The FDA is requiring stronger warnings in the prescribing information for tumor necrosis factor (TNF) blockers. An updated boxed warning highlights the increased risk of cancer drugs in children and adolescents who receive these drugs to treat juvenile rheumatoid arthritis, inflammatory bowel disorder, Crohn’s disease, and other inflammatory disorders.
TNF antagonists neutralize TNF-a, a protein that is overproduced in the body as a result of chronic inflammatory disease. TNF-a can cause damage to bones, cartilage, and tissue. The drugs in this class include infliximab (Remicade, Centocor Ortho Biotech Inc.), etanercept (Enbrel, Amgen/Wyeth), adalimumab (Humira, Abbott), certolizumab pegol (Cimzia, UCB), and golimumab (Simponi, Centocor Ortho Biotech Inc.).
The updated prescribing information will also mention reports of psoriasis associated with the use of TNF blockers.
Source: FDA, August 5, 2009
