Valproate (Belvo, Convulex, Depakote, Dyzantil, Epilim, Epilim Chrono or Chronosphere, Episenta, Epival, and Syonell): review by two specialists required for male patients

Drug safety update: The MHRA has published a drug safety update on the requirements for initiating valprote products.

Published: 13 February 2025

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a Drug Safety Update for Valproate products.  The Commission on Human Medicines (CHM) has advised a review by two specialists is required for initiating valproate in male or female patients under 55 years but not for men (or male patients) already taking valproate.

The MHRA has produced infographics for the follow situations to clarify in which situations review by two specialists may be required:

A list of who might qualify as a specialist can be found in the Valproate safety measures collection. Healthcare professionals are reminded to report suspected adverse reactions associated with valproate using the Yellow card scheme.

Patients are advised not to stop taking valproate without advice from a specialist.

Further information, advice for healthcare professionals and advice for healthcare professionals to provide to patients can be found on the MHRA website.