New UK regulations on sodium valproate for men come into force

New regulations on the prescribing of sodium valproate to men living with epilepsy will come into effect today (31 January).

This will be the first time that valproate prescribing restrictions will also apply to men and boys.

This comes in light of a recent review of the latest safety data by the Commission on Human Medicines (CHM).

A study submitted to the MHRA, and other regulatory bodies suggested an increased risk of neurodevelopmental disorders in children whose fathers took valproate during the three-month period before they were conceived.

This is compared to children whose fathers had taken the anti-seizure medications lamotrigine or levetiracetam.

The MHRA has also said that there may be a risk of reduced fertility in men and boys taking valproate.

In the UK, no one under the age of 55 will be newly prescribed sodium valproate unless two specialists agree there is no other effective or tolerated treatment or reproductive risks do not apply.

A recent study by the European Medicines Agency (EMA), also showed that 5 out of 100 children had a neurodevelopmental disorder when born to fathers treated with valproate, compared with 3 out of 100 when born to fathers treated by lamotrigine or levetiracetam.

However, the organisation said the study had some limitations, such as differences between patient groups and being too small.

It said that as a result it was not possible to confirm that this increased risk was caused by valproate, but that it was implementing the recommendations as a precautionary measure.

As a precaution, male patients on valproate who are planning a family this year should talk to their healthcare professional about their treatment.

No one should stop taking valproate without advice from their healthcare professional. Patients who have concerns should talk to their healthcare professional.


Epilepsy Scotland response

Epilepsy Scotland Chief Executive, Lesslie Young said: “Sodium Valproate has proven to be a highly effective medication in controlling seizures. Seizure control is vital to the physical and emotional wellbeing of people with epilepsy.

“Throughout 2023, we have raised concerns around the new sodium valproate regulations and expressed concerns when it came to their impact on patient safety and workability for healthcare professionals.

“We will continue to engage with the MHRA and others on this issue and continue to call for openness, evidence and positive opportunities for engagement and balanced messaging, so people can make a properly informed choice about their treatment and safety.

“We advise men living with epilepsy to talk to their healthcare professional about their treatment if they are looking to start planning a family.”