The Food and Drug Administration has completed its safety assessment of Ketek (telithromycin). Ketek has been associated with rare cases of serious liver injury and Ketek liver failure with four reported deaths and one liver transplant after the administration of the drug.

FDA determined that additional warnings are required for Ketek and the manufacturer is revising the drug labeling to address this safety concern. FDA is advising both patients taking Ketek and their doctors to be on the alert for signs and symptoms of liver problems.

Patients taking Ketek should be aware of any Ketek side effects and be aware of signs or symptoms of live problems.  “We are advising both patients taking Ketek and their doctors to be on the alert for signs and symptoms of liver problems," said Dr. Steven Galson, Director for FDA’s Center for Drug Evaluation and Research.  "Patients experiencing such signs or symptoms should discontinue Ketek and seek medical evaluation, which may include tests for liver function."  The signs and symptoms of liver failure include fatigue, malaise, loss of appetite, nausea, yellow skin and dark-colored urine.

On January 20, 2006, the FDA announced that the Annals of Internal Medicine published an article reporting three patients who experienced serious liver toxicity following administration of Ketek (telithromycin).  As the FDA investigates these issues, they provided the following recommendations to healthcare providers and patients:

If you have been injured as a result of taking Ketek, you should contact an attorney by filling out the form below.