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.
Design: Case series.
Setting: The U.S. Food and Drug Administration's MedWatch program.
Patients: 47 patients who developed new or worsening heart failure during TNF antagonist therapy.
Measurements: 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.
Conclusion: In a fraction of patients, TNF antagonists might induce new-onset heart failure or exacerbate existing disease.