Case reports of heart failure after therapy with a tumor necrosis factor antagonist.
BACKGROUND
Etanercept and infliximab are U.S. Food and Drug Administration-approved tumor necrosis factor (TNF) antagonists.


OBJECTIVE
To describe adverse event reports of heart failure after TNF antagonist therapy.


METHODS
Case series.


METHODS
The U.S. Food and Drug Administration's MedWatch program.


METHODS
47 patients who developed new or worsening heart failure during TNF antagonist therapy.


METHODS
Clinical and laboratory reports.


RESULTS
After TNF antagonist therapy, 38 patients developed new-onset heart failure and 9 patients experienced heart failure exacerbation. Of the 38 patients with new-onset heart failure, 19 (50%) had no identifiable risk factors. Ten patients younger than 50 years of age developed new-onset heart failure after receiving TNF antagonists. After TNF antagonist therapy was discontinued and heart failure therapy was started in these 10 patients, 3 had complete resolution of heart failure, 6 improved, and 1 died.


CONCLUSIONS
In a fraction of patients, TNF antagonists might induce new-onset heart failure or exacerbate existing disease.
Kwon
Hyon J
HJ
Division of Epidemiology, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland 20852, USA. kwon@cber.fda.gov
Coté
Timothy R
TR
Cuffe
Michael S
MS
Kramer
Judith M
JM
Braun
M Miles
MM
D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D017668:Age of Onset; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000009:adverse effects*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy; D003424:Crohn Disease / Q000188:drug therapy; D000068800:Etanercept; D005260:Female; D006333:Heart Failure / Q000139:chemically induced*; D006801:Humans; D007074:Immunoglobulin G / Q000009:adverse effects*; D000069285:Infliximab; D008297:Male; D008875:Middle Aged; D018124:Receptors, Tumor Necrosis Factor; D012307:Risk Factors; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*; D014481:United States; D014486:United States Food and Drug Administration
D000911:Antibodies, Monoclonal; D007074:Immunoglobulin G; D018124:Receptors, Tumor Necrosis Factor; D014409:Tumor Necrosis Factor-alpha; D000069285:Infliximab; D000068800:Etanercept