HC Deb 22 October 1984 vol 65 cc506-7W
Mr. Ashley

asked the Secretary of State for Social Services what studies the Committee on Safety of Medicines has considered since 1980 which give a reliable indication that Debendox could be a teratogenic agent with a probability of danger to the foetus in excess of in 100.

Mr. Ashley

asked the Secretary of State for Social Services whether, in its eight considerations of the drug Debendox, the Committee on Safety of Medicines found any scientifically acceptable evidence that Debendox is a low grade teratogen.

Mr. Kenneth Clarke

None of the studies considered by the committee indicates that Debendox might carry a teratogenic risk.

Mr. Ashley

asked the Secretary of State for Social Services whether the Committee on Safety of Medicines considered together or separately the three studies considered by the American Food and Drug Administration which investigated the relationship between the use of Debendox (Bendectin in the United States of America) and the occurrence of pyloric stenosis in infants, and which led the Food and Drug Administration in its Drug Bulletin, volume 13, No. 2, to express concern.

Mr. Kenneth Clarke

The Committee considered the 1982 Report by Eskenazi and Bracken. The FDA Bulletin, reporting preliminary results by the Boston collaborative drug surveillance programme and the findings of a recent study by the drug epidemiology unit of Boston university, were issued after production of Debendox ceased in June 1983.