Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what recent progress has been made by the (a) Medicines and Healthcare Products Regulatory Agency and (b) the Commission on Human Medicines to (i) understand the (A) current and (B) historic risks of sodium valproate when taken during pregnancy, and (ii) in communicating these risks to (1) healthcare professionals and (2) patients.

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, and the Patient Information Leaflets, as well as updates to associated educational materials as required.

The magnitude and type of risks associated with valproate use in pregnancy have been communicated in articles in the MHRA bulletin, Drug Safety Update, and via letters cascaded out through the NHS Central Alerting System. These communications have been supported by messages from the relevant professional bodies and regulatory requirements reinforced through changes to clinical guidelines and improved alerts on general practitioner prescribing systems.

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

In January 2024, the MHRA communicated, in an article in a Drug Safety Update, the latest advice from the CHM, that valproate must not be started in new patients, 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 if there are compelling reasons that the reproductive risks do not apply. It was advised that women and girls of childbearing potential who are already receiving valproate should have their treatment reviewed 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 are undertaken by a single specialist.

Updated educational materials were made available to healthcare professionals and patients electronically, and sent to healthcare professionals in hard copy format, that could be provided to patients and which could support the discussions between healthcare professionals and patients.