Case Reports of Heart Failure after Therapy with a Tumor Necrosis Factor Antagonist
- Hyon J. Kwon, PharmD, MPH;
- Timothy R. Coté, MD, MPH;
- Michael S. Cuffe, MD;
- Judith M. Kramer, MD, MS; and
- M Miles Braun, MD, MPH
- From the U.S. Food and Drug Administration, Rockville, Maryland, and Duke Clinical Research Institute, Durham, North Carolina.
Abstract
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.
Article and Author Information
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Acknowledgments: The authors thank Ellis Unger, MD, and Jeffrey N. Siegel, MD, for their help and advice in reviewing the manuscript.
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Grant Support: In part by Dr. Kwon's appointment to the Research Fellowship Program at the Center for Biologics Evaluation and Research, administered by Oak Ridge Associated Universities through a contract with the U.S. Food and Drug Administration.
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Potential Financial Conflicts of Interest:Consultancies: M.S. Cuffe (Wyeth); Honoraria: M.S. Cuffe (Wyeth).
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Requests for Single Reprints: Hyon J. Kwon, PharmD, MPH, Division of Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Suite 200S, HFM-224, Rockville, MD 20852; e-mail, kwon{at}cber.fda.gov.
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Current Author Addresses: Drs. Kwon, Coté, and Braun: Division of Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Suite 200S, HFM-224, Rockville, MD 20852.
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Dr. Cuffe: Duke University Medical Center, Box 3850, Durham, NC 27710.
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Dr. Kramer: Duke Clinical Research Institute, PO Box 17969, Durham, NC 27715.
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Author Contributions: Conception and design: H.J. Kwon, M.S. Cuffe, M.M. Braun.
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Analysis and interpretation of the data: H.J. Kwon, T.R. Coté, M.S. Cuffe, J.M. Kramer, M.M. Braun.
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Drafting of the article: H.J. Kwon, M.S. Cuffe.
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Critical revision of the article for important intellectual content: H.J. Kwon, T.R. Coté, M.S. Cuffe, J.M. Kramer, M.M. Braun.
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Final approval of the article: H.J. Kwon, T.R. Coté, M.S. Cuffe, J.M. Kramer, M.M. Braun.
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Administrative, technical, or logistic support: H.J. Kwon.
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Collection and assembly of data: H.J. Kwon.
- Copyright ©2004 by the American College of Physicians
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