Quoted from http://www.reuters.com/article/governmentFilingsNews/idUSN1150215320090611
U.S. FDA weighs Wyeth's Rapamune liver data
Thu Jun 11, 2009 3:55pm EDT
By Susan Heavey
WASHINGTON, June 11 (Reuters) - 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.
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.