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Pregnancy: Sodium Valproate

Question for Department of Health and Social Care

UIN 137887, tabled on 25 April 2018

To ask the Secretary of State for Health and Social Care, what representations his Department and its agencies have received on the resources necessary to improve patient safety and engage with health professionals to raise awareness of the potential health risks for women of child-bearing age taking Sodium Valproate; and if he will make a statement.

Answered on

3 May 2018

The Medicines and Healthcare products Regulatory Agency (MHRA) is working in partnership with the Department, professional bodies and the healthcare system to deliver a package of measures to raise awareness of the significant risks associated with sodium valproate in pregnancy and to support healthcare professionals in reducing the harms from valproate in women of child-bearing age and improving patient safety in line with the strengthened regulatory position. Educational materials for healthcare professionals and patients are being sent to general practitioners (GP) and specialist prescribers. The National Institute for Health and Care Excellence has updated its guidelines which mention valproate to reflect the new regulatory measures. GP electronic system providers have provided a search and audit function to facilitate the identification of women of childbearing age on valproate and are updating the alerts for valproate.

All parties involved are fully committed to this important work using the resources available from each relevant organisation. In addition, since 2016 the MHRA has been working with a network of over 40 stakeholder organisations (termed the Valproate Stakeholders’ Network) to foster cross-sector support for the new measures and leverage their collective communications reach.

The effectiveness of the new measures in reducing prescribing of valproate in women of childbearing potential will be closely monitored. Relevant data will be published and there will be ongoing follow-up to ensure that the harms to the child from valproate in pregnancy are minimised.

I would particularly like to thank the families involved in the Valproate Stakeholder Network who have shared their experiences and expertise. Their dedication, support and altruism will help to keep future generations of children safe.