Mar 22 2000
Diabetes Drug - Rezulin - Banned by the FDA
Mar 22, 2000 — The diabetes drug Rezulin (troglitazone), prescribed for adult-onset diabetes, was withdrawn from the market on Tuesday following a request from the U.S. Food and Drug Administration (FDA). A spokesperson for the FDA said that the drug, which lowers blood sugar in diabetics, has been linked to 63 deaths and 90 confirmed cases of liver failure. There are 15 million Americans who suffer from adult-onset diabetes.
Sidney Wolfe, M.D., director of the Public Citizen Health Research Group, said the 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. Its just another example of how low the standards have gotten at FDA,” Wolfe said. If the agency had acted earlier, some of these patients would still be alive.
Top officials of the FDA were publicly warned by their own expert epidemiologist in March 1999, that every patient taking Rezulin for diabetes was at risk of sudden liver failure and that no reliable way existed to protect them. But FDA officials decided to keep Rezulin on the market anyway.
The FDA made Rezulin among the fasted-approved prescription drugs in this decade. Critics now claim that the FDA has become too responsive to drug manufacturers by rushing to approve risky, non-essential medications.
On March 15, 2000, Public Citizen urged the FDA to initiate a criminal investigation of Warner-Lambert, the manufacturer of Rezulin. The group said that it had learned from a member of the clinical investigating team of physicians that the Warner-Lambert failed to notify the FDA of liver toxicity among patients in the original clinical studies until after the drug had received approval.
In a statement issued on Tuesday night, Warner-Lambert said that it had voluntarily withdrawn the drug from the market, although it “continues to believe that the benefits of the drug outweigh its associated risks.”
The company added, “repeated media reports sensationalizing the risks associated with Rezulin therapy have created an environment in which patients and physicians are simply unable to make well-informed decisions regarding the safety and efficacy of Rezulin.”
Both the FDA and Warner-Lambert urged patients to “not discontinue taking Rezulin or other treatments for diabetes without discussing alternative therapies with their physicians.”
Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said, “…safety data from Rezulin as compared to similar, alternative diabetes drugs indicate that continued use of Rezulin now poses an unacceptable risk to patients.”
According to the FDA, Actos, which is sold by Eli Lilly in the US, and SmithKline Beecham’s Avandia, both of which were approved last year, “offer the same benefits as Rezulin without the same risk.”
Rezulin has generated sales of $1.7 billion, but Warner-Lambert expected sales to fall by 47% to only $400 million this year due to safety concerns. At its height there were 1 million patients taking Rezulin. There are currently about 500,000 patients still taking Rezulin. Hopefully, they hear the news. If you have a loved one with diabetes, please tell them and tell them to seek a natural alternative. I wouldn’t trust Actos or Avandia either.
DRUG : Rezulin (troglitazone)
SIDE-EFFECTS: Death, Liver Failure, Liver Toxicity
CONTRAINDICATIONS: personal history of liver disease, active liver disease, elevated liver enzymes, cirrhosis, hepatitis, alcohol abuse.
SIMILAR CLASS DRUGS: Avandia (rosiglitazone), Actos (pioglitazone)|
NATURAL ALTERNATIVE: Glucoright™ (Momardica charantia, Gymnema sylvestra, Juniper berry, Grape seed extract, Alpha Lipoic Acid, Vanadyl sulfate, Chromium polyniacinate)
