Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what recent steps he has taken to ensure pregnant women prescribed sodium valproate are aware of the potential health risks.

The product information, approved by the Medicines and Healthcare products Regulatory Agency (MHRA) which outlines the potential health risks of sodium valproate, is available online and in hard copy to support discussions between medical professionals and all women and to help ensure the use of sodium valproate is minimised during pregnancy. Healthcare professionals have been reminded of their responsibility to inform women and girls of the risks of sodium valproate specifically through letters from the United Kingdom’s Chief Medical Officers and Chief Pharmaceutical Officers and by articles in the MHRA’s electronic bulletin Drug Safety Update.

Guidance for specialists to support adherence to the pregnancy prevention requirements for women of childbearing potential taking sodium valproate during the pandemic, particularly patients who are shielding due to other health conditions was published by the MHRA in May 2020. This included guidance on annual review of patients using digital consultations. Materials that form the basis of the Pregnancy Prevention Programme were updated and redistributed in hard copy in December 2020.