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Cimzia, is a TNF (tumor necrosis factor) blocker -- the same class of drugs as Enbrel, Remicade, and Humira. Cimzia is the only drug in the TNF class that touts being less poisonous to cells because of its chemical properties (e.g., PEGylated, Fc region free). In addition, compared to other TNF blockers, Cimzia reportedly has a higher affinity for human TNF. Serious Cimzia Side Effects Serious side effects have developed in patients taking Cimzia. The prescribing information available for Cimzia warns about: serious infections, including tuberculosis cancer, including lymphoma nervous system problems, including multiple sclerosis allergic reactions blood problems new or worsening heart failure immune reactions, including lupus-like syndrome The most common side effects associated with Cimzia are upper respiratory infections, urinary tract infections, joint pain, and injection site reactions. FDA Approval and Warnings for Cimzia On April 22, 2008, Cimzia was FDA-approved to treat moderate to severely active Crohn's disease in adults who have not been helped by usual treatments. Cimzia is currently being reviewed and is not yet approved for the treatment of rheumatoid arthritis. On January 5, 2009, the FDA issued a Complete Response Letter to UCB regarding its application for approval of Cimzia for rheumatoid arthritis. The letter states that, as a prerequisite for approval of Cimzia for rheumatoid arthritis, a new safety update (with all clinical data, including new data that was generated since the filing of the Biologics License Application in February 2008) must be submitted. UCB is working to fulfill the latest request by the FDA.
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