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FDA Urges Halt of Ketek Antibiotic Trials in Children

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An official within the FDA called for a halt of clinical trials in children of Sanofi-Aventis’ antibiotic, Ketek, based on concerns that the drug might be deadly. The drug is being tested on ear infections and tonsillitis in nearly 4,000 infants and children in over a dozen countries, including the U.S., in spite of its having caused liver failure, blurred vision, and loss of consciousness in adults. Evidence is mounting that Ketek may be unusually toxic. “How does one justify balancing the risk of fatal liver failure against one day less of ear pain?” asks Dr. Rosemary Johann-Liang, an FDA offical in the Office of Drug Safety in a memorandum obtained by the New York Times.