Changes to Advice for Males on Valproate

The Medicines and Healthcare products Regulatory Agency (MHRA) has recently updated their advice for all males taking valproate. The new guidance now states: 

Male patients on valproate who are planning a family in the next year should talk to their healthcare professional about their treatment.

The update is linked to a study commissioned by the European Medicines Agency researching outcomes in children whose fathers took valproate at the time of conception. 

This study suggests there may be an increased risk of neurodevelopmental disorders in children fathered by men on valproate in the three months prior to conception compared with men on other antiseizure medicines.   

In the study, around 5 children in 100 born to fathers treated with valproate around conception were diagnosed with a neurodevelopmental disorder. This is compared to 3 in 100 children whose fathers were taking lamotrigine or levetiracetam around conception (two other anti-seizure medicines). This risk is much smaller than the risk associated with valproate in pregnancy. 

The results from the study are still being analysed by the MHRA, but in the meantime as a precaution, male patients on valproate who are planning a family in the next year are advised to talk to their healthcare professional about their treatment. 

New safety measures are due to be introduced in the coming weeks as part of the MHRA safety review launched in 2022 which also considered the views of patients and other stakeholders.  

The new measures mean that valproate must not be started in new patients (male or female) younger than 55 years, unless two specialists independently consider and document that there is no other effective or tolerated treatment, or there are compelling reasons that the reproductive risks do not apply.  

No one should stop taking valproate without advice from their healthcare professional. If you have any concerns please talk to your healthcare professional.