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FDA Alters Topamax Labeling to Warn of Risk of Birth Defects


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FDA Alters Topamax Labeling to Warn of Risk of Birth Defects

Topamax, an anticonvulsant medication used for the treatment of migraine headaches and epileptic seizures, will receive a stronger warning label. According to a study conducted by the North American Antiepileptic Drug Pregnancy Registry, the medication and its generic equivalents dramatically increase the risk of birth defects such as cleft lip and cleft palate deformities when taken by pregnant women.

"Healthcare professionals should carefully consider the benefits and risks of topiramate when prescribing it to women of childbearing age," said Dr. Russell Katz, director of the Division of Neurology Products of the Food and Drug Administration, told the website Drug Watch.

According to the source, the risk of birth defects are especially high when taken by women during their first trimester of pregnancy or if a woman is unaware that she is pregnant.

The drug's labeling already contains warnings about the risk of birth defects when taking the medication. Now the label will be revised so that it contains even stronger language, stating that there is "positive evidence of human fetal risk based on human data."