It was more than a year ago that an article published in the Annals of Internal Medicine caused both the FDA, and Health Canada to issue public warnings about the potential for compromising the liver. In the report, three cases of liver failure stemming from Ketek use were profiled. One patient eventually recovered, another required a liver transplant, and still another died.The FDA referred to the article in a release dated January 20th, 2006, and took further steps in late June of last year with additional warnings about liver toxicity.
Finally approved in 2004 after two failed attempts, Ketek (telithromycin) is a class of antibiotic prescribed to treat bacterial infections. The drug is manufactured by sanofi-aventis and is the first marketed ketolide antibiotic.
The list of side effects include drowsiness, nausea, blurred or double vision, dizziness, jaundice - and the one that has everyone worried - liver damage.
There is apparently no requirement for prior liver disease to be affected. Lawyersandsettlements.com recently profiled [Andy Johnson], who is an otherwise healthy 35-year old with no history of liver problems in his family, and no history of alcohol consumption. And yet, a prescription for Ketek led to liver problems that put him into hospital.
For one young Hispanic man profiled in the March 21, 2006 Annals of Internal Medicine report, five days of taking Ketek led to his death.
According to the summarized report, telithromycin was found to elevate liver enzymes in clinical trials prior to approval of the drug in 2004. However, incidence rates were very low and telithromycin was deemed as safe and effective as other antibiotics.
However, experience with three otherwise healthy patients who developed liver damage prompted researchers to raise the red flag. The patient who recovered began having liver problems soon after taking Ketek, and improved soon after coming off it. In the March 21st 2006 issue of the Annals of Internal Medicine, the author concludes that while a definitive link cannot be made, there is sufficient cause to suspect that Ketek has the potential to cause serve liver damage, and should be used with caution until such time as the drug is deemed safe.
An editorial summary in the same issue cautions physicians to only use telithromycin when it is, conclusively, the most appropriate antibiotic for the circumstances.
FDA approval of Ketek has been shrouded in controversy. Writing in the New England Journal of Medicine, Dr. David B. Ross, M.D., Ph.D. recalls that twice the FDA denied approval for Ketek until it was finally given the green light in early 2004. Since then there has been dozens of reports, according to the author, of severe liver injury linked to Ketek. A doctor involved in one of the clinical trials was jailed for committing fraud, and two congressional investigations were launched into the acceptance by the FDA, of fraudulent data.
Dr. Ross goes on to say that, ironically, safoni-aventis touted the launch of Ketek as being the most successful introduction of an antibiotic in history.
Barely seven months after the drug was approved on April 1st 2004, a patient died of drug-related liver failure, after taking Ketek.
In a joint communiqué with the FDA, dated December 15 2006, safoni-aventis recommends the "continued marketing of Ketek® (telithromycin) in mild to moderate community acquired pneumonia (CAP), but recommends against continued marketing in acute exacerbation of chronic bronchitis (AECB) and acute bacterial sinusitis (ABS)."