On June 11, 2009, the Food and Drug Administration (FDA) issued a warning to physicians and healthcare professionals about the use of Rapamune in liver transplant patients. Rapamune is an immunosuppressant medication intended to manage the symptoms of hemolytic-uremic syndrome (HUS) in kidney transplant patients. Many physicians also prescribe the medication to liver transplant patients, an off-label use not approved by the FDA.

The FDA warning follows a study conducted by Wyeth, the manufacturers of Rapamune, that discovered a link between Rapamune use in liver transplant patients and an increased risk of death.

Rapamune Side Effects - Diabetes and Death

Wyeth conducted a study comparing liver transplant patients taking more traditional calcineurin inhibitor (CNI)-based immunosuppressants to those taking Rapamune. The results concluded that the potential for liver rejection was "significantly higher" in those taking Rapamune.

Many Rapamune patients also experienced a number of adverse side effects, including:

• Mouth ulcerations
• Peripheral edema
• Rash
• Stomatitis

Although Rapamune already carries the FDA's sternest warning – the "black box" warning – the FDA is considering reevaluating the labeling requirements to further alert consumers.

In addition to potentially fatal side effects in liver transplant patients, Rapamune has been linked to an increased risk of diabetes in kidney transplant patients. In July 2008, the Journal of the American Society of Nephrology discovered that Rapamune increases the chance of diabetes by 36 percent in kidney transplant patients.

Rapamune Lawsuits

If you or someone you love has experienced damage because of Rapamune, you may be entitled to compensation. As a defective drug manufacturer, Wyeth is subject to strict product liability laws, and is held liable for the damage their products cause to consumers. The defective drug lawyers of Aylstock, Witkin, Kreis and Overholtz have vast experiencing in filing claims against defective drug manufacturers and will lend their expertise to your case. To learn more about filing a claim against Wyeth, contact their law office at (850) 202-1010.