FDA Drug Safety Communication

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FDA Date: 9/16/11

Tumor Necrosis Factor-alpha blockers FDA Drug Safety Communication

Drug labels for the Tumor Necrosis Factor-alpha (TNF alpha) blockers now include warnings about infection with Legionella and Listeria bacteria Safety Announcement

FDA is informing healthcare professionals that the Boxed Warning for the entire class of Tumor Necrosis Factor-alpha (TNF alpha) 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 TNF alpha 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 TNF alpha blockers. These infections can involve various organ systems and sites due to bacterial, mycobacterial (eg, tuberculosis), fungal (eg, histoplasmosis, aspergillosis, candidiasis, coccidioidomycosis, blastomycosis, pneumocystosis), viral (eg, hepatitis B), and other opportunistic pathogens.

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

- The class of TNF alpha blockers are biologic products that include Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab pegol), and Simponi (golimumab).

- TNF alpha blockers are used to treat Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, and/or juvenile idiopathic arthritis.

- Since TNF alpha blockers are immunosuppressants, patients who take these biologic products are at increased risk of serious infections.

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

View the full FDA Drug Safety Communication on FDA.gov