Written question asked by Baroness Ford (Labour), in the House of Lords. It was answered by Earl Howe (Conservative) on Thursday, 30 June 2011.

Health: Drugs

Question: To ask Her Majesty’s Government whether the guidance for the use of valproate drugs in pregnant women has been reviewed in the past 12 months.

Answer: The product information for prescribers, (the summary of product characteristics) and the patient information leaflet for all antiepileptic medicines, including sodium valproate, contain clear warnings about the safety of use during pregnancy and the potential risk of birth defects. The valproate product information was recently reviewed at a European level and considered to reflect the available evidence in relation to safety of its use in women who are pregnant or of child-bearing potential. The British National Formulary also contains advice about the use of antiepileptic medicines during pregnancy. The National Institute for Health and Clinical Excellence has published a clinical guideline covering the diagnosis, treatment and management of epilepsies in adults and children in primary and secondary care, which includes the treatment and management of epilepsy in pregnancy. A partial update to this guideline is ongoing covering the pharmacological management of epilepsy in adults and children including women who are pregnant or of child-bearing age.

Secondary information