Document Detail

Ischaemic colitis in rheumatoid arthritis patients receiving tumour necrosis factor-α inhibitors: an analysis of reports to the US FDA Adverse Event Reporting System.
MedLine Citation:
PMID:  23580194     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Tumour necrosis factor-α (TNF-α) inhibitors are immunosuppressants, approved for the treatment and maintenance of rheumatoid arthritis (RA). Immunosuppression has been shown to induce ischaemic colitis (IC) in an animal model; however, a relationship between TNF inhibitors and IC has rarely been reported in the published literature.
OBJECTIVE: The aim of this study was to better characterize the association between TNF-α inhibitors with IC in RA patients, by analysing adverse event reports submitted to the US FDA Adverse Event Reporting System (AERS) and the published literature.
METHODS: The FDA AERS database was searched and we identified all reports between January 2003 and June 2011. The search was limited to an indication of RA, a 'primary suspect' drug of TNF-α inhibitors and a reaction of IC. Full-length reports were obtained and analysed utilizing the Freedom of Information Act. The cases were organized by age, sex, type of TNF-α inhibitor, concomitant drugs and medical co-morbidities. Cases were labelled as definite, probable, possible or doubtful drug-induced adverse events based on the Naranjo Scale. A PubMed search was performed to obtain published literature documenting events of anti-TNF-associated IC.
RESULTS: Twelve cases were eliminated because of more likely causes for IC. Thirty-five primary suspect reports of TNF-α inhibitors associated with IC in RA patients were identified in the FDA AERS. Thirteen cases were reported with infliximab, 12 with adalimumab, 7 with etanercept and 3 with certolizumab. The majority of the cases were in females (29/35) and those between the ages of 50 and 65 years (18/35). Use of the Naranjo Scale revealed 17 probable and 18 possible cases of anti-TNF-induced IC. In the literature, one report of IC associated with adalimumab was identified.
CONCLUSION: TNF-α inhibitors may be initiating factors or co-factors in the development of IC in RA patients, and further research to determine the mechanism of this association is warranted.
Allison Salk; Derrick J Stobaugh; Parakkal Deepak; Eli D Ehrenpreis
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Drug safety     Volume:  36     ISSN:  0114-5916     ISO Abbreviation:  Drug Saf     Publication Date:  2013 May 
Date Detail:
Created Date:  2013-05-09     Completed Date:  2014-02-04     Revised Date:  2014-11-17    
Medline Journal Info:
Nlm Unique ID:  9002928     Medline TA:  Drug Saf     Country:  New Zealand    
Other Details:
Languages:  eng     Pagination:  329-34     Citation Subset:  IM    
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MeSH Terms
Adverse Drug Reaction Reporting Systems* / statistics & numerical data
Aged, 80 and over
Antirheumatic Agents / adverse effects*
Arthritis, Rheumatoid / drug therapy*,  epidemiology
Colitis, Ischemic / chemically induced*,  epidemiology
Middle Aged
Research Report
Tumor Necrosis Factor-alpha / antagonists & inhibitors*,  metabolism
United States
United States Food and Drug Administration* / statistics & numerical data
Reg. No./Substance:
0/Antirheumatic Agents; 0/Tumor Necrosis Factor-alpha

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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