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FDA updates labeling for TNF-alpha blockers to include infection warning
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The boxed warning for tumor necrosis factor-alpha blockers has been updated to include the risk for infection from two bacterial pathogens, Legionella and Listeria, according to an FDA press release. The boxed warning and warnings and precaution sections of the labels for all TNF-alpha blockers have been revised to include consistent information about the risk for serious infections and the associated disease-causing pathogens.
According to the agency, patients treated with TNF-alpha blockers are at increased risk for developing serious infections involving multiple organ systems and sites that may lead to hospitalization or death due to bacterial, mycobacterial, fungal, viral, parasitic and other opportunistic pathogens.
The class of TNF-alpha blockers included are those used to treat Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis and/or juvenile idiopathic arthritis.
Before starting therapy in patients with chronic or recurrent infection, or those with underlying conditions that may predispose them to infection, consider the risks and benefits of TNF-alpha blockers, the FDA recommends. A complete listing of recommendations for health care professionals and patients, as well as a data summary, are available in the Drug Safety Communication.
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