Valproate (Belvo, Convulex, Depakote, Dyzantil, Epilim, Epilim Chrono or Chronosphere, Episenta, Epival, and Syonell▼): new safety and educational materials to support regulatory measures in men and women under 55 years of age
These materials support the new regulatory measures for valproate. Healthcare professionals should review the new measures and materials and integrate them into their clinical practice when referring patients and when prescribing or dispensing valproate.
Source:
Medicines and Healthcare products Regulatory Agency
SPS commentary:
The new strengthened safety measures (as discussed in a National Patient Safety Alert issued in November 2023) mean that valproate must not be started in new patients (male or female) younger than 55 years, unless two specialists independently consider and document that there is no other effective or tolerated treatment, or there are compelling reasons that the reproductive risks do not apply. They have been introduced to reduce the harms from valproate, including the significant risk of serious harm to the baby if taken during pregnancy and the risk of impaired fertility in males.
The MHRA is currently reviewing data which may suggest an increased risk of neurodevelopmental disorders in children whose fathers took valproate in the 3 months before conception. As a precaution, male patients who are planning a family within the next year are advised to discuss treatment options with a healthcare professional.