| NW Blue Penguin 2004-08-31, 10:09 pm |
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MedWatch - The FDA Safety Information and Adverse Event Reporting Program
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. 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/...04.htm#remicade
AFA - American Family Association - Promoting Traditional Family Values
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