Pregnancy: Sodium Valproate

The Medicines and Healthcare products Regulatory Agency (MHRA), taking advice from the Commission on Human Medicines (CHM), has worked to raise awareness among healthcare professionals and patients of the risks of valproate when taken during pregnancy through several updates to the valproate Summary of Product Characteristics for healthcare professionals, as well as Patient Information Leaflets and educational materials. The magnitude and type of risks associated with valproate use in pregnancy have been communicated in articles in the MHRA’s bulletin, Drug Safety Update, and letters through the NHS Central Alerting System, supported by messages from professional bodies and reinforced through changes to clinical guidelines and improved alerts in general practitioner prescribing systems.

The valproate Pregnancy Prevention Programme, implemented in 2018, is supported by educational materials for healthcare professionals and patients, and describes the neurodevelopmental disorders and major congenital malformations associated with the use of valproate in pregnancy, with information available electronically and in a hard copy format for healthcare professionals.

In January 2024, the MHRA communicated in an article in Drug Safety Update advice from the CHM that valproate must not be started in new patients, either male or female, younger than 55 years old 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. It was advised that women and girls of childbearing potential already receiving valproate should have their treatment discussed by two specialists at their next annual review. The requirement for two specialists to review these patients is a one off, and subsequent annual reviews required under the Pregnancy Prevention Programme (PPP) are undertaken by a single specialist.

In May 2025, further updates to the PPP’s educational materials have been made available to all healthcare professionals and patients electronically, and these will be sent to healthcare professionals in a hard copy format that can provided to patients, to support the discussions between healthcare professionals and patients.