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Volume 355:2260-2261 November 23, 2006 Number 21
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Telithromycin and Acute Liver Failure

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 by Johnston, S. L.
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To the Editor: In their study of the efficacy of telithromycin in patients with acute asthma exacerbations, Johnston et al. (April 13 issue)1 discount the risk of acute liver failure. They do not mention that in 2001 an advisory committee of the Food and Drug Administration (FDA) voted against approval of telithromycin primarily because of concern about hepatotoxicity.2 In response, the drug's manufacturer conducted a trial involving 24,000 patients that was plagued by issues of fraud and data integrity of such magnitude that the FDA could not use the results to support approval.2

Lacking reliable data to counter the advisory . . . [Full Text of this Article]


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