Helvetica; font-size: 11.5pt;"><b><br /></b></span></div>
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<span lang="EN-US" style="color: #373737; font-family: Helvetica; font-size: 11.5pt; mso-ansi-language: EN-US;">Although
the <b>Black Triangle</b> has been used
since the 1980s in the <st1:country-region w:st="on">UK</st1:country-region> to
indicate that a drug is under intensive surveillance, new pharmacovigilance
legislation in <st1:place w:st="on">Europe</st1:place> now extends the Black
Triangle symbol across the EU. <o:p></o:p></span></div>
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<span lang="EN-US" style="color: #373737; font-family: Helvetica; font-size: 11.5pt; mso-ansi-language: EN-US;">The <b>Black Triangle</b> will have to be present
in the manufacturer’s Summary of Product Characteristics (SPC) and associated
packaging patient leaflet (PIL) of any product subject to additional
monitoring, along with the phrase <em>“This
medicinal product is subject to additional monitoring”</em>.<o:p></o:p></span></div>
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<span lang="EN-US" style="color: #373737; font-family: Helvetica; font-size: 11.5pt; mso-ansi-language: EN-US;">Further
information about all drugs available in the <st1:place w:st="on"><st1:country-region w:st="on">UK</st1:country-region></st1:place> are on the web site <a href="http://www.medicines.org.uk/">www.medicines.org.uk</a> this is the Association of British Pharmaceutical
Industries (APBI) electronic medicines compendium and has masses of good
information. The SPC contains more information as it contains data the
manufacture must submit when the drug is first licensed and should be updated
as adverse reactions not originally listed are discovered.<o:p></o:p></span></div>
<div style="background: white;">
<span lang="EN-US" style="color: #373737; font-family: Helvetica; font-size: 11.5pt; mso-ansi-language: EN-US;">Additional
monitoring under the <b>Black Triangle</b>
scheme applies to:<o:p></o:p></span></div>
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<!--[if !supportLists]--><span lang="EN-US" style="color: #373737; font-family: Wingdings; font-size: 10pt; mso-ansi-language: EN-US; mso-bidi-font-family: Wingdings; mso-bidi-font-size: 11.5pt; mso-fareast-font-family: Wingdings;">§<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span lang="EN-US" style="color: #373737; font-family: Helvetica; font-size: 11.5pt; mso-ansi-language: EN-US;">all medicinal
products with a new active substance<o:p></o:p></span></div>
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<!--[if !supportLists]--><span lang="EN-US" style="color: #373737; font-family: Wingdings; font-size: 10pt; mso-ansi-language: EN-US; mso-bidi-font-family: Wingdings; mso-bidi-font-size: 11.5pt; mso-fareast-font-family: Wingdings;">§<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span lang="EN-US" style="color: #373737; font-family: Helvetica; font-size: 11.5pt; mso-ansi-language: EN-US;">biological
medicinal products, including biosimilars<o:p></o:p></span></div>
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<!--[if !supportLists]--><span lang="EN-US" style="color: #373737; font-family: Wingdings; font-size: 10pt; mso-ansi-language: EN-US; mso-bidi-font-family: Wingdings; mso-bidi-font-size: 11.5pt; mso-fareast-font-family: Wingdings;">§<span style="font-family: 'Times New Roman'; font-size: 7pt;">
</span></span><!--[endif]--><span lang="EN-US" style="color: #373737; font-family: Helvetica; font-size: 11.5pt; mso-ansi-language: EN-US;">Any other medicine
a regulator can demonstrate a specific requirement for additional monitoring<o:p></o:p></span></div>
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<span lang="EN-US" style="color: #373737; font-family: Helvetica; font-size: 11.5pt; mso-ansi-language: EN-US;">Black Triangle
status will normally last for 5 years, but can be extended if ongoing safety
