You are here

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

July 15, 2009 -- 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).

Further information for health care professionals

Information for consumers

Recent Headlines

Patients Had Improved Lung Function, Fewer Exacerbations
Particularly Serious: Antidepressants, Drugs for Parkinson’s and Epilepsy
Drug “Remarkably Effective” at Killing Range of Gram-Positive Bacteria
Up to 70% Greater Risk of Bacterial Infection, 48% Risk for Fungal Infection
Most Women Undergoing Surgery for Suspected Cancer Do Not Have It
Specific Monoclonal Antibodies Ensure Extreme Sensitivity, Accuracy
Record-High Number of Cases in France, Italy, Greece, Other Locations
Will Have a Longer Shelf Life Than Current, Expired Stockpile