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news.The FDA and Sanofi-Aventis are discussing the labeling of the company's antibiotic Ketek after it was linked to a number of cases of liver failure.
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According to an internal FDA communication first reported in the Wall Street Journal, the FDA has received reports of 12 cases of liver failure, including four deaths, in patients taking the drug. The memo is also reported to express the FDA's concern that these adverse events appear to be more frequent in patients taking Ketek than in those taking similar antibiotics.
Sanofi-Aventis has indicated that it still believes Ketek to be safe when used according to its label. “These complex evaluations require careful and rigorous analysis with leading experts before drawing any definitive conclusion,” the company said in a statement quoted by the Associated Press.
Ketek, known generically as telithromycin, is used to treat mild to moderate respiratory infections. The drug was approved in Europe in 2001 but was not approved in the US until April 2004 after the FDA asked for more safety information in 2001 and 2003.