§ Mr. Loydenasked the Secretary of State for Social Services (1) what was the date of the withdrawal of the drug Osmosin in the United Kingdom;
(2) if he will make a statement on the adverse reports of the drug Osmosin;
(3) when the Committee on Safety of Medicines will consider the future of the drug Osmosin;
(4) how many Osmosin-related deaths have been reported;
442W(5) how many adverse reports were received on the drug Osmosin (a) to the end of June 1983 and (b) to the end of August 1983.
§ Mr. Kenneth ClarkeOsmosin is a sustained release formulation of indomethacin, an established analgesic available on prescription for the treatment of arthritis. The product was first marketed in this country in December 1982. In August of this year the Committee on Safety of Medicines drew doctors' attention to the relatively large number of adverse reaction reports in respect of Osmosin. On 1 September the manufacturer concerned ceased marketing Osmosin in all countries, including the United Kingdom. This followed similar action in Germany earlier the same day at the request of the German drug regulatory authority, pending an inquiry there into the drug's safety. I understand that all stocks of Osmosin have now been withdrawn from pharmacies in the United Kingdom. The safety of Osmosin is currently under consideration by the CSM.
The total number of all reports of adverse reactions associated with Osmosin received by the CSM at the end of June 1983 was 312 and at the end of August 519. The total of reports where the administration of Osmosin was considered to have led to the death of the patient was 7 at the end of June, 13 at the end of August and 24 at the latest available date. It should be stressed that these reports do not necessarily indicate a causal relationship in all cases.