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Tuesday, 17 July 2018

Many U.S. adults take medicines that can cause depression


Many U.S. adults take medicines that can cause depression

Details of study in Journal of American Medical Association June 2018 repeats what we at APRIL have been warning for the past 20 years.

The researchers, from the University of Illinois at Chicago, looked at how more than 26,000 people from 2005 to 2014 used medications.

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..

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

https://abcnews.go.com/GMA/Wellness/american-adults-prescription-drugs-depression-study/story?id=55846725

Friday, 19 January 2018

Regulation of medicines safety

An excellent talk by Professor John Abraham is well worth listening to

https://www.youtube.com/watch?v=0qBd4KRbXNc

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Monday, 23 October 2017

Keep your own medical records


NHS boss reveals loss of further 162 000 pieces of medical correspondence


BMJ 2017; 359 doi: https://doi.org/10.1136/bmj.j4822 (Published 17 October 2017) Cite this as: BMJ 2017;359:j4822

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1.                         Gareth Iacobucci

1.The BMJ

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.
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

Wednesday, 27 September 2017

APRIL charity web site now back on line at www.april.org.uk


APRIL - Adverse Psychiatric Reactions Information Link


Our web site is back on line now click here to access  www.april.org.uk for information about many medicines linked to neuro-psychiatric adverse reactions, support groups, articles, videos of doctor's advice, personal experiences and much more.

If you previously found the url www.april.org.uk 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.

Please continue reviewing this APRIL charity blog from time to time for updates on latest research or news by inserting https://aprilcharity.blogspot.co.uk into the url box.

Our new web site at www.april.org.uk will continue being updated with content, so please refer back on a regular basis for added content. 

Adverse Drug Reactions (ADRs) and withdrawal effects changing mood and behaviour, need to be studied and understood.

We hope the information will be valuable for doctors and prescribers and those of us who rely on them to stay well.

Informed choice is the key, as awareness saves lives.

 How many more stories like the Sodium Valproate 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. 

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)

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.

       APRIL,  the charity that believes Awareness Saves Lives

posted by Millie Kieve
www.april.org.ukwww.april.org.uk

Wednesday, 31 May 2017

Please donate to APRIL the charity acting on behalf of victims of adverse drug reactions



Please donate to help APRIL as we rely on supporters, friends and family
to continue our efforts to improve patient safety.   http://www.charitychoice.co.uk/april

Monday, 8 May 2017

Another tragic suicide linked to acne drug Roaccutane

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

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.

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.

I just sent the following information to a journalist:

My main comment is that parents should look a the pharmaceutical company data sheet

 which states under the heading
 4.4 Special warnings and precautions for use:

Psychiatric disorders
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

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 https://vimeo.com/15986864
 
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!

The data sheet also contains the following information for istotretinoin /Ro-Accutane under the heading:

4.8 Undesirable effects

Psychiatric disorders:
Rare (≥ 1/10 000,<1 o:p="">
Very Rare (≤ 1/10 000)
Depression, depression aggravated, aggressive tendencies, anxiety, mood alterations
Abnormal behaviour, psychotic disorder, suicidal ideation, suicide attempt, suicide
Nervous system disorders:
Common (≥1/100, <1 o:p="">

Very Rare (≤ 1/10 000)
Headache
Benign intracranial hypertension, convulsions, drowsiness, dizziness

Monday, 1 May 2017

Clinical Trial Study 329 Ghostwritten by GSK - reanalysis of review of Seroxat Paxil


Restoring Study 329 - The study that disproved anti-depressants’ efficacy

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.

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.

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.

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.

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.

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.

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.

It has allowed Seroxat to gain widespread approval by the healthcare industry, becoming the most widely prescribed anti-depressant in the US, with over 14 billion dolllars worth of sales between 1997 and 2004.

Following a decade of public and legal pressure, GSK finally released the original data to the public, making its reanalysis possible.

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  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.

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.

A personal note to our readers:

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.  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. 

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.

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.

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.

Specialised bereavement counselling is also of benefit as it is more difficult for some people to express grief when blocked by drug effects.

 

©JBforAPRIL

 

Further Reading

 

Article on Study 329


British Medical Journal Analysis of Study 329


David Healy’s website on the controversy of Study 329


Restored Study 329