Rapamune® Death
Rapamune® (sirolimus) was approved by the U.S. Food and Drug Administration (FDA) in 1999 as an immunosuppressant to prevent the rejection of kidney transplants. Immunosuppresants depress the ability of the immune system to fight foreign invaders in the body such as infections. When a person has a kidney transplant, the body considers the transplanted kidney to be a foreign invader, and without immunosuppresants the body would reject the new organ.
While immunosuppresants are important for organ transplantation, they also leave our bodies open to more infections, serious viral infection in particular in the case of Rapamune®. The drug also increases the body’s susceptibility to certain cancers. These include lymphoma (a cancer of the lymph system, related to cancer in the blood) and skin cancer.
When the FDA approved Rapamune® in 1999, it was authorized to be used only as an immunosuppressant in the transplantation of kidneys. This approval is stated explicitly on the drug’s label. However, the drug has sometimes been used “off label”, that is for uses not expressed on the label. Sometimes, this off-label use of Rapamune® has led to patients’ deaths.
The following situations have led to the deaths of transplant patients:
- When Rapamune® is used for lung transplantation, an off-label use, Wyeth warns on its label of the possibility of bronchial anastomotic dehiscence, or a situation in which the lung transplant becomes detached. This has led to death.
- In the case of liver transplantation, another off-label use of Rapamune®, the label warns of “excess mortality, graft loss and hepatic artery thrombosis (HAT).” This means there was a higher than normal number of deaths in these transplant patients; the grafted lung failed to work; and the artery carrying blood to the liver had blood clots in it. All could lead to death.
Other off-label uses of the drug have been for transplants of hearts, pancreases, and islet cells.
A boxed FDA warning on the label says, “Sirolimus may increase the risk of severe side effects, including death, when used with certain other immunosuppresants in liver or lung transplant patients. Use of Sirolimus in liver or lung transplant patients is not recommended.”
Sirolimus has been used experimentally to extend the life span of mice. It is used also to coat stents in the heart. The stent, a scaffold to keep arteries open, sometimes fail and the artery closes up again. When sirolimus is used to coat the stent, the device slowly releases the drug to prevent scarring and drug clots from blocking the artery.
Wyeth, the previous owner of Rapamune®, was bought by Pfizer in October 1999 for $68 billion.
If you believe your loved one’s death could have been caused by Rapamune®, you should speak with an attorney about filing a Rapamune lawsuit. You and your family might be eligible for financial compensation. Contact us today for more information.
