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

The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) endorsed precautionary measures recommended by EMA’s safety committee (PRAC) 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.

Further information:

To the risk information (available in German only)

Details on the procedure can be found on the website of the European Medicines Agency (EMA):