The FDA demands changes to Ketek label

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. 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.

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.

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

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