Nephropathy with Certain Organ Transplant Drugs

Nephropathy with Certain Organ Transplant Drugs
FDA Patient Safety News: Show #90, September 2009

FDA is requiring that the labeling for several immunosuppressant drugs used to prevent organ rejection after transplants be updated with a warning that these drugs increase the risk of nephropathy associated with the BK virus, which can lead to transplant loss.

The stronger warnings apply to the following drugs:
• Sirolimus, marketed as Rapamune
• Cyclosporine, marketed as Sandimmune and generics
• cyclosporine modified, marketed as Neoral and generics
• mycophenolate mofetil, marketed as Cellcept and generics
• mycophenolic acid, marketed as Myfortic

In FDA's analysis, BK virus-associated nephropathy was primarily seen in kidney transplant patients. Clinicians should carefully monitor transplant patients, and consider adjusting their immunosuppressant therapy if they develop BK virus-associated nephropathy.

FDA is continuing to review the safety of these drugs, and will provide updates as they are available.

Additional Information:

FDA MedWatch Safety Alert. Immunosuppressant Drugs: Required Labeling Changes. July 14, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm171828.htm
FDA Patient Safety News is available at www.fda.gov/psn