Valproate: Learning points for Marketing Authorisation Holders
- Jackie Roberts
- Jun 12
- 2 min read
The MHRA's findings on valproate highlight concerns regarding its use, particularly in relation to reproductive health and neurodevelopmental risks. Here are the key points:
1. Risk of Neurodevelopmental Disorders in Children
A retrospective observational study suggests a possible link between valproate use in men around conception and an increased risk of neurodevelopmental disorders in their children.
The study found a higher cumulative risk (4.0%–5.6%) in children of fathers treated with valproate compared to those treated with lamotrigine or levetiracetam (2.3%–3.2%).
While the risk is lower than the 30–40% risk observed in children born to mothers taking valproate during pregnancy, the causal role of valproate is not confirmed, making this advice precautionary.
2. Regulatory Measures & Prescribing Restrictions
New prescribing restrictions were introduced in January 2024:
Valproate must not be started in new patients (male or female) under 55 years, unless two medical specialists confirm that there is no alternative suitable treatment.
Annual specialist reviews are required for women who could become pregnant.
Updated risk minimization materials include:
Revised Patient Information Leaflets (PILs)
New Risk Acknowledgement Forms for male patients.
3. Precautionary Advice for Healthcare Professionals
Men taking valproate should be informed about the potential risk to their children.
Effective contraception is recommended during treatment and for at least 3 months after stopping valproate.
Patients should not stop taking valproate without consulting a healthcare professional.
Here is a link to the safety update on the MHRA website: Valproate (Belvo, Convulex, Depakote, Dyzantil, Epilim, Epilim Chrono or Chronosphere, Episenta, Epival, and Syonell▼): new safety and educational materials to support regulatory measures in men and women under 55 years of age - GOV.UK
This really shows the importance of having a good understanding of the requirements for risk management and pharmacovigilance issues in the UK. PharmaGuard are here to help you navigate the UK regulatory and pharmacovigilance arena, contact us for more information.
