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  • FDA Date: 06/11/2009

    Rapamune (sirolimus) FDA Drug Safety Communication

    Information for Healthcare Professionals: Sirolimus (marketed as Rapamune)

    This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.

    FDA is notifying 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).

    FDA is determining whether a labeling change for sirolimus is needed. In the interim, physicians should continue to use the professional labeling as a guide to therapy. The Agency will continue to examine the data on mortality and other adverse events in this study, and will make further recommendations, as appropriate.

    This information reflects the current analysis of data available to FDA concerning sirolimus. Posting this information does not mean that FDA has concluded there is a causal relationship between the drug product and the emerging safety issue. Nor does it mean that FDA is advising healthcare professionals to discontinue prescribing this product. FDA intends to update this communication when additional information or analyses become available.

    View the full FDA Drug Safety Communication on FDA.gov