Ketek
April 25, 2007
Ketek: How did Ketek get approved and into the marketplace even though its efficacy was questioned every step of the way by many experts and every study is plagued by fraud and negligence?
Ketek: How is it possible that Ketek got approved? Before it was put into the marketplace its efficacy was questioned over and over again. Experts pointed out that the studies were plagued by fraud and negligence!
The FDA wais far from perfect when it came to Ketek.
Everything that could go wrong with Ketek. Yet, by large brush strokes of ineptitude and deceit, Ketek was approved and marketed for three indications.
Posted by Michael Monheit at 09:49 AM | Permalink
January 11, 2007
Ketek Drug Maker Continues Discussion with FDA
Sanofi-Aventis, the drug maker, said yesterday that it planned additional discussions with the Food and Drug Administration after an advisory panel to the agency said the company should not be allowed to continue marketing the antibiotic Ketek.
Posted by Michael Monheit at 07:56 AM | Permalink
December 13, 2006
Ketek: More safety warnings will affect sales
The antibiotic Ketek is likely to face more safety warnings. Sanofi-Aventis’ stock for the sales of Ketek will most likely be hurt in the United States and Europe. (New Ratings)
Posted by Michael Monheit at 07:59 AM | Permalink
December 12, 2006
FDA seeks outside review of Ketek antibiotic on December 14 and 15
The antibiotic Ketek, is under scrutiny amid reports of liver failure in a dozen patients. Ketek, approved in 2004, is also the subject of a Senate Finance Committee investigation because of the FDA's handling of the approval and of possibly faulty data.
Posted by Michael Monheit at 08:08 AM | Permalink
November 20, 2006
Ketek Labeling to Include Strong Liver Warning
The FDA and Sanofi-Aventis, the makers of Ketek, have announced that Ketek’s labeling will now include a strong warning about serious and potentially fatal Ketek liver side effects and other serious injuries. While developing serious Ketek side effects is rare, dozens of people have been seriously injured because of this medication. (Source)
Posted by Michael Monheit at 10:44 AM | Permalink
