PRAC concludes evidence of potential risk of neurodevelopmental disorders in children born to men treated with valproate is inconsistent  

Committee recommends updating product information to reflect available data 

EMA’s safety committee, the PRAC, has completed its review of a safety signal for valproate and related substances, and concluded that based on the evaluation of new data, the evidence on neurodevelopmental disorders (NDDs) in children born to men treated with valproate is inconsistent and the causal role of valproate is uncertain. In light of this uncertainty, the committee recommended maintaining existing precautionary measures for male patients. These measures were put in place in 2024 to address a potential increased risk of NDDs in children born to men treated with valproate during the three months before conception.

In addition, PRAC recommended that the medicines’ product information be updated to reflect the most recent data related to…