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

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    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/2....htm#Remicade2
  2. 1 Comments so far...

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


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