Men taking the medicine sodium valproate are advised to use effective contraception by the Medicines and Healthcare Products Regulatory Agency (MHRA) in a release published yesterday in the UK.
The MHRA advises that men taking sodium valproate use condoms and ask female partners to use contraception to prevent an unplanned pregnancy.
This is because taking the medicine may cause a “potential small increased risk” of neurodevelopmental disorders in children born to fathers taking sodium valproate.
Sodium valproate is an epilepsy medicine which people may know by its brand names: Epilim, Episenta, Epival, Dyzantil or Depakin.
The MHRA says no one should stop taking valproate without advice from their specialist, so doing so could worsen their seizures.
However, it advises that health professionals should discuss the risks with men taking the medicine at their next epilepsy appointment. They should also discuss available options with their patients.
The new advice also encourages patients to attend their routine appointments to discuss their treatment plans and ask any questions.
The organisation says men shouldn’t donate sperm while taking sodium valproate and three months after stopping the medicine.
Precautionary action
For anyone not currently taking sodium valproate, but wanting to have it prescribed, the restrictions brought in in January 2024 will apply.
These say that no one under the age of 55 will be prescribed sodium valproate unless two specialists agree there is no other effective or tolerated treatment, or unless there are “compelling reasons that the reproductive risks do not apply”.
The new guidance is precautionary and is based on a study from a few Scandinavian countries. This research looked at health records and found that around five in 100 children whose fathers were taking sodium valproate at conception had a developmental disorder, according to the MHRA.
The researchers compared this to around three in 100 children born to fathers who were taking lamotrigine or levetiracetam.
The MHRA said that “this study does not prove that valproate use in men increased the risk of problems in children”. However, it said that it is “an important safety issue”, which needs “precautionary” action.
“Confused at best, very worried at worst”
Alison Fuller, director of health improvement and influencing at Epilepsy Action, said: “When the MHRA introduced regulations for new sodium valproate prescriptions in January 2024, we raised concerns about adding additional restrictions to a potentially effective medication.
“We know there are around 65,000 boys and men currently on sodium valproate in the UK. The measures are precautionary, meaning they will not require two signatories to stay on their medication. That said, they will still need to have an in-depth conversation with a healthcare professional. We think healthcare professional capacity is still going to be a real issue.
“At Epilepsy Action we are working with the information we have been provided to support people this has a potential impact on, but we know these changes will raise questions within the epilepsy community. We are concerned people with epilepsy will feel confused at best, and very worried about what this means for their treatment at worst.
“We’ll continue to monitor the implementation of the new rules closely and ask for more information from the MHRA. If anyone has any questions or concerns, please call our Helpline at 0808 800 5050 and we’ll do our best to answer them, or seek more clarity from the MHRA.”