The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) is currently evaluating data on the potential risk of neurodevelopmental disorders in children conceived by fathers taking valproate-containing medicines.

The evaluation focuses on data from a retrospective observational study. This had to be carried out by pharmaceutical companies following the risk assessment procedure completed in 2018 to review the use of valproate during pregnancy. Further details on the study are published in the HMA-EMA Catalogues of real-world data sources and studies (former ENCePP Resources Database) under the number 34201.

To the risk information (full text available in German only)