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EMA Recommends Precautions When Prescribing Valproate for Men

 
• By Ian Schofield

Despite the limitations of a retrospective study of the risks of neurodevelopmental disorders in children whose fathers took valproate medicines, the EU drugs regulator has advised caution when prescribing the product to male patients.

pencil erasing word risk
Regulators are trying to mitigate the risks of using valproate • Source: Shutterstock

The EU’s pharmacovigilance committee, the PRAC, has recommended precautionary measures to avoid the potential increased risk of neurodevelopmental disorders (NDDs) in children born to men treated with valproate products during the three months before conception.

The committee says that treatment with valproate in male patients should be initiated and supervised by a specialist in managing epilepsy, bipolar disorder or migraine, and that doctors should inform...

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