Update December 2006

Update on Roaccutane / Accutane generic name isotretionoin. Other trade names include
Sotoret and Amnesteem

APRIL (www.april.org.uk) is still receiving emails from people who are suffering from long term neurological and psychological adverse effects, including suicide attempts, apparently since taking isotretionoin.

Wikipedia the free on line encyclopedia states:

One study utilising positron emission tomography (PET) showed functional brain imaging changes in patients treated with isotretinoin, however the clinical relevance of this finding is unclear.[16]

http://en.wikipedia.org/wiki/Isotretinoin

Please note that on the Accutane Action web site there is a translation of a Swiss Documentary film in which is stated that Roche had no record of a person who participated in clinical trials for isotretionoin (accutane/Roaccutane) and who died by suicide. The parents of this young man were devastated at the apparent cover up.

www.accutaneaction.com

http://www.accutaneaction.com/swiss_tv/061114swisstv.html

Roaccutane update September 2006

WARNING FOR CHILDREN AND ADULTS WHO MAY BE PRESCRIBED ROACCUTANE FOR ACNE

A study reported in The Guardian today Tuesday 19th September 2006 again highlights the risk of depression caused by

Roaccutane/ Accutane/ isotretinoin

The UK regulator is the Medicines and Healthcare Products Regulatory Agency (MHRA)and has received 1,588 reports of suspected adverse events experienced by people taking the drug between licensing in 1983 and September this year. 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.

The MHRA Paediatric Working group was asked to review the drug and published findings in April 2005

They stated "Serious adverse events are too few to draw any conclusions from the data."

Please read the following which is available on the MHRA web site:

"The MHRA has asked the marketing authorisation holder for the market leader product for information on the efficacy and safety of Roaccutane (isotretinoin) in children, in line with the strategy to improve paediatric access to medicines.

Isotretinoin is currently indicated in the EU for the treatment of “severe forms of acne (such as cystic and conglobate acne or acne at risk of permanent scarring) resistant to adequate courses of standard therapy with systemic antibacterials and topical therapy.” The drug is not indicated for the treatment of prepubertal acne and is not recommended in patients less than 12 years of age.

The adverse event profile includes; teratogenicity, metabolic effects (increases in liver transaminases, elevation of plasma triglycerides and VLDL), psychiatric disorders (depression, including suicidal ideation, suicide attempts and suicide); musculo-skeletal effects (myalgia, arthralgia, premature epiphyseal closure and hyperostosis when used at high doses for prolonged periods); neurological effects (benign intracranial hypertension); ophthalmic effects (dry eyes, decreased night vision); intestinal effects (inflammatory bowel disease); allergic reactions; and mucocutaneous adverse effects (cheilitis , dry skin, epistaxis).teratogenicity, metabolic effects (increases in liver transaminases, elevation of plasma triglycerides and VLDL), psychiatric disorders (depression, including suicidal ideation, suicide attempts and suicide); musculo-skeletal effects (myalgia, arthralgia, premature epiphyseal closure and hyperostosis when used at high doses for prolonged periods); neurological effects (benign intracranial hypertension); ophthalmic effects (dry eyes, decreased night vision); intestinal effects (inflammatory bowel disease); allergic reactions; and mucocutaneous adverse effects (cheilitis , dry skin, epistaxis).

The drug was the subject of a recent European wide arbitration procedure "

PERSONAL MESSAGE FROM MILLIE AT APRIL

For a long time, I have been receiving emails from people who complain that Roaccutane caused depression, psychosis and for some led to suicidal thoughts and actions. I have been informed of suicides in people with no previous history of depression or psychosis.

I have over 70 such emails. Most people did not suffer any kind of mental illness prior to taking Roaccutane.
The effects seem to be long lasting and people have told me about ruined careers, studies that are discontinued and similar stories of devastated lives.

The families of trainee pharmacist David Roberts and medical student Jon Medland are convinced that Roaccutane led to the suicide of their sons.

Roche the manufacturer did not respond to an invitation to appear at the inquest in September 2005 of David Roberts and the Liverpool coroner remarked on this at the inquest.

Manchester Coroner called for a study of this drug yet other coroners have taken on board the manufacturers assertion that Roaccutane is not linked to suicides.

There is no evidence that Roaccutane is NOT linked to suicides and those that survive the depression and psychosis that hits them while taking Roaccutane are not convinced by the protestations of Roche. A recent analysis of USA FDA statistics for reports of suicide, showed the drug most linked to suicide in the FDA records was Roaccutane which is known in the USA as Accutane (isotretinoine)

The drug is derived from vitamin A which is well known for psychological adverse effects if given in high doses.
In the USA anyone taking the same drug known there as Accutane, is required to sign a disclaimer acknowledging the fact that they may become suicidal while taking it.

