KETEK Questions
Q: What is Ketek?
A: Ketek is an FDA-approved antibiotic drug, which belongs to the ketolide class, marketed in the United States by Sanofi-Aventis. Ketek was approved by the Food and Drug Administration in April 2004.
Q: What is Ketek used to treat?
A: Ketek is used for the treatment of adults with serious bacterial infections—like strep throat, pneumonia, sinus infections and chronic bronchitis.
Q: What did Dr. David Graham of the FDA’s Office of Drug Safety say about Ketek?
A: He opposed its approval, and he wrote that he was “unaware of any unique or life-saving advantage offered by telithromycin [Ketek] that might offset or balance against either an absence of safety data or evidence of unusually high hepatotoxicity.”
The AIM had reports of three healthy patients taking Ketek, all of whom fell sick. One patient recovered, one required a transplant, and one died.
Q: How about Dr. Steven Glason, director of the FDA’s Center for Drug Evaluation and Research?
A: He advised patients taking Ketek and their doctors to be alert for signs and symptoms of liver problems.
Q: What are the primary side effects of Ketek?
A: Jaundice, hepatitis, liver disease, nausea and headache are just a few.
Q: Is there some connection between Ketek and heart troubles?
A: Yes, some people taking Ketek have had cardiac palpitations and arrhythmia—possibly life-threatening conditions.
Q: What about the three reports about Ketek in the Annals of Internal Medicine?
A: These reports are significant due to the serious nature of the adverse events. Three patients taking Ketek, all of whom had been healthy, came down with jaundice and abnormal liver function. One patient recovered, one required a transplant, and one died.
Q: What should patients do regarding this new information about Ketek?
A: Patients who have been prescribed Ketek and who do not have side effects should continue taking it as before. But patients who notice any yellowing of their eyes or skin, or other problems like blurry vision should contact their doctor.
Q: What should doctors do regarding this new information about Ketek?
A: They should monitor patients taking Ketek for signs or symptoms of liver problems, in which case Ketek should be stopped.
Q: What did the FDA do about Ketek on June 29, 2006?
A: A strong FDA warning was issued, stating that Ketek has been proven to be a direct link to liver toxicity, liver failure and death in some patients.
