Drugs
-
Information on Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi)
TNF blockers suppress the immune system by blocking the activity of TNF, a substance in the body that can cause inflammation and lead to immune-system diseases, such as Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis. The drugs in this class include Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab pegol) and Simponi (golimumab).
This information reflects FDA’s current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.
To report any unexpected adverse or serious events associated with the use of these drugs, please contact the FDA MedWatch program using the information at the bottom of this page.
-
Related Information
FDA Drug Safety Communication: UPDATE on Tumor Necrosis Factor (TNF) blockers and risk for pediatric malignancy
11/3/2011FDA Drug Safety Communication: Drug labels for the Tumor Necrosis Factor-alpha (TNFα) blockers now include warnings about infection with Legionella and Listeria bacteria
9/7/2011FDA Drug Safety Podcast for Healthcare Professionals: Safety Review update on reports of Hepatosplenic T-Cell Lymphoma in adolescents and young adults receiving tumor necrosis factor (TNF) blockers, azathioprine and/or mercaptopurine
4/18/2011FDA Drug Safety Communication: Safety Review update on reports of Hepatosplenic T-Cell Lymphoma in adolescents and young adults receiving tumor necrosis factor (TNF) blockers, azathioprine and/or mercaptopurine
4/14/2011Information for Healthcare Professionals: Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi)
8/4/2009Follow-up to the June 4, 2008 Early Communication about the Ongoing Safety Review of Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi)
8/4/2009FDA: Cancer Warnings Required for TNF Blockers
8/4/2009Information for Healthcare Professionals: Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab)
FDA ALERT [9/4/2008]Early Communication About an Ongoing Safety Review of Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, and Cimzia)
6/4/2008
-
-
Labeling and Regulatory History from Drugs@FDA
Certolizumab Pegol (marketed as Cimzia) Prescribing and Labelng Information Etanercept (marketed as Enbrel) Prescribing and Labeling Information Adalimumab (marketed as Humira) Prescribing and Labeling Information Inflixmab (marketed as Remicade) Prescribing and Labeling Information Golimumab (marketed as Simponi) Prescribing and Labeling Information
-
-
-