MHRA Alert – Valproate: Two-Specialist Review Now Required for New Patients Under 55
MHRA alert 13 February 2025 · Updated 15 October 2026
Source: MHRA Drug Safety Update, Valproate (Belvo, Convulex, Depakote, Dyzantil, Epilim, Epilim Chrono or Chronosphere, Episenta, Epival, and Syonell▼): review by two specialists is required for initiating valproate but not for male patients already taking valproate. Read the alert itself before acting on it.
Key Update on Valproate Initiation Requirements
The Commission on Human Medicines (CHM) has clarified prescribing requirements for valproate, a medication used to treat epilepsy and other conditions. Two specialist reviews are now mandatory for all patients under 55 years of age initiating valproate, regardless of sex or gender.
Important Clarification for Existing Male Patients
Male patients already taking valproate are not required to undergo a two-specialist review. This exemption applies only to those currently established on the medication and does not apply to new initiations or to female patients at any stage.
Affected Medications
This alert applies to all valproate formulations, including:
- Belvo
- Convulex
- Depakote
- Dyzantil
- Epilim and Epilim Chrono
- Chronosphere
- Episenta
- Epival
- Syonell
What You Need to Do
If you are initiating valproate in a patient under 55 years of age, ensure that two specialist opinions are obtained before treatment begins. Prescribers should verify that this requirement has been met before issuing a prescription. No change is required for male patients already established on valproate therapy.
For full details and background on valproate safety, visit the MHRA Drug Safety Update.
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