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FDA Strengthens Warning Label for Topamax

[ Thursday, March 24, 2011 ]

The FDA has indicated that changes will be made to the warning label of the anti-epileptic drug Topamax® in response to new data linking the drug with the development of birth defects.

The data, collected and presented by the North American Antiepileptic Drug Pregnancy Registry at MassGeneral in Boston, outlines the risk for developmental irregularities in children maternally exposed to the drug during pregnancy.  Researchers found that exposure to Topamax® during pregnancy raises the prevalence of major malformations from about 1.3% to 3.8%.  Furthermore, these newborns were more likely to develop cleft lip and exhibit abnormally low birth weight when compared to similar anti-epileptic drugs, as well as control groups.

In response to these data, the FDA will rescheduled Topamax® from pregnancy category C, to class D, representing the newly acknowledged risk for birth defects if taken during pregnancy.