Troglitazone-Associated Hepatic Failure
Authors: Robert I. Misbin
Journal: Annals of Internal Medicine (1999)

Letters16 February 1999Troglitazone-Associated Hepatic FailureRobert I. Misbin, MDRobert I. Misbin, MDU.S. Food and Drug Administration; Rockville, MD 20857 (Misbin)Author, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-130-4-199902160-00009 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail TO THE EDITOR:Through 5 June 1998, the U.S. Food and Drug Administration (FDA) had received 560 reports of troglitazone-associated hepatotoxicity. There were 24 cases of liver failure in which troglitazone appears to be the likely cause. Twenty-one patients died of liver failure, and three patients received transplants. One of the transplant recipients died soon after surgery. An additional patient was recovering from troglitazone-associated hepatitis but died unexpectedly of heart failure. In 13 reported deaths, troglitazone could not reasonably be implicated.Reversible elevation of alanine aminotransferase (ALT) levels led to discontinuation of troglitazone therapy in 0.8% of diabetic patients in ...References1. Watkins PB, Whitcomb RW. Hepatic dysfunction associated with troglitazone [Letter]. N Engl J Med. 1998;338:916-7. CrossrefMedlineGoogle Scholar2. Neuschwander-Tetri BA, Isley WL, Oki JC, Ramarakhiani S, Quiason SG, Phillips NJ, et al . Troglitazone-induced hepatic failure leading to liver transplantation. Ann Intern Med. 1998;129:38-41. LinkGoogle Scholar3. Gitlin N, Julie NL, Spurr CL, Lim KN, Juarbe HM. Two cases of severe clinical and histologic hepatotoxicity associated with troglitazone. Ann Intern Med. 1998;129:36-8. LinkGoogle Scholar4. Vella A, de Groen PC, Dinneen SF. Fatal hepatotoxicity associated with troglitazone [Letter]. Ann Intern Med. 1998;129:1080. LinkGoogle Scholar5. Prescribing information for Rezulin. Ann Arbor, MI: Parke-Davis; 6 July 1998. Google Scholar Author, Article, and Disclosure InformationAffiliations: U.S. Food and Drug Administration; Rockville, MD 20857 (Misbin) PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoTroglitazone-Induced Hepatic Failure Leading to Liver Transplantation: A Case Report Brent A. Neuschwander-Tetri , William L. Isley , Julie C. Oki , Sanjay Ramrakhiani , Stella G. Quiason , Nancy J. Phillips , and Elizabeth M. Brunt Troglitazone-Associated Hepatic Failure Brent A. Neuschwander-Tetri , William L. Isley , and Julie C. Oki Metrics Cited byWhat Is Pharmacoepidemiology?Hy's Law and eDISH for Clinical StudiesThiazolidinedionesIncretin Therapy and Islet Pathology: A Time for CautionWhat is Pharmacoepidemiology?The safety of thiazolidinedionesINSULINS AND OTHER HYPOGLYCEMIC DRUGSPharmacogenetics of thiazolidinedione therapyGene Expression Analysis of Troglitazone Reveals Its Impact on Multiple Pathways in Cell Culture: A Case for In Vitro Platforms Combined with Gene Expression Analysis for Early (Idiosyncratic) Toxicity ScreeningThiazolidinedionesOntology-based knowledge management of troglitazone-induced hepatotoxicityHepatotoxicity of the thiazolidinedionesAmphipathic 3-Phenyl-7-propylbenzisoxazoles; human pPaR γ, δ and α agonistsFilling a Prescription for the Public's HealthTroglitazone enhances the hepatotoxicity of acetaminophen by inducing CYP3A in rats"Did This Drug Cause My Patient's Hepatitis?" and Related QuestionsDavid W. Nierenberg, MDOral agents for the treatment of type 2 diabetes mellitus: Pharmacology, toxicity, and treatmentAcute liver failurePrevention of pancreatic cancer induction in hamsters by metforminInsulin, glucagon, and hypoglycemic drugsThe rise and fall of troglitazoneSafety of Drugs Commonly Used to Treat Hypertension, Dyslipidemia, and Type 2 Diabetes (The Metabolic Syndrome): Part 2Troglitazone-induced fulminant hepatitisSafety of Drugs Commonly Used to Treat Hypertension, Dyslipidemia, and Type 2 Diabetes (The Metabolic Syndrome): Part 1Troglitazone-Associated Hepatic Failure 16 February 1999Volume 130, Issue 4_Part_1Page: 330KeywordsAlanine aminotransferaseDrugsFood and Drug AdministrationGlucose intoleranceHeart failureHepatitisLiverLiver transplantationSurgeryTransplantation Issue Published: 16 February 1999 Copyright & PermissionsCopyright © 1999 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...