FDA requires label change for some transplant drugs

WASHINGTON (Reuters) - 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 opportunistic infections when using the medicines, the U.S. Food and Drug Administration said.

The label changes are required for Wyeth's Rapamune; Novartis' Neoral and Myfortic; Roche's Cellcept and Sandimmune, the FDA said in a statement Tuesday posted on the agency's web site.

Organ transplant patients who take the drugs are at increased risk for infections such as BK virus-associated nephropathy, based on the FDA's analyses of its adverse event reporting system, the FDA said.

"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 FDA said.

The FDA also said it was continuing to review the safety of immunosuppressant drugs used in kidney transplant patients.

The agency posted its announcement at: here .

(Reporting by Julie Vorman; Editing by Tim Dobbyn)