Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what assessment has been made of the MHRA’s effectiveness at communicating known risks of sodium valproate, particularly in pregnancy, prior to 2018.

As with all medicines, the safety of valproate has been kept under continual review by the Medicines and Healthcare products Regulatory Agency (MHRA), ensuring the product information reflects what is known about valproate.

The known risks of valproate are outlined in the Summary of Product Characteristics and Patient Information Leaflet. Over the years information about the reproductive risks has been updated as data emerged. The MHRA also issued communications via their bulletins Current Problems and Drug Safety Update on valproate, particularly the reproductive risks.

The report of the Independent Medicines and Medical Devices Safety Review published in 2020 examined how the healthcare system, including MHRA and its predecessors, responded to risks from medicines and medical devices, including valproate, and annex C of the report includes a timeline of key events including communications and updates to the product information undertaken by the MHRA.

Since 2016, the MHRA has carefully reviewed feedback from patients and healthcare professionals within the Valproate Stakeholder Network (VSN) to assess the effectiveness of communications on the risks of sodium valproate use during pregnancy. The VSN also informed the design of a pictogram warning on the medicine carton and blister pack.

In addition, the MHRA has rigorously monitored the effectiveness of the communication of the known risks through healthcare professional and patient surveys started in 2014, which have formed part of a European Union wide post authorisation safety study for valproate.