MHRA - Medicines and Healthcare products Regulatory Agency

05/09/2024 | Press release | Distributed by Public on 05/09/2024 13:44

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

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.

Get emails about this page

Documents

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

PDF, 782 KB, 64 pages

This file may not be suitable for users of assistive technology.

Request an accessible format.
If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email [email protected]. Please tell us what format you need. It will help us if you say what assistive technology you use.

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.

Updates to this page

Published 5 September 2024

Sign up for emails or print this page

Get emails about this page
Print this page

Explore the topic