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The Marketed Health Products Directorate (MHPD), Therapeutic Products
Directorate (TPD) and Biologics and Genetic Therapies Directorate
(BGTD) post safety alerts, public health advisories, press releases
and other notices from industry as a service to health professionals,
consumers, and other interested parties. Although MHPD, TPD and
BGTD approve therapeutic products, MHPD, TPD and BGTD do not endorse
either the product or the company. Any questions regarding product
information should be discussed with your health professional.
This is duplicated text of a letter from Wyeth
Pharmaceuticals.
Contact the company for a copy of any references, attachments or
enclosures.
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Wyeth Pharmaceuticals  Scientific
Affairs
50 Minthorn Boulevard
Markham, Ontario
L3T 7Y2
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PUBLIC ADVISORY
Bronchial Problems Associated with Rapamune®
(sirolimus) |
May 9, 2003
Dear Patients:
SUBJECT: Important
drug safety information for lung transplant patients being treated with
Rapamune® (sirolimus)
Health Canada and Wyeth Pharmaceuticals are advising patients who are
lung transplant recipients of new safety information concerning the medication
Rapamune. Rapamune is approved in Canada for the prevention of organ rejection
in patients receiving kidney transplants, and it is recommended that Rapamune
be used in combination with other anti-rejection medications.
In consultation with Health Canada, Wyeth has recently informed all Canadian
transplant centers and transplant physicians of the following important
safety information regarding the use of Rapamune in lung transplant patients.
Wyeth has received reports of a medical complication, called bronchial
anastomotic dehiscence, that has occurred in certain lung transplant patients
treated with Rapamune in combination with other anti-rejection medications.
Bronchial anastomotic dehiscence is a breakdown of the surgically created
connections between the recipient's airways and the donated lung(s). In
four cases, this serious event resulted in death. None of the cases of
bronchial anastomotic dehiscence occurred in Canada.
Health Canada and Wyeth advise lung transplant recipients who are being
treated with Rapamune to consult their physicians, so that patients may
discuss with him/her their individual medical needs and considerations,
and the best treatment option for them. Patients are advised NOT to
discontinue their Rapamune medication without first consulting their
prescribing physician.
In addition to advising all transplant physicians and lung transplant
patients of this safety information, Wyeth is working with Health Canada
to ensure that the information is included in a revised Product Monograph
for Rapamune.
Sincerely,
original signed by
Neil Maresky, M.B., B.Ch.
Vice-President
Scientific Affairs
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Any suspected adverse reactions can also be reported to:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0201C2
OTTAWA, Ontario, K1A 1B9
Tel: (613) 957-0337 or Fax: (613) 957-0335
Toll free for consumers and health professionals:
Tel: 866 234-2345, Fax: 866 678-6789
cadrmp@hc-sc.gc.ca
The AR Reporting Form and the AR Guidelinescan be found on the TPD web site or in The Canadian
Compendium of Pharmaceuticals and Specialties.
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