Public Communication - Health Canada Endorsed Safety Information on AVASTIN(R) (bevacizumab)



    Subject: Association of AVASTIN(R) (bevacizumab) with
    tracheo-esophageal fistulas

    TORONTO, June 12 /CNW/ - Hoffmann-La Roche Limited, in consultation with
Health Canada, has informed Canadian healthcare professionals of important new
safety information concerning AVASTIN (bevacizumab).
    AVASTIN is used in combination with a specific type of chemotherapy for
the treatment of cancer of the bowel and rectum which has spread to other
sites. Please note the following new safety information for the use of
AVASTIN:

    Tracheo-esophageal Fistulas
    ---------------------------

    Tracheo-esophageal fistula is an abnormal connection in one or more
places between the esophagus (the tube that leads from the throat to the
stomach) and the trachea (the tube that leads from the throat to the lungs,
also known as the windpipe). Normally, the esophagus and the trachea are two
separate tubes that are not connected. Tracheo-esophageal fistula is also
known as TE fistula.
    In a clinical trial conducted by a physician in the U.S. using AVASTIN in
combination with chemotherapy and radiation in patients with small cell lung
cancer, a total of two (2) confirmed cases of TE fistulas have been reported.
One (1) of these cases resulted in death. A third case that resulted in death
was also reported, in which TE fistula was suspected but not confirmed. TE
fistulas have also been reported in patients using AVASTIN to treat other
types of lung cancer and cancer of the esophagus. A direct cause and effect
between AVASTIN and these events has not been established, but cannot be ruled
out. AVASTIN should no longer be given to patients who develop a TE fistula.
    In Canada, AVASTIN is not authorized for use in lung cancer or in
combination with radiation for any other cancer.
    Hoffmann-La Roche Limited has sent a letter to healthcare professionals
informing them of this new safety information. A copy of the healthcare
professional letter and this communication are available on the Health Canada
website
(http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/2007/index_e.html
).
    The prescribing information for AVASTIN will be revised to include more
information on the association of AVASTIN with fistulas.

    
    Some examples of signs and symptoms of TE fistula are:
        -  Chest pain, shortness of breath, wheezing or labored breathing.
        -  Coughing or choking when eating or drinking.
        -  Coughing up food or liquids.
        -  Wheezing sounds following every breath.
    

    If you develop any of the above or any other unusual signs or symptoms,
please contact your doctor or healthcare professional immediately.
    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 post-marketing adverse
reactions are generally presumed to underestimate the risks associated with
health product treatments. Any serious or unexpected adverse reactions in
patients receiving AVASTIN should be reported to Hoffmann-La Roche Limited, or
Health Canada at the following addresses:

    -----------------------------------------------------------------------
    Hoffmann-La Roche Limited
    Drug Safety Department
    2455 Meadowpine Boulevard
    Mississauga, ON L5N 6L7
    or call toll-free at 1-888-762-4388
    or Fax at: 905-542-5864
    or email to: mississauga.drug_safety@roche.com

    Any suspected adverse incident 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.

    http://hc-sc.gc.ca/dhp-mps/medeff/report-declaration/form/ar-ei_form_e.ht
ml
    http://hc-sc.gc.ca/dhp-mps/medeff/report-declaration/guide/ar-ei_guide-
ldir_e.html
    -------------------------------------------------------------------------

    Sincerely,

    (signed)

    Lorenzo Biondi,
    Vice President, Medical and Regulatory Affairs
    Hoffmann-La Roche Limited





For further information:

For further information: 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


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