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FDA: Risk of Oral Birth Defects in Children Born to Mothers Taking Topiramate
Date:3/4/2011

t prevalence of oral clefts, compared with a prevalence of 0.38 percent – 0.55 percent in infants exposed to other antiepileptic drugs.

Infants of mothers who did not have epilepsy and were not being treated with other antiepileptic drugs had a prevalence of 0.07 percent. Similar data from the United Kingdom Epilepsy and Pregnancy Register supported the North American AED Pregnancy Registry data.

Based on the data, topiramate will have a stronger warning in its prescribing information (labeling). The pregnancy category will be changed to Pregnancy Category D. This means that there is positive evidence of human fetal risk based on human data, but the potential benefits of the drug in pregnant women may outweigh the risks in certain situations. The FDA previously designated the drug as Pregnancy Category C because of the lack of human data. More information about the Pregnancy Categories can be found in the FDA's Drug Safety Communication: http://www.fda.gov/Drugs/DrugSafety/ucm245085.htm

The patient medication guide and prescribing information for Topamax and generic topiramate will be updated with the new information.

Before starting topiramate, pregnant women and women of childbearing potential should discuss other treatment options with their health care professional. Women taking topiramate should tell their health care professional immediately if they are planning to or become pregnant. Patients taking topiramate should not stop taking it unless told to do so by their health care professional.  

Women who become pregnant while taking topiramate should talk to their health care professional about registering with the North American Antiepileptic Drug Pregnancy Registry (http://www2.massgeneral.org/aed/), a group that collects information about outcomes in infants born to women treated with antiepileptic dru
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SOURCE U.S. Food and Drug Administration
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