FDA issues public health advisory for use of Ketek after patients' livers fail.The US Food and Drug Administration issued a public health advisory on Jan. 20 for Sanofi-Aventis' antibiotic Ketek (telithromycin) following reports three patients at Carolinas Medical Center Carolinas Medical Center (CMC) is a public, not for profit hospital located in Charlotte, North Carolina. The hospital was organized in 1940 as Charlotte Memorial Hospital on Blythe Boulevard in the Dilworth neighborhood. in Charlotte, NC, had experienced serious liver toxicity following administration of the drug. Physicians at the Carolinas Medical Center physicians notified the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. that one patient died, one required a liver transplant liver transplant Hepatic transplant Transplant surgery A procedure that replaces a cancer conquered, metabolically defeated, or substance subjugated liver with one no longer required by its owner, many of whom donate same after an MVA Diseases requiring transplant , and a third developed drug-induced hepatitis Hepatitis, Drug-Induced Definition Inflammation of the liver due to an adverse reaction with a drug. Description The liver is a very important organ to the body. but later recovered, either during treatment or shortly after the patients started taking Ketek. The FDA reported in the advisory that all three patients developed jaundice jaundice (jôn`dĭs, jän`–), abnormal condition in which the body fluids and tissues, particularly the skin and eyes, take on a yellowish color as a result of an excess of bilirubin. and abnormal liver function. The patient who died and the patient receiving the transplant showed massive tissue death when they were examined in the lab. These two patients had reported some alcohol use. All three patients had previously been healthy and were not using other prescription drugs. The three case reports were released on Jan. 20 in an online edition of Annals of Internal Medicine Annals of Internal Medicine (Ann Intern Med) is an academic medical journal published by the American College of Physicians (ACP). It publishes research articles and reviews in the area of internal medicine. Its current editor is Harold C. Sox. . "These cases could represent an unusual clustering of a rare, idiosyncratic drug reaction Idiosyncratic drug reactions, also known as type B reactions, are drug reactions which occur rarely and unpredictably amongst the population. This is not to be mistaken with idiopathic which entails that the cause is not known. Some patients have multiple-drug intolerance. at one medical center," said John Hanson, MD, a hepatologist with the liver transplant center at Carolinas Medical Center and one of the articles' authors. "However, the severity of live injury in two of our patients warrants this report in the medical literature and will alert other physicians to this possible link with telithromycin." While the FDA is continuing its investigation into the problems linked to the antibiotic, the public health advisory made the following recommendations to healthcare providers and patients: *Healthcare providers should monitor patients taking telithromycin for signs or symptoms of liver problems and its use should be stooped in patients if problems are found. *Patients who have been prescribed telithromycin and are not experiencing side effects such as jaundice should continue taking their medicine as prescribed unless otherwise directed by their healthcare provider. *Patients who notice any yellowing of their eyes or skin or other problems like blurry vision should contact their healthcare provider immediately. *As with all antibiotics, telithromycin should only be used for infections caused by a susceptible microorganism microorganism /mi·cro·or·gan·ism/ (-or´gah-nizm) a microscopic organism; those of medical interest include bacteria, fungi, and protozoa. . Telithromycin is not effective in treating viral infections, so a patient with a viral infection should not receive the antibiotic since they would be exposed to the risk of side effects without any benefit. Sanofi-Aventis has not commented on the problems. |
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