New Safety Guidance on Valproate Use
The MHRA has published new safety and educational materials for valproate-containing medicines to support regulatory measures protecting men and women under 55 years of age from serious harm.
Key Points
- Valproate carries a significant risk of serious birth defects and developmental disorders if taken during pregnancy
- New safety materials have been introduced for both patients and healthcare professionals
- These materials support existing regulatory measures to minimise harm across all age groups under 55
- The alert applies to all valproate formulations regardless of indication (epilepsy, migraine, bipolar disorder)
Affected Medications
This alert covers valproate in all formulations, including:
- Belvo
- Convulex
- Depakote
- Dyzantil
- Epilim, Epilim Chrono, Epilim Chronosphere
- Episenta
- Epival
- Syonell
Recommended Actions
- Review current valproate use in patients under 55 years of age
- Ensure patients have access to the new safety materials and understand the risks
- Consider alternative treatments where clinically appropriate
- Reinforce the importance of effective contraception in women of childbearing potential
- Document discussions about risks and benefits in patient records
For the full regulatory update, visit the MHRA Drug Safety Update.