18/06/2026
EMA Holds Precautions Despite Mixed Evidence.
Unresolved Evidence Drives Continued Caution:
The most recent review was triggered in July 2025 after publication of a Danish nationwide registry-based study that found no increased NDD risk in children born to men treated with valproate. In reassessing the full evidence base, PRAC concluded that differences in study design — including patient selection criteria and approaches to controlling for underlying health conditions — probably account for much of the variation in findings.
PRAC could not determine whether a potential risk for NDDs in children of fathers treated with valproate before conception results from valproate or other factors, such as the fathers’ underlying medical condition. In light of remaining uncertainties and pending results of an ongoing study expected in 2028, PRAC agreed that precautionary measures introduced in 2024 should remain in place.
EMA has found inconsistent data on developmental disorders in children of fathers using valproate before conception and retains existing precautions.