New Sodium Valproate Measures Announced by the EU

4th April 2024

Valproate prescriptions for men with epilepsy are now subject to precautionary measures across the European Union (EU), as announced by the European Medicines Agency (EMA). These measures align with the guidelines set by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) but are comparatively less stringent.

In the UK, individuals under the age of 55 will not be newly prescribed sodium valproate unless two specialists concur that there is no alternative effective or tolerated treatment, or reproductive risks are not applicable. In the EU, doctors are permitted to continue prescribing valproate under certain conditions:

  1. Specialised oversight is now required for valproate prescriptions in men with epilepsy across the European Union.
  2. Men prescribed valproate should be informed about potential risks of neurodevelopmental disorders in their future children.
  3. Physicians are mandated to discuss the necessity of effective contraception, including for female partners, both during valproate use and for a minimum of three months after treatment cessation.
  4. Regular consultations with healthcare professionals are essential to assess the ongoing appropriateness of valproate as a treatment for men.
  5. Men taking valproate are advised against sperm donation.
  6. A patient card, highlighting the potential risks associated with valproate, should be provided to men as part of their medication.

The EMA, responsible for evaluating medicines in the EU, attributed these recommendations to a review conducted by its Pharmacovigilance Risk Assessment Committee. The review was prompted by a study from Norway, Denmark, and Sweden that investigated the correlation between fathers’ exposure to valproate and the risk of neurodevelopmental disorders and congenital malformations in their children, including autism.

The study indicated a higher incidence of neurodevelopmental disorders in children born to fathers treated with valproate compared to those treated with lamotrigine or levetiracetam. However, the EMA acknowledged limitations in the study, such as differences between patient groups and its small size, making it impossible to definitively attribute the increased risk to valproate. Nevertheless, the EMA implemented these recommendations as a precautionary measure.

The UK regulations took effect on January 31, following the MHRA’s announcement in November 2023. Epilepsy Action chief executive Philip Lee expressed the hope that individuals affected by this policy would receive personalised information from health professionals, emphasising ongoing engagement with regulatory bodies and a commitment to advocating for transparency and informed decision-making in epilepsy treatment.

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