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U.S. Department of Health and Human Services

Safety

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Rapamune (sirolimus)

Audience: Transplantation surgeons and other healthcare professionals

Wyeth, in cooperation with FDA, notified healthcare professionals of post-marketing reports of bronchial anastomotic dehiscence, including fatal cases, in lung transplant patients treated with Rapamune in combination with tacrolimus and corticosteroids. The safety and efficacy of Rapamune as immunosuppressive therapy has not been established in lung transplant patients.

[February 2003 - Letter - Wyeth]