New safety advice for valproate use in men

Men taking valproate are being advised to use effective contraception during valproate treatment and for at least three months after stopping valproate.

New MHRA safety advice follows research that reports a possible association between valproate use by men and a small increased risk of a range of neurodevelopmental disorders in their children (aged 0 to 11 years) when compared to men prescribed lamotrigine or levetiracetam.

Around five out of 100 children had a neurodevelopmental disorder when born to fathers treated with valproate compared with around three out of 100 when born to fathers treated with lamotrigine or levetiracetam. According to the MHRA, these results warrant action on a precautionary basis.

In addition, patients should not donate sperm during treatment with valproate and for three months after stopping valproate.

Healthcare professionals should inform male patients about this newly identified risk at their next routine treatment review. For those patients wishing to change their treatment the MHRA recommends that priority be given to male patients who are planning to father a child in the next year.

Patients should not stop taking valproate without advice from a specialist because of the importance of keeping their condition under control. 

Clinical guidance news MHRA