Potential risk of neurodevelopmental disorders in children born to men treated with valproate medicines: PRAC recommends precautionary measures

EMA’s safety committee (PRAC) is recommending precautionary measures for the treatment of male patients with valproate medicines. These measures are to address a potential increased risk of neurodevelopmental disorders in children born to men treated with valproate during the 3 months before conception. Valproate medicines are used to treat epilepsy, bipolar disorders and, in some EU countries, migraine.

To the risk information (available in German only)

Details of the PRAC recommendation can be found under the following link at the European Medicines Agency (EMA):