Ketek

Ketek is the brand name for Telithromycin, an FDA approved antibiotic drug, which belongs to the ketolide class, marketed in the U.S. by Sanofi-Aventis. Telithromycin was approved in the U.S., in April 2004. Ketek (telithromycin) is used for the treatment of the following types of bacterial infections:

community-acquired pneumonia (including multi-drug resistant Streptococcus pneumoniae)

acute bacterial sinusitis

acute bacterial exacerbation of chronic bronchitis

Ketek received an update to it's label on June 29, 2006 to specificly highlight the WARNINGS section of the labeling to raise attention to the risk of liver toxicity associated with Ketek and strengthen the WARNINGS for patients with myasthenia gravis. The new labeling information is based on a review of safety data relating to hepatic adverse event reports. For Ketek, the FDA continues to believe that the benefits of the drug outweigh the risks when used appropriately and that the benefit/risk profile for Ketek is similar to that of other approved antibiotic drugs used to treat the same types of infections. FDA will continue to monitor reports of adverse events with Ketek and will take appropriate additional regulatory actions if new information leads to a different conclusion about Ketek�s benefit/risk profile.

At the time of approval, the Ketek (telithromycin) product label included a precautionary statement advising doctors that hepatic adverse events (hepatic dysfunction, increased liver enzymes and hepatitis, with or without jaundice) had been reported with Ketek and that these events were generally reversible. This precaution was based upon the findings from the phase 3 clinical studies and postmarketing data from other countries. As with any drug, Ketek labeling contains known adverse events that are described in the product labeling, however after the one year post-approval assessment FDA was alerted to an increased rate of liver toxicity through AERS. FDA promptly initiated another safety assessment which was recently completed and provides support for the action that FDA took on June 29, 2006.

The Food and Drug Administration (FDA) announced on February 12, 2007, 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 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).

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.

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