Valproate and developmental disorders: new alert asking for patient review and further consideration of risk minimisation measures

Babies born to mothers who take valproate medicines (Epilim▼, Depakote▼) during pregnancy have a 30–40% risk of developmental disability and a 10% risk of birth defects. Despite communications to prescribers in January 2015 and February 2016 on the magnitude of this risk and the actions to take, there is evidence that women are still not aware of the risk. Patient Safety Alerts have now been issued asking all organisations to undertake systematic identification of women and girls taking valproate. A new European review is considering whether further regulatory action is necessary and there will be a public hearing at the European Medicines Agency later in 2017.