Valproate medicines are used for treating epilepsy and bipolar disorder. It has been known for some time that using anti-epileptic medicines in pregnant women increases the risk of birth defects in their children and that valproate medicines may be associated with a higher risk of certain birth defects than other anti-epileptic medicines. It has also been known that development may be delayed in children born to women who were treated with valproate medicines during pregnancy. The product information for valproate medicines in the EU contains information on their use during pregnancy.
The review of valproate medicines has been requested by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) following the publication of new studies suggesting that in some children problems in development, which can include autism, may be long-lasting. The MHRA also noted that there was a need to update the product information of these medicines to bring them in line with current evidence.
The European Medicines Agency will now review the available data on the benefits and risks of valproate and related substances and issue an opinion on the use of these medicines in pregnant women. ”