New warnings about malignancies in pediatric patients added to labels of TNF-blockers

After completing an analysis of safety data for tumor necrosis factor (TNF)-blockers, FDA has stated that there is an increased risk of lymphoma and other cancers in pediatric patients who are treated with these agents. FDA is requiring the manufacturers of these agents to add this information to the boxed warning sections of the product labels. The agency is also requiring the manufacturers to include further information about the occurrence of leukemia in adult and pediatric patients who are treated with TNF-blockers, as well as new information regarding cases of new-onset psoriasis in patients treated with these agents.

The TNF-blockers affected by these changes include infliximab (Remicade, Centocor Ortho Biotech), etanercept (Enbrel, Amgen/Wyeth), adalimumab (Humira, Abbott), certolizumab (Cimzia, UCB), and golimumab (Simponi, Centocor Ortho Biotech), which are used for the treatment of conditions such as juvenile idiopathic arthritis, rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, and ankylosing spondylitis.

FDA’s analysis identified 48 cases of malignancies in children and adolescents who were treated with TNF-blockers. Approximately half of these cases were lymphomas; other malignancies included leukemia, melanoma, and solid organ cancers. Among these reported malignancy cases, 11 deaths occurred. A total of 88% of patients with malignancies were concomitantly using other immunosuppressive therapies such as azathioprine and methotrexate, which also have been associated with an increased risk of lymphoma. Despite this, FDA could not exclude the role of TNF-blockers in the development of malignancies in these patients.

FDA advises healthcare professionals to consider the risk:benefit profile of TNF-blockers in pediatric patients before initiating treatment and to monitor for the emergence of malignancies and psoriasis once therapy has begun.