Thursday, December 14, 2006

Ketek Liver Failure -- Stay Tuned

This reported on CBS News yesterday. . .
Iraq war veteran Chuck Gregg was back home with his family last winter when he got bronchitis. His doctor prescribed Ketek [telithromycin], a relatively new antibiotic, CBS News chief investigative correspondent Armen Keteyian reports. Five days later, Gregg was in the hospital with liver failure. >Full Story: CBS News
. . . and we learn today. . .
Two Food and Drug Administration committees are hosting public meetings today and tomorrow to discuss whether Ketek, used to fight pneumonia, bronchitis and sinusitis, is safe enough to remain on the market. . . The regulators identified 79 reports of liver damage linked to the drug as of April, including four reports of deaths in the U.S., according to the documents. About 390 patients had reported blurred vision and other impairments as of July 7, and 137 patients had some loss of consciousness while taking the drug. >Full Story: Bloomberg
There is no doubt that there has been ongoing controversy regarding FDA review of this issue over that last several years. It's also likely that alternative standard and cheaper antibiotics may have been appropriate in some of these patients. But, keep in mind that although yearly prescriptions for standard antibiotic therapies are of course much higher than with Ketek, it has been estimated that in the U.S. there are some 66 cases annually of acute liver disease resulting in hospitalization with erythromycin, 114 with sulfonamides, and 31 with tetracycline (Carson JL et al. Ann Intern Med 1993;119:576-583.).

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