FDA MedWatch

Sirolimus (marketed as Rapamune):clinical trial suggests increased mortality in stable liver transplant patients after conversion from CNI-based immunosuppressive regimen to sirolimus

Sirolimus (marketed as Rapamune)

Audience: Transplantation healthcare professionals

06/11/2009 - FDA notified healthcare professionals of clinical trial data that suggest increased mortality in stable liver transplant patients after conversion from a calcineurin inhibitor (CNI)-based immunosuppressive regimen to sirolimus (Rapamune). The trial was conducted by sirolimus manufacturer, Wyeth. The Agency will continue to examine the data on mortality and other adverse events in this study, and will make further recommendations, as appropriate. The FDA is determining whether a labeling change for sirolimus is needed. In the interim, physicians should continue to use the drug’s professional labeling as a guide to therapy. See the FDA Healthcare Professional Information sheet for current FDA recommendations.

Read the complete MedWatch 2009 Safety summary, including a link to the FDA Healthcare Professional Information Sheet, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/Safety
AlertsforHumanMedicalProducts/ucm165731.htm