Source: DGNews  |  Posted 2 years ago

SILVER SPRING, Md -- August 14, 2009 -- The US Food and Drug Administration (FDA) and Roche have notified healthcare professionals that cases of pure red cell aplasia (PRCA) have been reported in patients treated with mycophenolate mofetil (CellCept). The WARNINGS and ADVERSE REACTIONS sections of the CellCept Prescribing Information have been revised to reflect this new safety information.

Roche has identified 41 cases of PRCA reported in patients receiving mycophenolate. Some patients were also receiving other medicines that could have contributed to the development of PRCA (alemtuzumab, tacrolimus, and azathioprine). In 16 of the reported cases, mycophenolate dose reduction (4 cases) or discontinuation (12 cases) led to resolution of the condition. The mechanism by which mycophenolate is associated with PRCA is not known but may be related to immunosuppression. When PRCA occurs in a patient on multiple immunosuppressants, the relative contribution of the drugs to PRCA and the prophylaxis of rejection must be considered before a decision is made to discontinue a drug.

Approximately 5% of all cases of PRCA are drug induced. Patients with PRCA may present with fatigue, lethargy, and/or abnormal pallor. Anaemia is the primary clinical concern in PRCA. Patients with severe anaemia have symptoms and signs of uncompensated anaemia and present with weakness, tachycardia, and dyspnoea. In some cases, PRCA was found to be reversible with dose reduction or cessation of mycophenolate therapy. In transplant patients, however, reduced immunosuppression may place the graft at risk.

SOURCE: US Food and Drug Administration