At a recent meeting of the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC), it has been decided to retain the precautionary safety measures associated with Sodium Valproate (Epilim) treatment in men.
Sodium Valproate (Epilim) is an anti-seizure medication, which is also used in the treatment of bi-polar. For women with epilepsy, risks associated with Sodium Valproate use during pregnancy are now well-established. However, in 2023, a study emerged suggesting that there was a potential increased risk of neurodevelopmental disorders (NDDs) in children whose fathers were treated with Sodium Valproate.
This triggered a review of safety information of the medication by the EMA, leading to precautionary safety measures for the treatment of males with Sodium Valproate being introduced in 2024. These measures included the following:
- It is recommended that in male patients, valproate is initiated and supervised by a specialist experienced in treatment of epilepsy or bipolar disorder.
- Prescribers should inform male patients about the potential risk and discuss with them the need to consider effective contraception, including for a female partner, while using valproate and for 3 months after stopping the treatment.
- Treatment with valproate in male patients should be regularly reviewed by prescribers to evaluate whether valproate remains the most suitable treatment for the patient. For male patients planning to conceive a child, suitable alternative treatment options should be considered and discussed with the patient. Individual circumstances should be evaluated for each patient. It is recommended that advice from a specialist experienced in the management of epilepsy or bipolar should be sought as appropriate.
- Male patients should be advised to not donate sperm during treatment and for at least 3 months after treatment discontinuation.
Patient information materials were also developed, specifically for males on the medication.
At the most recent meeting of PRAC, these safety measures were discussed as well as other emerging debate and evidence on the matter of valproate treatment in males and potential risks to their children.
Following their deliberations, PRAC could not conclude whether potential risks of neurodevelopmental disorders in children of fathers treated with valproate before conception is due to valproate or other factors. The committee therefore concluded that the available evidence at the moment is inconsistent, and a link between NDDs and valproate use in males is uncertain.
However, PRAC have decided to retain the current safety measures – considering remaining uncertainties on this potential link and because an ongoing study requested by PRAC - which is further investigating this matter - is due to conclude in 2028.
Further information on the recent PRAC meeting can be found by visiting the ‘European Medicines Agency’ website – while a history of emerging developments on this matter can also be found by visiting the 'Men’ section of our website.
It is important to clearly state that it has yet to be fully established whether the increased risk for neurodevelopmental disorders is directly a result of Sodium Valproate use. We know that these measures and the uncertainty surrounding them may be worrying for men with epilepsy who are planning on starting a family.
However, please DO NOT stop taking your medication without first discussing this with your medical team. Discontinuing or reducing your anti-seizure medications is likely to lead to the recurrence of seizures or an increase in seizure frequency.
You can also get in touch with your Epilepsy Ireland Community Resource Officer for assistance or support on your journey with epilepsy. You can find their details by visiting the 'Our Local Service' section of our website.