The FDA has slapped a birth-defect warning on Johnson & Johnson's Topamax drug, saying doctors should reconsider prescribing the drug to women of childbearing age. Approved to treat epileptic seizures and to prevent migraine headaches, but also prescribed off-label for psychiatric use, Topamax has been linked with increased risk of cleft lip and cleft palate, the FDA said.
"Health care professionals should carefully consider the benefits and risks of topiramate when prescribing it to women of childbearing age," said Russell Katz, director of the FDA's Division of Neurology Products. "Alternative medications that have a lower risk of birth defects should be considered."
The warning will apply to copycat versions of the drug, whose chemical name is topiramate. Generic versions are made by Teva Pharmaceutical Industries, Watson Pharmaceuticals, Mylan and other copycat drugmakers, Reuters reports.
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