Hepatotoxicity due to troglitazone: Report of two cases and review of adverse events reported to the United States Food and Drug Administration

Two patients (a 48-year-old woman and a 62-year-old man) developed clinical and laboratory signs of hepatotoxicity due to troglitazone (Rezulin), a th iazolidinedione used in treatment of diabetes mellitus. There was no clear clinical evidence of drug allergy, although the woman experienced colitis b efore the onset of recognized hepatotoxicity. Liver biopsies showed bridgin g necrosis and fibrosis in the woman and hepatitis with granuloma formation in the man. The abnormalities in liver chemistries resolved promptly upon cessation of the drug. Cases involving 46 patients reported to the United S tates Food and Drug Administration are also reviewed. Troglitazone is a use ful new oral antihy-perglycemic agent, but in about 1.9% of patients hepato toxicity has occurred, which may be severe and even fatal. Frequent monitor ing of serum liver chemistries in patients taking the drug is essential. (A m J Gastroenterol 2000;95: 272-276. (C) 2000 by Am. Cell. of Gastroenterolo gy).