§ Mrs. GillanTo ask the Secretary of State for Health when the Medical Control Agency will report on the effects of the drug Roaccutane; and if he will make a statement. [73141]
§ Mr. LammyRoaccutane (isotretinoin) is licensed for the treatment of conglobate and cystic acne and severe acne which has failed to respond to antibiotics.
The Medicines Control Agency (MCA) is currently leading a European-wide review of the safety of Roaccutane, which will consider the balance of risks and benefits and will aim to ensure that up to date and consistent information is provided to health professionals and patients to optimise its safe use. This is likely to take several months.
The safety and side effects of all medicines on the United Kingdom market are continuously monitored by the MCA with independent expert advice from the committee on safety of medicines. The side effects known or suspected to be caused by Roaccutane are listed in the product information which is produced by the manufacturer and authorised by the licensing authority. The product information consists of a summary of product characteristics for healthcare professionals and a patient information leaflet.