Risks of Rapamune Off-Label Use

Wyeth Promotes Off-Label Rapamune Use Despite Risk of Death

The immunosuppressant drug Rapamune (sirolimus) has come under intense scrutiny due to its potential to increase the risk of death. Studies have linked Rapamune with an increased risk of death when used to prevent organ rejection among liver transplant recipients, a use for which the drug has never been approved by the Food and Drug Administration.

Moreover, a lawsuit filed in 2005 and recently made public alleges that Wyeth, the manufacturer of the drug, engaged in illegal and unethical marketing practices by promoting the drug for “off-label” use and by targeting African-American patients for these unapproved uses despite the higher risk of adverse effects among this group of patients.

About Rapamune and Off-Label Risks

Rapamune, marketed by Wyeth (now owned by Pfizer), was approved by the FDA in 1999 to aid in the prevention of organ rejection following kidney transplantation in patients 13 or older. It has not been approved by the FDA for any other use; however, it has been prescribed for off-label use as an immunosuppressant in liver, lung, pancreas, heart and islet cell transplant patients.

On June 11, 2009, the FDA alerted healthcare professionals about the results of a Wyeth study regarding Rapamune risks associated with off-label use of the drug. The study found that liver transplant patients switched to Rapamune from traditional medications known as calcineurin inhibitor (CNI)-based immunosuppressive drugs (a process known as “conversion”) had an increased risk of death. The FDA also reported other side effects associated with Rapamune conversion, including:

  • Peripheral edema (fluid retention in the lower limbs)
  • Stomatitis (inflammation of the mucus of the mouth)
  • Rash
  • Mouth ulceration
  • Elevated lipid concentrations

In 2005 two former Wyeth sales representatives, Marlene Sandler and Scott Paris, filed a whistleblower lawsuit against both Wyeth and Pfizer. In their suit, which was recently made public, Sandler and Paris state that Wyeth aggressively marketed Rapamune for off-label use in non-approved organ transplant patients. In addition, the claimants allege that Wyeth promoted converting patients from CNI-based drugs to Rapamune despite a lack of FDA approval for this use of the drug and despite a lack of evidence of the effectiveness of this treatment approach.

Targeting African-Americans for Off-Label Rapamune Use

The Sandler and Paris suit contains a number of additional allegations, including charges that Wyeth paid kickbacks to physicians who promoted the drug at speaker events and that Wyeth attempted to distort the facts pertaining to the safety of Rapamune in various ways. One of the most alarming accusations is that Wyeth specifically targeted African-American patients for Rapamune off-label use even though research did not support use of the drug with these patients.

African-American transplant patients are considered higher-risk patients due to their high rate of transplant rejection. Despite this fact, Wyeth specifically targeted sales of Rapamune for off-label use at medical centers with predominantly African-American patient populations—the State University of New York Downstate Medical Center and the Einstein Medical Center in Philadelphia, whose transplant population is about 75 percent African-American.

In response to such charges, Edolphus Towns, the Democratic Congressman from New York and the chairman of the House Oversight and Government Reform Committee, has launched an investigation into Wyeth’s marketing practices. He has asked Wyeth to hand over any documents regarding the side effects of Rapamune, stating, “The most egregious problem here is that, unbeknown to the African Americans [Wyeth] allegedly targeted, their lives were placed at serious risk for life threatening ailments.”

In his press release announcing the investigation, Towns compared Wyeth’s marketing strategy to the Tuskegee experiments of the mid-20th century, when researchers withheld penicillin from African-American syphilis patients. “This type of irresponsible experimentation is another example of big companies preying on vulnerable consumers,” said Towns. “Unfortunately, these marketing techniques are reminiscent of Tuskegee all over again.”

Rapamune Lawsuit

If Wyeth has knowingly placed patients at risk of injury or death, these patients and their loved owes may be entitled to compensation for lost wages, pain and suffering, or wrongful death. If you believe that Rapamune may have harmed you or a loved one, contact the skilled personal injury attorneys at Aylstock, Witkin, Kreis & Overholtz at (844) 794-7402 for a thorough discussion of your case. The Pensacola Rapamune lawyers of AWKO Law are prepared to evaluate your circumstances and vigorously defend your rights.