KETEK causes severe liver toxicityKetek, known generically as telithromycin, is a ketolide antibiotic used for the treatment of respiratory infections including chronic bronchitis, acute bacterial sinusitis and community-acquired pneumonia. Ketek is manufactured by Sanofi-Aventis.
In April 2004, the Food and Drug Administration (FDA) approved Ketek for the treatment of respiratory infections including sinusitis, bronchitis, and pneumonia after two previous application rejections in 2001 and 2003 after the agency requested more safety data. On Jan. 20, 2006, researchers reported three cases of severe liver toxicity following the use of Ketek. Of these cases, one patient needed a liver transplant and another died. Examination of these patients' livers showed massive tissue death. All patients had been healthy previous to the use of Ketek.  Since then, a confidential FDA Ketek memo has been announced publicly; the report reveals twelve cases of liver failure including four deaths associated with Ketek. The Wall Street Journal reported about the memo, but the FDA is not releasing it to the public. New concerns have been raised about Ketek’s liver risks, and as such, the FDA is currently examining the frequency of liver-related adverse effects of Ketek and similar antibiotics. In doing so, a determination will be made whether or not labeling changes or other actions are necessary. However, the current Ketek label warns doctors of the potential for liver-related adverse effects associated with the use of the antibiotic.
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On Jan. 20, 2006, researchers reported three cases of severe liver toxicity following the use of Ketek. Of these cases, one patient needed a liver transplant and another died. Examination of these patients' livers showed massive tissue death. All patients had been healthy previous to the use of Ketek.  Since then, a confidential FDA Ketek memo has been announced publicly; the report reveals twelve cases of liver failure including four deaths associated with Ketek. The Wall Street Journal reported about the memo, but the FDA is not releasing it to the public. New concerns have been raised about Ketek’s liver risks, and as such, the FDA is currently examining the frequency of liver-related adverse effects of Ketek and similar antibiotics. In doing so, a determination will be made whether or not labeling changes or other actions are necessary. However, the current Ketek label warns doctors of the potential for liver-related adverse effects associated with the use of the antibiotic.


