Babies born to mothers who take valproate medicines (Epilim and Depakote) during pregnancy have a 30-40% risk of developmental disability and a 10% risk of birth defects.
Despite communications sent out by the MHRA 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 being informed of the risk.
Patient Safety Alerts were issued in 2017 asking all organisations to systematically identify women and girls taking valproate. A European review is considering whether further regulatory action is necessary and is due to complete in Spring 2018.
Our resource page on sodium valproate use in women and girls of childbearing years links to joint RCPCH and British Paediatric Neurology Association (BPNA) guidance.
Our Medicines for Children website provides three age-appropriate patient information leaflets on sodium valproate. These cover how to give the medicine and also the risk of harm to a developing baby during pregnancy. These information leaflets are available to share with patients, or with younger patients’ parents or carers.