The FDA has approved new safety warnings for the label of the antibiotic Ketek (telithromycin). There have been several reports of serious liver injury and liver failure associated with Ketek. The FDA advises Ketek users and their doctors to watch for signs of liver problems, which include dark-colored urine, fatigue, yellow skin and malaise. However, “the agency has concluded that the drugs’ benefit to patients for the approved indications outweighs its risk, including the rare risk of liver failure, and supports its continued availability.” Ketek is used to treat chronic bronchitis, community acquired pneumonia and acute bacterial sinusitis.
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