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Please, if you take rezulin, look at this report from MSNBCFrom: CL (anonymous@obgyn.net)Tue, 21 Mar 2000 21:29:42 -0600 (CST)
Diabetes drug pulled from market FDA: Rezulin more toxic than comparable drugs MSNBC STAFF AND WIRE REPORTS March 21 — The diabetes drug Rezulin was withdrawn from the market Tuesday after a review of safety data showed it was more toxic to the liver than comparable drugs. ‘We are now confident that patients have safer alternatives in this important class of diabetes drugs.’ — DR. JANET WOODCOCK THE FOOD and Drug Administration said it requested that Rezulin, a drug for treatment of type II diabetes, no longer be sold. The agency said that Park-Davis/Warner-Lambert, the manufacturer, agreed to the action. Rezulin, the first of a new class of drugs that helps the body respond better to insulin, was withdrawn after a review of recent test data showed that the drug was more toxic to the liver than two other drugs, Avandia and Actos, which also are for type II diabetes, the FDA said. Type II diabetes afflicts 15 million Americans and can lead to blindness, heart disease and amputations. “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 asked Congress to help him persuade the agency officials to remove the drug from the market. Liver damage has been known to occur with Rezulin since 1997. Parke-Davis has strengthened the drug’s labeling several times and has recommended close monitoring of liver function in patients taking Rezulin. Last March, the FDA ruled Rezulin should not be used as a first-line treatment because of the risk of liver failure, but recommended continued availability for cases where other therapies are not adequately effective. Dr. Sidney Wolfe, director of the Public Citizen Health Research Group, said Rezulin “should have been gone a long time ago.” “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. Public Citizen last week called for an FDA probe into Parke-Davis/Warner-Lambert, charging the company knew of instances of liver problems associated with the drug Rezulin before it went on the market, but delayed informing the FDA. The Associated Press contributed to this report.
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