Division of Epidemiology, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland 20852, USA. kwon@cber.fda.gov
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.