Video originally created by FDA -- posted by Lawsuit.com on August 10, 2009

FDA is alerting healthcare professionals that stable liver transplant patients may have an increased risk of death if they are switched from an immunosuppressive regimen based on a calcineurin inhibitor (CNI) to sirolimus. Sirolimus, which is marketed as Rapamune, is approved to prevent organ rejection in patients 13 and older who receive kidney transplants. It is not approved to treat patients with liver or lung transplants.

The higher mortality risk was found in a clinical trial conducted by Wyeth, the manufacturer of Rapamune. The trial also suggested that patients converted to Rapamune were more likely to experience treatment failure at one year, and more likely to discontinue the drug because of adverse events, than patients who remained on CNI-based therapy.

FDA is reminding healthcare professionals that the boxed warning for Rapamune states that the safety and efficacy of the drug as an immunosuppressant have not been established in liver or lung transplant patients. FDA’s alert also points out that therapeutic drug monitoring is recommended for all Rapamune patients, but it should not be used as the sole basis for adjusting Rapamune therapy. The patient’s signs and symptoms should also be considered, along with tissue biopsy and laboratory findings.