Recent research suggests that Rapamune® – also known as sirolimus – may increase the risk of diabetes after a kidney transplant
What is Rapamune?
Rapamune is FDA approved for the management of hemolytic-uremic syndrome (HUS) following kidney transplantation. Patients suffering from HUS who are faced with kidney transplantation may be prescribed Rapamune to prevent recurrence of the serious condition. In addition, many doctors prescribe the drug to patients receiving a liver transplant. This off-label use of the anti-organ transplant rejection drug has been linked with an increased risk of death, spurring an FDA investigation.
Rapamune Linked to New-Onset Diabetes
In the July 2008 issue of the Journal of the American Society of Nephrology, a study linked the user of Rapamune to an increased risk of new-onset diabetes. Researchers reviewed data for 20,000 Medicare patients who received a kidney transplant between 1995 and 2003. When compared to those who received another anti-rejection drug, the diabetes risk was between 36% and 66% higher among patients treated with sirolimus.
Rapamune Side Effects
Wyeth conducted a study comparing liver transplant patients taking more traditional calcineurin inhibitor (CNI)-based immunosuppressants to those taking Rapamune. The results concluded that the potential for liver rejection was “significantly higher” in those taking Rapamune. Many Rapamune patients also experienced a number of adverse side effects, including (but not limited to):
- Mouth ulcerations
- Peripheral edema
Although Rapamune already carries the FDA’s sternest warning – the “black box” warning – the FDA is considering reevaluating the labeling requirements to further alert consumers.