FDA Date: 8/3/09
Enbrel (etanercept) FDA Drug Safety Communication
Follow-Up to the June 4, 2008 FDA Early Communication about the Ongoing Safety Review of Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi)
FDA has 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. This new safety information is now being added to the Boxed Warning for these products. In addition, FDA has identified new safety information related to the occurrence of leukemia and new-onset psoriasis in patients treated with TNF blockers. FDA is also requiring updates to the current Medication Guide to help patients understand the risks associated with TNF blocker therapy.