What information was known about liver problems related to telithromycin prior to approval?
Based on the pre-marketing clinical data it appeared that the risk of liver injury with telithromycin was similar to that of other marketed antibiotics. Prior to approval, FDA looked extensively at the potential for hepatic toxicity in patients treated with Ketek. The data examined included a 25,000 patient controlled study, as well as information in nearly 4 million postmarketing prescriptions outside the United States. Ketek was the subject of two advisory committee meetings with input from a national expert on drug-induced liver disease. The committee concluded that the risk for hepatotoxicity from Ketek was similar to Augmentin and erythromycin which are other approved antibiotics.
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- What information was known about liver problems related to telithromycin prior to approval?
