HC Deb 22 October 1982 vol 29 cc231-2W
Mrs. Renée Short

asked the Secretary of State for Social Services if he will hold an inquiry as to why it took the Committee on Safety of Medicines so long to suspend the drug Opren from use, in view of the number of complaints about side effects and deaths that had been reported; and if he will make a statement.

Mr. Kenneth Clarke:

No. I am satisfied that the Committee on Safety of Medicines maintained a close scrutiny of the adverse reactions to Opren and that there was no avoidable delay prior to the suspension of the product licence.

Mrs. Renée Short

asked the Secretary of State for Social Services if the Committee on Safety of Medicines has yet completed its investigations into the adverse effects of Opren, in view of the fact that the drug was suspended from use in August; and if he will make a statement about its future use.

Mr. Kenneth Clarke:

Following the suspension of the product licences for Opren by the licensing authority the company concerned, Dista Products Ltd., voluntarily

surrendered its licences on 1 September 1982 and recalled all stocks of the product. The Committee on Safety of Medicines has not, therefore, been required to advise the licensing authority further on the safety of this drug.