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Rezulin Labeling Changes Result Of Potential Liver Injury Risk WASHINGTON, MD -- November 6, 1997 -- The manufacturer of the diabetes drug Rezulin (troglitazone) is changing prescribing information for the product and adding new warning information to the labeling, in response to reports of liver injury associated its use. Parke Davis’ Rezulin is used in combination with insulin or sulfonylurea in patients with type II diabetes (adult-onset diabetes mellitus) whose blood glucose levels are not adequately controlled by these other therapies alone. About 500,000 patients in the United States have been treated with Rezulin since it came on the market in January 1997 -- of those, approximately 85,000 have been taking the drug for six months or more. As of Oct. 21, 1997, 35 post-marketing reports of liver injury of various degrees have been received. These reports ranged from mildly elevated blood levels of the liver transaminase enzymes to liver failure leading to one liver transplant and one death. Whether the drug was solely responsible for all of these reports of liver injury is as yet unknown, due to confounding medical factors in some of the reported cases. Based on these reports, Untied States Food and Drug Administration and the manufacturer are recommending that serum transaminase levels in patients be checked routinely within the first one to two months of Rezulin therapy, every three months thereafter during the first year of treatment, and periodically thereafter. In addition, liver function tests should be performed on any patient on Rezulin who develops symptoms of liver dysfunction, such as nausea, vomiting, abdominal pain, fatigue, loss of appetite, or dark urine. Patients on Rezulin who develop jaundice or whose laboratory results indicate liver injury should stop taking the drug. Based on clinical trials, approximately two percent of patients on Rezulin can be expected to have to stop taking the drug because of elevated liver enzymes. Few, if any, of these patients will go on to develop permanent liver damage if the drug is stopped. The new prescribing information and labeling warning are designed to give health care providers and patients the latest available information about possible risks associated with Rezulin and recommendations for safer use of the drug. E-mail this page to a friend or colleague! To print, use this version