Have You Been
Injured by Ketek?
On January 20, 2006, researchers reported three cases of severe liver problems, including one death, in patients at a North Carolina hospital after they began taking the antibiotic Ketek (Generic: Telithromycin). Federal regulators said they are examining an unknown number of U.S. cases involving Ketek and are consulting with overseas counterparts.
Ketek, manufactured by Sanofi-Aventis, was approved in 2004 for the treatment of acute bacterial infections from chronic bronchitis, acute bacterial sinusitis and community-acquired pneumonia. An FDA spokeswoman said that the agency would examine its databases for other reports of liver problems in patients taking Ketek.
Dr. John Hanson, who works in the liver transplant center at Carolinas Medical Center, said that the severity of the cases warranted alerting doctors to a possible link between liver damage and Ketek. One patient at Carolinas Medical Center in Charlotte, N.C., died after taking Ketek. Another patient received a liver transplant, and the third contracted drug-induced hepatitis but recovered after treatment with Ketek was stopped.
FDA Action
On May 19, 2006 the FDA was able to connect 12 cases of liver failure, which include four deaths to the antibiotic Ketek. Based upon these finding, the FDA is urging Sanofi-Aventis, the manufacturer of Ketek to add a warning label to the drug. Members of the U.S. government have been wary of the FDA's approval of Ketek due to accusations of flawed information from one of the manufacturers tests. Ketek was refused approval by the FDA back in 2001 and 2003 due to the lack safety information on the drugs label.
If you or a loved one took Ketek and suffered side effects, Click here for a free lawsuit case evaluation by a qualified drug side effects attorney.
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Ketek
Current News
Health Canada Endorsed Important Safety Information on Ketek (telithromycin)
Sanofi-aventis Canada Inc. in consultation with Health Canada would like to inform health care professionals of important updated safety information regarding Ketek (telithromycin) tablets. Based on information in published case reports and post-market adverse event reports, the Canadian Product ...read more
FDA Completes Safety Assessment of Ketek New Safety Information to be Added to Product Labeling
The Food and Drug Administration (FDA) today completed its safety assessment of Ketek (telithromycin) and is advising health practitioners and patients to be aware of rare but potentially serious health risks. Ketek is the first FDA-approved antibiotic of the ketolide class. It is indicated for the ...read more
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