19 gennaio 2024 – 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 three months before conception. Valproate medicines are used to treat epilepsy, bipolar disorders and, in some EU countries, migraine. The PRAC recommends that valproate treatment in male patients is started and supervised by a specialist in the management of epilepsy, bipolar disorder or migraine.

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