CellCept, an immunosuppressant medication approved for treatment of transplant patients and is taken to keep the body from rejecting a new organ, is also prescribed “off-label” for lupus patients. Friday, the FDA announced labeling for the medication will be changed to add warnings that the drug could cause a type of anemia known as Pure Red Cell Aplasia (PRCA).

Roche Laboratories, Inc., which manufactures CellCept (mycophenolate mofetil), notified healthcare professionals last week that it was making revisions to the drug’s warning label after receiving reports of 41 users who developed Pure Red Cell Aplasia as a possible side effect of CellCept.

Pure Red Cell Aplasia (PRCA) is a type of anemia that affects the precursors to red blood cells, causing bone marrow to cease to produce red blood cells. Symptoms of PRCA include fatigue, lethargy, and abnormal paleness of the skin. Treatments include cessation of any drug causing the condition and corticosteroids. PRCA is not considered a condition that significantly increases mortality.

Other side-effects for CellCept include a potential increased risk of a rare brain infection known as Progressive Multifocal Leukoencephalopathy or PML, which affects the central nervous system. There is no known cure for the brain infection and it is fatal in many cases.  There is already a “black box” warning carried on the medication’s label for lymphoma and potential CellCept birth defects.