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Medicine recalls and shortages › Drug Safety Update › 20 Jun 2024
Drug Safety Update

Topiramate (Topamax)

Published on 20 Jun 2024 · source: MHRA — Medicines and Healthcare products Regulatory Agency
Topiramate is now contraindicated in pregnancy and in women of childbearing potential unless the conditions of a Pregnancy Prevention Programme are fulfilled. This follows a review by the MHRA which c…
Drug Safety Update on GOV.UK ↗ All events: Topiramate (Topamax)

What this means

Drug Safety Update is the MHRA bulletin for healthcare professionals: new safety information, restrictions of use and recommendations for monitoring.

Summary

Topiramate is now contraindicated in pregnancy and in women of childbearing potential unless the conditions of a Pregnancy Prevention Programme are fulfilled. This follows a review by the MHRA which concluded that the use of topiramate during pregnancy is associated with significant harm to the unborn child. Harms included a higher risk of congenital malformation, low birth weight and a potential increased risk of intellectual disability, autistic spectrum disorder and attention deficit hyperactivity disorder in children of mothers taking topiramate during pregnancy.

Tracked from information published by the MHRA and the NHSBSA. This information is for guidance only and does not replace advice from your doctor or pharmacist.