title: Causality assessment of drug-induced hepatotoxicity: promises and pitfalls.
abstract: Drug-induced liver injury is the leading cause of acute liver failure in the United States, but the ability to ascribe hepatic injury confidently to a specific drug remains a challenging and often difficult pursuit. This article explores the ongoing challenges inherent in what is currently a clinical process of elimination made in the attempt of assigning causality in drug-induced liver injury. In particular, it points out the shortcomings and pitfalls that often limit the applicability of the causality-assessment methodologies currently in use.
authors.affiliation: Hepatology Section, Division of Gastroenterology, Georgetown University Hospital, Georgetown University Medical Center, Washington, DC 20007, USA.
authors.forename: Max A
authors.initials: MA
authors.lastname: Shapiro
authors.forename: James H
authors.initials: JH
authors.lastname: Lewis
mesh_terms: D015984:Causality; D056486:Chemical and Drug Induced Liver Injury; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D008099:Liver / Q000187:drug effects / Q000378:metabolism / Q000473:pathology; D008297:Male