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Drug & Device News
Ketek Label Change Reflects Evidence of Liver-Damage Risk
Just over a year ago, the FDA warned consumers and health care providers that Ketek' (telithromycin), an antibiotic often used to treat pneumonia and upper respiratory infections, had been implicated in three reported cases of liver toxicity. On Jan. 20, 2006, the agency stated it was 'continuing to evaluate the issue of liver problems in association with use of telithromycin in order to determine if labeling changes or other actions are warranted.' FDA Public Health Advisory, Ketek (telithromycin) Tablets, at: www.fda.gov/cder /drug/advisory/telithromycin.htm.
That labeling change was finally announced Feb. 12 of this year. The label changes include the removal of two of the three previously approved indications from the drugs label; Ketek is no longer approved for the treatment of acute bacterial sinusitis or acute bacterial exacerbations of chronic bronchitis. The medication will now also contain a 'boxed warning' on its label, the strongest form of FDA warning, stating that Ketek should not be used in patients with myasthenia gravis, a disease that causes muscle weakness. The announcement about the label changes can be accessed at: www.fda.gov/bbs/topics/NEWS/2007/NEW01561.html.
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