2378 - Epilepsy: Drugs (Answered)

Fiona Bruce
To ask the Secretary of State for Health, what information the Government gave to doctors and patients about the risks for unborn children of taking certain anti-convulsant drugs in pregnancy prior to the warning issued by the Medicines and Healthcare Products Regulatory Agency in January 2013.

George Freeman

The warning issued in January 2013 by the Medicines and Healthcare products Regulatory Agency (MHRA) related specifically to the new data that became available on the risk to the unborn child of using valproate during pregnancy. Prior to the warning issued by the MHRA in January 2013, the product information for valproate has contained warnings about the teratogenic potential of the drug in animals and the possible hazard to women of childbearing age since the early 1970s. As new data has come to light the product information has been regularly updated to include the known risk of birth defects in humans and the risk of developmental delay and autistic spectrum disorders.