The drug, manufactured by Roche is marketed as Roaccutane in Europe and Accutane in the US.
In the UK the Medical Control Agency (MCA) released figures that since the introduction of Roaccutane in 1,795 adverse reactions have been recorded on their database, of which 23 were fatal, 14 being actual suicides. More than 200 of the adverse reactions were psychiatric with 20 reports of suicidal thoughts or suicide attempts. There were 80 reports of depression and 13 reports of mood swings. In the US there are believed to have been in excess of 500 suicides, attempted suicides and suicide ideation recorded for the drug.
It is licensed in the UK for use as a drug that should only be used for severe cystic acne, a treatment of “last resort” but some 74% of UK patients prescribed Roaccutane had mild or moderate acne according to a study among UK dermatologists.
There are over 40 independent studies published in medical journals linking the ingestion of the drug to the emergence of depression, psychosis and suicidal thoughts/actions.
Accutane should only be used for severe recalcitrant cystic acne as a treatment of last resort, in accordance with the license. We believe that more than 80% of patients prescribed Accutane have mild or moderate acne, which is in violation of the license. A study published by Cunliffe (Leeds University Hospital) involving survey of several hundred dermatologists showed that 74% of patients were prescribed Accutane for mild or moderate acne.
Patients should be psychiatrically assessed before and during Roaccutane treatment (for example by using the Hamilton scale of depression questionnaire) and in the event of an adverse reaction, the patient should be immediately taken off the treatment and the adverse event should be reported to the national health authority.