You are here

FDA, Centocor Revise Label for Infliximab

ROCKVILLE, MD -- August 24, 2004 -- FDA and Centocor revised the WARNINGS and ADVERSE REACTIONS sections of the labeling for Remicade, 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.

For further information, click here:

Recent Headlines

Despite older, sicker patients, mortality rate fell by a third in 10 years
Study finds fewer than half of trials followed the law
WHO to meet tomorrow to decide on international public heath emergency declaration
Study of posted prices finds wild variations and missing data
Potential contamination could lead to supply chain disruptions
Declining lung cancer mortality helped fuel the progress
Kinase inhibitor targets tumors with a PDGFRA exon 18 mutation
Delayed surgery reduces benefits; premature surgery raises risks
Mortality nearly doubled when patients stopped using their drugs