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CellCept Patients at Risk for Severe Formof Anemia

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There is another warning for CellCept.  This time the Food & Drug Administration (FDA)  says CellCept has been associated with a severe type of anemia called pure red cell aplasia (PRCA).

PRCA is a type of anemia that can cause fatigue, lethargy or abnormal paleness of the skin. Approximately 5% of all cases of PRCA are drug induced. According to a Reuters report, 41 PRCA cases were reported to Roche from 1995 through February 2008. 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 transplanted organ at risk, the letter said.

According to the FDA, The WARNINGS and ADVERSE REACTIONS sections of the CellCept Prescribing Information have been revised to reflect this new safety information.

CellCept—generically known as mycophenolate mofetil—is part of a class of drugs called immunosuppressants and was approved in 1995 to prevent rejection of solid organ transplants, including kidney, heart, and liver. When CellCept is used  with cyclosporine and corticosteroids, it greatly reduces the patient’s immune system from attacking the transplanted organ. As with all immunosuppressants, CellCept carries certain risks, including development of lymphoma and other malignancies and is also linked to an increased risk of developing opportunistic infections and sepsis.

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