Indication Changes for the Antibiotic Ketek

The Food and Drug Administration (FDA) today 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


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


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 (rare but severe symptoms of liver disease) were strengthened in June 2006.


The antibiotic Ketek was originally approved in 2004 and is manufactured by Sanofi Aventis.