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Published on Mar 28, 2011 by Edgar Snyder

Topamax Gets Stronger Warning Label Due to Birth Defect Data

Topamax birth defect

The U.S. Food and Drug Administration is strengthening the warning label on antiseizure drug topiramate, also sold under the brand name Topamax by Johnson & Johnson. New data suggests that the dangerous drug increases the risk of birth defects, especially if taken during the first trimester of pregnancy.

Research conducted by the North American Antiepileptic Drug Pregnancy Registry showed that topiramate increases the chances of a baby being born with a cleft lip or cleft palate. The medication's pregnancy category will change to Category D, meaning there is evidence of risk to a fetus but that the benefits of the drug may outweigh the risks in certain situations. Its previous category was C due to a lack of human data.

Topamax and its generic counterparts are approved to treat certain types of seizures in epilepsy as well as migraines. In addition to antiseizure medications, topiramate is also found in the diet drug Qnexa, which is currently under development.

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