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Saturday 1st January, 2005


Severe hepatic reactions, including acute liver failure, jaundice, hepatitis and cholestasis, have been reported in postmarketing data.


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Chron's disease


Severe hepatic reactions, including acute liver failure, jaundice, hepatitis and cholestasis, have been reported in postmarketing data in patients receiving Remicade.

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.

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.

Patients with symptoms or signs of liver dysfunction should be evaluated for evidence of liver injury. If jaundice and/or marked liver enzyme elevations (e.g., ≥5 times the upper limit of normal) develops, Remicade should be discontinued, and a thorough investigation of the abnormality should be undertaken. As with other immunosuppressive drugs, use of Remicade has been associated with reactivation of hepatitis B in patients who are chronic carriers of this virus (i.e., surface antigen positive). Chronic carriers of hepatitis B should be appropriately evaluated and monitored prior to the initiation of and during treatment with Remicade. In clinical trials, mild or moderate elevations of ALT and  AST have been observed in patients receiving Remicade without progression to severe hepatic injury.

In addition, Centocor has added pneumonia to the existing Warnings on Risk of Infections based on clinical trial data in RA patients described in the Adverse Reactions section of the labeling.

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