UPDATE 2-FDA requires label change for some transplant drugs

* FDA requires label change for transplant drugs

* Agency still reviewing drugs for kidney transplants

(Adds company comments)

WASHINGTON, July 14 (Reuters) - The U.S. Food and Drug Administration said on Tuesday it will require Novartis AG (NOVN.VX), Roche Holding AG (ROG.VX) and other makers of drugs to prevent transplanted organ rejection to add information to product labels about the risk of infections.

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

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 agency 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.

Novartis spokeswoman Maureen Byrne said the company would add more information about the risk of infections, including ones from BK virus, to the prescribing information for its drugs. Byrne said it, "has long been recognized that immunosuppression necessary to facilitate organ transplantation increases the risk of infections, including those caused by BK virus."

Roche also will make the changes ordered by the FDA, company spokesman Christopher Vancheri said.

"We feel that it is important that physicians and patients are aware of this new information," Vancheri said.

Rapamune already carries a boxed warning required for all immunosuppressants about an increased susceptibility to infections, Wyeth spokesman Doug Petkus said.

Wyeth will "analyze its database for relevant safety information pertaining to BK virus specific to (Rapamune) and propose appropriate labeling changes to the FDA," he added.

The agency posted its announcement at: here . (Reporting by Julie Vorman; editing by Andre Grenon)