The Food and Drug Administration has asked manufacturers of tumor necrosis factor blockers to enhance their follow-up of pediatric and young adult patients who develop malignancies while on these treatments.
The agency also is advising health care professionals to “remain vigilant” for malignancies in these patients, according to a statement issued by the FDA Nov. 4.
Manufacturers of TNF blockers have been asked by the FDA to report cases of malignancies in children, adolescents, and adults aged 30 years and younger treated with TNF blockers and to conduct in-depth follow-up of them. They also are asked to provide the agency with annual summaries and assessments of malignancies and data on the use of TNF blockers in these age groups.
“This type of safety surveillance is important for our improved understanding of malignancies in pediatric and young adult patients treated with TNF blockers, because it will allow FDA to more completely capture and analyze all reported malignancies based on more complete and consistent reports,” the agency said in its statement.
The FDA statement updates the agency’s ongoing safety review of TNF blockers and malignancies in children, adolescents, and young adults, and does not include any new cases or previously unrecognized risks associated with TNF blockers in this patient population.
The agency has previously issued reports about the increased risk of lymphomas and other cancers associated with the use of TNF blockers and malignancies in children and young adults in June 2008, August 2009, and most recently, April 2011.
TNF blockers are used to treat Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, and/or juvenile idiopathic arthritis. TNF blockers used in the United States are infliximab (Remicade), etanercept (Enbrel), adalimumab (Humira), certolizumab pegol (Cimzia), and golimumab (Simponi).
Health care professionals also should report these cases to the FDA’s Medwatch program.