Pharmacy Services
Arava (leflunomide) associated with severe infections and potentially fatal hepatic injury
November 21, 2003
Aventis and the FDA have revised the WARNINGS section of the prescribing information for leflunomide (Arava) to inform healthcare professionals of reports of serious hepatic injury (including cases with fatal outcome) and severe infections (including sepsis) in patients receiving leflunomide therapy.
Additional information is available at the following links:
- MedWatch Alert:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm153278.htm - Letter to Healthcare Professionals:
http://www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/UCM168409.pdf - Revised Product Label (June 2003):
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20905slr007,20905se1-006_arava_lbl.pdf
Updated
November 21, 2003; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.
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