Ketek (Generic: Telithromycin)

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Drug Description: 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 spokes woman said that the agency would examine its databases for other reports of liver problems in patients taking Ketek.

Warning Signs of Danger

On January 20, 2006, researchers reported three cases of severe liver problems, including one death, in patients at North Carolina hospital after they began taking the antibiotic Ketek (Telihromycin). Federal regulators said they are examining an unknown number of U.S. cases involving Ketek and are consulting with overseas counterparts.

Dr. John Hanson, who words in the liver transplant center in Carolinas Medical Center, said that they 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 on the the manufactures 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 has suffered injury as a result of taking Ketek we can help. Please click here to contact Pearson Law or call our toll free number at 888-525-1262 to schedule a FREE initial consultation.

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