§ Mr. Ashley
asked the Secretary of State for Social Services what were the numbers of adverse reactions to the drug Opren in each year it has been available in Great Britain, including the latest available figures; if he has recently received any additional information about this drug from the Committee on Safety of Medicines; and when he intends to reply to the letter from the right hon. Member for Stoke on Trent, South on issues relating to Opren.
§ Mr. Kenneth Clarke
I refer the right hon. Member to my replies to the hon. Member for Wolverhampton North-East, (Mrs. Short) on 13 May—[Vol. 23, c.307–8]—and 21 June—[Vol. 26, c. 29–30].292W
Up to the end of March 1982 the latest date for which precise figures are readily available, the Committee on Safety of Medicines (CSM) had received 2,773 reports of adverse effects suspected to have been associated with benoxaprofen (Opren). The vast majority of these reactions were not serious, for example, skin sensitivity, and resolved when treatment was discontinued. I must emphasise that the existence of these reports does not necessarily imply a causal relationship between the drug and the suspected reaction in all cases. Figures for each year since the drug was first marketed in 1980 are not readily available.
In view of the serious reactions reported recently to this drug I am asking the CSM to review its advice to the licensing authority.
I will reply as soon as possible to the right hon. Member's letter which I received on 6 July.