New Research Questions Safety of Paternal Valproate Use and Neurodevelopmental Risks

A recent study conducted by researchers at Aarhus University and Aarhus University Hospital has provided new insights into the safety of paternal valproate use during spermatogenesis. The study found no evidence of an increased risk of neurodevelopmental disorders in children fathered by men treated with valproate. These findings were published in JAMA Network Open and bring attention to the European Medicines Agency's (EMA) recent precautionary recommendations.

In January 2024, EMA advised caution for treating male patients with valproate, citing a report by IQVIA that suggested potential risks. However, subsequent analysis by the Aarhus research team, which re-evaluated their extensive register-based dataset with methods aligned closely with IQVIA’s definitions, did not support the initial concerns. Their additional analyses confirmed that there was no statistically significant increase in neurodevelopmental issues in children of fathers who used valproate.

The conflicting results between studies have raised calls for greater transparency from the involved research groups, including the publication of analytical code and thorough peer review of the IQVIA study. Experts from Aarhus emphasize that measures based on weak or unconfirmed scientific evidence could lead to unnecessary anxiety among patients and healthcare providers.

"We have examined this issue from multiple perspectives and still find no support for the concerns underlying EMA’s guidelines," stated Jakob Christensen, a neurologist at Aarhus University Hospital.

The study underscores the importance of scientific rigor and transparency when implementing precautionary health measures, especially those that influence patient treatment protocols. Further research and open discussion are recommended to ensure decisions are evidence-based and do not cause unwarranted patient worry.

Source: https://medicalxpress.com/news/2025-05-precautionary-paternal-valproate.html