issues require it.<o:p></o:p></span></div>
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<span lang="EN-US" style="color: #373737; font-family: Helvetica; font-size: 11.5pt; mso-ansi-language: EN-US;">Please report ALL
suspected adverse drug reactions to any drug which has a black triangle symbol
next to it to <a href="http://www.yellowcard.gov.uk/">www.yellowcard.gov.uk</a> and APRIL will appreciate information about
psychiatric adverse reactions to add to our data, used to promote action and
improve education for health professionals.<o:p></o:p></span></div>
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<b><span lang="EN-US" style="color: #373737; font-family: Helvetica; font-size: 11.5pt; mso-ansi-language: EN-US;">Black Triangle drugs in the EU full list: go to the
complicated MHRA web site <a href="http://www.mhra.gov.uk/">www.mhra.gov.uk</a>
and be patient ! click on<o:p></o:p></span></b></div>
<div style="background: white; margin-left: 36pt; mso-list: l1 level1 lfo2; tab-stops: list 36.0pt; text-indent: -18pt;">
<!--[if !supportLists]--><b><span lang="EN-US" style="color: #373737; font-family: Helvetica; font-size: 11.5pt; mso-ansi-language: EN-US; mso-fareast-font-family: Helvetica;">1.<span style="font-family: 'Times New Roman'; font-size: 7pt; font-weight: normal;"> </span></span></b><!--[endif]--><b><span lang="EN-US" style="color: #373737; font-family: Helvetica; font-size: 11.5pt; mso-ansi-language: EN-US;">Safety
Information, <o:p></o:p></span></b></div>
<div style="background: white; margin-left: 36pt; mso-list: l1 level1 lfo2; tab-stops: list 36.0pt; text-indent: -18pt;">
<!--[if !supportLists]--><b><span lang="EN-US" style="color: #373737; font-family: Helvetica; font-size: 11.5pt; mso-ansi-language: EN-US; mso-fareast-font-family: Helvetica;">2.<span style="font-family: 'Times New Roman'; font-size: 7pt; font-weight: normal;"> </span></span></b><!--[endif]--><b><span lang="EN-US" style="color: #373737; font-family: Helvetica; font-size: 11.5pt; mso-ansi-language: EN-US;">MEDICINES (in left
menu) <o:p></o:p></span></b></div>
<div style="background: white; margin-left: 36pt; mso-list: l1 level1 lfo2; tab-stops: list 36.0pt; text-indent: -18pt;">
<!--[if !supportLists]--><b><span lang="EN-US" style="color: #373737; font-family: Helvetica; font-size: 11.5pt; mso-ansi-language: EN-US; mso-fareast-font-family: Helvetica;">3.<span style="font-family: 'Times New Roman'; font-size: 7pt; font-weight: normal;"> </span></span></b><!--[endif]--><b><span lang="EN-US" style="color: #373737; font-family: Helvetica; font-size: 11.5pt; mso-ansi-language: EN-US;">How we monitor the
safety of products<o:p></o:p></span></b></div>
<div style="background: white; margin-left: 36pt; mso-list: l1 level1 lfo2; tab-stops: list 36.0pt; text-indent: -18pt;">
<!--[if !supportLists]--><b><span lang="EN-US" style="color: #373737; font-family: Helvetica; font-size: 11.5pt; mso-ansi-language: EN-US; mso-fareast-font-family: Helvetica;">4.<span style="font-family: 'Times New Roman'; font-size: 7pt; font-weight: normal;"> </span></span></b><!--[endif]--><b><span lang="EN-US" style="color: #373737; font-family: Helvetica; font-size: 11.5pt; mso-ansi-language: EN-US;">Overview<o:p></o:p></span></b></div>
<div style="background: white; margin-left: 36pt; mso-list: l1 level1 lfo2; tab-stops: list 36.0pt; text-indent: -18pt;">
<!--[if !supportLists]--><b><span lang="EN-US" style="color: #373737; font-family: Helvetica; font-size: 11.5pt; mso-ansi-language: EN-US; mso-fareast-font-family: Helvetica;">5.<span style="font-family: 'Times New Roman'; font-size: 7pt; font-weight: normal;"> </span></span></b><!--[endif]--><b><span lang="EN-US" style="color: #373737; font-family: Helvetica; font-size: 11.5pt; mso-ansi-language: EN-US;">Medicines<o:p></o:p></span></b></div>
<div style="background: white; margin-left: 36pt; mso-list: l1 level1 lfo2; tab-stops: list 36.0pt; text-indent: -18pt;">
