Source: http://www.nbc5.com/health/13361549/detail.htmlTwo North Carolina patients took Ketek for sinus infections. One died and the other needed a liver transplant. What's wrong with this picture?
Ketek is a relatively new antibiotic drug prescribed for sinus infections and bronchitis.
It's a scandal picture painted by the drug manufacturer in France to the U.S. Congress, where senators like Iowa's Charles Grassley were shocked at how the drug got FDA approval in the first place.
Grassley's sub-committee heard testimony that one of the doctors used in the drug's safety study had falsified results, and that FDA managers hid that fact from the FDA panel that recommended the drug. Then the FDA muddled the problem by using unscientific foreign reports of Ketek's side effects to claim it was safe.
When cases of death and injury began to appear, the testimony alleges the FDA did not issue an adequate new warning label for at least a year.
In the United States, Ketek is still on the market, but not for coughs and sniffles anymore -- only for a type of pneumonia.
A Sanofi-Aventis spokesperson said they are committed to patient safety and only learned of the fraudulent behavior of one of their investigators when the FDA discovered it. Meanwhile the FDA said it tossed out that study but approved Ketek based on foreign data on side effects and other smaller drug studies.
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