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.
EMA Probe Into Paternal Valproate Exposure Risk Continues After ‘Errors’ Found In Study
Initial results from a study indicate that children born to men taking valproate medicines are at an increased risk of having neurodevelopmental disorders, but “important limitations” and “errors” with the data highlight the need for further analysis.
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