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FDA, Centocor Issue Alert for Revisions to Remicade Label

ROCKVILLE, MD -- October 13, 2004 -- FDA and Centocor notified healthcare professionals of revisions to the WARNINGS and ADVERSE REACTIONS sections of the prescribing information for Remicade, indicated for the treatment of rheumatoid arthritis and Crohn's disease. In controlled studies of all TNFá-blocking agents, including Remicade, more cases of lymphoma have been observed among patients receiving the agents than among control group patients. Malignancies have also been observed in open-label, uncontrolled clinical studies at a rate several-fold higher than expected in the general population. Patients with Crohn's disease or rheumatoid arthritis, particularly patients with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at a higher risk (up to several fold) than the general population for the development of lymphoma. FDA has recommended a warning concerning malignancy be added to the labeling for all therapeutic agents that block TNF.

To view the warning letter issued to health care professionals, click here: https://www.fda.gov/safety/medical-product-safety-information/medwatch-safety-alerts-human-medical-products.

Source: The Food and Drug Administration

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