The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) completed its review of the risk of neurodevelopmental disorders in children exposed to valproate in the womb. PRAC has recommended strengthening the restrictions on the use of valproate. In particular PRAC has recommended that valproate 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 and that the need for continued treatment should be reviewed regularly. The PRAC recommendations will now be sent to the Member States’ Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) for a final opinion in November. Healthcare professionals and patients will be informed of the new advice once the CMDh has reached a final opinion.