The FDA is requiring the manufacturers of tumor necrosis factor (TNF)-blockers to strengthen their existing cancer warnings in their prescribing information. 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, 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. Drugs in this class affected by this FDA action include Remicade (infliximab, from Centocor Ortho Biotech), Enbrel (etancercept, from Amgen), Humira (adalimumab, from Abbott), Cimzia (certolizumab pegol, from UCB) and Simponi (golimumab, from Centocor Ortho Biotech).
This action is based on the completion of an investigation which began in June 2008. An analysis of reports of cancer in children and adolescents treated with TNF-blockers showed an increased risk of cancer, occurring after 30 months of treatment on average. About half of the cancers were lymphomas, a type of cancer involving cells of the immune system. Some of the reported cancers were fatal.
For more information visit http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm175803.htm