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.
TNF Blockers currently available in the US are marketed Remicade, Enbrel, Humira, Cimzia, and Simponi.
AUGUST-04-09: Tumor Necrosis Factor (TNF) Blockers Boxed Warning Update [FDA: TUMOR NECROSIS FACTOR BLOCKERS]
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Last updated on Aug-4-09