<!--[if !supportLists]--><b><span lang="EN-US" style="color: #373737; font-family: Helvetica; font-size: 11.5pt; mso-ansi-language: EN-US; mso-fareast-font-family: Helvetica;">6.<span style="font-family: 'Times New Roman'; font-size: 7pt; font-weight: normal;"> </span></span></b><!--[endif]--><b><span lang="EN-US" style="color: #373737; font-family: Helvetica; font-size: 11.5pt; mso-ansi-language: EN-US;">Black Triangle
Medicines then right at the bottom of the page you will find a link to the
latest list of drugs designated with the Black Triangle <o:p></o:p></span></b></div>
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<span lang="EN-US" style="color: #373737; font-family: Helvetica; font-size: 11.5pt; mso-ansi-language: EN-US;">If MHRA web site
changes cause problems just put <b>Black
Triangle</b> in search box at <a href="http://www.mhra.gov.uk/">www.mhra.gov.uk</a> Unfortunately my attempts to
provide a direct link to the information are unsuccessful. I have written to the MHRA to suggest the Black Triangle information should be on the home page or found with just one click.<o:p></o:p></span></div>
Adverse Reactions APRILcharity bloghttp://www.blogger.com/profile/10938026980225981583noreply@blogger.com1tag:blogger.com,1999:blog-539198936050146545.post-31661099920315890452014-08-05T08:06:00.000-07:002014-10-28T13:53:02.907-07:00Contraceptive Pill links to Depression on BBC radio 4 Woman's Hour Today<br />
<a href="http://www.bbc.co.uk/programmes/b04cbv9g" target="_blank">Contraceptive Pill links to Depression</a><br />
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Today on BBC Radio 4 in the excellent programme Woman's Hour, I heard a discussion about the contraceptive pill and links to depression.<br />
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I would like to congratulate the presenter, Emma Barnett for her enlightened attention to what is a serious problem for many women. Sadly so many women do not link their mood swings, depression and failure to cope, with prescribed medication including the Pill. Many women are prescribed antidepressants to help them deal with depression that may not be a problem once they stop taking a particular contraceptive or other medication.<br />
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Please refer to my campaign about <a href="http://www.theguardian.com/society/2006/may/08/health.medicineandhealth" target="_blank">Dianette</a> ( click Dianette to link to Guardian article) as the doctor on the programme seemed to promote the fact that skin and other problems can improve with certain contraceptives.<br />
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He failed to mention that Dianette, the drug promoted for acne is the one that is not actually licensed for contraception (though it has a contraceptive action) due to higher risk of dvt, blood clots. Banned for a while by the EU this comes with warnings. It may be valuable for women considering this drug, to have their blood clotting factor checked before embarking on using Dianette (also known as Diane 35 and many other generic names.). The doctor did mention that loss of libido as a possible adverse drug reaction (ADR).<br />
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We will never know how many suicides are linked to prescribed drugs that cause depression - in other words, are not tolerated, with the addition drugs prescribed for the depression, that are also not tolerated.<br />
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You can hear the radio 4 programme on BBC iplayer <a href="http://www.bbc.co.uk/programmes/b04cbv9g" target="_blank">Contraceptive Pill links to Depression</a><br />
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<a href="http://www.bbc.co.uk/programmes/b04cbv9g" target="_blank">http://www.bbc.co.uk/programmes/b04cbv9g</a>Adverse Reactions APRILcharity bloghttp://www.blogger.com/profile/10938026980225981583noreply@blogger.com0