Ketek Information - December 2, 2008

FDA Revises Use and Labeling Of Antibiotic Ketek

February 12, 2007 - Topics ketek, fda, disease, prescription and telithromycin
The Food and Drug Administration (FDA) announced Monday it has issued revised usage and labeling of the antibiotic drug Ketek (generic name: telithromycin), manufactured by Sanoti-Adventis.

One of the major changes will be that two of the three previously approved usages of the Ketek will no longer apply. Ketek will no longer be prescribed for acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis. These indications (or treatment for these illnesses) will be removed from the drug labels

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FDA Warns Of Serious Health Risks Associated With Ketek

June 29, 2006 - Topics fda, ketek, research, safety and food
The Food and Drug Administration is advising health practitioners and patients to be aware of rare but potentially serious health risks associated with the antibiotic Ketek.

Ketek is indicated for the treatment of acute exacerbation of chronic bronchitis; acute bacterial sinusitis; and community acquired pneumonia of mild to moderate severity, including pneumonia caused by resistant strep infections

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Federal Regulators Probe Possible Death Caused by Novel Antibiotic

January 21, 2006 - Topics pneumonia, telithromycin, fda, medicine and research
Federal regulators said Friday they are reviewing the effects of a novel antibiotic that has resulted in three cases of severe liver problems, including one that has resulted in death. They are looking at a number of U.S. cases involving the drug and are also consulting with regulators overseas.

A patient at Carolinas Medical Center in Charlotte, N.C. died after taking Ketek (generic name: telithromycin), according to the Associated Press. Ketek is an FDA-approved antibiotic used to treat bacterial infections from bronchitis to pneumonia

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