Incidence of idiopathic acute liver failure and hospitalized liver injury in patients treated with troglitazone

American Journal of Gastroenterology

Volumn 98, Issue 1, 2003, Pages 175-179

  Graham, David J ^a,b   Drinkard, Carol R ^a,b   Shatin, Deborah ^a,b  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b UNITEDHEALTH GROUP   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

INSULIN; METFORMIN; TROGLITAZONE;

ADULT; AGED; ARTICLE; CALCULATION; COHORT ANALYSIS; CONFIDENCE INTERVAL; DISEASE ASSOCIATION; DRUG EXPOSURE; FEMALE; HEALTH CARE ORGANIZATION; HEALTH CARE PLANNING; HOSPITALIZATION; HUMAN; HUMAN TISSUE; IDIOPATHIC DISEASE; INCIDENCE; INSURANCE; JAUNDICE; LIVER FAILURE; LIVER INJURY; LIVER TOXICITY; MAJOR CLINICAL STUDY; MALE; MEDICAL RECORD; NON INSULIN DEPENDENT DIABETES MELLITUS; OBSERVATION; PATIENT CODING; PRESCRIPTION; PRIORITY JOURNAL; RETROSPECTIVE STUDY; RISK; SIDE EFFECT; VALIDATION PROCESS;

AGED; AGED, 80 AND OVER; CHROMANS; FEMALE; HEPATITIS, TOXIC; HOSPITALIZATION; HUMANS; HYPOGLYCEMIC AGENTS; INCIDENCE; LIVER FAILURE, ACUTE; MALE; MIDDLE AGED; RETROSPECTIVE STUDIES; THIAZOLES; THIAZOLIDINEDIONES;

EID: 0037259315     PISSN: 00029270     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1572-0241.2003.07175.x     Document Type: Article

References (44)

