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Pregnancy: Sodium Valproate

Question for Department of Health

UIN 989, tabled on 3 June 2015

To ask the Secretary of State for Health, what steps he is taking to ensure that every pregnant women prescribed the anti-epilepsy drug sodium valproate is warned of the risk to her unborn child.

Answered on

12 June 2015

After completion of a United Kingdom-led European review in 2014, the Department worked with the Medicines and Healthcare products Regulatory Agency, healthcare professionals and patient groups to raise awareness and encourage discussion about the risks and benefits of sodium valproate between healthcare professionals and their patients.

Several measures were put in place to minimise the prescribing of sodium valproate to women of childbearing potential (except where other drugs are ineffective or not tolerated) and to communicate the warnings around the drug sodium valproate to healthcare professionals and patients (particularly women of child bearing potential).

There is now a mandatory requirement for all manufacturers to include the very latest information about the known risks of sodium valproate to the unborn child. The product information for healthcare professionals and patients has been updated to contain strengthened warnings about use in pregnancy and in women of child bearing age. New educational materials have been produced for use by healthcare professionals and patients that further highlight warnings of the risk of sodium valproate to the unborn child. Other actions include:

- working with the Health and Social Care Information Centre on introducing red-flag warnings on general practitioner and community pharmacy IT systems;

- updating the British National Formulary (BNF) and BNF for children; and

- using existing Departmental and National Health Service communication channels to raise awareness and provide information to patients.