FDA investigates pediatric cancer risk with TNF-blockers
The FDA is investigating a possible link between the use of tumor necrosis factor (TNF)-blockers and the development of lymphoma and other cancers in children and young adults treated for immune system diseases including juvenile idiopathic arthritis (JIA), rheumatoid and psoriatic arthritis, plaque psoriasis, Crohn's disease, and ankylosing spondylitis.
Cancer risk warnings already appear in the labeling of the four TNF-blockers available in the U.S. The FDA has asked makers of Remicade (infliximab, from Centocor), Enbrel (etanercept, from Amgen and Wyeth) and Humira (adalimumab, from Abbott) to provide information about all cancer cases reported in children taking these products. The FDA has asked UCB to initiate a long-term study to assess the risk of cancer in children taking its TNF-blocker, Cimzia.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm105999.htm.