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• Rapamune Off Label
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Our Rapamune® lawyers are investigating lawsuits on behalf of people who believe they’ve been harmed by this medication. To discuss your case, contact us today.

What is Rapamune®?

Rapamune® is an immunosuppressant drug used to prevent organ rejection in 13-year-old or older patients who have kidney transplants.

The body’s immune system is meant to attack what it considers to be foreign, such as viral or bacterial infections. When a patient has an organ transplant, such as a kidney, the body’s natural tendency is to use its immune system to try and reject the organ as foreign. Immunosuppressant drugs, or drugs that suppress the work of the immune system, help the body to accept transplanted organs.

Rapamune® is supposed to be given after a kidney transplant in conjunction with cyclosporine and corticosteroids.

Rapamune® Side Effects

Rapamune® may cause a serious viral infection of the brain that can cause disability or death. Patients are warned to watch for:

• Changes in mental state
• Problems speaking or walking
• Problems with vision

Such symptoms can begin slowly, and then worsen rapidly. The medication can also increase a person’s chances of getting lymphoma or other kinds of cancer.

Other side effects, that can be life threatening, include:

• Risk of death in patients receiving transplanted liver, lung, pancreas, heart or islet cells
• Anemia
• Suppression of bone marrow (where the body’s infection fighting cells are made)
• Slow wound healing
• Proteinuria (a kidney disorder causing abnormally high amounts of protein in the urine)
• Blood clots
• Leukopenia (shortage of disease-fighting white blood cells)
• Thrombocytopenia (abnormally low level of platelets needed to help blood clot when we need it, such as in wound healing)
• Liver failure

Rapamune® Off-Label Uses and Dangers

Wyeth (now part of Pfizer), the drug’s manufacturer, is claimed to have promoted the drug for “off-label” uses, or uses not approved by the U.S. Food and Drug Administration (FDA) that are listed on the drug literature’s label.

The only approved use listed on the drug label is to help prevent rejection of transplanted kidneys. But, Wyeth is being accused of marketing the drug for use in patients receiving liver, lung, pancreas, heart, or islet cell transplants.

In another matter, it is alleged in a lawsuit against Wyeth, that the company targeted two hospitals for marketing Rapamune®. They were Philadelphia’s Einstein Medical Center and New York’s SUNY Downstate Medical Center.

Both hospitals have mostly African American patients, who are considered to be a high-risk group because they mount stronger immune responses to transplanted organs. According to the lawsuit, some hospitals protested to Wyeth that patients were having very serious side effects, but nothing was done.

If you or someone you love has suffered severe side effects after taking Rapamune® following an organ transplant, you should contact a lawyer to seek compensation for your pain and suffering.

Contact our Rapamune® lawyers for a free evaluation of your case.

"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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