FDA to require label changes for immunosuppressant drugs

ROCKVILLE, Md. The Food and Drug Administration is requiring changes to the labeling of some drugs used to prevent rejection of kidney transplants.

The FDA announced Tuesday that it would require immunosuppressant drugs to update their labels following reports of opportunistic viral infections, including BK virus-associated nephropathy, which mostly affects kidney patients and can lead to kidney graft loss.

Affected drugs include Wyeth’s Rapamune (sirolimus), Novartis’s Myfortic (mycophenolic acid) and branded and generic versions of Novartis’s Sandimmune (cyclosporine) and Neoral (cyclosporine modified) and Roche’s Cellcept (mycophenolate mofetil).