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  • FDA Drug Safety Communication

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  • FDA Date: 08/04/2009

    Remicade (infliximab) 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)

    This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.

    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.

    View the full FDA Drug Safety Communication on FDA.gov