Rezulin

(Generic name Troglitazone)

Type 2 Diabetes develops when the body no longer responds to insulin, a hormone required to process sugar in the blood. In 1997, when Rezulin was introduced, doctors hailed it because it promised treatment for patients who failed other therapies. Untreated diabetes can cause heart and kidney failure, blindness and other problems.

Rezulin was a "fast track" drug that went through an abbreviated version of the FDA's approval process and was approved over the objections of several FDA scientists. After Rezulin was on the market, the FDA began receiving reports of patients suffering from liver failure after taking the drug. Rezulin was banned in England in December 1997 following the death of an American who took the drug.

The FDA soon ordered Parke-Davis to put stronger liver toxicity warnings on the drug and an advisory committee recommended the drug be available to only a select group of patients — those whose diabetes was not well-controlled by other drugs. The drug manufacturer, Warner-Lambert, successfully fought a Rezulin ban in the U.S. for 27 months before the FDA decided to prohibit sales of the drug on March 21, 2000. Warner Lambert had strong reason to delay the banning: Rezulin is estimated to have made over $1.8 billion in sales. At its peak, the drug was prescribed 488,000 times in January of 1999.

The recall finally came after an FDA whistleblower shared his findings and internal FDA email messages with a Los Angeles Times reporter. This information and interviews with several doctors led to a series of articles in the Los Angeles Times discussing the dangers of Rezulin. The information raised questions about the irregularities in the FDA's "fast track" approval of the drug.

At least 61 patients have died of liver failure while taking Rezulin and another seven required liver transplants. There is strong reason to believe that there are hundreds and possibly thousands more with similar complications.

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