1. Imura H. A novel antidiabetic drug, troglitazone - reason for hope and concern. N Engl J Med 1998;338:908-9 (editorial).
2. Rezulin. In: Physicians' desk reference. Montvale, NJ: Medical Economics Company, 1998:2218-21.
3. Willman D. Fears grow over delay in removing Rezulin. Company's conduct in development of the drug also comes under fire. Los Angeles Times 2000;10 Mar:A-18.
4. Graham DJ, Drinkard CR, Shatin D, et al. Liver enzyme monitoring in patients treated with troglitazone. JAMA 2001; 286:831-3.
5. Gitlin N, Julie NL, Spurr CL, et al. Two cases of severe clinical and histologic hepatoxicity associated with troglitazone. Ann Intern Med 1998;129:36-8.
6. Neuschwander-Tetri BA, Isley WL, Oki JC, et al. Troglitazone-induced hepatic failure leading to liver transplantation. Ann Intern Med 1998;129:38-41.
7. Shibuya A, Watanabe M, Fujita Y, et al. An autopsy case of troglitazone-induced fulminant hepatitis. Diabetes Care 1998; 21:2140-3.
8. Herrine SK, Choudhary C. Severe hepatotoxicity associated with troglitazone. Ann Intern Med 1999;130:163-4 (letter).
9. Murphy EJ, Davern TJ, Shakil AO, et al. Troglitazone-induced fulminant hepatic failure. Dig Dis Sci 2000;45:549-53.
10. Jagannath S, Rai R. Rapid-onset subfulminant liver failure associated with troglitazone. Ann Intern Med 2000;132:677 (letter).
11. Stolberg SG. Stricter rules are urged on use of a diabetic drug. The New York Times 1999;27 Mar:A-9.
12. Graham DJ, Green L. Epidemiology of hepatotoxicity with troglitazone. FDA Metabolic-Endocrine Drugs Advisory Committee Meeting, Bethesda, MD, March 26, 1999. Available from U.S. Food and Drug Administration via the Internet at: www.fda.gov/ohrms/dockets/ac/99/transcpt/3499tla.pdf;/3499t1b.pdf;/ 3499t1c.pdf;/34991d.pdf;/34991e.pdf. Accessed January 8, 2002.
13. Graham DJ, Green L. Final report: Liver failure risk with troglitazone. Office of Postmarketing Drug Risk Assessment, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD, December 19, 2000.
14. Lee WH. Acute liver failure. N Engl J Med 1993;329:1862-72.
15. Williams R. Classification, etiology, and consideration of outcome in acute liver failure. Semin Liver Dis 1996;16:343-8.
16. Almdal TP, Sorensen TIA. Incidence of parenchymal liver disease in Denmark, 1981 to 1985: Analysis of hospital registry data. Hepatology 1991;13:650-5.
17. Beard K, Belic L, Aselton P, et al. Outpatient drug-induced parenchymal liver disease requiring hospitalization. J Clin Pharmacol 1986;26:633-7.
18. Garcia Rodriguez LA, Gutthann SP, Walker AM, et al. The role of nonsteroidal anti-inflammatory drugs in acute liver injury. Br Med J 1992;305:865-8.
19. Carson JL, Strom BL, Duff A, et al. Safety of nonsteroidal anti-inflammatory drugs with respect to acute liver disease. Arch Intern Med 1993;153:1331-6.
20. Schiodt FV, Atillasoy E, Shakil AO, et al. Etiology and outcome for 295 patients with acute liver failure in the United States. Liver Transplant Surg 1999;5:29-34.
21. US Census Bureau. Available via the Internet at: http://www.census.gov/population/cen2000/tab02.pdf. Accessed January 28, 2002.
22. Garcia Rodriguez LA, Williams R, Derby LE, et al. Acute liver injury associated with nonsteroidal anti-inflammatory drugs and the role of risk factors. Arch Intern Med 1994;154:311-5.
23. Jick SS, Stender M, Myers MW. Frequency of liver disease in type 2 diabetic patients treated with oral antidiabetic agents. Diabetes Care 1999;22:2067-71.
24. Everhart JE. Digestive diseases and diabetes. In: Diabetes in America, 2nd ed. National Diabetes Data Group, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD. NIH Publication No. 95-1468, 1995:457-84.
25. Garcia Rodriguez LA, Wallander MA, Stricker BH. The risk of acute liver injury associated with cimetidine and other acid-suppressing anti-ulcer drugs. Br J Clin Pharmacol 1997;43:183-8.
26. Garcia Rodriguez LA, Stricker BH, Zimmerman HJ. Risk of acute liver injury associated with the combination of amoxicillin and clavulanic acid. Arch Intern Med 1996;156:1327-32.
27. Maggini M, Raschetti R, Agostinis L, et al. Use of amoxicillin and amoxicillin-clavulanic acid and hospitalization for acute liver injury. Ann Ist Super Sanita 1999;35:429-33.
28. Derby LE, Jick H, Henry DA, et al. Erythromycin-associated cholestatic hepatitis. Med J Aust 1993;158:600-2.
29. Carson JL, Strom BL, Duff A, et al. Acute liver disease associated with erythromycin, sulfonamides and tetracyclines. Ann Intem Med 1993;119:576-83.
30. Garcia Rodriguez LA, Duque A, Castellsagne J, et al. A cohort study of the risk of acute liver injury among users of ketoconazole and other anti-fungal drugs. Br J Clin Pharmacol 1999;48:1847-52.
31. Silverman JF, Pories WJ, Caro JF. Liver pathology in diabetes mellitus and morbid obesity: Clinical, pathological, and biochemical considerations. Pathol Annu 1989;24:275-302.
32. McCullough AJ. Update on nonalcoholic fatty liver disease. J Clin Gastroenterol 2002;34:255-62.
33. Youssef W, McCullough AJ. Diabetes mellitus, obesity, and hepatic steatosis. Semin Gastrointest Dis 2002;13:17-30.
34. Chitturi S, Farrell GC. Etiopathogenesis of nonalcoholic steatohepatitis. Semin Liver Dis 2001;21:27-41.
35. Pagano G, Pacini G, Musso G, et al. Nonalcoholic steatohepatitis, insulin resistance, and metabolic syndrome: Further evidence for an etiologic association. Hepatology 2002;35:367-72.
36. Wanless IR, Leutz JS. Fatty liver hepatitis (steatohepatitis) and obesity: An autopsy study with analysis of risk factors. Hepatology 1990;12:1106-10.
37. Bernal-Reyes R, Saenz-Lubra A, Bernardo-Escudero R. Prevalencia de la esteatohepatitis no alcoholica (EHNA). Estudio comparativo con diabeticos. [Prevalence of non-alcoholic steatohepatitis. Comparative study with diabetic patients]. Rev Gastroenterol Mex 2000;65:58-62.
38. Angulo P, Lindor KD. Insulin resistance and mitochondrial abnormalities in NASH: A cool look into a burning issue. Gastroenterology 2001;120:1281-5 (editorial).
39. Clark JM, Brancatti FL, Diehl AM. Nonalcoholic fatty liver disease. Gastroenterology 2002;122:1649-57.
40. Sanyal AJ, Campbell-Sargent C, Mirshahi F, et al. Nonalcoholic steatohepatitis: Association of insulin resistance and mitochondrial abnormalities. Gastroenterology 2001;120:1183-92.
41. Jaeschke H, Gores GJ, Cederbaum AI, et al. Mechanisms of hepatotoxicity. Toxicol Sci 2002;65:166-76.
42. Yamamoto Y, Nakajima M, Yamzaki H, et al. Cytotoxicity and apoptosis produced by troglitazone in human hepatoma cells. Life Sci 2001;70:471-82.
43. Reid AE. Nonalcoholic steatohepatitis. Gastroenterology 2001;121:710-23.
44. Contos MJ, Sanyal AJ. The clinicopathologic spectrum and management of nonalcoholic fatty liver disease. Adv Anat Pathol 2002;9:37-51.