FDA and Centocor revised the WARNINGS and ADVERSE REACTIONS sections of the labeling for Remicade (infliximab), indicated for the treatment of rheumatoid arthritis and Crohn's disease.
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Cases of leukopenia, neutropenia and pancytopenia, some with fatal outcome, and cases of CNS manifestation of systemic vasculitis, were described in patients receiving Remicade. The ADVERSE REACTIONS section was updated to include neutropenia, pericardial effusion and systemic and cutaneous vasculitis.
Read the MedWatch 2004 safety summary, including links to the "Dear Healthcare Professional" letter and the revised label, at: http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#remicade