According to the U.S. Food and Drug Administration (FDA), Novartis AG, Roche Holding AG and other makers of drugs to prevent rejection of transplanted organs will be required to note on their labels that patients are at risk for infections when using the medicines. The label changes are required for Wyeth's Rapamune, Novartis' Neoral and Myfortic, and Roche's Cellcept and Sandimmune.
 
Organ transplant patients who take these drugs are at increased risk for infections such as BK virus-associated nephropathy. BK virus-associated nephropathy can progress to organ rejection in kidney transplant recipients. Monitoring for this serious risk and early intervention by the health care provider is critical. The FDA is also continuing to review the safety of immunosuppressant drugs used in kidney transplant patients.

This article originally appeared in the August 2009 issue of Kidney Transplant Today.