Antibiotic :: FDA restricts use of Sanofi-Aventis’ antibiotic Ketek

The US Federal regulators – FDA has narrowed the approved uses and indications of the controversial Sanofi-Aventis’ antibiotic Ketek.

The Food and Drug Administration (FDA) 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 – acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis – from the drug’s label.

The FDA agency 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 (acquired outside of hospitals or long-term care facilities).

In addition, the agency has worked with the company, Sanofi Aventis, to update the product labeling with a “boxed warning,” FDA’s strongest form of warning. The warning states that Ketek is contraindicated (should not be used) in patients with myasthenia gravis, a disease that causes muscle weakness.

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