2379 - Pregnancy: Sodium Valproate (Answered)

Fiona Bruce
To ask the Secretary of State for Health, what information he has on whether his Department had knowledge prior to 2000 of the fact that the anti-convulsant drug Epilim, Sanofi Aventis, known previously as Sanofi Pharma, was potentially teratogenic to foetuses.

George Freeman

The information available for Epilim in 1974 contained a warning that the compound was known to be teratogenic in animals and that any known hazards should be balanced against benefit when used in human pregnancy.

In January 1983 the Committee on Safety of Medicines published warnings about reported increase of incidence of congenital malformations in association with sodium valproate; this was based mainly on various epidemiological studies. Further advice was published in June 1993 in relation to an increased risk of neural tube defects associated with sodium valproate, the need to inform women of the potential consequences and for healthcare professionals to refer the patient to an appropriate specialist, in addition to ensuring that appropriate screening is in place.