SAFETY ALERT: TNF-alpha Blockers' Boxed Warning Updated to Include Risk of Infection

The FDA has notified healthcare professionals that the Boxed Warning for the tumor necrosis factor-alpha (TNF-alpha) blocker class of drugs has been updated to include the risk of infection from Legionella and Listeria. In addition, the Boxed Warning and Warnings and Precautions sections of the labeling 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. Because TNF-alpha blockers are immunosuppressants, patients treated with these agents are at increased risk for developing serious infections that may lead to hospitalization or death due to bacterial, mycobacterial, fungal, viral, parasitic, and other opportunistic pathogens.

TNF-alpha blockers are biologic products that include Remicade (infliximab; Centocor Ortho Biotech), Enbrel (etanercept; Amgen), Humira (adalimumab; Abbott), Cimzia (certolizumab pegol; UCB), and Simponi (golimumab; Centocor Ortho Biotech). TNF-alpha blockers are indicated to treat Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, and/or juvenile idiopathic arthritis.

For more information visit www.fda.gov/Drugs/DrugSafety/ucm270849.htm.