DESCRIPTION: In January 1997, the FDA approved troglitazone, traded under the brand name Rezulin. It was designed for use in patients with Type 2 diabetes whose blood glucose levels were not adequately controlled by other therapies alone. The approval followed a controversial investigation by the FDA, where the drug was investigated on a "fast track" approval process which was dominated by the influence of the drug's manufacturer, Warner-Lambert.

For the next three years, the FDA received hundreds of reports of liver injury and deaths following the use of Rezulin. Warner-Lambert altered its warning label four times to reflect the need for monitoring of liver function. It was determined early on, however, that even the most vigilant testing would not save all Rezulin users from the acute onset of liver failure. The continued viability of Rezulin as a drug for diabetics, especially in view of newer, safer drugs, created great dissension within the diabetic community and within the FDA.

By early March 2000, the divisiveness within the FDA became unusually public. Amid mounting pressure to remove Rezulin, a growing number of FDA physicians expressed concern that further delay would claim the lives of diabetics. On March 21, 2000, the FDA requested that Warner-Lambert withdraw Rezulin from the market. Warner Lambert capitulated, though it continued to maintain that Rezulin's benefits outweighed the risks. At the time of its withdrawal, it was estimated that 500,000 people were currently on Rezulin. The drug had then been linked to 90 confirmed reports of liver failures including 60 deaths. It had generated over $1.8 billion in sales.

There is a currently a Rezulin MDL in the Southern District of New York. In Re Rezulin Products Liability Litigation, MDL No. 1348. There are dozens of suits filed in federal courts, even more in state courts, and numerous state class actions.

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Last modified: 10/08/02