Antibiotic Telithromycin (KETEK) Can Cause Liver Damage, Respiratory Failure and Death

The Food and Drug Administration (FDA) missed yet another opportunity to protect public health when it failed to completely ban the dangerous antibiotic telithromycin (KETEK), which has caused liver damage and multiple deaths.

The agency announced on Feb. 12, 2007, that it is revoking approval of telithromycin for treatment of two of the three previously approved conditions. The drug had been approved to treat chronic bronchitis, acute bacterial sinusitis and mild-to-moderate community-acquired pneumonia.  

As a result of the FDA’s action, telithromycin is now approved to treat only mild-to-moderate community-acquired pneumonia. Further, the agency will now require stronger warnings in the professional product label (package insert) regarding hepatotoxicity (liver injury), loss of consciousness and visual disturbances for the remaining approved condition. Pharmacists must now distribute FDA-approved text in the form of a medication guide with every filled and re-filled prescription for the drug.

The agency also included a black box warning, the agency’s strongest warning, saying that the drug should not be used by the few patients who have myasthenia gravis, a muscle disease that leads to weakness, because it can cause respiratory failure in those patients. These warnings come as a result of the FDA’s recently completed safety assessment.

Public Citizen considers this a weak response to the findings of this assessment, particularly because there are other drugs available that are equally or more effective treatments for the same conditions treated by telithromycin. Instead, consumer health is compromised and only Sanofi-Aventis, the drug’s manufacturer, benefits.

The full text of the FDA’s announcement and additional information can be found at: www.fda.gov/bbs/topics/NEWS/2007/NEW01561.html.

What to watch for
Telithromycin can cause severe liver damage, in some cases leading to a liver transplant or death. Severe liver damage has occurred even after a few doses or immediately following initial treatment.

The signs of liver toxicity include:

• fatigue
• loss of appetite
• yellowing of the skin and/or eyes
• right upper belly pain
• light-colored stools
• dark urine
• itchy skin

In addition, telithromycin can cause profound and debilitating vision problems. Blurred vision, trouble focusing, double vision and vision problems when looking quickly from near objects to far objects have been reported.

Fainting is also a side effect of telithromycin. Of course, fainting and vision problems can affect the ability to drive or do other dangerous activities.

What You Can Do
You should not take telithromycin. There are safer antibiotics that are equally or more effective than this drug to treat community-acquired pneumonia.  

If you experience one or more of the signs of liver toxicity listed above, you should stop taking telithromycin and call your physician immediately. Do not take another dose of the drug unless instructed to do so by your physician.