Supporting the safety of girls and women being treated with valproate

A resource alert has been issued jointly by NHS Improvement and the Medicines and Healthcare products Regulatory Agency (MHRA) to support the safety of girls and women of childbearing potential being treated with valproate.

Patient Safety Alerts are shared rapidly with healthcare providers via the Central Alerting System (CAS). 

About this alert

Valproate, also known as valproic acid (brand names include Epilim and Depakote), is an effective medication usually used as a treatment for epilepsy and bipolar disorder.

Unborn babies exposed to valproate are at very high risk of neurodevelopment disability and other birth defects. In girls and women of childbearing potential, valproate should be initiated and supervised by a specialist and only when other medications have not been tolerated or have been found to be ineffective.

It is vital where valproate is prescribed to girls and women of childbearing potential that they are made aware of the risks of taking the medication in pregnancy. The need for effective contraception planning must also be emphasised, along with the requirement for specialist oversight to safely change their medication if planning a pregnancy.

MHRA has updated its valproate toolkit, providing a range of resources to support providers, staff and patients in the safe use of valproate.

This alert asks all providers to undertake systematic identification of girls and women who are taking valproate, and to ensure the MHRA resources are used to support them to make informed choices.

MHRA have also produced a video for GPs, pharmacists and other healthcare professionals on the latest advice about the risk of valproate medicine during pregnancy and the contents of the valproate toolkit.

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