§ Dr. GibsonTo ask the Secretary of State for Health if he will make a statement on the safety of the acne/contraceptive drug Dianette. [20341]
§ Mr. BoatengDianette is a medicine authorised for use in the treatment of severe acne and moderately severe hirsutism in women only. It is considered to have an acceptable level of safety in relation to its benefits. A rigorous evaluation of quality, safety and efficacy of Dianette by the Licensing Authority and its expert advisory body, the Committee on Safety of Medicines (CSM) was carried out before a marketing authorisation was granted in 1987.
As for all medicines, Dianette has side-effects, and the Medicines Control Agency (MCA) and CSM continue to monitor its safety. If new relevant evidence comes to light this is reviewed in order to ensure the risk of possible side-effects is outweighed by the benefits. Information on how to use Dianette, including its side effects and precautions in use, is available to health care professionals and to patients through the manufacturer's product information authorised by the MCA and in the British National Formulary, copies of which are available in the Library.