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FDA NOTE TO CORRESPONDENTS

For Immediate Release:  July 14, 2009

Media Inquiries: Pat El-Hinnawy, 301-796-4763, patricia.el-hinnawy@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Requires Labeling Change for Some Drugs Used to Prevent Rejection of Kidney Transplants

The U.S. Food and Drug Administration today said that it will require manufacturers of some immunosuppressant drugs used in kidney (renal) transplantation to update their labeling to reflect an increased risk of infections.

The required label changes affect the following immunosuppressant drugs used to help prevent rejection of transplanted organs:

  • Rapamune (sirolimus)
  • Sandimmune (cyclosporine) and cyclosporine generics
  • Neoral (cyclosporine modified), and generics
  • Cellcept (mycophenolate mofetil) and generics
  • Myfortic (mycophenolic acid)

The FDA is requiring the labeling changes based on its review of reported adverse events. The labeling changes must reflect the reported increased risk for opportunistic infections, including activation of latent viral infections. These include BK virus-associated nephropathy, which can mainly affect kidney transplant patients. Such infections may lead to serious outcomes, including kidney graft loss.  

Information about the increased risk for opportunistic infections already is included in the labeling of the immunosuppressive drug Prograf (tacrolimus).

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