New measures introduced to address concerns around epilepsy drug use in men


The inquiry into the use of valproate among pregnant women in Ireland remains without a chair six months after being announced. Precautionary steps are being introduced regarding the prescribing of sodium valproate to men due to potential increased risk of neurodevelopmental disorders in children. The European Medicines Agency advised new precautionary measures, including specialized supervision, effective contraception, regular reviews, and discouragement of sperm donation during and after treatment. A Nordic study found an increased risk of neurodevelopmental disorders in children born to fathers treated with valproate, but a causal association was not confirmed. The risks of valproate to pregnant women and their children are well-established, leading to the announcement of a non-statutory inquiry into its regulation and prescription in Ireland.

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