Valproate: new safety and educational materials to support regulatory measures in men and women under 55 years of age (MHRA, 22 January 2024)

Summary

New safety and educational materials have been introduced for men and women and healthcare professionals 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.

These safety and educational materials support the new regulatory measures announced in the National Patient Safety Alert.

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.

Content

Advice for healthcare professionals:

• 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. For the majority of patients, other effective treatment options are available.
• At their next annual specialist review, women of childbearing potential and girls receiving valproate should be reviewed using the revised valproate Annual Risk Acknowledgement Form. A second specialist signature will be needed if the patient is to continue on valproate, however subsequent annual reviews will only require one specialist.
• General practice and pharmacy teams should continue to prescribe and dispense valproate and if required offer patients a referral to a specialist to discuss their treatment options. Valproate should be dispensed in the manufacturer’s original full pack.
• Report suspected adverse drug reactions associated with valproate on a Yellow Card.

Advice for healthcare professionals to provide to patients:

• Do not stop taking valproate without advice from a specialist. This is because epilepsy or bipolar disorder may worsen without treatment
• if you are on valproate, please attend any offered appointments to discuss your treatment plan and talk to a healthcare professional if you are concerned.
• Consult the Patient Information Leaflet and new Patient Guide for information about the risks of valproate – see also the MHRA information page for resources.
• As a precaution, male patients who are planning a family within the next year should speak to a healthcare professional about their treatment options.