A Food and Drug Administration advisory committee has recommended that the controversial diabetes drug Rezulin (troglitazone) can stay on the market but has suggested restrictions on its use.
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee, which reviewed the drug on March 26, found that Rezulin should be used in combination with insulin or sulfonylurea drugs but should not be used as lone therapy for type 2 diabetes, according to the Associated Press and Reuters news service. The committee decided to reassess Rezulin following numerous reports of liver failure and death that have been linked to the drug since its introduction in the United States two years ago. While the committee’s recommendations are not binding on the FDA, the agency usually follows its suggestions.
The FDA believes that several months’ worth of Rezulin therapy caused acute liver failure in 38 patients, including 28 patients who died and seven who survived only after undergoing liver transplants. One FDA epidemiologist estimated that, due to underreporting, Rezulin could be responsible for about 400 cases of liver failure.
However, drug-maker Warner-Lambert maintains that the benefits of Rezulin therapy far outweigh the risks for the estimated 750,000 Americans who are taking it. The company says that the rate of liver-related deaths and transplants has fallen from about 1 in 36,000 in 1997 to about 1 in 57,000 since label changes were made on Jan. 1, 1998, that recommend ongoing monitoring of liver function.
"Warner-Lambert will continue to work with the FDA to further refine the label," Robert Zerbe, MD, a senior vice president at Warner-Lambert said in a company statement on March 26.
For Your Information:
Warner-Lambert has posted background information and a number of press releases on Rezulin at www.rezulinnews.com.
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