FDA Advises of Pure Red Cell Aplasia Found in CellCept Patients

The U.S. FDA and Roche have informed healthcare practitioners that patients being treated with CellCept, have reported cases of Pure Red Cell Aplasia, also known as PRCA.  As a result, the WARNINGS and ADVERSE REACTIONS portions of CellCept’s Prescribing Information has been reconsidered, in an attempt to demonstrate the new safety details.

PRCA is a form of anemia where there is a selective lessening red blood cell precursors on bone marrow examination.  Patients suffering from PRCA may experience fatigue, lethargy and/or uncommon pallor.  In some instances, PRCA was able to be reversed with dose minimization or termination of CellCept treatment.  In transplant patients, lessened immunosuppression may put the graft in danger.