MHRA Valproate warning review

Strengthened warnings mooted

By Ailsa Colquhoun

The MHRA is considering updating the warnings for valproate to girls and women.

The potential new wording may recommend that valproate medicines should not be used to treat epilepsy and bipolar disorder in girls, women who can become pregnant or pregnant women unless other treatments are ineffective or not tolerated.

The review follows a decision by the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA). The recommendations will now be sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) for a final opinion.

There are already strong warnings contained in product information for patients and prescribers on the potential for birth defects and developmental disorders in children born to women taking valproate during pregnancy.