U.S. FDA weighs Wyeth’s Rapamune liver data

U.S. health regulators are weighing possible action after results from a clinical trial suggested increased death in certain liver transplant patients switched to Wyeth’s transplant drug Rapamune (generic name sirolimus).

In a statement on Thursday, the Food and Drug Administration said it was weighing possible changes to the product labeling for the drug, which is FDA-approved to prevent kidney rejection in transplant patients aged 13 or older.

Results from a company-sponsored clinical trial provided to the FDA in March “suggest increased mortality in stable liver transplant patients” who were given Rapamune following another type of treatment known as a calcineurin inhibitor (CNI)-based immunosuppressive regimen.

Wyeth first released the results at a medical conference last year to help ensure patient safety, spokesman Doug Petkus said. The company will provide final results from the trial to the FDA by the end of July.

“We will continue to work with the FDA on this matter to incorporate this information into the label so that physicians are informed of the company’s research to date,” he said in a statement.

Rapamune’s label already carries the strongest warning possible - a so-called black box - advising against using the drug immediately after liver transplantation. The study looked at liver patients during other stages.

“The boxed warning was based on a specific way of using the drug, and we are investigating other ways that may be better,” he said.

The FDA will “continue to examine the data on mortality and other adverse events in this study, and will make further recommendations, as appropriate,” it said.

In the meantime, doctors should continue to follow Rapamune’s current drug labeling instructions, the FDA said.

The FDA posted the notice on its website at http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm165015.htm

By Susan Heavey
WASHINGTON (Reuters)