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

Review of results from a Scandinavian post-authorisation safety study (PASS)

PDF, 783 KB, 65 pages

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Details

Post-publication note – December 2024

This Public Assessment Report has been updated to improve clarity on the estimated level of valproate in maternal plasma following exposure via seminal fluid and the level of valproate in the maternal plasma following a standard dose of valproate.

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