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Latest on REZULINFrom: Ann (anonymous@obgyn.net)Wed, 22 Mar 2000 13:27:23 -0600 (CST)
Web posted at: 9:00 a.m. EST (1400 GMT) WASHINGTON (AP) -- Rezulin, which once was cheered as offering new hope for some diabetes patients, has been withdrawn from the market after being linked to at least 61 deaths from liver poisoning. The Food and Drug Administration requested the drug be removed Tuesday. The agency said the drug's manufacturers, Parke-Davis/Warner-Lambert of Morris Plains, New Jersey, agreed to the action. Rezulin was prescribed for type 2, or adult onset, diabetes patients who had not responded to other therapies. It was used by about 750,000 Americans. A frequent critic of the FDA, Dr. Sidney Wolfe, said the drug should have been taken off the market long ago. He described Rezulin as "one of the most dangerous drugs" on the market. According to an FDA announcement, a review of recent safety data showed that Rezulin was more toxic to the liver than two newer drugs, Avandia and Actos, which have similar action. "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 Dr. 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. 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. The question is, why did it take the FDA so long to take it off the market?" said Wolfe. He said 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. 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. Untreated diabetes can cause heart and kidney failure, blindness and other problems. After Rezulin was on the market, the FDA began receiving reports of patients suffering from liver failure after taking the drug. 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. Eventually, at least 61 patients died of liver failure while taking Rezulin and another seven required liver transplants. Avandia, manufactured by SmithKline Beecham, and Actos, made by Takeda Pharmaceuticals and marketed by Eli Lilly & Co., 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.
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