On July 30, 2013, The New York Times posted an article online that stated the drug company Pfizer will pay almost $491 million to settle accusations of off-label marketing of the drug Rapamune (sirolimus). Drug company employees allegedly promoted Rapamune for indications which it is not approved to treat.
Rapamune is an immunosuppressive agent indicated for the prevention of organ rejection in kidney transplant patients. Marketed by Pfizer, Rapamune was approved by the FDA in 1999. Wyeth originally marketed the drug, but the company was bought by Pfizer in 2009.
Wyeth employees were accused of encouraging doctors to use Rapamune for off-label uses, such as prescribing this drug for other types of organ transplants. This type of marketing is illegal, and the U.S. Department of Justice became involved in the case after such actions became apparent. In a press release posted on July 30, the Department of Justice stated:
Wyeth trained its sales force to promote Rapamune for off-label uses not approved by the FDA, including ex-renal uses, and even paid bonuses to incentivize those sales. This was a systemic, corporate effort to seek profit over safety.
Pfizer underlined that this unlawful marketing was practiced prior to the company’s acquisition of Wyeth, and therefore Pfizer was not the target of these charges.
Rapamune (sirolimus) is an immunosuppressive agent indicated for the prevention of organ rejection in patients who receive kidney transplants. It is approved for patients 13 years of age and older. Rapamune was FDA approved on September 15, 1999 and is currently marketed by Pfizer.
Using FAERS data (from 11/01/1997 to 08/27/2012), aggregated and standardized by the AdverseEvent RxFilter process, we identified 6,631 serious adverse events which listed Rapamune as a suspect drug. Of these reports, 4,478 listed Rapamune as the primary suspect.
The most commonly reported side effects were kidney transplant rejection, blood creatinine increased, and pyrexia (fever). We identified 2,679 hospitalizations and 526 patient deaths where Rapamune was indicated as the primary suspect.