Celecoxib-induced Liver Injury Analysis of Published Case Reports and Cases Reported to the Food and Drug Administration

Background: Celecoxib is a widely prescribed nonsteroidal anti-inflammatory drug, and has been associated with rare instances of idiosyncratic drug-induced liver injury (DILI). The aim of this study is to describe and analyze the salient features of published cases of celecoxib DILI. Materials and Methods: A literature search using common terms for liver injury cross-referenced with celecoxib was undertaken from the year 2000 through June 2016. Identified cases were analyzed with respect to reported demographic and clinical data with descriptive. Results: Celecoxib DILI was reported in 18 patients with a median age of 54 years (range, 29 to 84) and 15 (88%) were female. The median daily dose was 200 mg (range, 200 to 533), and median duration and latency were 13 days (1 to 730) and 17 days (2 to 730), respectively. In 15 (83%) cases, DILI occurred after relatively short treatment duration, median of 12 days (1 to 42). Rash and immunoallergic features were noted in these patients, with peripheral or histologic findings of eosinophilia in 6 (40%). In 3 cases, DILI occurred after prolonged exposure (range, 152 to 730 d), none with immunoallergic features. The pattern of liver injury included hepatocellular (6), mixed (5), and cholestatic (4), and was unknown in 3 cases. Clinical outcomes included 2 (11%) requiring liver transplantation, 4 (22%) with chronic liver injury and recovery in 12 (67%) cases. Conclusions: Women are overrepresented in published reports of celecoxib DILI. Latency was short (< 3 mo) in most patients but some subjects may present with DILI following prolonged celecoxib use. Although rare, celecoxib-DILI can have potentially life threatening consequences.