§ Ms. Richardsonasked the Secretary of State for Social Services (1) if all the recommendations of the panel appointed to conduct the 1983 hearing on Depo Provera will be incorporated into the licensing agreement;
(2) what post-marketing surveillance of Depo Provera the licensing authority is recommending to the manufacturer;
(3) if the licence for short-term contraceptive use of Depo Provera with rubella vaccinations has been withdrawn;
(4) what measures are being taken to ensure that informed consent procedures on Depo Provera are drawn up and sent to doctors;
(5) if the recommendations of the Committee on Safety of Medicines in 1982 which were not covered in the recommendations of the panel on Depo Provera will be incorporated in the licensing agreement.
§ Mr. Kenneth ClarkeThe new data sheet for Depo Provera will incorporate in full the advice of the panel of persons appointed and the Committee on Safety of Medicines.
In addition to stressing the importance of a simple explanation by the patient's doctor of the benefits and likely side effects of the drug the panel made two recommendations which would help to ensure that women were informed of the possible risks of treatment. Firstly, that the company should insert in its product literature reminders to doctors of the importance of patient counselling. Secondly that the company should provide a leaflet written in simple lay terms which the doctor should give the patient. Both these recommendations are being implemented. Moreover, at my request the Chief Medical Officer of our Department will be writing to all doctors in England to underline the importance we attach to the panel's advice on the counselling of patients. Similar action is being undertaken in other parts of the United Kingdom.
Officials of our Department are discussing with the company the arrangements for post marketing surveillance following the grant of the licence for long term contraceptive use.
The panel made no recommendation relating to the uses of Depo Provera as a short term contraceptive and no change is proposed in relation to its currently licensed use in women who are being immunised against rubella. The product data sheet however will be revised to warn that because of the risk of heavy bleeding the drug should be used with caution in the puerperium.