HC Deb 23 January 2002 vol 378 c966W
Paul Flynn

To ask the Secretary of State for Health what assessments she has made of the adequacy of the warning of the side effects of(a) roaccutane and (b) antidepressants; and what is his estimate of the effects of both. [28118]

Jacqui Smith

[holding answer 17 January 2002]: The safety of all medicines on the United Kingdom market is continuously monitored by the Medicines Control Agency and the independent advisory body, the Committee on Safety of Medicines (CSM). 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.

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.

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.

Two major classes of antidepressant are the Selective Serotonin Re-uptake Inhibitors (SSRIs) and the Tricyclic Antidepressants. The safety profiles of SSRIs and TCAs are well-established and are reflected in the product information for prescribers and patients. MCA/CSM carried out a major review of the safety profile of SSRIs, which was completed in 2000 and resulted in product information being updated and an article being published in the drug safety bulletin "Current Problems in Pharmacovigilance".