Alerts
Mycophenolic Acid (Myfortic®) - warning for risk of Pure Red Cell Aplasia (PRCA)
September 9, 2009
Mycophenolate mofetil (Cellcept®) was associated with pure red cell aplasia (PRCA) in post-marketing reports. Patients in these reports were receiving combination therapy with other immunosuppressive medications, potentially contributing to PRCA development. Pure red cell aplasia is a major reduction in red blood cell precursors, presenting as sub-clinical to severe anemia. Mycophenolate mofetil labeling was updated to include the risk of PRCA. Mycophenolic acid (Myfortic) is the active form of mycophenolate mofetil and labeling of mycophenolic acid now also reflects the risk of PRCA.
Common symptoms of PRCA include pallor, lethargy, and fatigue. Reducing the dose or stopping mycophenolate mofetil has reversed PRCA in some cases. Risk of graft endangerment requires careful assessment before discontinuing or reducing the dose of mycophenolate mofetil or mycophenolic acid in transplant patients who develop PRCA.
For additional information:
- MedWatch Safety Alert (Myfortic®) - September 2009:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm181306.htm - MedWatch Safety Alert (Cellcept®) - August 2009:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm177397.htm - Dear Health Care Professional (Novartis) - August 2009:
http://www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/UCM181308.pdf - Revised Mycophenolic Acid (Myfortic®) Label:
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050791s007lbl.pdf
Updated
September 9, 2009, University of Utah, Drug Information Service.
Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.
