Valproate's hidden danger: Fathers' use linked to child developmental risks

New warnings have been issued about valproate, a drug commonly used to treat epilepsy and bipolar disorder. A study from France shows that men taking the medication before conceiving a child may increase the risk of neurological developmental disorders in their offspring. The findings have led to stricter guidelines across Europe.

The European Medicines Agency (EMA) took action on February 19, 2024, after reviewing data from 2.8 million children. Among them, 4,773 had fathers who took valproate within three months before conception. These children faced a 24% higher risk of neurological developmental disorders compared to those whose fathers did not take the drug.

The most significant increase was seen in intellectual disabilities, with the risk nearly doubling. ADHD and autism risks also rose sharply when fathers used valproate before conception. The EMA now requires specialists to oversee valproate prescriptions for men, ensuring close monitoring.

Under the new measures, male patients must be informed of the potential risks to their future children. They are also required to use effective contraception during treatment and for at least three months after stopping the drug. Doctors must regularly reassess whether valproate remains the best option, particularly if pregnancy is planned.

Germany already restricts valproate use due to risks during pregnancy. The latest warnings extend these precautions to men, ahead of stricter French regulations set for 2025.

The EMA's updated guidelines aim to reduce risks linked to valproate use in men. Specialists will now oversee prescriptions, and patients must follow contraception rules. The changes follow clear evidence of higher neurological disorder risks in children whose fathers took the drug before conception.