The European Medicines Agency’s pharmacovigilance committee, PRAC, is reviewing data from a retrospective observational study it commissioned to investigate the potential increased risk of neurodevelopmental disorders (NDDs) in children born to men who took valproate medicines in the three months prior to the child’s conception.
Initial results from the study, which compared the risk of NDDs in children conceived by men taking valproate compared to children conceived by men taking alternative epilepsy treatments lamotrigine or...