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World J Gastroenterol. Dec 7, 2010; 16(45): 5651-5661
Published online Dec 7, 2010. doi: 10.3748/wjg.v16.i45.5651
Non-steroidal anti-inflammatory drugs: What is the actual risk of liver damage?
Fernando Bessone
Fernando Bessone, Department of Gastroenterology and Hepatology, University of Rosario School of Medicine, 2000, Rosario, Argentina
Author contributions: Bessone F solely contributed to this paper.
Correspondence to: Fernando Bessone, MD, Associate Professor of Gastroenterology, Department of Gastroenterology and Hepatology, University of Rosario School of Medicine, Alvear 740 1er. Piso, 2000, Rosario, Argentina. bessonefernando@gmail.com
Telephone: +54-341-4259265 Fax: +54-341-4259265
Received: June 3, 2010
Revised: September 6, 2010
Accepted: September 13, 2010
Published online: December 7, 2010

Non-steroidal anti-inflammatory drugs (NSAIDs) constitute a family of drugs, which taken as a group, represents one of the most frequently prescribed around the world. Thus, not surprisingly NSAIDs, along with anti-infectious agents, list on the top for causes of Drug-Induced Liver Injury (DILI). The incidence of liver disease induced by NSAIDs reported in clinical studies is fairly uniform ranging from 0.29/100 000 [95% confidence interval (CI): 0.17-051] to 9/100 000 (95% CI: 6-15). However, compared with these results, a higher risk of liver-related hospitalizations was reported (3-23 per 100 000 patients). NSAIDs exhibit a broad spectrum of liver damage ranging from asymptomatic, transient, hyper-transaminasemia to fulminant hepatic failure. However, under-reporting of asymptomatic, mild cases, as well as of those with transient liver-tests alteration, in conjunction with reports non-compliant with pharmacovigilance criteria to ascertain DILI and flawed epidemiological studies, jeopardize the chance to ascertain the actual risk of NSAIDs hepatotoxicity. Several NSAIDs, namely bromfenac, ibufenac and benoxaprofen, have been withdrawn from the market due to hepatotoxicity; others like nimesulide were never marketed in some countries and withdrawn in others. Indeed, the controversy concerning the actual risk of severe liver disease persists within NSAIDs research. The present work intends (1) to provide a critical analysis of the dissimilar results currently available in the literature concerning the epidemiology of NSAIDS hepatotoxicity; and (2) to review the risk of hepatotoxicity for each one of the most commonly employed compounds of the NSAIDs family, based on past and recently published data.

Keywords: Non-steroidal anti-inflammatory drugs, Side effects, Fulminant hepatic failure, Cholestasis, Liver damage, Liver injury, Hepatitis, Hepatotoxicity