A recent study reported in The Guardian 19.09.06 supports the link to depression

ROACCUTANE STUDY IN MICE SHOWS LINK TO DEPRESSION

http://www.guardian.co.uk/medicine/story/0,,1875493,00.html

Animal tests show link between acne treatment and depression
September 19: Study provides first scientific evidence

The MHRA issued a WARNING IN THEIR PUBLICATION CURRENT PROBLEMS IN PHARMACOVIGILANCE August 1998
They stated that at that time 5% of all reported Adverse Drug Reactions (ADRs) were psychiatric.
Isotretinoin (Roaccutane)
Important precautions should be taken due to serious adverse reactions including teratogenicity and depression
Roaccutane is an oral preparation of isotretinoin, a derivative of Vitamin A. It was authorised in the UK in 1982 for the treatment of severe acne which has failed to respond to conventional antibiotic treatment.

Adverse reaction profile
Since 1982 we have received 841 suspected adverse drug reaction (ADR) reports for Roaccutane describing 1349 reactions.

Frequently reported reactions were:

• skin disorders (18% of total) e.g. rash, dry skin and photosensitivity.
• musculoskeletal disorders (11%) e.g. myalgia and arthralgia.
• gastrointestinal disorders (10%) e.g. cheilitis, abdominal pain and dry mouth.
• eye disorders (7%) e.g. conjunctivitis, dry eyes and blurred vision.
• neurological disorders (7%) e.g. migraine and convulsions.

Psychiatric disorders
Five percent of all reported ADRs to Roaccutane are psychiatric reactions including depression and rarely 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.

FDA Warning of suicide and depression risk issued in the USA June and December 2005 as follows:
FDA ALERT [7/2005]: Suicidal Thoughts or Actions: In addition to the strengthened risk management program, FDA continues to assess reports of suicide or suicide attempts associated with the use of isotretinoin. 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]

This information reflects FDA’s preliminary analysis of data concerning this drug. FDA is considering, but has not reached a final conclusion about, this information. FDA intends to update this sheet when additional information or analyses become available.

The previous Warning from the FDA Center for Drug Evaluation and Research stated:

ADVERSE REACTIONS
Neurological: pseudotumor cerebri (see WARNINGS: Pseudotumor Cerebri), dizziness, drowsiness, headache, insomnia, lethargy, malaise, nervousness, paresthesias, seizures, stroke, syncope, weakness

Psychiatric: suicidal ideation, suicide attempts, suicide, depression, psychosis (see WARNINGS: Psychiatric Disorders), emotional instability

Of the patients reporting depression, some reported that the depression subsided with discontinuation of therapy and recurred with reinstitution of therapy.

URGENT NEW WARNING FROM THE USA FOOD AND DRUG ADMINISTRATION Safety Information March 2nd 01. Accutane (Roacutane) Isotretinoin

http://www.fda.gov/medwatch/safety/2001/safety01.htm#accuta

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Research on psychiatric adverse reactions to the drug Roaccutane has revealed startling figures.

Roaccutane is prescribed for severe cystic nodular acne.

The manufacturer Roche originally after months of requests admitted they had 6 cases of suicide reported for this drug, this had risen to 26 cases of suicide in correspondence dated January l998.

Data from the World Health Organisation, which collects and records from individual drug monitoring agencies, differs from data supplied by Roche. This discrepancy in recorded reports of psychiatric ADR’s is being investigated.

The kind of response the researcher is getting from dermatologists is that depression is a common feature among people in the age group

15 - 25 and also that depression would be more prevalent among acne sufferers than non-acne sufferers. Roaccutane is considered the "wonder drug" and if depression does occur then it is attributed to the acne condition - the question of the drug causing the depression is never considered.

If depression was simply a reflection of the population in the age group

15 - 25 who suffered from acne one would expect the number of ADR reports for 5 or 6 of the other most frequently used acne medications to be similar to those for Roaccutane. The researcher found that Roaccutane had 500% more ADR’s than any of the other medications. In spite of the fact that the sale volumes for those other acne medications are much higher than those for Roaccutane.

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, have issued a warning to doctors headed Isotretinoin (Roaccutane) " Important precautions should be taken due to serious adverse reactions including teratogenicity and depression". The item goes on to say " 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".

If you have suffered a psychiatric adverse reaction to this drug please email us at reactions@april.org.uk