Document Detail

Clinical and histopathologic features of fluoroquinolone-induced liver injury.
MedLine Citation:
PMID:  21356330     Owner:  NLM     Status:  MEDLINE    
BACKGROUND & AIMS: Fluoroquinolone-induced liver injury is rare; no prospective studies of well-characterized case series have been published. We studied patients with fluoroquinolone-induced hepatotoxicity from the Drug-Induced Liver Injury Network (DILIN) to characterize injury patterns, outcomes, and associated features.
METHODS: We identified subjects with fluoroquinolone hepatotoxicity enrolled in the DILIN from September 2004 to January 2010. Demographic, clinical, and laboratory data were analyzed by descriptive statistical methods.
RESULTS: Of the 679 registrants in the DILIN prospective study, 12 had fluoroquinolone hepatotoxicity (6 ciprofloxacin, 4 moxifloxacin, 1 levofloxacin, and 1 gatifloxacin). Seven were women; median age was 57 years (range, 23-80 years), and median time from fluoroquinolone start to symptoms was only 4 days (range, 1-39 days). Nine patients developed symptoms on medication; 3 did so 2, 8, and 32 days after stopping the medication. Cases were equally distributed among hepatocellular injury (predominantly increased levels of alanine aminotransferase), cholestatic injury (predominantly increased levels of alkaline phosphatase), and both. Seven patients had immunoallergic features. Patients with mixed hepatocellular and cholestatic injury had mild disease without jaundice; all recovered. In contrast, 2 of 4 patients with hepatocellular injury and jaundice died, 1 of acute liver failure. One patient with cholestatic injury developed vanishing bile duct syndrome and required liver transplantation; another had a persistently increased serum level of alkaline phosphatase.
CONCLUSIONS: Fluoroquinolone liver injury is rapid in onset and often has immunoallergic features, indicating a hypersensitivity reaction. The pattern of injury can be hepatocellular, cholestatic, or mixed; mixed cases are the least severe. Acute and chronic liver failure can occur.
Eric S Orman; Hari S Conjeevaram; Raj Vuppalanchi; James W Freston; James Rochon; David E Kleiner; Paul H Hayashi;
Publication Detail:
Type:  Journal Article; Research Support, N.I.H., Extramural; Research Support, N.I.H., Intramural     Date:  2011-02-26
Journal Detail:
Title:  Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association     Volume:  9     ISSN:  1542-7714     ISO Abbreviation:  Clin. Gastroenterol. Hepatol.     Publication Date:  2011 Jun 
Date Detail:
Created Date:  2011-05-30     Completed Date:  2011-09-07     Revised Date:  2013-07-25    
Medline Journal Info:
Nlm Unique ID:  101160775     Medline TA:  Clin Gastroenterol Hepatol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  517-523.e3     Citation Subset:  IM    
Copyright Information:
Copyright © 2011 AGA Institute. Published by Elsevier Inc. All rights reserved.
Division of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, USA.
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MeSH Terms
Aged, 80 and over
Alanine Transaminase / blood
Alkaline Phosphatase / blood
Anti-Bacterial Agents / adverse effects*
Aspartate Aminotransferases / blood
Drug-Induced Liver Injury / pathology*,  physiopathology*
Fluoroquinolones / adverse effects*
Hypersensitivity / pathology
Liver / drug effects*,  pathology*
Liver Function Tests
Middle Aged
Grant Support
1U01-DK082992-01/DK/NIDDK NIH HHS; 1U01-DK083020-01/DK/NIDDK NIH HHS; 1U01-DK083023-01/DK/NIDDK NIH HHS; 1U01-DK083027-01/DK/NIDDK NIH HHS; 2U01-DK065176-06/DK/NIDDK NIH HHS; 2U01-DK065184-06/DK/NIDDK NIH HHS; 2U01-DK065201-06/DK/NIDDK NIH HHS; 2U01-DK065211-06/DK/NIDDK NIH HHS; 5U01-DK065238-08/DK/NIDDK NIH HHS; 5U01DK065193-04/DK/NIDDK NIH HHS; U01 DK065176/DK/NIDDK NIH HHS; U01 DK065184/DK/NIDDK NIH HHS; U01 DK065193/DK/NIDDK NIH HHS; U01 DK065201/DK/NIDDK NIH HHS; U01 DK065201-06/DK/NIDDK NIH HHS; U01 DK065211/DK/NIDDK NIH HHS; U01 DK065238/DK/NIDDK NIH HHS; U01 DK082992/DK/NIDDK NIH HHS; U01 DK083020/DK/NIDDK NIH HHS; U01 DK083023/DK/NIDDK NIH HHS; U01 DK083027/DK/NIDDK NIH HHS; UL1 RR024134/RR/NCRR NIH HHS; UL1 RR024134/RR/NCRR NIH HHS; UL1 RR024150/RR/NCRR NIH HHS; UL1 RR024982/RR/NCRR NIH HHS; UL1 RR024986/RR/NCRR NIH HHS; UL1 RR025747/RR/NCRR NIH HHS; UL1 RR025761/RR/NCRR NIH HHS
Reg. No./Substance:
0/Anti-Bacterial Agents; 0/Fluoroquinolones; EC Aminotransferases; EC Transaminase; EC Phosphatase

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