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FDA Warns of Off-Label Use

Rapamune® (sirolimus) is a drug approved by the U.S. Food and Drug Administration (FDA) for use in kidney transplant patients. It is used to suppress the patient’s immune system and keep it from rejecting the newly transplanted kidney.

However, the drug has been used as an immunosuppressant in the transplantation of organs other than the kidney. This is called off-label use and has been criticized by the FDA.

Black Box Warning

The agency added a black box warning to the label of Rapamune® (Sirolimus).

In bold letters, the warning states, “BOX WARNING: IMMUNOSUPPRESSION, USE IS NOT RECOMMENDED IN LIVER OR LUNG TRANSPLANT PATIENTS.”

The label goes on to say that the drug may increase a patient’s “susceptibility to infection and the possible development of lymphoma may result from immunosuppression.” It advises that only physicians who are experienced in immunosuppressive therapy and management of kidney transplant patients should use Rapamune®.

Off-Label Use Linked to Death

The drug has been linked to patient deaths when used to treat patients receiving lung or liver transplants. In the case of lung transplantation, the drug can cause bronchial anastomotic dehiscence, a usually fatal lung condition following lung transplant surgery.

Drug maker Wyeth and the FDA sent a letter to healthcare providers, warning of bronchial anastomotic dehiscence, and printed in boldface, “The safety and efficacy of Rapamune® as immunosuppressive therapy has not been established in lung transplant patients, and, therefore, such use is not recommended.”

The FDA issued a warning saying that there was an increased risk of death in patients who were switched from one type of immunotherapy to Rapamune® after having a liver transplant. The black box on the label said that when used in liver transplant patients, Rapamune® resulted in “excess mortality, graft loss, and hepatic artery thrombosis” or a blood clot lodged in the hepatic artery (artery leading to the liver).

Wyeth, manufacturer of Rapamune® has been accused of promoting the off-label use of its drug despite the findings of dangerous, potentially fatal, side effects. A number of lawsuits have been filed against the drug maker for causing serious sometimes-fatal side effects and for marketing the drug for off-label purposes.

For more information, contact a Rapamune® lawyer today.

"Rapamune® Off-Label Uses Spur Lawsuits"

The U.S. Department of Justice plus nine states and the District of Columbia last fall requested that they be allowed to intervene (participate) in a whistle-blower lawsuit against drug maker Wyeth. The lawsuit contends that the drug company illegally ...

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