August 14, 2009
FDA warns of pure red cell aplasia (PRCA) with CellCeptThe FDA and Roche have notified healthcare professionals that cases of pure red cell aplasia (PRCA), a type of anemia in which there is a selective reduction of red blood cell precursors on bone marrow examination, have been reported in patients treated with CellCept (mycophenolate mofetil). The Warnings and Adverse Reactions sections of the CellCept Prescribing Information have been revised to reflect this new safety information.
Patients with PRCA may present with fatigue, lethargy, and/or abnormal paleness of the skin. In some cases, PRCA was found to be reversible with dose reduction or cessation of CellCept therapy. In transplant patients, however, reduced immunosuppression may place the graft at risk.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm177397.htm.