Wide variation in valproate prescribing in women

  • Date: 20 December 2018

USE of valproate medicines in female patients continues to slowly decline but there is wide variation in prescribing between Clinical Commissioning Groups, according to the Medicines and Healthcare products Regulatory Agency (MHRA).

In April of this year the MHRA issued a warning that valproate medicines should no longer be used in women or girls of childbearing potential unless a Pregnancy Prevention Programme is in place. Valproate has been found to be highly teratogenic with evidence that use in pregnancy leads to physical birth defects in 10 in every 100 babies (compared with a background rate of 2 to 3 in 100) and neurodevelopmental disorders in approximately 30 to 40 in every 100 children born to mothers taking the drug.

Valproate medicines should not be used in girls and women of childbearing potential unless there is no suitable alternative as judged by a specialist experienced in the management of epilepsy or bipolar disorder. The National Institute for Health and Care Excellence (NICE) has updated clinical guidelines relevant to valproate medicines to reflect the regulatory changes.

However, women continue to report instances when they have not received patient information with their dispensed valproate medicine. In a recent alert the MHRA states: "All healthcare professionals must continue to identify and review all female patients on valproate, including when it is used outside the licensed indications (off-label use) and provide them with the patient information materials every time they attend their appointments or receive their medicines (including the Patient Information Leaflet at dispensing)."

This page was correct at the time of publication. Any guidance is intended as general guidance for members only. If you are a member and need specific advice relating to your own circumstances, please contact one of our advisers.

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