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FDA Announces Label and Indication Changes for Antibiotic Ketek

Feb 12, 2007 | Citing various safety issues, the U.S. Food and Drug Administration (FDA) has changed the approved usages for the antibiotic Ketek (telithromycin). Two of the three currently approved indications acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis will be removed from the product’s label.

“The agency has determined that the balance of benefits and risks no longer support approval of the drug for these indications,” the FDA explained. “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).”

Additionally, the FDA has asked drug maker Sanofi Aventis to add a “black box” warning to Ketek’s labels, stating that Ketek should not be used in patients with myasthenia gravis, a disease that causes muscle weakness. The company has also been required to strengthen the warning section regarding adverse events including visual disturbances and loss of consciousness. (In June of last year, warnings for hepatic toxicity severe symptoms of liver disease were bolstered.)

“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,” the agency noted.

Ketek was originally approved by the FDA in 2004, but the approval process for the controversial drug has come under scrutiny by both houses of Congress as the issue of prescription drug safety has gained momentum in recent months. The FDA originally rejected Ketek in 2001, citing risks including liver damage and blurred vision. In response, Sanofi Aventis commissioned a rather dubious study of the drug that suffered from falsified data, inappropriate subjects, criminal doctors, and significant violations of the study’s guidelines.

Though that study was rejected and a subsequent clinical trial was rife with inaccuracies–an FDA advisory panel pushed for Ketek’s approval in 2003. Although the full FDA declined approval that year, they reversed their decision the following year. The controversy has ignited calls from medical professionals and congressmen for more stringent standards in the FDA’s approval of pharmaceuticals.

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