PUBLIC COMMUNICATION - Health Canada Endorsed Important Safety Information on ENBREL(R) (etanercept)

    Subject: Risk of Histoplasmosis and Other Serious Fungal Infections
    Associated with ENBREL(R) (etanercept)

    TORONTO, April 23 /CNW/ - Amgen Canada, on behalf of Immunex, in
collaboration with Health Canada, wishes to inform the Canadian public of
updated safety information regarding ENBREL(R) (etanercept).
    ENBREL(R) is a medicine called a Tumor Necrosis Factor (TNF) blocker. It
is currently authorized in Canada for the treatment of rheumatoid arthritis,
psoriatic arthritis, juvenile idiopathic arthritis, ankylosing spondylitis and
plaque psoriasis. It is estimated that over 500,000 patients have been
administered ENBREL(R) worldwide.
    Amgen Canada would like to alert the public to the risk of invasive
fungal infections, including histoplasmosis, in patients taking TNF blockers,
including ENBREL(R). This is to help patients and their health care
professionals better recognize and treat these infections.

    -   There have been reports of patients developing serious fungal
        infections, such as histoplasmosis, coccidioidomycosis, and
        blastomycosis, in the lung and sometimes, spreading throughout the
        body (invasive fungal infection) while taking TNF blockers, such as
        Enbrel(R). In some patients, these types of fungal infections were
        not recognized at first, delaying treatment. Some of these patients
        died from invasive fungal infection.

    -   If you are taking a TNF blocker, you should tell your doctor if you
        develop symptoms, such as fever, tiredness, weight loss, sweats,
        cough, or difficulty in breathing. You should also tell your doctor
        if you live or work in, or have traveled to, areas where these
        infections are more common (See below).

    Serious fungal infections such as histoplasmosis are non-contagious
diseases caused by molds (fungus) usually found in the soil, or hay. Certain
invasive fungal infections including histoplasmosis are seen most frequently
in the central and eastern portions of the United States of America (U.S.A.)
and in the Saint Lawrence River valley in Canada. Coccidioidomycosis is
commonly found in the Southwestern portion of the U.S.A. The vast majority of
people infected with this fungus have either no symptoms or mild flu-like
symptoms that do not require medical attention, however, sometimes in people
with weakened immune systems, the fungus can spread through the body and be
fatal if untreated.
    Patients with questions regarding their current treatment are asked to
contact their doctor or pharmacist. The safety information in the Canadian
Product Monograph (CPM) for ENBREL(R), has been revised to highlight the risk
of invasive fungal infection, and a letter has been sent to Canadian
healthcare professionals to inform them of this update. A copy of that letter
can be found on the Health Canada website:
    The CPM can be found at the following link:
    Detection of adverse reactions related to marketed health products, such
as Enbrel(R), depends in part on reports received from health care
professionals and patients like you. The number of adverse events reported in
the post-marketing setting for a marketed health product is generally presumed
to underestimate the actual risk of that adverse event associated with the
marketed health product since many people fail to report such adverse events.
Any case of serious fungal infection or other serious or unexpected adverse
reactions in patients receiving ENBREL(R) should be reported to Amgen Canada
or Health Canada at the following addresses:

    Amgen Canada Inc. on behalf of Immunex Corporation
    6775 Financial Drive, Suite 100
    Mississauga, Ontario L5N 0A4
    Tel: (866) 512-6436; Fax: (888) 264-3655

    Any suspected adverse reaction can also be reported to:
    Canada Vigilance Program
    Marketed Health Products Directorate
    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

    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

    This advisory is in addition to a letter issued to healthcare
professionals discussing the above mentioned safety information. This letter
can be accessed at the Health Canada website at the following address:



    Andrew Vieira, MD
    Medical Director, Inflammation
    Amgen Canada

For further information:

For further information: For other inquiries related to this
communication, please contact Health Canada at: Marketed Health Products
Directorate (MHPD), E-mail:, Telephone: (613) 954-6522,
Fax: (613) 952-7738

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