Group asks FDA to ban Rezulin
Group asks FDA to ban Rezulin
Citing as many as 26 deaths worldwide from liver failure, a consumer activist group urged the Food and Drug Administration (FDA) to ban the recently approved drug troglitazone (Rezulin, Parke-Davis, Morris Plains, NJ).
Public Citizen, the Washington, DC-based consumer advocacy group founded by Ralph Nader, cited FDA records dated June 5 that show the agency has reports of at least 21 deaths among Rezulin users, 100 hospitalizations for liver toxicity, and three liver transplants in the first 15 months that Rezulin was available.
These reports have led to three labeling changes for Rezulin in just nine months. Parke-Davis responded to the latest change by sending letters to 500,000 physicians informing them that the FDA had upgraded its warning for Rezulin. Physicians are now urged to test patients' livers for signs of toxicity monthly for the first eight months of Rezulin therapy.
The FDA responded to Public Citizen's demands by stating that Rezulin offers an important benefit for type II diabetics who aren't helped adequately by other drugs. The problem, the FDA says, is that doctors aren't following repeated warnings to closely test every diabetic to see if Rezulin is harming his or her liver, so the patient can stop taking the drug before it causes permanent damage.
Rezulin has been called a breakthrough drug because it helps diabetics use their own body's insulin to improve blood sugar control.
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