Pharmacy Services
Infliximab (Remicade) associated with hepatotoxicity
December 22, 2004
Infliximab (Remicade) has been associated with hepatotoxicity including cholestasis, hepatitis, jaundice, and liver failure. These cases occurred as soon as 2 weeks following infliximab administration and also in patients receiving therapy for over one year. Some cases required liver transplantation or were fatal. Additionally some cases resulted in a diagnosis of autoimmune hepatitis. The FDA has issued a MedWatch warning and Centocor has updated the product labeling to include this information.
Additional information is available at the following link:
- MedWatch Alert:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm155493.htm
Updated
January 13, 2005; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.

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