Neurodevelopment disorders after in utero exposure to topiramate

Excerpt

The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) is requiring updates to product information of topiramate (Topina tablets and fine granules) because of the risk of neurodevelopment disorders after in utero exposure to topiramate.Patients with Reproductive Potential should be added to PRECAUTIONS Concerning Patients with Specific Backgrounds, along with a precautionary statement that patients should be informed of the risks in infants and children after use of topiramate in women of childbearing potential. The following precautions should be added to the Pregnant Women section: when topiramate is used during pregnancy or when women become pregnant when using topiramate, patients should be informed of risks in infants and children after in utero topiramate exposure; there may be a possible relationship between infants and children born to mothers exposed to topiramate during pregnancy and neurodevelopmental disorders including autism spectrum disorder, attention-deficit hyperactivity disorder, and intellectual development disorders (mental retardation).This follows a review of overseas epidemiological literature reporting neurodevelopmental disorders in infants and children born to mothers exposed to topiramate during pregnancy.Precautions for teratogenicity was already included in PRECAUTIONS. …