§ Mr. Alan Williams
asked the Secretary of State for Social Services when he first received reports suggesting a link between the drug Epilim and congenital defects; what assessment he has made of the findings of the report in the 11 December 1982 edition of The Lancet in this connection; whether he has taken any steps as a result and when; and if he will make a statement.
§ Mr. Geoffrey Finsberg
When a product licence for Epilim (sodium valproate), which is used in the treatment of epilepsy, was granted in 1972 it was known that the drug had caused congenital abnormalities in animals. A warning of this fact and the need to balance the benefit of treatment against possible risks in women of childbearing age was included in the product literature circulated to doctors. Similar warnings are given in the product literature of other drugs in this class.
The Committee on Safety of Medicines has considered recent reports in the professional literature including the report in The Lancet which suggested that sodium valproate was associated with congenital abnormalities in man. The committee concluded that there was no clear evidence that this drug was safer or more dangerous in this respect than other similar drugs used in the treatment of epilepsy, a serious disease which itself is associated with a higher incidence of congenital abnormalities. The committee's advice to doctors on this point has just been published in "Current Problems No. 9". A copy is available in the Library.