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Wyeth (Pfizer) Promotes Off-Label Use of Rapamune®

In a whistle-blower lawsuit against Wyeth, two former hospital sales representatives charged that the company “openly encouraged and directed their entire Rapamune® sales force” to promote the drug to hospitals and physicians who practiced transplanting heart, lung, liver, pancreas and islet cells.

The U.S. Food and Drug Administration (FDA) has approved the drug only to be used as an immunosuppressant after kidney transplants. But, the drug company gave its salespeople scientific literature supporting its use for other types of organ transplantation, thus encouraging them to sell the drug for other uses.

FDA Alerts: Off-Label Uses Linked To Death And Serious Injuries

The FDA added a black box warning (the strictest kind of warning it can make) to the drug label warning against off-label uses. The label specifically says, “use is not recommended in liver or lung transplant patients.”

In its medication guide accompanying the drug, the FDA warns that “serious complications and death may happen in people who take Rapamune® after a liver or lung transplant.

“You should not take Rapamune® if you have had a liver or lung transplant without talking with your doctor.”

Other warnings on the medication guide say that in patients taking Rapamune® there is an increased risk of:

• Infections — “Serious infections,” the guide says,” can happen including infections caused by viruses, bacteria, and fungi (yeast).
• Certain cancers — “People who take Rapamune have a higher risk of getting lymphoma and other cancers, especially skin cancer.”

In addition to promoting off-label use of Rapamune®, Wyeth is being accused of marketing the drug to high-risk patients, especially African Americans. Two hospitals with mostly African American patients were targeted for sales. Wyeth sales management chose Einstein Medical Center in Philadelphia as a marketing target for Rapamune® in a three-month period in 2005. In that year, about 75 percent of the transplant patients at Einstein were African American.

The other hospital targeted for sales was SUNY Downstate Medical Center in New York, also having mostly African American patients.

In another FDA alert, the agency warned healthcare professionals of the danger of converting stable liver transplant patients from one type of immunosuppressive treatment (calcineurin inhibitor-based immunosuppressive regimen or CNI) to Rapamune®.

In a clinical trial conducted by Wyeth, researchers found that a significantly higher number of deaths occurred in patients converted to the Rapamune® regimen than in patients who were not converted and remained on the CNI treatment.

Contact our Rapamune lawyers today for more information.

"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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