EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) is reviewing data on the potential risk of neurodevelopmental disorders (NDDs) in children conceived by fathers taking valproate medicines.
The review is focussing on data from a retrospective observational study conducted by companies as an obligation following a previous review of valproate use during pregnancy.
This retrospective observational study compared the risk of NDDs (including autism spectrum disorder) in children born to men taking valproate with the risk in children born to men taking lamotrigine or levetiracetam (other treatments for epilepsy). It was carried out using multiple registry databases in Denmark, Norway and Sweden.
Initial results of the study may indicate an increased risk of NDDs in children born to men taking valproate in the three months before conception. However, the PRAC has identified important limitations with the data from the study…
