FDA Warns of Pure Red Cell Aplasia Cases in Myfortic Users

Kidney transplant patients taking the immunosuppression drug Myfortic to discourage organ rejection have been developing Pure Red Cell Aplasia (PRCA), a serious type of anemia that can put the newly transplanted organs at risk, the Food and Drug Administration just warned.

In an urgent notice issued today to healthcare professionals, the FDA and Novartis Pharmaceuticals, the maker of Myfortic (mycophenolic acid), said cases of PRCA have been reported and that changes to warnings in the drug’s packaging have been made to reflect the risk.

Other drugs which are similar to Myfortic that may present the same risks of PRCA include:

• Rapamune (sirolimus)

• Sandimmune (cyclosporine)

• Neoral (cyclosporine modified)

• Cellcept (mycophenolate mofetil)

Severe Anemia Reported

PRCA is a type of anemia in which there is a selective reduction of red blood cell precursors on bone marrow examination, the FDA said. Patients with PRCA may develop symptoms including fatigue, lethargy, and/or abnormal paleness of the skin.

Some PRCA cases diagnosed in patients treated with Myfortic were reversible once the dosage was either reduced or stopped, the FDA said. However, stopping the therapy reverses immunosuppression, which can place the graft at risk of rejection by the body.

Earlier FDA Warning About Infections Risk

In July 2009, the FDA ordered the makers of Myfortic and similar immunosuppression drugs to include in their products’ packaging stronger warnings about the increased risks of infections. Patients receiving Myfortic and the other drugs had reported adverse events an opportunistic infections, including latent viral infections that become reactivated in patients taking the drugs.

BK virus-associated nephropathy, which is most common in patients who have undergone kidney transplants, can result in serious health complications, including kidney graft loss, the FDA said.

Another immunosuppressive drug, Prograf (tacrolimus), already carries stronger labeling warnings about the risks of opportunistic infections.

No related posts.