By THE ASSOCIATED PRESS
Published: March 4, 2011
The Food and Drug Administration warned women of child-bearing age that the epilepsy drug Topamax can increase the risk of birth defects around the mouth. Regulators said Friday that data showed a higher rate of cleft lip and cleft palate in children whose mothers were taking Topamax in the first trimester of pregnancy. Infants who were exposed to the drug had a 1.4 percent rate of mouth defects, more than three times as high as that seen with other seizure medications. Johnson & Johnson and generic companies that market the drug, known as topiramate, will be required to add a stronger warning label about its effect on pregnancies.
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