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Drug & Device News

By ALM Staff | Law Journal Newsletters |
March 27, 2007

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.

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