Theodoros and Rooth, P.C.

What is Rapamune and What are the Dangers?

Rapamune is a type of antibiotic, also called sirolimus, that the Federal Drug Administration (FDA) approved for only one use: helping patients with kidney transplants prevent tissue rejection.

Despite its approval, Rapamune also has well-known potential severe side effects. According to WebMD, they include:

  • Risk of developing infections
  • Risk of developing cancer, such as lymphoma or skin cancer

Patients taking Rapamune should inform their physicians right away if they develop any of the following:

  • Unusual skin changes (appearances of changes in sizes of moles)
  • Unusual growths or lumps
  • Swollen glands
  • Night sweats
  • Unexplained weight loss
  • Fever or sore throat

Wyeth Pharmaceuticals, Inc., a company acquired by Pfizer, Inc. in 2009, is the manufacturer of Rapamune. The U.S. Department of Justice (DOJ) issued a release in 2013 that Wyeth reached a settlement of $490.0 million in a court case brought against it for promoting off-label uses. Information in the case alleged that Wyeth trained its national sales representatives to promote the use of Rapamune for use in non-renal transplant patients. In fact, Wyeth trained the sales teams how to incorporate the medication’s use as part of their presentations to transplant physicians. They targeted all transplant patients, not just renal transplants, and the reason was boost sales profits.

Patients with liver transplants were particularly vulnerable for risks from Rapamune use, which caused life threatening side effects such as:

  • Liver failure
  • Leukopenia
  • Blood clots
  • Bone marrow suppression
  • Wounds that would not heal
  • Death

If you or a loved one suffered adverse side effects from off label use of Rapamune, consult with an Indiana pharmaceutical litigation lawyer to protect your rights and discuss the prospects of recovering compensation.