§ Mr. Gareth WardellTo ask the Secretary of State for Health what evidence she has correlating defects in the newborn with the ingestion of sodium valproate during pregnancy.
§ Mr. SackvilleSodium valproate is a drug used in the treatment of epilepsy and like several other anti-epileptics is known to be teratogenic. Articles in the medical literature and spontaneous reports received by the Committee on Safety of Medicines indicate that there is an increased risk of birth defects in children whose mothers take anti-epileptics. In particular, the use of sodium valproate in early pregnancy is associated with neural tube defects. However, the risks to both mother and child of inadequate treatment of epilepsy during pregnancy are also well recognised and need to be balanced against the risk of birth defects. For this reason many women continue taking anti-epileptics during pregnancy.
The risk of birth defects with sodium valproate was drawn to the attention of doctors by the CSM in its bulletin, "Current Problems", No. 9, published in January 1983. A reminder was also issued in June 1993 in "Current Problems in Pharmacovigilance", Volume 19. Information on birth defects associated with the use of anti-epileptic treatment can also be found in the product data sheets produced by the manufacturers and authorised by the Licensing Authority, and in the British National Formulary which is sent free to all doctors. Copies of "Current Problems" are available in the Library.