RPWB is
not taking new clients for Rezulin, but don't hesitate to
contact us with any questions or if you'd like to explore your legal rights concerning another pharmaceutical drug.
Rezulin is a Parke-Davis/Warner Lambert trade name for a drug called Troglitazone. Rezulin is a member of a class of drugs called hypoglycemic agents and is a pill which was intended to improve insulin sensitivity and to decrease hepatic glucose production for patients suffering from diabetes. Before it was removed from the market on March 21, 2000, Rezulin was used to manage Type 2 diabetes (non-insulin-dependent diabetes mellitus "NIDDN"), also known as adult onset diabetes. In its brief time on the market between early 1997 and its withdrawal in 2000, Rezulin is known to have caused over 60 deaths and approximately 600 cases of liver damage, several of which required liver transplants. These numbers are simply the numbers that have been reported to the FDA and many people believe the actual numbers to be much, much higher as physicians only report a small fraction of adverse events to the FDA.
In addition to this outrageously high number of adverse events, Rezulin is unique in several ways:
- After the original medical officer assigned by the FDA to evaluate Rezulin recommended rejecting the drug due to its potential harm to the liver, he was reassigned by the FDA.
- The United Kingdom banned Rezulin on December 1, 1997, less than a year after its introduction yet it took until March 21, 2000, for the drug to be removed from the market in the United States.
- The FDA launched an independent investigation of claims that Parke-Davis/Warner Lambert withheld knowledge of the fact that Rezulin caused liver toxicity and that the company misrepresented and/or failed to report serious adverse events that occurred during the clinical trials prior to the drug's approval.
- As recently as June 30, 2002, The San Francisco Chronicle reported that documents show Warner-Lambert Company executives who promoted Rezulin "masked early indications of the drug's danger to the liver from federal regulators and later delayed sharing information about its lethal toxicity with family doctors." The Times further reported that "company management rebuffed employees who questioned liver-injury totals from clinical studies that excluded 38% of the cases."
- Rezulin stands to many as a symbol of the problems with the power of the pharmaceutical industry to push drugs through the FDA approval process. We at RPWB are committed to working to ensure that if this process was abused, that those harmed are compensated.
