Rezulin

Troglitazone

History and Background

In January 1997, the Food and Drug Administration approved troglitazone, traded under the brand name Rezulin. Rezulin is used in combination with insulin or sulfonylurea in patients with type II diabetes. Of the 15 million Americans who suffer from type II diabetes, more that 1.4 million have taken Rezulin since it became available in March 1997. 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.

Injuries surrounding the drug range from mildly elevated blood levels of the liver transaminase enzymes to total liver failure which may result in death or require a transplant. At the time of the products withdrawal in March 2000, it was estimated that 500,000 people were on Rezulin. The drug had then been linked to 90 confirmed reports of liver failures, including 63 deaths.

Legal Issues Surrounding Rezulin

The FDA ordered Warner-Lambert, the manufacturer of Rezulin, 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 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 warnings, as well as the eventual removal from the market of the drug, comes too late for those who have taken the drug and have experienced severe side effects and extreme liver damage.

How Rezulin Treats Diabetes

Diabetes is a condition in which the body produces little or no insulin. Insulin is a hormone that allows sugar to be stored or used for energy. In diabetics, the level of sugar in the blood becomes very high. Rezulin is designed to lower blood sugar levels in patients with type II diabetes. Type II diabetes usually starts in adulthood, and is by far the most common kind of diabetes in the United States, accounting for about 90 percent of the 16 million cases.

Side Effects and Signals

Ø      Yellow eyes or skin

Ø      Back pain

Ø      Infection

Ø      Pain

Ø      Painful or increased urination

Ø      Swelling of feet or lower legs

Ø      Dizziness

Ø      Headache

Ø      Nausea

Ø      Unusual tiredness

Ø      Weakness

Ø      Diarrhea

Ø      Sore throat

Ø      Stuffy nose

Ø      Stomach pain

Ø      Dark urine

Ø      Loss of appetite

Ø      Low Blood Sugar

Ø      Vomiting

Ø      Elevated blood levels of the liver enzymes

Ø      Liver failure