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

ROCKVILLE, Md., June 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 (<!-- ppurl -->Rapamune<!-- /ppurl -->). The trial was conducted by sirolimus manufacturer, <!-- cpurl -->Wyeth<!-- /cpurl -->. 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/SafetyAlertsforHumanMedicalProducts/ucm165731.htm<http://www.fda.gov/FDAgov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/UCM165731>

Posted: June 2009

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