Ketek | Chronic Bronchitis

On February 12, 2007, the FDA (Food & Drug Administration) ordered Sanofi-Aventis, the manufacturer for the antibiotic drug, Ketek, to include a black box warning (the sternest warning available) detailing liver problems associated with the drug. This warning pertained to two of the uses for Ketek – acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis, and was issued to ensure that Ketek is used to only treat pneumonia due to the potential damage caused by this dangerous drug.

Additionally the warning states that Ketek should not be used in patients with myasthenia gravis, a disease that causes muscle weakness. The FDA also strengthened warnings for hepatotoxicity (liver damage, loss ofconsciousness and visual disturbances).

The FDA has received over 100 reports of liver problems related to Ketek usage. Their statistics indicate that liver failure from Ketek is almost four times as high as with other antibiotics. To date, there have been 35 Adverse Event Reports of liver damage. In fact, as of December, 2006, the FDA documented three cases of severe liver toxicity due to the use of Ketek. As a result, the FDA investigated the damage that Ketek can inflict on healthy livers. According to their statistics, the rate of liver failure associated with Ketek use is almost four times as high as with other antibiotics.

Numerous government officials and medical experts have questioned the way the FDA approved the use of Ketek in 2004, and what damage may have been caused to the estimated 5.6 million people that have taken the drug since that time.

The FDA advises patients taking Ketek to follow the following precautions:

• People taking standard or generic versions of Ketek should be advised to be aware of the signs of liver damage.
• Conditions such as yellowed skin and eyes (jaundice) should be reported to a doctor immediately.
• Burning eyes or blurred vision are also a sign of potentially dangerous conditions.
• Antibiotics like Ketek should not be used to treat viral infections.

If you believe your Ketek use has put you or someone you care about in danger, please fill out our Case Review Contact Form to the right on this page to find out what your case is worth.