FDA MedWatch - Remicade (infliximab) and severe hepatic reactions reported in postmar

[Brian, ASN, RN]

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

liver transplantation.

Read the MedWatch 2004 safety summary, including links to the "Dear

Healthcare Professional" letter and the revised label, at:

http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#Remicade2

[sharann, BSN, RN]

As one who has had Remicade I thank you for the info.