Valproate use in women, girls of childbearing years and boys - guidance

This page has updated guidance on the medicine, valproate in accordance with regulation changes from the Medicines & Healthcare products Regulatory Agency (MHRA) in January 2024.

Valproate (Epilim, Depakote, Convulex, Episenta, Epival, Kentlim, Orlept, Syonell, Valpal and Belvo) is associated with a significant risk of birth defects and developmental disorders in children born to women who take valproate during pregnancy.

Since 2018, the use of valproate in patients of childbearing potential had to comply with Pregnancy Prevention Programme measures.

MHRA updated their guidance for paediatricians regarding the prescription of valproate as detailed in the MHRA National Patient Safety Alert in November 2023.  

As of 31 January 2024, boys are also included, rather than just post-pubertal girls. There also needs to be dual sign-off of new prescriptions for new patients commencing valproate. This results in a change of practice for many paediatricians, and we recommend those who are not familiar with this updated information to review the drug safety update from MHRA in January 2024.  

In addition, British Association of Paediatric Neurology (BPNA), Organisation of Paediatric Epilepsy Networks in the UK (OPEN UK) and RCPCH have issued guidance to support the implementation of the new regulations, which you can download below.