Archived - For the Public - Association of Trasylol (aprotinin) with hypersensitivity reactions and renal dysfunction - Bayer Inc.

Starting date:

March 27, 2007

Posting date:

March 30, 2007

Type of communication:

Public Communication

Subcategory:

Drugs

Source of recall:

Health Canada

Audience:

General Public

Identification number:

RA-19000611

This is duplicated text of a letter from Bayer Inc.
Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Public Communication
Health Canada Endorsed Important Safety Information on Trasylol^®

March 27, 2007

Subject: Association of Trasylol^® (aprotinin) with life-threatening allergic reactions and kidney problems

Bayer Inc. (Bayer), in consultation with Health Canada, has informed health care professionals of new safety information regarding the drug Trasylol^® (aprotinin). Trasylol^® is a drug injected during heart bypass surgery to help reduce bleeding and the need for blood transfusions.

• Trasylol^® should only be used in heart bypass surgery when the patient is at high risk of bleeding and needing a blood transfusion.
• Trasylol^® may cause life-threatening allergic reactions. Health care professionals have been advised that they should have the necessary medications and equipment on hand to deal with these reactions, including a heart-lung machine.
• Trasylol^® must not be used in any patients who have previously taken Trasylol^®, or any other product containing the drug aprotinin, within the last 12 months because of the increased risk of an allergic reaction.
• 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^®.

Although most allergic reactions following re-exposure to Trasylol^® have occurred within 12 months of the last exposure to this drug or any other product containing aprotinin, a few cases have occurred where the time interval was longer than 12 months. As a result, health care professionals have been advised that they must carefully assess the risks and benefits of using Trasylol^® in patients who have had any prior exposure to this drug or any other aprotinin-containing drug.

When kidney problems have occurred, most cases have been only detectable by blood tests and have resolved completely. However, some cases have progressed to kidney failure needing dialysis. The majority of kidney problems have occurred shortly after surgery while the patient was still hospitalized.

This advisory is in addition to a letter issued to health care professionals concerning this information. The letter can be accessed at Bayer's website via the following link: www.bayerhealth.com. In addition, the letter can be found at Health Canada's website.

The Canadian prescribing information for Trasylol^® has been updated to include new information in the Contraindications, Warnings and Precautions, and Adverse Reaction sections. In addition, Consumer Information for Trasylol^® in the Canadian prescribing information has been updated with new safety information. The prescribing information is available on the Bayer website via the following link: www.bayerhealth.com.

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. Reporting rates determined on the basis of spontaneously reported postmarketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. 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

Any suspected adverse incident can also be reported to:
Any suspected adverse reaction can also be reported to:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
Health Canada
Address Locator: 0701C
Ottawa, Ontario, K1A 0K9
Tel: (613) 957-0337 or Fax: (613) 957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
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 Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.

For other inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate (MHPD)
E-mail: MHPD_DPSC@hc-sc.gc.ca
Tel: (613) 954-6522
Fax: (613) 952-7738

Sincerely,

original signed by

Shurjeel H. Choudhri, MD, FRCPC
Head, Medical & Scientific Affairs
Bayer Inc.