Ketek, an antibiotic manufactured by Sanofi-Aventis, is used to treat bacterial infections such as chronic bronchitis, sinusitis, and pneumonia, and other serious or drug-resistant infections. This drug, generic name telithromycin, is one of a group of antibiotics called ketolide antibiotics or macrolids that includes erythromycin, Zithromax, and Biaxin. The Ketek claim is that it can treat infections resistant to other antibiotics.
Ketek was approved by the FDA in April 2004, but after reports of risks of liver damage its use has been limited. It’s now approved only for the treatment of community-acquired pneumonia and some drug resistant infections. Avandia has been marketed and used widely in many countries including the U.S., Europe, and Japan.
The FDA (Food and Drug Administration) issued a MedWatch Alert on January 20, 2006 after an early online version of an article for the Annals of Internal Medicine was posted. The article, which appeared in the March 21, 2006 print version of the magazine, revealed that three patients in a North Carolina hospital suffered serious liver damage after taking Ketek. One patient died, one required a liver transplant, and one contracted drug-induced hepatitis. See Ketek Information and Updates for information about the safety of this drug.
By 2008, it was estimated that at least 134 cases of liver damage have resulted from the use of Avandia. In February 2007 the FDA took the unusual step of withdrawing its approval of two uses for the drug: treatment of acute bacterial sinusitis and chronic bronchitis.
The European Medicines Agency (EMEA) issued a statement on the safety of Ketek on January 27, 2006 and asked the manufacturer, Sanofi-Aventis, to place a stronger warning on the drug indicating the possibility of liver damage. Health Canada issued a warning on February 7, 2006.
Check out the following articles for more information about Ketek, filing a Ketek lawsuit and finding a Ketek attorney.
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