Case reports of heart failure after therapy with a tumor necrosis factor antagonist

Ann Intern Med. 2003 May 20;138(10):807-11. doi: 10.7326/0003-4819-138-10-200305200-00008.


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.

Publication types

  • Research Support, U.S. Gov't, P.H.S.
  • Review

MeSH terms

  • Adult
  • Adverse Drug Reaction Reporting Systems
  • Age of Onset
  • Aged
  • Aged, 80 and over
  • Antibodies, Monoclonal / adverse effects*
  • Arthritis, Rheumatoid / drug therapy
  • Crohn Disease / drug therapy
  • Etanercept
  • Female
  • Heart Failure / chemically induced*
  • Humans
  • Immunoglobulin G / adverse effects*
  • Infliximab
  • Male
  • Middle Aged
  • Receptors, Tumor Necrosis Factor
  • Risk Factors
  • Tumor Necrosis Factor-alpha / antagonists & inhibitors*
  • United States
  • United States Food and Drug Administration


  • Antibodies, Monoclonal
  • Immunoglobulin G
  • Receptors, Tumor Necrosis Factor
  • Tumor Necrosis Factor-alpha
  • Infliximab
  • Etanercept