FDA official warns of potential Ketek danger to children

06/8/2006 | NYTimes.com

An FDA official reportedly has urged a halt to clinical trials of Sanofi-Aventis' antibiotic Ketek for possible use in children because of potentially fatal side effects. More than 4,000 infants and children in a dozen countries are involved in trials to determine if Ketek, approved only for adults, is effective in treating children's ear infections and tonsillitis. The drug has been reported to cause problems, including loss of consciousness and liver failure, in adults.

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