Document Detail


Duloxetine hepatotoxicity: a case-series from the drug-induced liver injury network.
MedLine Citation:
PMID:  20815829     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Case reports suggest that duloxetine hepatotoxicity may arise, but risk factors, presenting features and clinical course are not well-described.
AIM: To describe the presenting features and outcomes of seven well-characterized patients with suspected duloxetine hepatotoxicity.
METHODS: Patients enrolled in the Drug-Induced Liver Injury Network Prospective Study underwent an extensive laboratory and clinical evaluation to exclude competing aetiologies of liver injury as well as a standardized assessment for causality and disease severity.
RESULTS: Between 1/2006 and 9/2009, six of the seven cases of DILI attributed to duloxetine were assessed as definite or very likely. Median patient age was 49 years, six (86%) were women and the median latency from drug initiation to DILI onset was 50 days. Six patients developed jaundice and the median peak alanine aminotransferase in the five patients with acute hepatocellular injury was 1633 IU/L. Ascites developed in one patient and acute renal dysfunction in two others (29%). All patients recovered without liver transplantation even though three had pre-existing chronic liver disease. Liver histology in four cases demonstrated varying patterns of liver injury.
CONCLUSIONS: Duloxetine hepatotoxicity developed within 2 months of drug intake and led to clinically significant liver injury. A spectrum of laboratory, histological and extra-hepatic features were noted at presentation.
Authors:
R Vuppalanchi; P H Hayashi; N Chalasani; R J Fontana; H Bonkovsky; R Saxena; D Kleiner; J H Hoofnagle;
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Publication Detail:
Type:  Case Reports; Journal Article; Research Support, N.I.H., Extramural     Date:  2010-09-03
Journal Detail:
Title:  Alimentary pharmacology & therapeutics     Volume:  32     ISSN:  1365-2036     ISO Abbreviation:  Aliment. Pharmacol. Ther.     Publication Date:  2010 Nov 
Date Detail:
Created Date:  2010-11-02     Completed Date:  2011-02-24     Revised Date:  2014-09-08    
Medline Journal Info:
Nlm Unique ID:  8707234     Medline TA:  Aliment Pharmacol Ther     Country:  England    
Other Details:
Languages:  eng     Pagination:  1174-83     Citation Subset:  IM    
Copyright Information:
© 2010 Blackwell Publishing Ltd.
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MeSH Terms
Descriptor/Qualifier:
Adult
Antidepressive Agents / adverse effects*
Biopsy
Drug-Induced Liver Injury*
Female
Humans
Liver / drug effects*
Male
Middle Aged
Prospective Studies
Thiophenes / adverse effects*
Grant Support
ID/Acronym/Agency:
1U01DK065021/DK/NIDDK NIH HHS; 1U01DK065176/DK/NIDDK NIH HHS; 1U01DK065184/DK/NIDDK NIH HHS; 1U01DK065193/DK/NIDDK NIH HHS; 1U01DK065201/DK/NIDDK NIH HHS; 1U01DK065211/DK/NIDDK NIH HHS; 1U01DK065238/DK/NIDDK NIH HHS; K24 DK069290/DK/NIDDK NIH HHS; K24 DK069290-05/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 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
Chemical
Reg. No./Substance:
0/Antidepressive Agents; 0/Thiophenes; O5TNM5N07U/duloxetine
Comments/Corrections

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