Neurodevelopmental Disorders
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EMA safety_alert · 2026-06-12Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 June 2026
PRAC evaluated new data on potential risk of neurodevelopmental disorders in children born to men treated with valproate.
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EMA safety_alert · 2024-01-12Potential risk of neurodevelopmental disorders in children born to men treated with valproate medicines: PRAC recommends precautionary measures
PRAC recommends precautionary measures for men treated with valproate medicines due to potential risk of neurodevelopmental disorders in the…