New regulatory measures are in place to reduce the known harms from valproate.

This includes the significant risk of serious harm to the baby if taken during pregnancy and the risk of impaired fertility in males.

Safety and educational materials are available from the MHRA together with a Drug Safety Update.

These include a pharmacy poster, patient card and guide, warning stickers to be added to medicine packaging in exceptional circumstances where the original pack cannot be dispensed, and a healthcare professional guide.

The guide provides updated information on the risks of valproate in pregnancy and the risks for male patients, the new conditions for valproate prescribing and key points for patient discussions. 

The resources also include an Annual Risk Acknowledgement Form for female patients starting valproate and at annual review, and a Risk Acknowledgement Form for male patients starting valproate.

The new regulatory measures came into force on January 31.

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.

At their next annual specialist review, women of childbearing potential and girls should be reviewed using a revised valproate Risk Acknowledgement Form, which will include the need for a second specialist signature if the patient is to continue with valproate and subsequent annual reviews with one specialist unless the patient’s situation changes.