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HEALTHWATCH WITH NESITA KWAN


Simple Sinus Drug Spurs Severe Side Effects

FDA Still Approves Ketek

POSTED: 5:13 pm CDT May 21, 2007
UPDATED: 9:34 am CDT May 22, 2007

It was supposed to clear up a simple sinus infection, but that same pill is now being linked to liver disease and even death.

NB5 Nesita Kwan reported on the so-called cure that was, for some, worse than the disease itself.

North Carolina's Dr. John Hanson said it killed one of his patients, and only a liver transplant saved another.

"What struck us was, 'My gosh, we have two patients who took the same drug,'" said Hanson.

The drug was Ketek, a new antibiotic for bronchitis and sinus infections that the Food and Drug Administration now associates with the deaths of four people and for sickening dozens of others.

What Hanson discovered in early 2005 was about to unleash an international scandal.

It's a scandal that reaches from the drug manufacturer in France to the U.S. Congress, where senators like Iowa's Charles Grassley were aghast 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, and that the FDA then used unscientific foreign reports of the drug's side effects to claim it was safe. And 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.

The legal fallout is just beginning. Cook County court reporter Tom Manno said he could have taken other antibiotics last June, but his doctor prescribed Ketek long before the FDA changed it's label. What followed, he says, was pure hell.

"I had chills really bad. I had trouble walking and was dizzy. I had pain in my legs, and fevers -- I really thought I was getting a catastrophic illness," he said.

After eight agonizing weeks, Manno said his liver slowly began to recover. And now he and his lawyer plan to sue the drug's French manufacturer, Sanofi-Aventis.

"When you are a normally functioning person, a high energy person, in a demanding profession and all of a sudden you're almost like a puddle on the floor -- it's very frightening," Manno said.

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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