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Hot off the press.
FDA NOTE TO CORRESPONDENTS
For Immediate Release: Aug. 4, 2009
Media Inquiries: Office of Public Affairs, 301-796-4540
Consumer Inquiries: 888-INFO-FDA
FDA: Cancer Warnings Required for TNF Blockers
The U.S. Food and Drug Administration is requiring stronger warnings in the prescribing information for a class of drugs known as TNF blockers. The warnings, which include an updated boxed warning, highlight the increased risk of cancer in children and adolescents who receive these drugs to treat juvenile rheumatoid arthritis, the inflammatory bowel disorder, Crohn’s disease, and other inflammatory diseases.
In addition, the FDA is working with manufacturers to explore new ways to further define the risk of cancer in children and adolescents who use these drugs.
TNF blockers target and neutralize tumor necrosis factor-alpha (TNF-α), a protein that, when overproduced in the body due to chronic inflammatory diseases, can cause inflammation and damage to bones, cartilage and tissue. The drugs in this class include Remicade (infliximab), Enbrel (etancercept), Humira (adalimumab), Cimzia (certolizumab pegol) and Simponi (golimumab).
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm175803.htm
FDA NOTE TO CORRESPONDENTS
For Immediate Release: Aug. 4, 2009
Media Inquiries: Office of Public Affairs, 301-796-4540
Consumer Inquiries: 888-INFO-FDA
FDA: Cancer Warnings Required for TNF Blockers
The U.S. Food and Drug Administration is requiring stronger warnings in the prescribing information for a class of drugs known as TNF blockers. The warnings, which include an updated boxed warning, highlight the increased risk of cancer in children and adolescents who receive these drugs to treat juvenile rheumatoid arthritis, the inflammatory bowel disorder, Crohn’s disease, and other inflammatory diseases.
In addition, the FDA is working with manufacturers to explore new ways to further define the risk of cancer in children and adolescents who use these drugs.
TNF blockers target and neutralize tumor necrosis factor-alpha (TNF-α), a protein that, when overproduced in the body due to chronic inflammatory diseases, can cause inflammation and damage to bones, cartilage and tissue. The drugs in this class include Remicade (infliximab), Enbrel (etancercept), Humira (adalimumab), Cimzia (certolizumab pegol) and Simponi (golimumab).
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm175803.htm
