ROCKVILLE, Md. Reports of a type of anemia have prompted changes to the warning label of a drug used to prevent the immune system from rejecting transplanted organs.
The Food and Drug Administration announced Friday that patients using CellCept (mycophenolate mofetil) had reported cases of pure red cell aplasia, which causes selective reduction of red blood cell precursors in the bone marrow. Patients with PRCA may experience fatigue, lethargy and pale skin.
Swiss drug maker Roche manufactures CellCept, and several generic drug companies make their own versions.
In July, the FDA required changes to the labeling of several immunosuppressant drugs, including CellCept, following reports of opportunistic viral infections among patients using them.