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New warning regarding RAPAMUNE® (sirolimus) and Bronchial Anastomotic Dehiscence including fatal cases by Wyeth Pharmaceuticals

Date: 2003-03-11

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MHPD_DPSC

Wyeth Pharmaceuticals
50, Minthora Boulevard
Markham, Ontario
L3T 7Y2
Scientific Affairs

IMPORTANT DRUG SAFETY INFORMATION

February 19, 2003

Dear Healthcare Provider:

SUBJECT:

New warning regarding RAPAMUNE® (sirolimus) and Bronchial Anastomotic Dehiscence including fatal cases by Wyeth Pharmaceuticals

Following discussions with Health Canada, Wyeth Pharmaceuticals wishes to inform you about important safety information regarding the off-label use of Rapamune® in de novo lung transplant patients.

The safety and efficacy of Rapamune in lung transplant patients as immunosuppressive therapy has not been established, and, therefore, such use is not recommended.

Wyeth has received post-marketing reports of bronchial anastomotic dehiscence, including fatal cases, in patients treated with Rapamune in combination with tacrolimus and corticosteroids. Two centers have reported this serious adverse event in lung transplant recipients in whom this immunosuppressive regimen was initiated at the time of transplantation. At one center, four of fifteen (4/15) patients enrolled in an investigator-sponsored study developed bronchial anastomotic dehiscence; a fatal outcome was identified in three of these four patients. The second center reported two cases of bronchial anastomotic dehiscence, one of which was fatal.

Rapamune is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal transplants. It is recommended that Rapamune be used in a regimen with cyclosporine and corticosteroids.

We are working with Health Canada to amend the prescribing information for Rapamune, to reflect this most recent safety information.

The identification, characterization, and management of drug-related adverse events are dependent on the active participation of healthcare professionals in adverse drug reaction reporting programmes. Reporting rates determined on the basis of spontaneously reported post-marketing adverse events are generally presumed to underestimate the risks associated with drug treatments.

Healthcare professionals are asked to report any suspected adverse reactions in patients receiving Rapamune to Wyeth or the Marketed Health Products Directorate at the following addresses:

Wyeth Medical Information & Pharmacovigilance
50 Minthorn Boulevard
MARKHAM, Ontario, L3T 7Y2
Tel: 1-800-461-8844
Fax: (905) 470-4385

Your professional commitment in this regard has an important role in protecting the well-being of your patients by contributing to early signal detection and informed drug use.

Please share this information with your colleagues involved in the care of transplant patients. Please contact Wyeth Medical Information at 1-800-461-8844 with any questions or concerns.

Sincerely,

original signed by

Neil Maresky, M.B., B.Ch.
Vice-President
Scientific Affairs