| News From Transplant Week of April 28, 2002 / Vol. 3 No. 17 |
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Wyeth Warns Against Using Rapamune With Liver Transplant Recipients |
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The U.S. Food and Drug Administration has alerted doctors that Wyeth has warned transplant surgeons and physicians against using its anti-rejection drug, Rapamune (sirolimus), to treat liver transplant recipients. The FDA posted on MedWatch a letter Wyeth sent on April 24th to members of the American Society of Transplantation and the American Society of Transplant Surgeons alerting them that the drug, approved for kidney transplant patients, now contains a black box warning on its label that it is not recommended for liver transplant patients. "The safety and efficacy of Rapamune as immunosuppressive therapy has not been established in liver transplant patients, and therefore, such use is not recommended,'' the warning states. Studies found that Rapamune -- when used in combination with the two principal transplant immunosuppressive drugs, cyclosporine and tacrolimus -- was linked to an increase in cases of hepatic artery thrombosis, a blood clot in the vessels that lead to the liver. Wyeth said it suspended enrollment in a clinical trial of Rapamune in combination with tacrolimus in liver transplant patients after six out of 110 patients developed hepatic artery thrombosis. "As of April 10, 2002, based on additional information, we have learned that the use of sirolimus plus tacrolimus was associated with an excess rate of death and graft loss in a transplant study," Wyeth said. The company said a previous trial in which Rapamune was used in combination with cyclosporine "revealed an excess of hepatic artery thrombosis in patients on the combination regimen." Other sources: Wyeth |
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