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Trasylol (aprotinin) - Important New Safety Information - For the Public
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(PDF Version - 24 K)Contact: Marketed Health Products Directorate
The Health Products and Food Branch (HPFB) posts on the Health Canada Web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we 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 Bayer Inc.
Contact the company for a copy of any references, attachments or enclosures.
PUBLIC COMMUNICATION
Health Canada Endorsed Important Safety Information on TRASYLOL
September 21, 2011
Subject: Important new safety update to the TRASYLOL® Product Monograph
Bayer is pleased to announce that the temporary market authorization suspension of TRASYLOL® (aprotinin) is lifted effective immediately. In November 2007, Bayer, after consultation with Health Canada, announced the temporary suspension of marketing for TRASYLOL® due to safety concerns based on a study. TRASYLOL® was later made available through a limited access program.
TRASYLOL® is a drug injected during heart bypass surgery to help reduce bleeding and the need for blood transfusions. Bayer, in consultation with Health Canada, has informed health care professionals of new safety information regarding TRASYLOL®.
- An association between TRASYLOL® use and increased mortality has been reported in some studies. TRASYLOL® should only be used as authorized in heart bypass surgery, after careful consideration of the potential risks and benefits.
- TRASYLOL® can affect certain laboratory tests for blood clotting. In patients who receive TRASYLOL® during heart bypass surgery, specific methods are recommended to monitor blood clotting. These recommendations need to be followed to ensure an adequate amount of medication designed to limit clotting (sometimes called "blood thinners") is administered during treatment with TRASYLOL®.
- The use of TRASYLOL® may lead to kidney problems and there may be a need for dialysis after surgery. Patients who may already have kidney problems, or receive other drugs during surgery that can harm the kidney, are at higher risk of developing kidney problems when given TRASYLOL®.
An association between TRASYLOL® use and increased mortality has been reported in some studies, but not in other studies. TRASYLOL® was usually administered to patients who were already at a greater risk of death compared to those who did not receive TRASYLOL®. In a clinical trial, TRASYLOL® prolonged certain blood clotting tests used to check if the right amount of medication designed to limit clotting (sometimes called "blood thinners") is used. This may affect the management of blood clotting during surgery.
The use of TRASYLOL® has also been associated with abnormal blood tests of kidney problems. Most cases have resolved completely, but some have progressed to kidney failure needing dialysis. It has not been established that TRASYLOL® caused or contributed to the need for dialysis in these cases. The majority of kidney problems have occurred shortly after surgery while the patient was still hospitalized.
The Canadian prescribing information for TRASYLOL® has been updated to include new information in the Warnings and Precautions, and Adverse Reaction sections. In addition, Consumer Information for TRASYLOL® in the Canadian prescribing information has also been updated with new safety information. The prescribing information is available on the 
Bayer website.
In addition to this advisory, a letter is being issued to health care professionals concerning this information. A copy of the letter can be accessed at Bayer website. In addition, the letter can also be found at Health Canada's website For Health Professionals - 2011. The Canadian prescribing information for TRASYLOL® is available on the Bayer website.
Bayer Inc. continues to actively review information pertaining to the use of TRASYLOL® and has requested that health care professionals closely monitor patients following TRASYLOL® administration and report any serious adverse events to Bayer Inc.
Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Any case of serious and/or unexpected adverse reactions in patients receiving TRASYLOL® should be reported to Bayer Inc. or Health Canada at the following addresses:
Bayer Inc.
77 Belfield Road
Toronto, Ontario M9W 1G6
Tel: 1-800-265-7382
Fax: 1-866-232-0565
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at MedEffect™ Canada
- Call toll-free at 1-866-234-2345
- Complete a Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Health Canada
Postal Locator 0701E
K1A 0K9
The Reporting Forms, postage paid labels, and Guidelines can be found on the MedEffectTM Canada Web site in the Adverse Reaction and Medical Device Problem Reporting section.
For other health product inquiries related to this communication, please contact Health Canada at:Marketed Health Products Directorate
E-mail: mhpd_dpsc@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738
Sincerely,
original signed by
Shurjeel H. Choudhri, MD, FRCPC
Senior Vice President and Head, Medical & Scientific Affairs
Bayer Inc.
