In response to a comprehensive safety review prompted by a recent European study, the Medicines...

Published: 6:33 am June 21, 2024
Updated: 11:57 am October 8, 2025
MHRA Implements New Safety Measures for Topiramate (Topamax) Following European Study – UKNIP

In response to a comprehensive safety review prompted by a recent European study, the Medicines and Healthcare Products Regulatory Agency (MHRA) is introducing enhanced safety protocols for topiramate, commonly known by its brand name Topamax.

The Commission on Human Medicines (CHM) scrutinised research findings related to topiramate use during pregnancy. These studies revealed that children born to mothers who took topiramate faced a risk level approximately 2 to 3 times higher for intellectual disability, autism spectrum disorders, and attention deficit hyperactivity disorder.

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