§ Mr. Ashley
asked the Secretary of State for Social Services (1) if he will give the number of cases reported to the Committee on Safety of Medicines of the congenital abnormality in babies born in (a) 1979 and (b) 1980 to mothers who were prescribed Debendox during pregnancy;
(2) what action has been taken by the Committee on Safety of Medicines to validate the reports it has received of congenital abnormality in babies born to mothers who had been prescribed Debendox; for what percentage, what further information has been sought; and what methods were used.
§ Sir George Young
The number of reports received by the Committee on Safety of Medicines of babies with congenital abnormalities born in 1979 and 1980 to mothers who were prescribed Debendox during their pregnancy is as follows:
1979 28 1980 (to 30 June) 19
Reports on suspected adverse reactions to Debendox are followed up in the same 213W way as reports on other medicinal products as described in my hon. Friend's reply to the right hon. Gentleman on 9 July.—[Vol. 988, c. 188.] I can add nothing useful to that reply.