HC Deb 07 March 1984 vol 55 cc631-2W
Mr. Ashley

asked the Secretary of State for Social Services if he will list the non-steroidal anti-inflammatory drugs which have been withdrawn in the last five years; whether it was a company decision or a response to a request from the Committee on Safety of Medicines; and, for each drug, how long it was on the market and what was the approximate number of prescriptions dispensed.

Mr. Kenneth Clarke

[pursuant to his reply, 27 February 1984, c. 75–76]: Of the non-steroidal anti-inflammatory drugs that may be suppled only on prescription, four have been withdrawn from the market following concern about their safety during the last five years. The information requested about them is as follows.

Opren The product was marketed for 22 months and approximately 1½ million prescriptions were issued for it. The product licence was suspended by the Licensing Authority following advice from the Committee on Safety of Medicines (CSM).

Zomax The product was marketed for 23 months and approximately 900,000 prescriptions were issed for it. It was withdrawn by the manufacturer following discussions with officials of the Licensing Authority.

Osmosin The product was marketed for 10 months and approximately 400,000 prescriptions were issued for it. The product was withdrawn by the manufacturer following discussions with officials of the Licensing Authority.

Flosint The product was marketed for 12 months and approximately 120,000 prescriptions were issued for it. The product licence was suspended by the Licensing Authority.

In the case of Opren and Osmosin the CSM had already warned doctors of the possible dangers attaching to these drugs before they were withdrawn. In the case of Zomax and Flosint urgent action was taken by the licensing authority in the light of new information not previously available to the CSM.