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Sodium Valproate: Females

Question for Department of Health and Social Care

UIN 107603, tabled on 22 October 2020

To ask the Secretary of State for Health and Social Care, what steps his Department is taking to raise awareness of the potential health risks for women aged between 15-45 years who are prescribed sodium valproate.

This answer is the replacement for a previous holding answer.

Answered on

17 November 2020

The Medicines and Healthcare products Regulatory Agency (MHRA) has updated the patient information leaflets for all valproate-containing medicines to ensure women have access to the latest information on the risk of neurodevelopmental disorders in children born to women who took the medicine during pregnancy. A pictogram warning of the risks of use in pregnancy has been added to the outer packing of valproate medicines and a patient card is available to provide more detail on actions to take.

The documents that form the basis of the valproate Pregnancy Prevention Program, including a patient guide, have been made available electronically and disseminated as hard copies to doctors and pharmacists to support discussion of the risks with women. Healthcare professionals have been reminded of their responsibility to inform women taking valproate of the risks 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.

We are working with the Valproate Stakeholder Network to explore additional ways of improving the reach of regulatory communications through platforms in the healthcare and patient setting.

Answered by

Department of Health and Social Care
Named day
Named day questions only occur in the House of Commons. The MP tabling the question specifies the date on which they should receive an answer. MPs may not table more than five named day questions on a single day.