OMEPRAZOLE-INDUCED HEPATOTOXICITY - A CASE-REPORT

Case report - We observed a serious symptomatic hepatocellular liver i njury in an 85-year-old man treated with omeprazole for many years. Pe ak values for AST, ALT and AP were 1542 U/l (normal range 14-50), 1236 U/l (11-60) and 154 U/l (30-125) respectively. Abdominal CT scan was normal and viral serologic testing was negative. Omeprazole was discon tinued and liver enzymes normalized in 12 days. The patient was known to suffer from ischemic heart disease and had had a myocardial infarct ion 6 months previously. He was reexposed to omeprazole and the level of liver enzymes rose again and normalized after stopping omeprazole. Despite the improvement of his liver function, the patient died 5 days later due to chronic congestive heart failure. Discussion - Five case s of omeprazole-induced liver injury have been reported to the Swiss D rug Regulatory Agency since 1990, among them two of cholestatic hepati tis and one of hepatic failure. The WHO Data Base has collected 13,630 ADRs related to omeprazole, with more than 80 cases of hepatitis, 60 of jaundice and about 40 of cholestatic hepatitis. In contrast, only o ne case of severe symptomatic hepatotoxicity is described in the liter ature. Clinical studies reported minimal increase of liver enzymes onl y, in 1-5% of cases. Conclusion - This case with reexposure, together with those reported internationally, suggests that hepatitis is a poss ible but obviously rare complication of omeprazole treatment. (C) 1998 John Wiley & Sons, Ltd.