Sodium Valproate Precautionary Measures for Males

Father holding child's hand.

Background

In May of 2023, a study which was undertaken at the request of the European Medicines Agency highlighted how there was a potential increased risk of neurodevelopmental disorders in children whose fathers were treated with Sodium Valproate (Epilim) at the time of conception. It found a risk of 5.6% to 6.3% of these disorders for children born to fathers treated with valproate, compared with 2.5% to 3.6% for children born to fathers treated with the other anti-seizure medications.

Neurodevelopmental disorders are problems with development that begin in early childhood, such as autism spectrum disorders, intellectual disability, communication disorders, attention deficit/hyperactivity disorders and movement disorders.

While the teratogenic impact of Valproate use in women who are pregnant has been well-established, this was the first study that suggested a potential increased risk for fathers who are treated with the medication. (For more on the pregnancy prevention programme associated for Sodium Valproate for women, visit the ‘Women’ section of our website.)

Following a review of the data, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) recommended that new precautionary safety measures for the treatment of males with sodium valproate be introduced.

From the outset, it is important to note that the European Medicines Agency have stated that the study does have limitations, and it has yet to be fully established whether the increased risk for neurodevelopmental disorders is directly a result of Sodium Valproate use.

Precautionary Measures

The new precautionary measures which introduced are as follows:

  • 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

As part of the introduction of these precautionary measures, a new patient guide for males taking Sodium Valproate have been produced. This guide is available to read and download at the end of this page.

Resources for Healthcare Professionals

A range of resources for prescribers and pharmacists have also been made available and can be found by visiting the HPRA website. The guide for Healthcare Professionals is also available to read and download at the end of this page.

Further Information

History

The below are articles from the ‘News’ section of our website, which follows the process of how and why these new precautionary measures were introduced.

IMPORTANT

If you are a man with epilepsy taking Sodium Valproate (Epilim), DO NOT stop taking your medication without first having a discussion 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.

Downloadable Resources
Valproate Male Patient Guide
Valproate Healthcare Professional Patient Guide