Published Dec 22, 2004
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
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
Read the MedWatch 2004 safety summary, including links to the "Dear
Healthcare Professional" letter and the revised label, at:
sharann, BSN, RN
As one who has had Remicade I thank you for the info.
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