TELITHROMYCIN UPDATE (FDA) Why is FDA revising the labeling and keeping this drug on the market instead of withdrawing the drug from the market? When new, unanticipated risks are detected after approval, an FDA review team (consisting of medical doctors, statisticians, safety evaluators, epidemiologists, and other experts) carefully evaluates the information provided by the sponsor and/or the information gathered from the post marketing surveillance program.   As part of its review the FDA must assess the severity and frequency of the adverse event and reach a determination regarding the benefit/risk profile of the drug.  No drug is absolutely safe. All drugs have side effects. When FDA determines that a drug is safe and effective "Safe" means that the benefits of the drug appear to outweigh the risks when used as directed in the FDA approved labeling. For Ketek, the FDA continues to believe that the benefits of the drug outweigh the risks when used appropriately and that the benefit/risk profile for Ketek is similar to that of other approved antibiotic drugs used to treat the same types of infections.  FDA will continue to monitor reports of adverse events with Ketek and will take appropriate additional regulatory actions if new information leads to a different conclusion about Ketek’s benefit/risk profile What information was known about liver problems related to Ketek 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.

FDA looked extensively at the potential for hepatic toxicity in patients treated with Ketek. Data was examined from clinical studies, as well as information in nearly 4 million post marketing 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. Excerpts from:(Questions and Answers on Telithromycin (marketed as Ketek) July 5, 2006

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