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U.S. Department of Health and Human Services

Safety

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Remicade (infliximab) Dec 2004

Audience: Rheumatologists, gastroenterologists and other healthcare professionals

FDA and Centocor notified healthcare professionals of revisions to the WARNINGS, ADVERSE REACTIONS sections and PATIENT PACKAGE INSERT of the prescribing information for Remicade, indicated for the treatment of rheumatoid arthritis, Crohn's disease and ankylosing spondylitis. Severe hepatic reactions, including acute liver failure, jaundice, hepatitis and cholestasis, have been reported in postmarketing data in patients receiving Remicade. Autoimmune hepatitis has been diagnosed in some of these cases. Severe hepatic reactions occurred between two weeks to more than a year after initiation of Remicade. Some of these cases were fatal or necessitated liver transplantation.

[December, 2004 - Letter - FDA]
[December, 2004 - Label - FDA]