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Growing List of Infections Linked to TNF Blockers

Growing List of Infections Linked to TNF Blockers Potentially fatal Legionella and Listeria infections are the latest opportunistic infections to be added to the boxed warning for medications that block tumor necrosis factor (TNF). The US Food and Drug Administration (FDA) announced that it is requiring the labels of all drugs in this class to be updated to reflect this risk. TNF blockers, which include infliximab, etanercept, adalimumab, certolizumab pegol, and golimumab, are used to treat such diseases as Crohn disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, and juvenile idiopathic arthritis. These drugs suppress immune function, and their labels already bear warnings about the risk of opportunistic infections caused by bacteria, including mycobacteria, fungi, and viruses such as hepatitis B. Using its Adverse Events Reporting System, the FDA has identified 80 cases of Legionella pneumonia, including 14 deaths, in patients taking infliximab, adalimumab, etanercept, and golimumab between 1999 and 2010. Most of the patients, who ranged in age from 25 to 85 years, were treated for rheumatoid arthritis; many patients received other immunosuppressive drugs concurrently. Additionally, agency officials identified reports in the literature of 26 cases of serious Listeria monocytogenes infections, including 7 deaths, among patients treated with TNF blockers. Many of these individuals also received other immunosuppressive drugs. The FDA said that physicians should weigh the risks and benefits of TNF blockers before initiating therapy in patients who experience chronic or recurrent infections or who have factors predisposing them to infection. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

Growing List of Infections Linked to TNF Blockers

JAMA , Volume 306 (13) – Oct 5, 2011

Growing List of Infections Linked to TNF Blockers

Abstract

Potentially fatal Legionella and Listeria infections are the latest opportunistic infections to be added to the boxed warning for medications that block tumor necrosis factor (TNF). The US Food and Drug Administration (FDA) announced that it is requiring the labels of all drugs in this class to be updated to reflect this risk. TNF blockers, which include infliximab, etanercept, adalimumab, certolizumab pegol, and golimumab, are used to treat such diseases as Crohn disease, ulcerative colitis,...
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Publisher
American Medical Association
Copyright
Copyright © 2011 American Medical Association. All Rights Reserved.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.2011.1387
Publisher site
See Article on Publisher Site

Abstract

Potentially fatal Legionella and Listeria infections are the latest opportunistic infections to be added to the boxed warning for medications that block tumor necrosis factor (TNF). The US Food and Drug Administration (FDA) announced that it is requiring the labels of all drugs in this class to be updated to reflect this risk. TNF blockers, which include infliximab, etanercept, adalimumab, certolizumab pegol, and golimumab, are used to treat such diseases as Crohn disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, and juvenile idiopathic arthritis. These drugs suppress immune function, and their labels already bear warnings about the risk of opportunistic infections caused by bacteria, including mycobacteria, fungi, and viruses such as hepatitis B. Using its Adverse Events Reporting System, the FDA has identified 80 cases of Legionella pneumonia, including 14 deaths, in patients taking infliximab, adalimumab, etanercept, and golimumab between 1999 and 2010. Most of the patients, who ranged in age from 25 to 85 years, were treated for rheumatoid arthritis; many patients received other immunosuppressive drugs concurrently. Additionally, agency officials identified reports in the literature of 26 cases of serious Listeria monocytogenes infections, including 7 deaths, among patients treated with TNF blockers. Many of these individuals also received other immunosuppressive drugs. The FDA said that physicians should weigh the risks and benefits of TNF blockers before initiating therapy in patients who experience chronic or recurrent infections or who have factors predisposing them to infection.

Journal

JAMAAmerican Medical Association

Published: Oct 5, 2011

Keywords: infections,tumor necrosis factor inhibitors

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