On 24 January 2024, the CMDh  endorsed precautionary measures recommended by EMA’s safety committee (PRAC) for the treatment of male patients with valproate medicines. These measures are to address a potential increased risk of neurodevelopmental disorders in children born to men treated with valproate during the 3 months before conception. Valproate medicines are used to treat epilepsy, bipolar disorders and, in some EU countries, migraine.

It is recommended that valproate treatment in male patients is started and supervised by a specialist in the management of epilepsy, bipolar disorder or migraine.

Doctors should inform male patients who are taking valproate about the possible risk and discuss the need to consider effective contraception, for both the patient and their female partner. Valproate treatment of male patients should be reviewed regularly to consider whether it remains the most suitable treatment, particularly when the patient is planning to conceive a child.

The potential risk of neurodevelopmental disorders and the precautionary measures will be reflected in updates to the product information and educational material for valproate medicines.

Following the adoption of the PRAC recommendations by the CMDh, these measures will now be implemented in all Member States where valproate-containing medicines are authorised.