Research and analysis

Valproate: Paternal exposure to valproate and risk of neurodevelopmental disorders and congenital malformations in offspring

Public Assessment Report of review of results of a post-authorisation safety study on paternal exposure to valproate.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 5 September 2024

Documents

Valproate: Paternal exposure to valproate and risk of neurodevelopmental disorders and congenital malformations in offspring

PDF, 782 KB, 64 pages

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Details

This report presents the review of the results of a study on the potential risk to children born to men who took valproate in the 3 months before conception, and the steps that the MHRA are taking to implement new safety measures in consultation with the clinical community and other stakeholders.

Published 5 September 2024