Rapamune Side Effects Prompt FDA Investigation
Rapamune users have been advised to consult with their physician following reports linking the immunosuppressant with serious adverse effects, including diabetes and death. The Food and Drug Administration (FDA) issued the warning on June 11, 2009, in response to a recent study conducted by Rapamune manufacturer Wyeth pharmaceuticals.
Rapamune, or sirolimus, is FDA approved for the management of hemolytic-uremic syndrome (HUS) following kidney transplantation. Patients suffering from HUS who are faced with kidney transplantation may be prescribed Rapamune to prevent recurrence of the serious condition. In addition, many doctors prescribe the drug to patients receiving a liver transplant. This off-label use of Rapamune, an anti-organ transplant rejection drug, has been linked with an increased risk of death, spurring an FDA investigation.
Liver transplant patients prescribed Rapamune to prevent donor organ rejection face an increased risk of death according to a study conducted by Wyeth. Results suggest that the potential for liver rejection is “significantly higher” in patients treated with Rapamune versus those with a more traditional calcineurin inhibitor (CNI)-based immunosuppressant.
According to the study, more liver transplant patients were forced to discontinue use of Rapamune due to adverse effects compared with those receiving CNI treatment. The FDA is evaluating whether to further adjust the labeling requirements for Rapamune, which already carries a “black box” warning, the most serious leveled by the federal agency.
In addition to liver rejection, the Wyeth study also highlighted frequent Rapamune side effects that include:
- Peripheral edema
- Mouth ulcerations
The FDA advises against the use of Rapamune immediately after liver transplantation. Patients prescribed Rapamune should consult with their physician for further information before discontinuing use.
Rapamune and Diabetes
A July 2008 study published in the Journal of the American Society of Nephrology linked Rapamune with an increased risk of diabetes. According to the study, the side effects caused by Rapamune use increases the likelihood of diabetes by 36 percent.
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 Pensacola personal injury attorneys of Aylstock, Witkin Kreis & Overholtz handle national litigation across the United States for victims injured by defective pharmaceuticals and medical devices. Contact AWKO Law today at 844-794-7402 to learn more about your rights as a Rapamune injury victim.