Ketek

Reports State that Bronchitis Drug Ketek May Cause Liver Failure, Death

On June 29, 2006, the U.S. Food and Drug Administration ordered the makers of Ketek to put a stronger warning on the drug labels because of its link to serious liver injury, liver failure and death. The FDA has received reports of 12 cases of acute liver failure, including four deaths, in patients treated with Ketek, according to an internal agency memo. FDA safety evaluators also uncovered 23 other cases where patients suffered serious liver injuries after receiving the antibiotic, also called telithromycin.

When the internal memo was leaked to the public, French drug manufacturer Sanofi Aventis confirmed on May 19 that it was in discussion with the USDA about its antibiotic Ketek after the USDA wanted a warning label put on the drug. The FDA had rejected the drug in 2001 and 2003, asking for more safety information.

Ketek is most frequently prescribed for patients with chronic bronchitis; acute bacterial sinusitis; and community acquired pneumonia of mild to moderate severity, including pneumonia caused by resistant strep infections. When the FDA approved Ketek in April 2004, the drug's labeling included precautions about liver injury and possible worsening of myasthenia gravis, as with other drugs in its class. Sanofi Adventis is now revising the drug labeling to address the new concerns about Ketek's potentially fatal impact.

Ketek's new label will also note that there have been reports of fatal worsening of the neuromuscular condition, myasthenia gravis. The FDA knows of three reported deaths in myasthenia gravis patients taking Ketek. These deaths occurred separately from the reported liver problems.

The drug is the first FDA-approved antibiotic of the ketolide class, and the FDA has concluded that the drugs benefit to patients for the approved indications outweighs its risk. Following an internal FDA memo reporting that Ketek has been linked to 12 cases of liver failure and 4 deaths, French drug manufacturer Sanofi-Aventis confirmed on May 19 that it was in discussion with the USDA about its antibiotic Ketek after the USDA wanted a warning label put on the drug.

Recently, Ketek drug trials on children were widely criticized, even from a few members of Congress. The drug had only been approved to treat mild to moderate respiratory infections in adults.

The FDA has said that it could not determine how frequently Ketek was associated with adverse events, and concluded that since the drug's benefits outweighs its risks, it should stay on the market.

Patients on Ketek should be vigilant, and watch for these signs and symptoms of liver failure: fatigue, malaise, loss of appetite, nausea, yellow skin and dark-colored urine.

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