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U.S. Department of Health and Human Services

Safety

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Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi) August 2009

Audience: Rheumatologists, gastroenterologists, oncologists, dermatologists

[UPDATED 08/31/2009] Supplemental Q&As added

[Posted 08/04/2009] FDA notified healthcare professionals that it 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. FDA has also identified new safety information related to the occurrence of leukemia and new-onset psoriasis in patients treated with TNF blockers. The current prescribing information for TNF blockers does contain a warning for malignancies, but does not specifically mention leukemia. FDA is also requiring updates to the current Medication Guide to help patients understand the risks associated with TNF blocker therapy.

TNF blockers are approved for the treatment of one or more of a number of immune system diseases including juvenile idiopathic arthritis (JIA), rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, Crohn’s disease, and ankylosing spondylitis.

[08/28/2009 - Q&As - FDA]
[08/04/2009 - Information for Healthcare Professionals - FDA]
[08/04/2009 - Follow-up to Early Communication about the Ongoing Safety Review of Tumor Necrosis Factor (TNF) Blockers - FDA]

Previous MedWatch Alert:

[06/03/2008]