May 23, 2006

FDA Urges Stronger Warning for Ketek

Posted at May 23, 2006 8:10 AM in Drug Products .

Citing a growing number of deaths related to liver failure, the FDA has called for a stronger warning label for the antibiotic drug KetekThe FDA has received reports of 12 cases of acute liver failure, including the four deaths, in patients treated with Ketek, according to a copy of an FDA memo. FDA safety evaluators also uncovered 23 other cases where patients suffered serious liver injuries after receiving the antibiotic, which is formally called telithromycin.

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