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Archived – Bronchial Problems Associated with Rapamune® (Sirolimus) – For the Public
- Starting date:
- May 9, 2003
- Posting date:
- June 5, 2004
- Type of communication:
- Public Communication
- Subcategory:
- Drugs
- Source of recall:
- Health Canada
- Issue:
- Important Safety Information
- Audience:
- General Public
- Identification number:
- RA-1900095
This is duplicated text of a letter from Wyeth Pharmaceuticals.
Contact the company for a copy of any references, attachments or enclosures.
Notice about Health Canada advisories
Wyeth Pharmaceuticals
Scientific Affairs
50 Minthorn Boulevard
Markham, Ontario
L3T 7Y2
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
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 Guidelines can be found on the TPD web site or in The Canadian Compendium of Pharmaceuticals and Specialties.