Bayer HealthCare - Public Communication - Health Canada Endorsed Important Safety Information on TRASYLOL(R)

Subject:  Association of Trasylol(R) (aprotinin) with life-threatening
              allergic reactions and kidney problemsTORONTO, March 30 /CNW/ - Bayer Inc. (Bayer), in consultation with Health
Canada, has informed health care professionals of new safety information
regarding the drug Trasylol(R) (aprotinin). Trasylol(R) is a drug injected
during heart bypass surgery to help reduce bleeding and the need for blood
transfusions.-   Trasylol(R) should only be used in heart bypass surgery when the
        patient is at high risk of bleeding and needing a blood transfusion.

    -   Trasylol(R) 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(R) must not be used in any patients who have previously
        taken Trasylol(R), 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(R) 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(R).Although most allergic reactions following re-exposure to Trasylol(R)
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(R) 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 via the following link:
http://www.hc-sc.gc.ca/dhp- mps/medeff/advisories-avis/prof/2007/index_e.html.
    The Canadian prescribing information for Trasylol(R) has been updated to
include new information in the Contraindications, Warnings and Precautions,
and Adverse Reaction sections. In addition, Consumer Information for
Trasylol(R) 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 continues to actively review information pertaining to the use of
Trasylol(R) and has requested that health care professionals closely monitor
patients following Trasylol(R) administration and report any serious adverse
events to Bayer.
    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(R) should be reported to Bayer or
Health Canada at the following addresses:

    -------------------------------------------------------------------------
    Bayer Inc.
    77 Belfield Road
    Toronto, Ontario M9W 1G6
    Tel: [phone]
    Fax: [phone]

    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: [phone] or Fax: [phone]
    To report an Adverse Reaction, consumers and health
    professionals may call toll free:
    Tel: [phone]
    Fax: [phone]
    [e-mail]

    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.

    http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/form/ar-ei_form_
e.html
    http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/guide/ar-ei_guid
e-ldir_e.html
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    Sincerely,

    "signed"

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

For further information: For other inquiries related to this
communication, please contact Health Canada at: Marketed Health Products
Directorate (MHPD), E-mail: [e-mail], Tel: [phone], Fax:
[phone]