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Drug Labels For The Tumor Necrosis Factor-Alpha (Tnfα) Blockers Now Include Warnings About Infection With Legionella And Li

Posted Sep 07 2011 5:32pm

The U.S. Food and Drug Administration (FDA) is informing healthcare professionals that the Boxed Warning for the entire class of Tumor Necrosis Factor-alpha (TNFα) blockers has been updated to include the risk of infection from two bacterial pathogens, Legionella and Listeria. In addition, the Boxed Warning and Warnings and Precautions sections of the labels for all of the TNFα blockers have been revised so that they contain consistent information about the risk for serious infections and the associated disease-causing pathogens.

Serious, including fatal, infections are a known risk of TNFα blockers. These infections can involve various organ systems and sites due to bacterial, mycobacterial (e.g., tuberculosis), fungal (e.g., histoplasmosis, aspergillosis, candidiasis, coccidioidomycosis, blastomycosis, pneumocystosis), viral (e.g., hepatitis B), and other opportunistic pathogens (organisms that usually do not cause disease in healthy people, but can cause serious illness when a person’s immune system (resistance) has weakened).

Recently, FDA reviewed cases of infection in patients treated with TNFα blockers (see Data Summary below). The addition of Legionella and Listeria to the drug labels of the TNFα blockers will provide healthcare professionals with more information about opportunistic pathogens that can cause serious infections in patients treated with TNFα blockers.

It is important for healthcare professionals to be aware of the new labeling changes.

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