MHRA Alert – Valproate Reproductive Risk: Updated Safety Materials Now Available

Updated Safety Materials for Valproate Users

The MHRA has published updated safety and educational materials to support healthcare professionals and patients in discussing the reproductive risks associated with valproate medicines. These resources implement regulatory measures announced in the November 2023 National Patient Safety Alert and the September 2024 Drug Safety Update.

Key Points

• Valproate carries significant reproductive risks, particularly for pregnant women and those of childbearing potential
• New educational materials are designed to facilitate informed patient discussions about these risks
• Resources support implementation of existing regulatory safeguards
• All healthcare providers prescribing valproate should be familiar with these materials

Affected Medications

This alert applies to all valproate-containing products, including:

• Belvo
• Convulex
• Depakote
• Dyzantil
• Epilim, Epilim Chrono, Epilim Chronosphere
• Episenta
• Epival
• Syonell

Recommended Actions

• Review the updated MHRA safety materials
• Ensure all team members involved in valproate prescribing and dispensing are aware of reproductive risks
• Use the new educational resources when discussing treatment options with patients of childbearing age
• Document patient discussions and informed consent appropriately

For full details, visit the MHRA Drug Safety Update.