Warning Issued Against Use of Rapamune for Lung Transplant Recipients

A warning has been issued against the use of the immunosuppressive drug Rapamune for lung transplant recipients following reports of at least four deaths from bronchial anastomotic dehiscence, according to the U.S. Food and Drug Administration.

"The safety and efficacy of Rapamune as immunosuppressive therapy has not been established in lung transplant patients, and, therefore, such use is not recommended," the drug's manufacturer Wyeth said in a safety alert posted on the FDA's MedWatch website.

In a letter sent to doctors, Wyeth said four of the 15 lung transplant recipients that were placed on Rapamune in combination with Prograf and steroids at one unidentified medical center developed bronchial anastomotic dehiscence, and three of the four died.

It said a second unidentified center reported two cases of bronchial anastomotic dehiscence among lung transplant patients on the same combination of immunosuppressive medications, and one of the two died.

Wyeth said further information about the cases will be published in the journal Transplantation in the near future.

Other Sources: MedWatch