Precautionary measures to address potential risk of neurodevelopmental disorders in children born to men treated with valproate medicines

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Summary

EMA safety precautionary measures advise restricting valproate use in men prior to conception due to possible risk of neurodevelopmental disorders in their chil…

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Diseases / indications

• Bipolar Disorder
• Epilepsy
• Migraine

Drugs mentioned

• valproate medicines (valproate)

Snippet

On 24 January 2024, the 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.