FDA calls for warning on Roche's Cellcept

The US Food and Drug Administration has called for the label of Swiss drug major Roche's Cellcept (mycophenolate mofetil) to include a warning about cases of pure red cell aplasia (PRCA) which were reported in some patients who took the organ-transplant drug, the FDA announced. 41 cases of PRCA were reported between 1995 and February 2008, according to the drugmaker.

In a statement from Roche posted on the FDA's web site, it was noted that cases of PRCA have been reported in patients treated with CellCept in combination with other immunosuppressive agents. The mechanism for mycophenolate mofetil induced PRCA is unknown; the relative contribution of other immunosuppressants and their combinations in an immunosuppression regimen are also unknown. 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 graft at risk.