Diabetes Talking

Question:

<snip Also, go see http://www.latimes.com/news/nation/reports/rezulin/

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From The Oregonian, March 22, 2000, p A12 MANUFACTURER WITHDRAWS REZULIN, DIABETES DRUG LINKED TO 61 DEATHS By PAUL RECER, The Associated Press WASHINGTON – A diabetes drug that has been linked to at least 61 deaths was withdrawn from the market Tuesday after a review of safety data showed it was more toxic to the liver than comparable drugs. The Food and Drug Administration said it requested that Rezulin, a drug for treatment of Type 2, or adult-onset, diabetes, no longer be sold. The agency said that Park-Davis/Warner-Lambert, the drug manufacturer, agreed to the action. Rezulin was withdrawn, the FDA said, after a review of recent test data showed that the drug was more toxic to the liver than two other drugs, Avandia and Actos, which also are for Type 2 diabetes. "Data to date show that Avandia and Actos, both approved in the past year, offer the same benefits as Rezulin without the same risk," the FDA said. "We are now confident that patients have safer alternatives in this important class of diabetes drugs," said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. The action comes just days after the FDA announced that at least 61 deaths had been linked to Rezulin and an FDA physician had sent a letter asking Congress to help him persuade agency officials to remove the drug from the market. Dr. Sidney Wolfe, director of the Public Citizen Health Research Group, a consumer advocacy group, said Rezulin "should have been long gone." "The British government took it off the market a long time ago," Wolfe said. "The question is, why did it take the FDA so long to take it off the market?" He said that if the agency had acted earlier, some patients would still be alive. "It is just another example of how low the standards have gotten at FDA," he said. Rezulin was well-received when it first went on the market in 1997 because it was the only drug available that restored the body’s sensitivity to insulin. Eventually, about 750,000 Americans took the drug. Type 2 diabetes develops when the body no longer responds to insulin, a hormone required to process sugar in the blood. Doctors hailed Rezulin because it promised treatment for patients who failed other therapies. But within a short time, the FDA began receiving reports of patients suffering from liver failure after taking Rezulin. At least seven patients required liver transplants, and at least 61 died. The FDA ordered Parke-Davis to put stronger liver toxicity warnings on the drug, and an advisory committee recommended that the drug be available to only a select group of patients – those whose diabetes was not well-controlled by other drugs. Avandia, manufactured by SmithKline Beecham, and Actos, made by Takeda Pharmaceuticals and marketed by Eli Lilly, were approved last year as alternative drugs to Rezulin. The agency said Tuesday that after nine months on the market, it is clear that the newer drugs "have less risk of severe liver toxicity than Rezulin." "Continued use of Rezulin now poses an unacceptable risk to patients," said Woodcock. The FDA said patients now taking Rezulin should contact their doctors and discuss alternative treatments. Posted as a courtesy by Daniel B. Wheeler www.oregonwhitetruffles.com Before you buy.

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