The European Medicines Agency (EMA) has announced precautionary measures for prescribing valproate to men with epilepsy.
The measures follow those made by UK regulatory body the Medicines and Healthcare products Regulatory Agency (MHRA).
The European regulations are less strict than those made by the MHRA. 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.
In the EU, doctors will continue to be able to prescribe valproate following these recommendations:
- Valproate prescriptions for men should be supervised by a specialist
- Men should be informed of the potential risk of neurodevelopmental disorders for future children
- Doctors should discuss the need to consider effective contraception, including for female partners, while using valproate and for at least three months after stopping treatment
- Men should undergo regular reviews with doctors to assess if valproate remains the most appropriate treatment
- Men should be advised not to donate sperm while taking valproate
- Men should be given a patient card with their medicine, reminding them of the potential risks of using valproate.
The EMA is a European Union committee responsible for assessing medicines for humans. It said the recommendations were the result of a review by its Pharmacovigilance Risk Assessment Committee.
The review followed a study from Norway, Denmark and Sweden, which looked at the association between fathers’ exposure to valproate and the risk of neurodevelopmental disorders, including autism, and congenital malformations, in children.
According to the EMA, the study 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 with 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.
The UK regulations come into effect on January 31.
Speaking when the MHRA announcement was made in November 2023, Epilepsy Action chief executive Philip Lee said: “We hope that all people with epilepsy affected by this policy will receive personalised information about their epilepsy and associated risks from their health professionals.
“Epilepsy Action will remain engaged with the MHRA and others on this issue for as long as we feel we can have a positive benefit for people with epilepsy and the wider epilepsy community. We will continue to be alongside people and families and seek accountability and learning as needed. We will also continue to call for openness of evidence, positive opportunities for engagement and balanced messaging, so that people can make properly informed choices about their treatment and safety.”
For more information about valproate medicines click here.
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