§ Tim Loughton
To ask the Secretary of State for Health what assessment he has made of the possible side effects of the anti-acne drug Roaccutane. 1326W
§ Mr. Lammy
[holding answer 24 May 2002]: Roaccutane (isotretinoin) is licensed for the treatment of severe forms of acne. It has been associated with a number of serious side effects since evaluation of the clinical trial data at the time of licensing in 1982. These include dryness of the skin, eyes and mucous membranes, visual disturbances, liver disorders and increases in cholesterol levels.
The safety of all medicines on the UK market is continuously monitored by the medicines control agency. The product information includes the summary of product characteristics for prescribers and the patient information leaflet included in each pack of the medicine. These are also kept under continuous review to make sure that they provide the most up to date and relevant information to healthcare professionals and the public regarding the safe use of the medicine.
One of the key previous amendments to the product information was the strengthening of the warning relating to depression and other psychiatric reactions including suicide, which was approved in March 1998. The Committee on Safety of Medicines considered the issue of the Roaccutane and psychiatric reactions in September 2001 and advised that the existing wording adequately reflected the current level of knowledge with regard to these reactions.