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 such patients about the possible risks and discuss the
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