MHRA Alert – Valproate Safety Materials for Under-55s

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.