§ Mr. FlynnTo ask the Secretary of State for Health what reports he has received of adverse reactions following the use of the anti-acne drug Roaccutane/ Accutane; and if he will make a statement. [42061]
§ Ms JowellIn England, there have been more than 11,000 prescriptions for Roaccutane since 1987, the first year for which data are available. During this period, the Medicines Control Agency/Committee on Safety of Medicines have received a total of 625 reports covering 1,025 suspected adverse reactions associated with Roaccutane treatment in the United Kingdom. These reports cover a wide range of effects: the most frequently reported include skin and subcutaneous tissue reactions, musculoskeletal disorders and gastrointestinal disorders.
Roaccutane (oral isotretinoin) is available only on prescription for the treatment of severe acne which has failed to respond to antibiotics. It is recommended for use under the supervision of a consultant dermatologist. The product information for doctors and patients includes information on its adverse effects.