Three NC Hospital Cases Subject Of Article In Annals Of Internal Medicine
On January 20, 2006 the Annals of Internal Medicine published online an "early" release version of an article describing liver problems associated with the antibiotic Ketek (telithromycin). The print version of this article will be found in the March 21, 2006 edition of the medical journal.
In the three cases described in the Annals of Internal Medicine article, patients at Carolinas Medical Center, in Charlotte, North Carolina, developed differing degrees of liver problems after taking Ketek. One patient died from liver failure two weeks after taking Ketek for five days, another patient required a liver transplant after using Ketek, and a third person developed drug-induced hepatitis after Ketek therapy but later recovered. The authors of the article point out, however, that these three cases do not prove that Ketek caused the liver problems.
In connection with the early release of the Annals of Internal Medicine article about the three North Carolina cases involving liver problems after Ketek use, the FDA issued a MedWatch Alert concerning Ketek and possible liver problems.
The antibiotic Ketek is manufactured by Sanofi-Aventis SA, and was approved for the U.S. market by the FDA in April 2004 to treat acute bacterial bronchitis, sinusitis, and pneumonia. Ketek is part of a group of medications known as macrolides that includes erythromycin, Pfizer Inc.’s Zithromax, and Abbott Laboratories’ Biaxin. To date, there have been rare reports of liver problems associated with the use of Ketek and these similar antibiotics.
As quoted in a January 20, 2006 Wall Street Journal article, John S. Hanson, one of the article’s authors, tried to put the possible Ketek and liver problem "link" in perspective by stating:
"These cases could represent an unusual clustering of a rare, idiosyncratic drug reaction at one medical center…. However, the severity of liver injury in two of our patients warrants this report in the medical literature and will alert other physicians to this possible link with [Ketek]."
Meanwhile, Reuters reported on January 21, 2006 that Sanofi-Aventis says Ketek’s "safety profile" remains unchanged from their perspective.
(Posted by: Tom Lamb)
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