Risk minimisation measures to prevent topiramate use during pregnancy: maximal delay, minimal actionability

Mahase reports on the Medicines and Healthcare Products Regulatory Agency’s programme for risk minimisation measures to prevent topiramate use during pregnancy.1 Topiramate is contraindicated in women of childbearing potential unless there is no alternative and they agree to use birth control and take a pregnancy test before starting treatment. Two questions arise.Firstly, how to bypass a devastating global inertia? The first red flags about the effects of intrauterine exposure to topiramate on the neurodevelopment of children were published a decade ago.2 They were confirmed by several studies, the most recent one in July 2022, which showed increased adjusted hazard ratios for autism spectrum disorder and intellectual disability: 2.8 (95% confidence interval 1.4 to 5.7) and 3.5 (1.4 to 8.6), respectively.3 New Zealand was the first to move for safety, issuing restrictions in April 2023, and Janssen-Cilag, the sponsor for topiramate products had to send a “Dear healthcare professional letter.”4 Notably,…
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