Ketek is indicated for the treatment of acute exacerbation of chronic bronchitis; acute bacterial sinusitis; and community acquired pneumonia of mild to moderate severity, including pneumonia caused by resistant strep infections.
The FDA says in a statement that the drug has been associated with rare cases of serious liver injury and liver failure .
Four deaths have been reported and one liver transplant after the administration of the drug. The manufacturer is revising the drug labeling to address this safety concern.
The FDA says it is difficult to determine the exact frequency of Ketek-associated adverse events on the basis of FDA's mandatory and voluntary reporting systems.
Nevertheless, the agency has concluded that the drugs' benefit to patients for the approved indications outweighs its risk, including the rare risk of liver failure, and supports its continued availability.
Dr. Steven Galson, Director for FDA's Center for Drug Evaluation and Research, says, "We are advising both patients taking Ketek and their doctors to be on the alert for signs and symptoms of liver problems."
He adds, "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.
