The FDA has notified healthcare professionals of clinical trial data that suggest increased mortality in stable liver transplant patients after conversion from a calcineurin inhibitor-based immunosuppressive regimen to Rapamune (sirolimus, from Wyeth). The trial was conducted by Wyeth. The FDA will continue to examine the data on mortality and other adverse events in this study, and will make further recommendations, as appropriate.

Rapamune is indicated for the prophylaxis of organ rejection in patients ≥13 years of age receiving kidney transplants.  The safety and efficacy of Rapamune in liver or lung transplant patients have not been established by the FDA.  

For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm165731.htm.