ABSTRACT

I. INTRODUCTION Drug-induced liver disease represents an important problem for the following major reasons: (1) approximately 1000 drugs have been implicated in causing liver disease at least on rare occasion (1); (2) in the United States drug-induced liver disease is the most common cause of acute liver failure, accounting for one-third to one-half of cases (2,3); although acetaminophen accounts for the bulk of these, other drugs are still a more frequent cause of acute liver failure than viral hepatitis and other causes; (3) in addition, druginduced liver disease represents an important diagnostic/therapeutic challenge for physicians caring for patients presenting with liver disorders, since it can mimic all forms of acute or chronic liver disease; (4) the frequency and economic impact of this problem is a major challenge for the pharmaceutical industry and regulatory bodies, especially since the toxic potential of some drugs is not evident in preclinical and phase 1-3 clinical testing.