EMA recommends precautionary measures following review of study in children whose fathers were treated with valproate

Published: June 2023, Last updated: March 2024

The European Medicines Agency’s (EMA) safety committee (the Pharmacovigilance Risk Assessment Committee [PRAC]) has completed a review of results from a study to assess the risk of neurodevelopmental disorders (NDDs) in children whose fathers were treated with valproate during the three months before conception. Based on the outcome of this review, the PRAC is recommending precautionary measures for the treatment of male patients to address the potential risk of NDDs in children whose fathers are treated with valproate.  

Further information on the review and the precautionary measures are available within the EMA’s Public Health Communication.   

If you are a man being treated with valproate (Epilim ), do not stop taking your medicine without talking to your doctor, as your epilepsy or bipolar disorder could become worse. Sudden discontinuation of any treatment for epilepsy should be avoided as this may lead to seizures. 

The PRAC recommendations will now be sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) for adoption. Once a position is adopted, the marketing authorisation holder for Epilim in Ireland will apply to the HPRA to change the terms of their marketing authorisations (licenses) in accordance with the PRAC recommendations. Following HPRA approval, a Direct Healthcare Professional Communication and educational materials will be distributed. It is anticipated that these regulatory steps will be completed over the next several months.  

The latest PRAC recommendations come in addition to restrictions and other measures already in place to prevent exposure to valproate medicines in women during pregnancy due to the risk of congenital malformations (birth defects) and NDDs.