HC Deb 21 June 1982 vol 26 cc29-30W
Mrs Renée Short

asked the Secretary of State for Social Services (1) pursuant to his reply to the hon. Member for Wolverhampton, North-East on 13 May, Official Report, c. 307, how many patients using the drug Opren—benoxaprofen—have died, with their deaths linked to the drug; and what was the cause of death in each case;

(2) whether the Committee on Safety of Medicines has yet completed its consideration of the adverse reactions associated with the drug Opren—benoxaprofen—and what advice it is now giving.

Mr. Kenneth Clarke

Up to the end of March 1982—the latest date for which figures are readily available—the Committee on Safety of Medicines had received reports of 28 cases in which benoxaprofen was suspected of causing an adverse reaction and the patient had died. The adverse reaction reported in these cases were:

Number
Skin disorders 3
Gastro-intestinal disorders 17
Liver disorders 2
Blood disorders 4
Kidney disorders 2

It is emphasised that the existence of these reports does not necessarily imply either a casual relationship between drug and reaction in all cases, or that death was clue to the adverse reaction.

In addition, recent reports in professional literature have documented a further eight cases in which deaths from liver or kidney failure were suspected to be associated with treatment with benoxaprofen. The CSM is aware of these reports.

Nearly all the deaths associated with treatment with benoxaprofen have occurred in elderly patients, many of whom were also receiving other medical treatment. Following consideration of these reports and other data, the CSM has advised, and the company concerned has agreed, that in patients over the age of 65 the daily dose should not normally exceed 300mg—half that otherwise recommended. It had previously been agreed that benoxaprofen should be contra-indicated for patients with active peptic ulceration. Product information is being amended to reflect this advice and is expected to be posted to all prescribing doctors within the next week.