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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




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’

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.

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?
 
This information below will appear on the new APRIL web site which is still being edited:

Roaccutane
Also known as Accutane Sotoret Amnesteem Claravis
Active ingredient isotretinoin

Indication:
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.
Our mission
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.
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.
This article on David Healy’s Rxisk site blog discusses the history and extent of the pharmaceutical industry protecting this drug’s existence:
https://rxisk.org/roche-and-the-perfect-circle/
 “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:
https://www.youtube.com/watch?v=PgpYS33kMVc
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: http://vimeo.com/groups/aprilcharity/videos/16759077
Psychiatric Side Effects:
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.
http://www.medicines.org.uk/emc/medicine/32486
5% of all reported ADRs to Roaccutane are psychiatric reactions including depression, suicide and attempted suicide.
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.
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: 
http://www.independent.ie/irish-news/13-years-after-my-son-died-its-great-to-get-my-day-in-court-26663138.html
 

Patient Warnings and Advice
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.
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]  
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)
"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"
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.
For the latest research results see the Roaccutane Action web site www.accutaneaction.com
Evidence of side effects
The UK 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.
Further information
http://www.medicines.org.uk/EMC/searchresults.aspx?term=isotretinoin&searchtype=QuickSearch
If you have suffered a psychiatric adverse reaction please report them via the Yellow Card in the UK or to the FDA

 

 

4 comments:

Peter Hawkes said...

Whilst I appreciate your views, you need to consider the poor young and older people who suffer with acne. What are the statistics on suicide rate caused by the direct and indirect affects of acne? If you don't know then you can't make sweeping statements. I had a long fight to get Roaccutane, it took me until age 28.

Every death, every suicide, every depressed young person is a tragedy and I appreciate your concern. However without full facts you are discriminating and putting false information in the public domain. For me Roaccutane changed my life.

By creating barriers to accessing this drug you will be pushing people to source it online and it could be fake or they might take dosages higher than required.

All drugs have a huge side effect profile, but very few take medicines for no reason and for many they do help. Admittedly there is a cascading affect of requiring more medicine for the treatment of side effects but for some that is more than a price worth paying.

Driving a car is dangerous, 1827 died last year in the UK from road traffic accidents but many feel the benefits out weighs the risk. I'm not suggesting your view is any less valid than mine. It might be worth looking whether the cases of severe acne are increasing and why. Perhaps the increase in prescribing is due to a previous under prescribing.

Naturally my heart goes out to anyone who has been adversely affected by any medicine, whether that be short term side effects right up to fatal consequences.

Adverse Reactions APRILcharity blog said...

Thank you for taking the time to comment.
I fully appreciate your view and your experience Peter. I know the drug isotretinoin works well for some people but for those who suffer long term depression or worse, we have to be sure they have made an informed choice and are aware of early signs of mental changes. A pharmacist told me he thought it was more often a second course of the drug that led to problems.

I was so concerned for those who suffer from serious acne and need help, that I approached a leading professor of pharmacogenetics and was trying to obtain funding for a research study to find which people could take the drug safely and who may suffer from serious adverse drug reactions (ADRs). I asked for family members to contact me and twins did. One had been fine on the drug and the other collapsed and nearly died.

So what is needed is a genetic type test to find who can safely take this. During the meetings we had with the professor, I also met two dermatologists, one made sure to monitor patients on a weekly basis for mood changes etc. The other did not do this. I knew the less careful dermatologist had already lost a patient to suicide as I had been contacted by the family. So it is vital the people who prescribe isotretinoin do monitor the patients very carefully.

Peter Hawkes said...

I totally agree with your comments. I wasn't aware that a genetic test could be done, I am aware of future ideas on personal tailored care but that is a long way off and probably not for the masses.

I am actually a twin, my twin brother also had acne lasting into his thirties but he didn't go down the Roaccutane route.

I fully understand my positive experience doesn't mean everyone is so lucky. I do however know of others who have taken it and not had any issues, but that is 10's of people nothing statistically high enough to extrapolate anything substantial.

I think my main issue is the reporting. Your reply, is full, balanced and very well explained. Unfortunately the BBC article read to suggest that Roaccutane is something to be avoided at all costs.

My own personal experience is that Roaccutane improved my mental health because it took away one issue which was severely bothering me. Having a history of suicide attempts from age 11, I personally did not have any side effects other than dry lips. My dose was 20mg a day and I was 230lb due to being a bodybuilder at that point. I seriously doubt I could handle 30 or 40mg a day, my lips would have been bleeding every time I opened my mouth.

I had to argue strongly to be referred to a Dermatologist, my GP very reluctantly referred me, I would go as far as saying if he hadn't I would have taken it further. He stated I would not be prescribed it because my acne wasn't bad enough, which I found bizarre. When I saw the dermatologist he had no issue prescribing it. I had a liver function test first and was seen every 2 months. That was back in 1998 before any link to depression surfaced.

I was left on anti-biotics for acne for years which did nothing. I lost count of the number of tubes of benzoyl peroxide I got through.

I definitely appreciate you publishing my somewhat opposing opinions, so thank you. I have also learnt more and hopefully anyone researching might find this discussion useful.

I'm currently on medication for unrelated health issues with significant side effects. One being gabapentin, I am having facet joint injections in my back on Friday with the hope of relieving pain so I can stop gabapentin which is one drug I don't wish to continue. The side effects are awful not to mention memory issues. However the pain relief outweighs the huge side effect profile. The point being I am fully aware of both sides of medication efficacy and side effects.

Once again, thank you for having the integrity to publish opposing opinions, thank you for the extra info and most importantly thank you for the work you do on all medications.

Best wishes

Peter Hawkes - UK - County Durham

Adverse Reactions APRILcharity blog said...

My aim always has been for discussion and sharing information. I only wish more doctors would get involved in the discussion. Thankfully Professor Simon Maxwell who I discovered was trying so hard to improve medical education has always been willing to talk about the problems. He agreed to speak at our conference as several other medical people did.

I always invited the speakers to a dinner the night before so they could interact with the coroner and others who need to speak to each other. I was told that surgeons would never go to a meeting with anaesthetists and that is just the tip of the iceberg.

At the APRIL conferences all the professors and doctors stayed to hear each others talks including those of bereaved parents. People were impressed that Medical Professionals were willing to listen and understand.
Sadly most of the medical conference, unlike ours, are funded by the pharmaceutical industry and no such free discussions occur.

Anyway the good news for me is that after many years of pushing for improvement in medical education, so that doctors actually take notice of early signs of intolerance or do not treat adverser drug reactions (ADRs) as new disease, there will be a new exam for medical students. 'Standardised assessment for student graduating from UK medical schools' and about time too!

Thank you for your interest and hopefully the gabapentin won't cause any long lasting neurological harm.
If you are in the UK, I would recommend the Royal London Hospital for Integrated Medicine as brilliant plan for treating muscular or other complaints. It is a jewel in the crown of the NHS>