1 July 2019 - The PBS urgently needs to update anti‐epileptic drug prescribing restrictions that put patients and prescribers at risk
In May 2018, the European Medicines Agency banned the prescription of valproate to women of childbearing age for use in migraine and bipolar disorder unless they are enrolled in a special pregnancy prevention program. Its use in epilepsy is banned unless there is no other effective treatment available.
This follows numerous reports of a substantially increased, dose‐related risk of foetal malformations (in particular neural tube defects including spina bifida) in babies born to mothers exposed to valproate during pregnancy.