The Chief Safety Officer at the UK Medicines and Healthcare Regulatory Agency (MHRA) has echoed concerns about persistent sodium valproate prescribing for pregnant women.
Britain’s Alison Cave said she shared campaigners’ concerns about the number of women still being prescribed the anti-seizure medication, which is used to treat epilepsy, as data show that an NHS England target to reduce its prescribing to women of child-bearing age has not been met.
The issue has been raised by the Independent Foetal Anti-Convulsant Trust (INFACT), reports The Pharmaceutical Journal.
The use of valproate by pregnant women has been associated with a high risk of congenital malformations and neurodevelopmental disorders in their children.
In 2018, the MHRA announced that the medicine must not be prescribed to women or girls of child-bearing potential unless they are on a pregnancy prevention programme (PPP).
Figures published by NHS England show that 15 095 women under 54 were taking valproate in September 2024, and while this is a 45% reduction on the 27 441 females taking the medicine in April 2018, it has not met an NHS England target for a 50% reduction by the end of 2023.
Commenting on the data, Janet Williams and Emma Murphy, founders of the support group INFACT, said: “We are disappointed that women are failing to be regularly updated by GPs and neurologists, and are slipping through the net, finding themselves pregnant while still on valproate.
“We understand there will be a small number of women who are unable to switch medications or have already tried to do so with no success: they should be closely monitored and taken care of. However, children are still being harmed by this drug, with no support for families who are having great difficulty with diagnosis and leading to later problems as they go through the system.”
In January 2024, the MHRA said that new valproate prescriptions must be signed off by two specialist doctors. Female patients already taking the medicine also require an annual risk acknowledgement form to be completed at an annual review, which must be signed by two specialists for the medication to continue.
Williams and Murphy added: “The (Department of Health and Social care has) now had almost 18 months since the Hughes Report (published by Patient Safety Commissioner Henrietta Hughes) was released and therefore must make their decisions over the recommendations urgently and ensure those harmed do not continue to suffer any longer than necessary.”
Cave also said that the MHRA was “concerned to hear that some women are not being asked to complete the acknowledgement of risk form”.
“Our aim is to reach a position where valproate is only prescribed to those who really need it and that patients for whom other medicines are safe and effective are offered those treatments first, such that they and their offspring, are not exposed to the reproductive harms of valproate,” she added.
Tase Oputu, chair of the Royal Pharmaceutical Society (RPS) English Pharmacy Board, said: “While there is still room for improvement, a 45% reduction in valproate prescribing for women of child-bearing age is a significant and welcome step.”
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