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U.S. Department of Health and Human Services

Safety

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Remicade (infliximab) - Black Box Warning

Audience: Rheumatologists, Gastroenterologists and other healthcare professionals

FDA notifies health professionals that tuberculosis and other serious opportunistic infections, including histoplasmosis, listeriosis, and pneumocystosis, have been reported in both the clinical research and post-marking surveillance settings. Some of these infections have been fatal. Centocor has added a BOXED WARNING to the labeling for the product, and the WARNINGS and ADVERSE REACTIONS sections of the product labeling were revised.

[Oct 23, 2001 - Letter - Centocor]