Valproate prescribing rules will tighten from January, says MHRA

From January 2024 valproate must not be started in new patients aged under 55 unless two specialists agree that there are no alternative options or that “compelling reasons” mean that the reproductive risks “do not apply,” the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has said.1The change is one of the first round of measures set to be put in place by the agency to reduce the known harms of valproate, including the “significant risk of serious harm to the baby if taken during pregnancy and the risk of impaired fertility in males.”Doctors have been advised to discuss the upcoming measures—which apply to sodium valproate, valproic acid, and valproate semisodium—with their patients. An estimated one in nine babies exposed to valproate during pregnancy will be born with a major birth defect, and as many as four in 10 are born with a neurological disorder.In addition to the new rules…
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