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FDA Announces Label Change for Certain Immunosuppressant Drugs

The FDA announced yesterday that is requiring a label change for certain immunosuppressant drugs. The FDA conducted an analysis of its Adverse Event Reporting System on MedWatch and discovered a link between BK virus-associated nephropathy and the use of certain immunosuppressant drugs. The required label change is to reflect that immunosuppressed patients are at an increased risk for opportunistic infections, such as activation of latent viral infections, including the BK virus-associated nephropathy. The drugs affected by the label change are used to protect against the rejection of organs when a patient undergoes an organ transplant. The occurrence of BK virus-associated nephropathy has been primarily observed in renal (kidney) transplant patients.

The immunosuppressant drugs affected by the required label change are:

  • Sirolimus (brand name Rapamune)
  • Cyclosporine (brand name Sandimmune, also generics are affected)
  • Cyclosporine (brand name Neroral, also generics are affected)
  • Mycophenolate mofetil (brand name Cellcept, also generics are affected)
  • Mycophenolic acid (brand name Myfortic)

BK virus-associated nephropathy can progress to renal allograft loss. Monitoring for this serious risk and early intervention by the health care provider is critical. The association of BK virus-associated nephropathy has previously been linked with another drug, tacrolimus (brand name Prograf). The label changes that the FDA announced for the above listed drugs have already been included on the label of Prograf. The FDA is continuing to review the safety of immunosuppressant drug products used in renal transplantation. The FDA is urging health care professionals and patients to continue to report adverse events from the use of immunosuppressant drugs to the FDA’s MedWatch Adverse Event Reporting System.

For more information, see the FDA’s MedWatch Safety Information at:

See the FDA Press Release at:

See the Information for Healthcare Professionals at:

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