Rapamune® (sirolimus) FDA Warning
The U.S. Food and Drug Administration (FDA) issued a Rapamune® warning in 2009 about the use of the medication in liver transplant patients. The FDA sent the warning to alert patients and physicians about an increased risk of death when given to liver transplant patients.
Despite the warning, some liver transplant patients have still been given the drug.
Background
Sirolimus or Rapamune® was approved by the FDA in 1999. It is in a class of drugs known as immunosuppressive agents. Our bodies have a whole system whose job is to protect us from what is considered to be foreign, whether it is an infection or a transplanted body part.
In the case of Rapamune®, the drug works by defeating the ability of the body’s white blood cells to attack the transplanted organ. When used as an immunosuppressant, Rapamune® is approved only for kidney transplantation. Its drug label specifically warns against using Rapamune® to prevent organ rejection in lung and liver transplant patients.
Black Box Warning for Rapamune® Drug
The medication guide accompanying Rapamune® contains the following information:
“RAPAMUNE has not been shown to be safe and effective in people who have had liver or lung transplants. 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.”
In a clinical trial by the company’s manufacturer, Wyeth, liver transplant patients first received a calcineurin inhibitor-based immunosuppressive regimen or (“CNI”) to prevent organ rejection. Then, some patients were switched to Rapamune®. As a result, the patients switched from CNI to Rapamune® died in significantly greater numbers than patients who remained on the CNI regimen.
Wyeth was bought by Pfizer in January 2009 for $68 billion in dollars and stock. Part of lawsuit complications today have to do with charges against Wyeth for promoting Rapamune® off-label before the company was bought by Pfizer.
Off-Label Use for Rapamune Medication
Although Rapamune® has FDA approval only for use after kidney transplants to prevent organ rejection, some physicians have been prescribing Rapamune® for patients following liver and lung transplants. Some of these patients have met with serious complications or death.
According to whistleblowers who used to work for Wyeth, Rapamune has been used off label for transplants of hearts, lungs, livers, pancreases, and islet cells, in addition to kidneys. The whistle blowers were two sales representatives who accused Wyeth of targeting black populations for off-label use.
According to the suit, the drug company promoted sale of the drug to two hospitals with mostly black patient populations: New York’ SUNY Downstate Medical Center and Pennsylvania’s Einstein Medical Center in Philadelphia.
If you or a loved one was injured by off-label use of the drug, contact our Rapmune lawyers today to find out if you are entitled to file a lawsuit.
