Valproát – riziko pro děti léčených mužů je nejasné

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency completed a review of valproate safety regarding the risk of neurodevelopmental disorders in children born to men treated with this medication. Available evidence is inconsistent and a causal relationship with treatment has not been confirmed. Valproate is used to treat epilepsy, bipolar disorder, and in some countries for migraine prevention. In January 2024, a study based on registers from Denmark, Norway, and Sweden suggested a possible increased risk, but in July 2025, a new Danish study did not find this increased risk. While awaiting results of a larger study expected in 2028, preventive measures from 2024 remain in place, including the recommendation to use effective contraception during treatment and for 3 months after its discontinuation. PRAC recommended updating product information to reflect the latest findings.