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MHRA resources give guidance around new restrictions on valproate prescribing

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Mandy Ryan

MHRA resources give guidance around new restrictions on valproate prescribing

The Medicines and Healthcare Regulatory Agency (MHRA) has published new materials for patients and healthcare professionals to help them to understand and implement the restrictions on valproate prescribing that come in from next week.

Starting from 31 January 2024, no-one under the age of 55 – both men and women - should be started on valproate unless two specialists independently agree and document that there is no other safe and effective medication, or that there are compelling reasons why the reproductive risks linked to valproate, do not apply.

All women who could become pregnant and girls who are currently taking valproate will be reviewed at their next annual specialist review, using a revised valproate Annual Risk Acknowledgement Form. The MHRA has confirmed that two specialists will need to sign off prescriptions for continuing valproate at the first annual review, but in subsequent reviews only one specialist is required to make the decision, in consultation with the patient.

Image showing pregnant woman

The new restrictions follow concerns that women of childbearing age are still being prescribed valproate, even during pregnancy. 

There are also concerns about the link between valproate and the risk of impaired male fertility. While these have been recognised since 2011, additional emerging data from animal studies show adverse effects of valproate on the testes of juvenile animals as well as transgenerational effects. It is not yet known what this means for humans, but further studies are being undertaken.

The measures for men taking valproate will come in later in 2024, following advice from an independent expert group of the Commission on Human Medicines that the measures should be introduced in a phased manner to ensure ongoing patient care is not disrupted.

Alongside introducing the new measures, the MHRA has said that it will consider further recent registry data which may suggest an increased risk of neurodevelopmental disorders in children whose fathers took valproate in the three months before conception. As a precaution male patients on valproate who are planning a family within the next year should speak to a healthcare professional about their treatment options.

The new patient materials can also be accessed via a QR code on some patient information leaflets supplied in packs.

No-one should stop taking valproate without first consulting their doctor. 




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