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FDA Toughens Warnings of Liver Failure on Ketek

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In its second Safety Information Alert in six months, the FDA announced it is mandating tougher warnings about liver toxicity and liver failure, after receiving reports of four deaths and one liver transplant, in patients who were taking the antibiotic Ketek. Ketek was approved in April, 2004, for upper respiratory infections in adults. The drug’s maker, Aventis-Sanofi SA, had been testing the drug on thousands of infants and children until recently when it halted the clinical trial on the FDA’s demand. “How does one justify balancing the risk of fatal liver failure against one day less of ear pain?” asked Dr. Rosemary Johann-Liang, an FDA official in the Office of Drug Safety, in a memo obtained by the New York Times.