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NEW WARNING
The Food and Drug Administration (FDA) has issued an alert to health care professionals stating that patients who are stable after liver transplantation may have an increased risk of death if converted from a calcineurin inhibitor (CNI), such as tacrolimus, to sirolimus. The increased risk was revealed in a study conducted by the drug's maker.
Other risks identified by the study include:
- Overall treatment failure at 1 year was significantly higher for patients switched to sirolimus than for patients who continued receiving a CNI.
- Adverse effects severe enough to stop treatment occurred more often in patients receiving sirolimus. The most common adverse effects were peripheral edema, stomatitis, rash, and mouth ulcers.
- Lipid levels increased significantly after switching from a CNI to sirolimus and stayed elevated throughout the study's 1-year follow-up period.
Officials are working to determine whether the sirolimus label should be changed to reflect these study findings. For now, they urge health professionals to carefully follow the drug's current label instructions. Sirolimus is indicated for preventing kidney rejection in transplant patients age 13 and older. It isn't indicated for use after liver or lung transplantation.
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sirolimus