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EMA safety_alert · 2024-01-12

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

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Summary

PRAC recommends precautionary measures for men treated with valproate medicines due to potential risk of neurodevelopmental disorders in their children.

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Diseases / indications

Drugs mentioned

  • valproate medicines (valproate)

Snippet

EMA’s safety committee (PRAC) is recommending precautionary measures for the treatment of male patients with valproate medicines.