Rapamune is a drug used to keep the body from rejecting organ and bone marrow transplants. Rapamune blocks certain white blood cells that can reject foreign tissues and organs. It also blocks a protein that is involved in cell division. It is a type of antibiotic, a type of immunosuppressant, and a type of serine/threonine kinase inhibitor. Rapamune was previously called rapamycin and also called sirolimus.

Rapamune and Off-Label use

Rapamune was approved by the FDA in 1999 for the prevention of organ rejections following kidney transplants in patients 13 and older. It has not been approved by the FDA for any other use, but it has been prescribed for off-label use in liver, lung, pancreate, heart and islet cell transplant patients. Studies have linked Rapamune with an increased risk of death when used to prevent organ rejection among liver transplant recipients. The FDA warned against such off-label use in both 2004 and 2007. In 2005 to former hospital sales representative filed a lawsuit against the manufacturer of Rapamune over its use in off-label situations. The suit claims:

"Wyeth trained and encouraged its sales representatives to market Rapamune for uses outside those listed on the FDA-approved label and to misrepresent and withhold clinical information regarding the safety and efficacy of Rapamune. As a result of Wyeth's wrongdoing, patients were put at risk of serious physical and financial harm, including: the disruption or discontinuation of stable treatment regimens; increased costs associated with treating side effects caused or exacerbated by Rapamune; life-threatening side effects such as anemia, bone marrow suppression, inhibited wound-healing, proteinuria, blood clots, leukopenia, thrombocytopenia, liver failure, pulmonary dehiscence; and death."

Additionally, there are claims of Wyeth targeting African-American, even though they are at high risk of complications.

If you or a loved one has been injured as a result of using Rapamune, you may be entitled to receive compensation. Drug manufacturers are required to ensure the efficacy of their products. Failure to adequately measure the potential for side effects or to alert healthcare professionals and consumers about any adverse effects is considered negligent and grounds for personal injury litigation.The Monsour Law Firm boasts some of the finest personal injury attorneys Texas has to offer. Contact us today at (800) 815-2911 to learn more about your rights as a Rapamune injury victim.

U.S. Seeks to Join Pfizer Whistleblower Lawsuit

The U.S. Justice Department is seeking to join a whistleblower lawsuit over Pfizer Inc.’s organ transplant drug Rapamune alleging the medicine was illegally marketed, according to court papers. The government’s lawyers are asking a federal judge in Philadelphia to allow them to take over litigating claims that officials of Pfizer’s Wyeth unit pushed the drug for unapproved uses and specifically targeted black patients. “This means the government had determined that some or all of the allegations in our complaint are merit worthy,” Reuben Guttman, a Washington-based lawyer representing two former Wyeth employees who filed suit over the practices, said in a telephone interview today. Rapamune is approved to help prevent the rejection of kidney transplants. The U.S. Food and Drug Administration last year found the drug may increase the risk of death and organ rejection if given during a liver transplant. Pfizer officials said today Rapamune’s warning label included “appropriate caveats” about how the drug could be used safely in connection with transplants. “Pfizer has previously disclosed that the company is cooperating with the U.S. government regarding its review of Wyeth’s promotional practices involving Rapamune,” Raymond Kerins, a Pfizer spokesman, said in an e-mailed statement. New York-based Pfizer bought Wyeth last year for $68 billion. Marketing Tactics After investigating the whistleblowers’ claims about Wyeth’s Rapamune marketing tactics, Justice Department lawyers concluded they had “good cause to intervene” in the case, according to a court filing. U.S. District Judge John R. Padova in Philadelphia still must approve the government’s request to join the 2005 suit. The complaint was filed by Marlene Sandler and Scott Paris, two former Wyeth sales reps, who claim the drugmaker “directed their entire Rapamune sales force” to promote the drug among physicians involved in heart, lung, liver and pancreas transplants. The drug hasn’t been approved for use in any of those transplants, according to the complaint. The whistleblowers also claim Wyeth officials offered doctors and hospitals kickbacks, in the form of speaker fees and grants, in exchange for Rapamune prescriptions. Wyeth sales executives also targeted hospitals that served black populations in an effort to get doctors to switch transplant patients to Rapamune, according to the complaint. The FDA required the drugmaker in 2004 to include a black-box warning on Rapamune about such patient conversions, the suit said. That is the FDA’s highest safety warning. Pfizer officials said in February that federal prosecutors in Oklahoma are investigating whether Wyeth’s Rapamune marketing campaign violated any criminal laws. The drugmaker acknowledged the probe in a U.S. Securities and Exchange Commission filing. The case is U.S. v. Wyeth Pharmaceuticals Inc, CA 05-6609, U.S. District Court, Eastern District of Pennsylvania (Philadelphia). To contact the reporter on this story: Jef Feeley in Wilmington at This e-mail address is being protected from spambots. You need JavaScript enabled to view it . To contact the editor responsible for this story: David Rovella at This e-mail address is being protected from spambots. You need JavaScript enabled to view it . By Jef Feeley - Sep 21, 2010 5:52 PM CT - http://www.bloomberg.com/news/2010-09-21/u-s-joins-federal-suit-over-pfizer-liver-drug-according-to-court-filing.html