FDA issues warning for Ketek

July 10, 2006

FDA has completed its safety assessment of Sanofi Aventis' Ketek (telithromycin) and is advising health practitioners and patients to be aware of rare but potentially serious health risks. Ketek is the first FDA-approved antibiotic of the ketolide class.

FDA issues warning for Ketek

FDA has completed its safety assessment of Sanofi Aventis' Ketek (telithromycin) and is advising health practitioners and patients to be aware of rare but potentially serious health risks. Ketek is the first FDA-approved antibiotic of the ketolide class. It is indicated for the treatment of acute exacerbation of chronic bronchitis; acute bacterial sinusitis; and community-acquired pneumonia of mild to moderate severity, including pneumonia caused by resistant strep infections. The drug has been associated with rare cases of serious liver injury and liver failure with four reported deaths and one liver transplant after the administration of the drug. The manufacturer is revising the drug labeling to address this safety concern.

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