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EMA Probe Into Paternal Valproate Exposure Risk Continues After ‘Errors’ Found In Study

 
• By Eliza Slawther

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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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.

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• By Eliza Slawther

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More from Geography

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• By Kevin Grogan

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