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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)
U.S. health officials said they plan to ask outside advisers in December 2006 if the antibiotic Ketek manufactured by Sanofi-Aventis should stay on the market after a dozen reports of liver failure. (Source)
An independent study of five experts says the FDA does not have the authority to pull dangerous drugs unilaterally, force changes in drug labels, or sanction drug companies that skimp on safety monitoring.
The independent study recently published its critique in the Archives of Internal Medicine. The study also contended that the FDA lacks the money and structure to insulate itself from the influence of the pharmaceutical industry. The FDA is aware of these problems and as done very little to fix them. (Washington Post)