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FDA, Parke-Davis Urge Limits On Rezulin Use ROCKVILLE, MD -- June 17, 1999 -- The United States Food and Drug Administration and Parke-Davis have agreed to make new changes to the labelling and recommended uses for Parke-Davis' Rezulin (troglitazone) indicating that the use of Rezulin should be limited to patients not adequately controlled by other therapy and should not be used as initial single agent therapy in the treatment of type II diabetes (non-insulin dependent diabetes mellitus, or adult onset diabetes). These changes are being made because of further evidence of serious and sometimes fatal liver injury in patients treated with Rezulin. The labelling changes also include recommendations for more extensive monitoring of liver function in patients using Rezulin. A patient information sheet has been added to the labelling and will be available for distribution to patients by pharmacists with each Rezulin prescription. FDA and Parke-Davis agreed to these changes after careful analyses of the drug's safety profile, drawing upon clinical trials data, post-marketing surveillance data and the recommendations made by FDA's endocrinologic and metabolic drugs advisory committee during a March 26, 1999 meeting. The new labelling and other measures being taken regarding Rezulin are in keeping with the recommendations made by that panel of outside experts. Parke-Davis is issuing a U.S.-wide letter to healthcare professionals notifying them of these modifications. In addition to changes in labelling noted above, a new indication will be added to Rezulin's labelling for its use in combination with sulfonyureas and metformin in patients whose diabetes is not adequately controlled by the combined use of just these other diabetes drugs. This indication is based on new clinical data evaluated by the agency. Related Link: Rezulin E-mail this page to a friend or colleague! To print, use this version