The Food and Drug Administration has rejected a request from a consumer group to take the diabetes drug Rezulin (troglitazone) off the market.
On July 27, Public Citizen petitioned the FDA to remove the drug, claiming it was associated with at least 26 deaths related to liver failure and three cases in which patients needed liver transplants. According to Reuters news service, the FDA has confirmed 14 deaths and three liver transplants.
However, the FDA responded that it "believes that Rezulin provides a therapeutic benefit to people with type 2 diabetes but that health care providers must be even more vigilant in monitoring liver enzyme levels," Reuters said in a quote attributed to the FDA's Susan Cruzan.
Rezulin was approved by the FDA in the United States December 1996 and was banned in Britain a year later. In June, the National Institute of Diabetes and Digestive and Kidney Diseases stopped testing whether Rezulin could be used to prevent or delay the onset of diabetes after one of the study participants developed liver failure, required a transplant, and died.
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