Following media reports that have blamed Rezulin (troglitazone) for 33 deaths in the United States and Japan, Warner-Lambert has issued a statement standing by its diabetes drug.
Rezulin was first approved by the Food and Drug Administration in December 1996. Label revisions in 1997 recommended the periodic monitoring of liver function. Britain banned Rezulin last year.
According to Warner-Lambert, more than 1.4 million patients in the United States use Rezulin to treat type 2 diabetes. The company also recently announced plans to study the potential of Rezulin to delay or prevent impaired glucose tolerance from progressing to type 2 diabetes (see Transplant News Network news briefs, December 1, 1998). In June, the National Institute of Diabetes and Digestive and Kidney Diseases stopped studying Rezulin's potential to prevent type 2 diabetes after one of 585 study participants died following complications that led to the need for a liver transplant.
"... while there may be rare adverse hepatic events associated with Rezulin, these events must be viewed in the context of the hundreds of thousands of patients that are currently benefiting from the drug," Warner-Lambert said in a December 8 statement.
The company said that the 33 Rezulin-associated deaths that have been widely cited by the media occurred "with patients that started therapy prior to the most recent changes in labeling."
Warner-Lambert also pledged that it "will continue to thoroughly monitor adverse events through its extensive safety surveillance monitoring system and will continue to quickly communicate this information" to the FDA.
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