It is the responsibility of pharmaceutical companies to produce drugs that are safe for patients and consumers. Nonetheless, large pharmaceutical companies are often more concerned with profits than patient safety. Manufacturers fail to disclose potential side effects, thus making medical practitioners unaware of the dangers to patients. This is the case with Rapamune.
Rapamune is the trade name for sirolimus, an immunosuppressant used to prevent the body from rejecting an organ after a transplant. The drug is primarily used after kidney transplants, especially in those with hemolytic-uremic syndrome, which can recur in the transplanted kidney.
The combination of Rapamune and cyclosporine prevent your body from rejecting a kidney implant.
A study published in the Journal of the American Society of Nephrology in July 2008 linked sirolimus use to an increased risk of new-onset diabetes. Researchers analyzed data from 20,000 Medicare patients who received kidney transplants between 1995 and 2003. Patients receiving sirolimus had a 36% to 66% higher diabetes risk than those receiving another anti-rejection drug.
Adverse Reactions
Rapamune, also known as sirolimus, may increase the risk of diabetes after kidney transplantation. A kidney transplant could fail if this health concern is not addressed. Rapamune can cause diarrhea, acne, anemia, nausea, and increased cholesterol, blood pressure, and fatty acid levels. Rapamune suppresses the immune system, increasing the risk of infection and lymphoma. Rapamune’s effectiveness in other organs, such as lungs and livers, is suspect, as deaths have been attributed to its use in lung transplants.
Patients with diabetes can experience serious complications following kidney transplants. According to researchers, those who develop diabetes after a transplant have the same risk of transplant failure as those who develop acute transplant rejection.
The July 2008 report was the first large study to suggest a connection between Rapamune and diabetes. Studies in animals and small clinical studies have suggested that sirolimus may increase the risk of diabetes. A better understanding of the risk of diabetes among kidney transplant patients treated with Rapamune may require further research.
Rapamune is a drug approved by the Food and Drug Administration (FDA) for use as an immunosuppressant after kidney transplants to prevent patients’ bodies from rejecting the organs from their donors. This was Rapamune’s only FDA approval. Despite this, physicians prescribed Rapamune for other off-label uses following liver, pancreas, heart, and lung transplants. Even so, studies show that liver transplant patients face a high mortality rate, and the FDA issued warnings against off-label use. Wyeth, which produces Rapamune, misrepresented the drug to physicians and hospitals by promoting its off-label use. As a matter of fact, the company trained its sales representatives to market Rapamune for purposes that were not FDA-approved. Patients were exposed to unnecessary Rapamune side effects, including:
- Anemia
- Bone marrow suppression
- Blood clots
- Liver failure
- Discontinuation of proper treatment
- Wounds that cannot heal
- Deficiency of blood platelets
Status of the Drug
The Federal Drug Administration has recognized this link between adverse reactions and the drug.
Lawmakers investigated Wyeth, the drugmaker purchased by Pfizer Inc., after reports the organ transplant drug Rapamune was improperly marketed.
A letter sent to Pfizer Chief Executive Officer Jeffery Kindler said the House Oversight and Government Reform Committee would review whether Rapamune was targeted at black patients for unapproved uses. The committee is investigating whether Wyeth aggressively pushed Rapamune for organ rejection prevention following heart, lung, liver, pancreas, and islet cell transplants without FDA approval, the committee said in a statement.
Rapamune is approved to prevent the rejection of kidney transplants. According to the Food and Drug Administration, Rapamune may increase the risk of death and organ rejection if given during a liver transplant.
In a letter, New York Democrat Edolphus Towns urged Pfizer to provide materials about whether Wyeth targeted specific hospitals for the sale of Rapamune, whether the company tried to switch patients to Rapamune from other therapies, and records about its sale.
“The company shares Chairman Towns’ commitment to protecting patients’ health and will cooperate fully with his inquiry,” Pfizer spokesman Christopher Loder said. “Wyeth is committed to ensuring that information provided to physicians on the uses, benefits, and risks for Rapamune is consistent with its FDA-approved label.”
Eric T. Schneiderman later announced that he reached a $35 million settlement with Pfizer, along with 40 other Attorneys General and the District of Columbia, concerning alleged improper marketing and promotion of the immunosuppressive drug Rapamune. The state’s share of the settlement was over $1.7 million. As a parent of Wyeth Pharmaceuticals Inc., Pfizer agreed to abide by the judgment and resolve allegations that Wyeth unlawfully promoted Rapamune. The office of Attorney General Schneiderman oversaw this multi-state investigation.
“There has to be the same set of rules for everyone, no matter how rich or powerful they are, and that includes big pharmaceutical companies that make unapproved and unsubstantiated claims about their products to increase profits,” said Attorney General Schneiderman. “Patients and consumers need to be confident in the honesty of claims made by medical providers without worrying about drug companies manipulating the doctor-patient relationship. Their well-being and health depend on it.”
Rapamune is an immunosuppressive drug that prevents the body from rejecting a transplanted kidney. Its label, approved by the Food and Drug Administration (FDA), allows its use only immediately after kidney transplants in limited combinations with other drugs.
By filing the lawsuit in New York County Supreme Court, Attorney General Schneiderman alleged that Wyeth engaged in off-label marketing by promoting the drug for uses that were not FDA-approved. Wyeth improperly promoted Rapamune for:
- Liver, heart, and lung transplants when the drug was approved only for kidney transplants.
- Conversion use (switching from another drug to Rapamune) was also unapproved.
- Unapproved drug combinations.
Wyeth also allegedly violated state consumer protection laws by misrepresenting Rapamune’s use and benefits through an orchestrated campaign of promotional talks by Wyeth-employed doctors, misleading data presentations, and funding of studies at hospitals and transplant centers to encourage off-label uses of Rapamune.
Pfizer was prohibited from:
- Marketing any prescription drug or biological product manufactured, distributed, sold, marketed, or promoted by Pfizer for off-label use;
- Comparing the safety or efficacy of a Pfizer product to another product without supporting evidence;
- Offering financial incentives for sales attributable to off-label uses of Pfizer products;
- Making, or causing to be made, any claim about any Pfizer product that is false, misleading, or deceptive;
- Obtaining FDA approval for Rapamune inclusion in hospital protocols or standing orders for which Rapamune has not been approved;
- Disseminating information about Rapamune’s off-label or unapproved use unless such information and materials comply with applicable FDA regulations;
- Attempting to influence the prescribing of Rapamune in hospitals or transplant centers in any way (including by funding clinical trials) that violates the Federal anti-kickback statute.
Alabama, Arizona, Arkansas, California, Colorado, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, North Carolina, North Dakota, Ohio, Oklahoma, South Dakota, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, and Wisconsin, as well as the District of Columbia, participated in the settlement.
See your doctor if you have taken Rapamune and have experienced serious health problems.
Do I Need a Lawyer?
You may wish to contact an experienced class action attorney who can help protect your legal rights and get compensation for your Rapamune injuries. This is a complex area of the law that requires legal assistance.
