The FDA announced Tuesday that a new “Black Box” warning will be required on Remicade, Enbrel, Humira, Cimzia and Simponi about an increased risk risks of cancer in children. All of the medications fall under the classification of TNF blockers, which are used to treat inflammatory diseases such as arthritis and Crohn’s disease.
TNF blockers neutralize a protein called tumor necrosis factor-alpha that can cause inflammation in cartilage, tissues and bones when overproduced due to inflammatory diseases. In doing so, the drugs suppress the immune system.
The new warning comes after an FDA investigation that began in June 2008, involving an analysis of adolescent and child cancer reports after treatment with TNF blockers.
The FDA found that incidents of cancer began to appear about 30 months after TNF blocker treatment in some children being treated for juvenile rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, inflammatory bowel disorder and Crohn’s disease.
According to the FDA’s Adverse Event Reporting System, between 1998 and 2008, approximately 30 children using Remicade, Enbrel and Humira reportedly developed cancer. About half of the cancers were lymphomas, including both Hodgkin’s and non-Hodgkin’s lymphoma. The other cancers included leukemia, melanoma and solid organ cancers. In this week’s announcement, the FDA noted that some of those cases have been fatal.
The TNF blocker cancer black box warning will be added to Abbott Laboratories’ Humira, Johnson & Johnson’s Remicade and Simponi, and Amgen and Wyeth’s Enbrel. The warning will join another black box on TNF blockers that warns of the increased risk of serious fungal infections added in September 2008.
Black box warnings are the strongest risk warnings that the FDA can impose upon a drug.
The auto-immune disorder drugs are huge sellers nationwide, and the revenue generated account for a large portion of the total revenue for the pharmaceutical companies who sell the drugs. Enbrel and Remicade alone were responsible for a total of $6.5 billion in sales last year.