FDA Issues Alert On Wyeth Kidney Transplant Drug
June 11 2009 - 3:27PM
Dow Jones News
The Food and Drug Administration sent health-care professionals
an alert Thursday about a Wyeth (WYE) kidney-transplant drug that
discussed a possible increased risk of death.
The FDA said Wyeth submitted clinical trial data involving
Rapamune "that suggested that there may be increased mortality in
patients converted from calcineurin inhibitor therapy to
[Rapamune]." The study involved use of the drug in liver-transplant
patients.
The drug is only approved for use in kidney-transplant patients.
The agency said "the safety and efficacy of this drug in liver or
lung transplant patients have not been established."
The FDA said it is determining whether a labeling change is
needed. Rapamune already carries the agency's toughest
boxed-warning, which includes langauge cautioning against use of
the drug in liver patients.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;
jennifer.corbett@dowjones.com