Public communication - Health Canada Endorsed Important Safety Information on KETEK(R) (telithromycin)

    UPDATED INFORMATION on the antibiotic KETEK(R) (telithromycin)

    LAVAL, QC, Sept. 5 /CNW Telbec/ - Sanofi-aventis Canada Inc., in
consultation with Health Canada, would like to inform Canadian consumers of
important new changes regarding the antibiotic KETEK(R) (telithromycin).

    Do not take the antibiotic KETEK(R) to treat bronchitis, sinusitis,
    tonsillitis or pharyngitis (sore throat).

    Upon review of the available safety information, including reported cases
of severe liver problems, Health Canada has determined that the antibiotic
KETEK(R) should no longer be prescribed or used to treat bronchitis,
sinusitis, tonsillitis/pharyngitis (sore throat). If you are prescribed
KETEK(R) for any of these conditions, ask your doctor about using other
antibiotics instead.
    KETEK(R) can still be used to treat community-acquired pneumonia ("CAP").
Before taking KETEK(R), discuss the possible side effects with your doctor,
such as liver injury, fainting and difficulty seeing properly.
    You should not take KETEK(R) if you have myasthenia gravis (a disease
involving muscle weakness) or if you have had jaundice, hepatitis, or other
signs of liver injury while or after taking KETEK(R) or macrolide antibiotics
(such as clarithromycin (Biaxin(R)), azithromycin (Zithromax(TM)) or
    Complete product information will be available in the official Canadian
Product Monograph for KETEK(R) (see Part III: CONSUMER INFORMATION). The
revised Product Monograph will be posted at as soon as
it is available.
    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 case of serious liver-related problems,
exacerbations of myasthenia gravis, visual disturbances, fainting or other
serious or unexpected adverse reactions in patients receiving KETEK(R) should
be reported to sanofi-aventis Canada Inc. or Health Canada at the following

    Any suspected adverse reaction can be reported to:
    sanofi-aventis Canada Inc.:
    Toll-free telephone: 1-800-265-7927

    Regular mail:
    sanofi-aventis Canada Inc.
    2150 St. Elzear Blvd. West
    Laval, Quebec
    H7L 4A8

    Any suspected adverse reaction can also be reported to:
    Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
    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


    original signed by

    Franca Mancino, M. Sc.
    Senior Director, Regulatory Affairs & Pharmacovigilance
    sanofi-aventis Canada Inc.

For further information:

For further information: Health Canada: Marketed Health Products
Directorate (MHPD),, (613) 954-6522, Fax: (613)

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