Isotretinoin: an expert UK review of suspected psychiatric and sexual side effects- Review from 2021 with results in 2023

https://www.gov.uk/guidance/isotretinoin-an-expert-review-of-suspected-psychiatric-and-sexual-side-effects#contributions-from-patients-and-the-public

The review of the safety of isotretinoin/Roaccutane has concluded.

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).

The three meetings videos of the evidence from patients, bereaved family members and doctors are on the .Gov site

The final discussion on findings following evidence sessions is here: 

https://www.youtube.com/watch?v=jOX6hASHdTM 

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.

Before this the evidence sessions on Zoom occurred and we had all sent in written evidence too.

Contributions from patients and the public

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.

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.

Three sessions were held to allow the IEWG to hear from everyone who registered and wished to present.

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:

• IEWG Meeting 16 July 2021 https://www.youtube.com/watch?v=xTlvBr4QstI
• IEWG Meeting 21 July Meeting (morning session)
• https://www.youtube.com/watch?v=OxUOo5DK_zg
• IEWG Meeting 21 July 2021 Afternoon Session
• https://www.youtube.com/watch?v=KA2xlhmYr_o

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.

isotretinoin is marketed as Absorica, Absorica LD, Claravis, Amnesteem, Myorisan, and Zenatane, and is sometimes referred to by its former brand name, Accutane

Rizuderm, Reticutan in the UK

The MHRA Roaccutane / isotretinoin Inquiry into harms some people suffer, is still ongoing. Plus link to Millie Kieve's newest video.

 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.

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.

For my part (Millie)  - News of the work for APRIL which is ongoing, even though my age tells me to slow down!

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!

In the meantime I have updated some videos on the Vimeo web site and this one is the newest:

https://vimeo.com/683984803

It is a talk that started as a conversation between me and my long time volunteer and friend Kathy.

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.

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. 

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.

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! 

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 https://www.april.org.uk 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.

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.

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.

Inquiry invites your views as concern about psychiatric and physical harm from acne drug isotretinoin / Ro - Accutane / Reticutan / Rizuderm

 Isotretinoin / Roaccutane / Reticutan / Rizuderm / Accutane 

Please submit your views for an Expert Review of your experience or your relative or friend's as to the safety or otherwise of this acne medication.

https://www.gov.uk/government/consultations/isotretinoin-call-for-information-to-be-considered-as-part-of-an-expert-review 

Closing date for submission extend to 16th February 2021 

UK and non UK submissions welcome

Concerns about suicide, depression and physical harm linked to using this acne medication are worldwide. 

EU ADR database records psychiatric Adverse Drug Reactions (ADRs) 30,295 with reported cases of completed suicide by people using the acne drug 440 by 01/02/21

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.

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: https://vimeo.com/16759077 

 Roaccutane / isotretinoin and generic versions can cause serious adverse reactions for some people . 

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.

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

https://www.gov.uk/government/consultations/isotretinoin-call-for-information-to-be-considered-as-part-of-an-expert-review 

Non-psychiatric drugs linked to suicidal behaviour and depression in new study

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 Medicine’s Regulatory agency, the MHRA.

The paper published this September 2014 in the journal BMC Pharmacology & Toxicology is believed to be the first UK 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.

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.

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.

Figures found in the study are likely to underrepresent the true count of iatrogenic effects (drug-induced side effects) as the Yellow Card reporting system remains relatively underused by both patients and healthcare professionals.

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.

When a drug is licensed for prescription, pre-market trials do not undergo full powered studies 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.

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 study 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 press release 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. Clinical pharmacologist Dr Simon Maxwell published an article reporting that undergraduate study is in urgent need of review to improve the safe and effective use of drugs in patients. 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’.

If we are to reduce the effect of ADRs on the population, and their economic impact that costs the NHS an estimated £2 billion each year, healthcare professionals and pharmaceutical companies need to make best use of new information made available by patient reporting.

Jacqueline Bond blogging for APRIL

A small victory for families who have campaigned since tragic suicides linked to Roaccutane.

A small victory for families who have campaigned since tragic suicides linked to Roaccutane

.http://www.dailymail.co.uk/health/article-2615052/Controversial-acne-drug-Roaccutane-reviewed-government-panel-blamed-spate-suicides-depression.html#comments

The article in Mail on Line states there will be a review of Roaccutane (isotretinoin) by the Commission on Human Medicines. 

We have tried for years to persuade a Professor of pharmacogenetics to do a study to find a genetic test and discover why a drug, so popular with those it has helped with acne problems, yet has a devastating adverse effects for those it harms and for their families.

We even went so far, with the help of the Medland family who are featured in the article, as to have a meeting in Liverpool with dermatologists, the professor and others about how to go about this study.

We found family members where one had a severe adverse reaction and the other did not. In the case of twins, one rushed to hospital in a life threatening condition and the other not after taking Roaccutane.

The drug is derived from vitamin A which is a linked to severe psychiatric and other reactions in high doses. The fact that some people may be slow metabolisers and therefore may have toxic levels of Roaccuane due to the drug not dispersing quickly, seems to be seldom considered.

Please read the article and take into account that in the case of Jon Medland, his problem was not a severe case of acne and he was not really a person who should have been prescribed the drug. He was however a medical student at the time and therefore slipped through the net.

Others who have been prescribed were also not classic severe cases where many other treatments had failed. In some dermatology clinics, there is careful monitoring. In some cases no monitoring of the patient's mood. 

I was at an  inquest where the dermatologist not only shrugged off his responsibility and even prescribed Dianette to a depressed girl who was deeply concerned about the harm Roaccutane was doing by seriously drying up her skin. 

I asked him why he prescribed Dianette and he responded " I couldn't risk her getting pregnant on Roaccutane" (the drug is known to cause deformity in foetus). I said to him " but Dianette is not licensed as a contraceptive" to which he did not respond. This man runs a private practice in Harley Street and did not know Dianette is linked to depression and not licensed for contraception due to higher risk of blood clots than other drugs for this purpose. It is licensed for acne. 

The poor girl who died was also prescribed by other doctors = Prozac and Zopiclone...a potent cocktail for a deeply depressed vulnerable girl - her name was Angela Lee and the coroner just brushed asside the cocktail of drugs in the jury inquest I attended.

I personally know a young man who was an A grade student, he dropped out and later told me he thought Roaccutane had caused his depression. Sadly his family shunned his concerns and considered him a failure. Tragic and it still upsets me to think he understood the cause of his problems and yet got no support from his family. He is not the only person in this situation and many others have written to me with similar stories.

I just want to say how strongly I support the Medland family and all those family members who do not give up in their efforts to save other lives. We do understand why some families shut themselves away in their grief but if we all did that there would be no changes in patient safety issues. 

Angela Lee suicide

Angela Lee 'staggered' and fell in front of a train according to the shocked female train driver of a train travelling at 90 miles per hour. Angela had left a note and felt that the acne drug ro-accutane (isotretionoin) had caused lasting problems. I can confirm that many people who contact me say depression, which they believe was caused by roaccutane lasts for months and years after they stop taking the drug. Angela was prescribed fluoxetine (Prozac) and Zopiclone which she was taking at the time of her death.

I sat in the Walthamstow Coroner's court and heard the evidence given to the jury and was also shocked to hear that Angela was given Dianette at the same time as she was prescribed Roaccutane. None of the journalists commented on this cocktail of drugs - all linked to causing suicidal feelings.

Another problem was the failure of health professionals who cared for Angela, to communicate by picking up a telephone to speak to each other and discuss how best to protect her from harm.