FDA MedWatch - CellCept (mycophenolate mofetil) - cases of Pure Red Cell Aplasia reported in patients treated with CellCept

ROCKVILLE, Md., Aug. 14, 2009--FDA and Roche notified healthcare professionals that cases of Pure Red Cell Aplasia (PRCA) have been reported in patients treated with CellCept. The WARNINGS and ADVERSE REACTIONS sections of the CellCept Prescribing Information have been revised to reflect this new safety information.

PRCA is a type of anemia in which there is a selective reduction of red blood cell precursors on bone marrow examination. Patients with PRCA may present with fatigue, lethargy, and/or abnormal paleness of the skin (pallor). 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.

Read the MedWatch safety summary, including links to the Dear Healthcare Professional Letter and revised Prescribing Information, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm177397.htm

Posted: August 2009


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