The FDA ( Food and Drug Administration ) announced revisions to the labeling for the antibiotic Ketek ( Telithromycin ) designed to improve the safe use of Ketek by patients. The changes include the removal of two of the three previously approved indications from the drug's label: acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis.
The FDA has determined that the balance of benefits and risks no longer support approval of the drug for these indications. Ketek will remain on the market for the treatment of community acquired pneumonia of mild to moderate severity.
In addition, the FDA has updated the product labeling with a " boxed warning “.
The warning states that Ketek is contraindicated in patients with myasthenia gravis.
FDA also worked with the manufacturer to develop a Patient Medication Guide, that informs patients about the risk of the drug and how to use it safely. The Medication Guide ( an FDA-approved patient information sheet ) will be provided to patients with each prescription.
Other labeling changes included in today's action are a strengthened warning section regarding specific drug-related adverse events including visual disturbances and loss of consciousness. Warnings for hepatic toxicity were strengthened in June 2006.
The joint Advisory Committee, which met on December 14 and 15, 2006, advised that the available data including data acquired since the initial approval of Ketek support a conclusion that the benefits of Ketek outweigh the risks in patients with community acquired pneumonia, but not for patients with acute bacterial sinusitis or acute bacterial exacerbation of chronic bronchitis. They also recommended a boxed warning as well as Medication Guide for the drug.
The antibiotic Ketek was originally approved in 2004.
Source: FDA, 2007
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