FDA Warns of Risk of Legionella and Listeria with Enbrel and other TNFa blockers

Washington, DC: The Food and Drug Administration (FDA) has notified healthcare professionals that the Boxed Warning for the entire class of Tumor Necrosis Factor-alpha (TNFa) blockers including Enbrel (etanercept), Remicade (infliximab), Humira (adalimumab), Cimzia (certolizumab pegol), and Simponi (golimumab), has been updated to include the risk of infection from two bacterial pathogens, Legionella and Listeria.

The class of TNFa blockers are used to treat Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, and/or juvenile idiopathic arthritis.

The Boxed Warning and Warnings and Precautions sections of the labels for all of the TNFa blockers have also been revised so that they contain consistent information about the risk for serious infections and the associated disease-causing pathogens.

Patients treated with TNFa 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.

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Published on Sep-7-11