CellCept Pure Red Cell Aplasia Reports Lead to New Warnings

The FDA announced Friday that labeling for the organ transplant medication CellCept 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.

CellCept is an immunosuppressant medication approved for treatment of transplant patients and is taken to keep the body from rejecting a new organ. It is usually used with other immunosuppressant drugs. CellCept is also often prescribed for off-label uses, such as the treatment of lupus.

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.

The notice from Roche to healthcare professionals noted that in 16 of the 41 cases reported, reduction of dose or cessation of the use of CellCept resulted in a resolution of the condition. However, the company warned that healthcare professionals should consider the combination of drugs the patient is taking, and take the risk of organ rejection into account before ceasing use of CellCept.

There is already a “black box” warning carried on the medication’s label for lymphoma and potential CellCept birth defects. The medication warns that females of child-bearing age must use contraceptives while on CellCept, as women who use the medication and continue taking it into the first trimester of pregnancy could expose their child to an increased risk of birth defects, such as cleft palate, cleft lip and ear deformities.

CellCept side effects have also been connected to 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.