Nephropathy with Certain Organ Transplant Drugs

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.

FDA Patient Safety News: September 2009

For more information, please see our website:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=90#4

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Education

Tags:

• Sandimmune
• Neoral
• Cellcept
• Myfortic
• drug
• side effect
• FDA