§ Mr. Gareth Wardell
asked the Secretary of State for Social Services (1) if he will take steps to secure the inclusion in the British data sheet for Epilim of the psychiatric adverse reactions currently included in the United States Food and Drugs Agency data sheet;
(2) if he will take steps to secure the inclusion in the British data sheet for Epilim of the precautions regarding infertility currently included in the United States Food and Drugs Agency data sheet.
§ Mr. Kenneth Clarke
[pursuant to the reply, 21 January 1985, c. 324–5]: For prescription medicines such as Epilim, the product licence holder is responsible for producing a data sheet which must state, amongst other things, any essential warnings that the licensing authority included on the licence. If subsequently it is considered that additional warnings are necessary on grounds of safety, these can be added either voluntarily by the licence holder or, under the procedure of the Medicines Act, compulsorily by the licensing authority. The warnings issued by licensing authorities in other countries are taken fully into account by the licensing authority but are not in themselves conclusive grounds for altering the United Kingdom licence.
The licence holder of Epilim is currently reviewing the psychiatric adverse reactions reported in association with Epilim and, in the light of the evidence available and in consultation with the licensing authority, will be considering amendments to its data sheet.
Neither the licensing authority nor the licence holder has evidence of any effects on fertility that would justify an amendment to the data sheet.