Safety Alerts & Recalls
What does this mean?
This safety alert is based on the FDA's current analysis of this study report of switching LIVER transplant patients to a regimen that contains sirolimus. Currently there is a Boxed Warning on the sirolimus label to warn that the safety and the efficacy of sirolimus as an immunosuppressant has not been established in LIVER or LUNG transplant patients. The FDA is currently determining if additional labeling changes are needed for sirolimus. The Agency will continue to examine the data on death and other adverse events in this study, and will make further recommendations if needed.
If you are a LIVER or LUNG transplant patient and taking Sirolimus, please follow up with your doctor as soon as possible to review this new safety information and discuss the benefits and risks of continuing to take Sirolimus. Do not stop taking Sirolimus without first talking to your doctor.
If you are a KIDNEY transplant patient and taking Sirolimus, you should continue to take your medicine as directed. Sirolimus is currently indicated for the prevention of organ rejection in patients aged 13 years or older receiving KIDNEY transplants. Although this new safety information is directed to LIVER transplant patients taking Sirolimus, this safety alert is a good reminder to regularly review the risks and benefits of your medications with your transplant doctor during your visits for routine monitoring of your kidney function and drug levels of Sirolimus.
New Safety Information About the Use of Sirolimus (Rapamune) in LIVER Transplant Patients
The FDA is notifying healthcare professionals about the results of a recent study that suggest an increased risk of death in stable LIVER transplant patients who switch: FROM a calcineurin inhibitor (CNI)-based regimen that may include immunosuppressant medicines such as cyclosporine (Neoral, Sandimmune) or tacrolimus (Prograf)
TO a regimen that contains sirolimus (Rapamune).
The study also determined that overall treatment failure rates at one year were higher for the group of stable LIVER transplant patients converted to sirolimus compared to the group that continued on CNIs. Treatment failure was defined as the occurrence of acute rejection or the need to stop taking the study medicine for any reason. The trial was conducted by Wyeth, the sirolimus manufacturer.
Sirolimus is indicated for the prevention of organ rejection in patients aged 13 years or older receiving KIDNEY transplants. The safety and efficacy of this drug in LIVER or LUNG transplant patients have not been established by the FDA.
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