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Foetal Valproate Spectrum Disorder: Health Education

Asked by Andrew GwynneIndependentDepartment of Health and Social CareTabled Answered 17 July 2025UIN 65739

The question

To ask the Secretary of State for Health and Social Care, whether he has made an assessment of the potential merits of a public awareness campaign on foetal valproate spectrum disorder.

Answered by Karin Smyth

There are mechanisms in place to minimise the risk of foetal harm associated with valproate, and to ensure that healthcare professionals are also able to support any babies and families that are affected. These are considered to be more targeted than a public awareness campaign.

The valproate Pregnancy Prevention Programme ensures that women and girls taking valproate understand the potential risks should they become pregnant, are using effective contraception, and are regularly monitored. It 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.

The programme was updated in January 2024 to reflect updated Medicines and Healthcare Products Regulatory Agency advice 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 are undertaken by a single specialist.

Further information on the valproate pregnancy prevention programmes is available at the following link:

https://www.gov.uk/drug-safety-update/valproate-pregnancy-prevention-programme-actions-required-now-from-gps-specialists-and-dispensers

In addition, there are 14 Maternal Medicine Networks, in place across England, who provide expert care to women with complex medical conditions, including epilepsy, before, during, and after pregnancy, to ensure appropriate investigation and management to improve maternal and foetal outcomes.

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