Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 January 2024

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Summary

PRAC highlights potential risk of neurodevelopmental disorders in children born to men treated with valproate medicines and recommends precautionary measures.

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Diseases / indications

• Epilepsy
• Neurodevelopmental Disorders

Drugs mentioned

• valproate medicines (valproate)

Snippet

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