The FDA has issued several warnings about the use of topiramate by childbearing woman based on data from two registries, which showed an increased risk of oral clefts in infants exposed to monotherapy during the first trimester of pregnancy.
The FDA said topiramate would now be classified as a “Pregnancy Category D” drug, meaning there is evidence of human fetal risk based on human data.
Read FDA Warns That Topiramate Could Cause Birth Defects: What to Tell Patients
Neurology Today: 07 April 2011 – Volume 11 – Issue 7 – pp 1,8-9
FDA Safety Information for Patients and Providers:
Topiramate (marketed as Topamax) Information, 03 April 2011