2376 - Epilepsy: Drugs (Answered)

Fiona Bruce
To ask the Secretary of State for Health, what assessment he has made of the clarity and accuracy of warnings on anti-convulsant drugs for women with epilepsy who are also pregnant on the risk of developmental disorders and birth defects associated with the use of such drugs.

George Freeman

In 2013 the Medicines and Healthcare products Regulatory Agency (MHRA) initiated a Europe-wide review of the risk of developmental problems in children born to mothers who take the anticonvulsant drug valproate in pregnancy. This followed the publication of new studies providing further clarity and accuracy on the risk of neurodevelopmental disorders in children of mothers who took valproate in pregnancy.

As a result of this assessment the MHRA has better defined the size and nature of the risk of developmental disorders in updated product information for healthcare professionals and patients. The MHRA recommend that valproate should not be used in girls, women who can become pregnant or pregnant women unless other treatments are ineffective or not tolerated and that the need for continued treatment should be reviewed regularly.

There is now a mandatory requirement for all manufacturers to include the very latest information about the known risks of sodium valproate to the unborn child. The product information for healthcare professionals and patients has been updated to contain strengthened warnings about use in pregnancy and in women of child bearing age. New educational materials have been produced for use by healthcare professionals and patients that further highlight warnings of the risk of sodium valproate to the unborn child.