Pharmacy Services
Mycophenolate Mofetil (CellCept®) associated with Pure Red Cell Aplasia (PRCA)
August 17, 2009
Mycophenolate mofetil was associated with pure red cell aplasia (PRCA) in 41 post-marketing reports. Pure red cell aplasia is a major reduction in red blood cell precursors, presenting as sub-clinical to severe anemia. Patients in these reports were receiving combination therapy with other immunosuppressive medications, potentially contributing to PRCA development. Mycophenolate mofetil labeling was updated to reflect the risk of PRCA.
Common symptoms of PRCA include pallor, lethargy and fatigue. Mycophenolate mofetil discontinuation or dose reduction resulted in rapid resolution of PRCA in 18 of 41 patients. Risk of graft endangerment requires careful assessment before discontinuing or reducing the dose of mycophenolate in transplant patients who develop PRCA.
For additional information:
- MedWatch Safety Alert:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm177397.htm - Dear Health Care Professional (Roche):
http://www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/UCM177399.pdf - Revised mycophenolate mofetil (CellCept®) Label:
http://www.accessdata.fda.gov/drugsatfda_docs/ label/2009/050722s021,050723s019,050758s019,050759s024lbl.pdf
Updated
August 17, 2009; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.
Social Media
Copyright © 2013 University of Utah Health Care