§ Lynne Jones
To ask the Secretary of State for Health what discussions he has had with the Medical Control Agency about greater controls on the use of Roaccutane and better information on the packaging of this drug. 421W
§ Ms Blears
Roaccutane (isotretinoin) is licensed only for the treatment of very severe and disfiguring forms of acne. Roaccutane is a prescription only medicine and the terms of the marketing authorisation specify that it must be prescribed by, or under the supervision of, a consultant dermatologist. In addition, the supply of Roaccutane is restricted to hospitals or specified retail pharmacies. It is rare for the licensing authority to restrict prescription and supply in this way.
The safety of all medicines on the United Kingdom 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.
The product information for Roaccutane was last updated in June 2001 with regard to warnings and possible side effects. 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.