• Rapamune®
• Rapamune Lawsuit
• Rapamune FDA Warning
• Rapamune Off Label
• Rapamune Death

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The U.S. Food and Drug Administration (FDA) has cautioned patients and healthcare professionals about the possibility of Rapamune® causing death in liver and lung transplant patients. The only approved use for the immunosuppressant drug is for patients having kidney transplants.

In 1999, the FDA approved Rapamune® to be used to prevent rejection of transplanted kidneys in people 13 years old or older. The drug, however, has been used after other types of transplants, sometimes with significantly higher numbers of fatal results.

“The safety and efficacy of this drug in liver or lung transplant patients have not been established by the FDA,” the safety alert announced.

Wyeth, the drug company making Rapamune®, conducted a study of liver transplant patients and submitted the results to the FDA on March 25, 2009. The trial compared two types of stable liver transplant patients:

• Those who remained on a certain type of immunosuppressive medication (calcineurin inhibitor treatment or CNI)
• Those whose drug regimen was changed from CNI to Rapamune®

The Wyeth study concluded that there might be increased mortality or premature discontinuation of the drug in patients whose treatment regimen was converted from CNI to Rapamune®. The trial data showed that the occurrence of acute rejection in the transplanted liver patients was significantly higher in the patients whose drug regimen was converted compared to patients who remained on CNI.

The most common adverse events accounting for discontinuing participation in the trial were:

• Peripheral edema (fluid retention leading to swelling of the legs)
• Stomatitis (inflammation of any of the mucous membranes of the mouth, including the cheeks, tongue, throat, floor and roof of the mouth)
• Rash
• Mouth ulceration

The mean or average fasting lipid concentrations increased significantly after patients converted to Rapamune® from CNI and remained high throughout the one-year evaluation period following the study.

Wyeth has been accused in lawsuits of promoting the use of Rapamune® for uses other than kidney transplantation. The drug company’s sales management has encouraged its salespersons to promote the drug to be used after transplanting not only kidneys, but also transplants for liver, lung, pancreas, heart and islet cells.

Immunosuppressive drugs, such as Rapamune®, have been developed to prevent the immune systems of organ transplant patients from rejecting the new organs. The immune system normally attacks whatever the body considers to be a foreign substance, including transplanted organs.

Contact a Rapamune® Lawyer

If you think your loved one’s death may be linked to the use of Rapamune®, you should consider filing a Rapamune lawsuit to be compensated for the loss of your loved one’s life, and the pain and suffering caused by the drug.

Pfizer Inc. bought Wyeth in 2009.

"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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