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Editor: Ketek Lawyer
Profession: Attorney at Law

Category: Ketek News

On June 29, 2006, the FDA completed a safety assessment of Ketek (telithromycin), notifying patients and physicians of rare but potentially serious risks associated with the drug, including severe liver problems and failure.

Since its 2004 FDA approval, Ketek has been linked to liver injury and failure in some cases, including four deaths and one liver transplant reported among Ketek users. Ketek's maker, Sanofi Aventis, plans to revise the drug's label to address these risks and concerns.

The FDA has also warned physicians and patients to be on the lookout for symptoms of liver failure and other problems associated with Ketek.

"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.

The FDA plans to continue monitoring Ketek and the liver risks associated with it. Will it be necessary for the FDA to take further action to protect patients from potentially deadly liver problems?