United Kingdom's MHRA Bans Valproate Medicines Without The Pregnancy Prevention Programme

On April 24, 2018, the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) announced that 'to protect public health, the Medicines and Healthcare products Regulatory Agency (MHRA) has changed the license for valproate medicines (Epilim, Depakote and generic brands). Valproate must no longer be prescribed to women or girls of childbearing potential unless they are on the pregnancy prevention programme (PPP)'24.

The MHRA regulates medicines, medical devices and blood components for transfusion in the UK. MHRA is an executive agency, sponsored by the Department of Health and Social Care, United Kingdom25.

Background

Valproate (Epilim, Depakote and other generic brands) is associated with a significant risk of birth defects and developmental disorders in children born to women who take valproate during pregnancy.

Valproate is a treatment for epilepsy and bipolar disorder and is prescribed to thousands of women. Since its introduction in 1974, the product information for doctors has included a warning about the possible risk of birth defects. As the risks to unborn children have been increasingly understood, the warnings have been strengthened. In March 2018, the European Union's Coordination Group for Mutual Recognition and Decentralized Procedures - Human (CMDh) endorsed a strengthened regulatory position on valproate medicines26. Valproate must no longer be used in any woman or girl able to have children unless she has a pregnancy prevention programme in place. This is designed to make sure patients are fully aware of the risks and the need to avoid becoming pregnant.

MHRA Updates - April 2018

The agency has recommended that healthcare professionals who seek to prescribe valproate to their female patients must make sure they are enrolled in the PPP. This includes the completion of a signed risk acknowledgement form when their treatment is reviewed by a specialist, at least annually. The agency has also advised that all women and girls who are prescribed valproate should contact their General Practitioner (GP) and arrange to have their treatment reviewed. No woman or girl should stop taking valproate without medical advice.

These regulatory changes will be further supported in the upcoming months by:

smaller pack sizes to encourage monthly prescribing a pictogram/warning image on valproate labelling These new regulatory measures are being supported across the National Health Service (NHS) with other authorities also...