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Ketek (telithromycin) is a powerful antibiotic used to treat serious bacterial infections such as pneumonia, sinusitis, and chronic bronchitis in adults. Manufactured by the French drug maker Sanofi-Aventis, Ketek first received approval from the Food and Drug Administration in April 2004. However, the antibiotic came under scrutiny after an article appeared in the January 2006 issue of the Annals of Internal Medicine linking Ketek to severe, potentially fatal, liver damage including liver failure and death.
If you or a loved one has suffered serious liver problems or other adverse Ketek side effect, you may be eligible to seek compensation for your losses and suffering . Please click here to learn more about your legal rights and options.
Ketek Side Effects and Risks
Since its approval, Ketek has been linked to 23 cases of severe liver injury , 12 cases of complete liver failure, and 44 instances of other liver problems . Of the 12 cases of liver failure, four patients died and one required a liver transplant. Even worse, liver functioning rapidly deteriorated in previously healthy patients after only a few doses of Ketek.
In addition to acute liver damage, other adverse Ketek side effects include:
The FDA has advised doctors and patients to remain alert for signs and symptoms of liver problems during Ketek use. If you are experiencing any of these or other Ketek problems , you should consult with a physician immediately.
Ketek and the Law
The FDA has recently urged Sanofi-Aventis to include a heightened warning on the drug''s label. The revised Ketek warning label will include the increased risk of life-threatening liver disease and other negative effects on liver functioning.
Drug manufacturers like Sanofi-Aventis have a duty to inform the medical community and the public about dangers associated with their drugs. Individuals who have suffered serious injury as a result of taking Ketek may be able to hold Sanofi-Aventis liable for their losses.
Ketek has NOT been removed from the market, despite a recommendation made by an FDA safety official in July 2006. The FDA official stated that the drug should be immediately withdrawn from the market over serious safety concerns, particularly the increased risk of severe liver injury, liver failure and death. Agency documents show that Sanofi-Aventis, Inc.—the manufacturer of Ketek—failed to reveal these and other problems with the drug during clinical trials, and then negligently conducted postmarketing studies to protect their profits. Drug companies are notoriously reluctant to jeopardize profits, even if that means engaging in fraudulent or deceptive practices. According to the FDA safety official, approving Ketek was a mistake. Still, it has yet to be removed from the market.
In October 2006, Sanofi-Aventis Inc., the makers of the popular antibiotic Ketek, and Canada issued a public health advisory warning patients of the serious risks associated with use of the drug. Based on reports of serious liver injury – including liver damage, liver failure, hepatitis, and death – as well as reports of postmarket adverse events, the safety information on the drug was updated in both Canada and the United States. The October 2006 Doctor''s Guide memo revealed the potentially life-threatening risks linked to Ketek and alerted consumers that Ketek liver injury and other side effects could occur after only a few doses of the antibiotic.
Injured by Ketek? Ensure that your legal rights are protected. Please contact us today for a FREE consultation with a caring and experienced attorney who can evaluate your claim and help you determine a course of action.
The Food and Drug Administration said Ketek, an antibiotic manufactured by drug giant Sanofi-Aventis, can no longer be marketed as treatment for two common sicknesses, and will now be required to carry a stronger warning on its label.
Ketek sh...
A popular antibiotic that has been linked to rare cases of severe live damage including several deaths faces more scrutiny by the U.S. Food and Drug Administration as a panel of outside medical experts will thoroughly evaluate the risks and benefits of...
A United States senator is accusing the Food and Drug Administration of attempting to cover up information pertaining to its review of the controversial antibiotic Ketek .
The Senate Finance Committee, led by Republican Charles Grassley, is cu...
Doctor: FDA-Approved Antibiotic A ''Time Bomb'' - Doctor who reviewed Ketek''s safety for the FDA, says he warned his superiors that the drug was, in his words, a "time bomb," and was shocked last summer when the acting head of the agency, Dr. Andrew Von Eschenbach, told employees to keep concerns about the drug in-house -- and out of the press.
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