On August 4, 2009, the Food and Drug Administration stated that it had completed its analysis of tumor necrosis factor (TNF) blockers and has concluded that there is an increased risk of lymphoma and other cancers associated with the use of these drugs in children and adolescents. Therefore, the FDA said that a new cancer-related warning will be added to the black boxed warning that’s already on this category of drugs, which includes Remicade, Enbrel, Cimzia, Simponi, and Humira. Additionally, the FDA is requiring that the warning also be modified to specifically reflect the occurrence of leukemia and new-onset psoriasis in patients of all ages being treated with TNF blockers. The current boxed warning only alerts users to a risk of serious infections that can be fatal.
These revisions to the warning label come after the FDA announced in June that it was conducting a safety review of the TNF blockers after receiving about 30 reports of cancer in children and young adults over a 10-year period.
TNF blockers are drugs that neutralize a protein that, when overproduced, causes inflammation and damage to bones, cartilage and other tissue. As such, the drugs are approved to treat various immune-system diseases including juvenile idiopathic arthritis, rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, Crohn’s disease and ankylosing spondylitis. As a class, TNF blockers are among the top-selling drugs in the U.S. considering with all of the products being multibillion-dollar sellers. Enbrel had the largest U.S. market share of the group last year with sales of $3.4 billion, and Remicade was close behind with $3.1 billion of U.S. sales in 2008.
If you have any questions related to this information, please contact us at Pogust Braslow & Millrood. Additionally, as with any medication, side-effects related to these drugs should be reported to the FDA.