Public Communication - Health Canada Endorsed Important Safety Information on Ketek(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).

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     Do not take the antibiotic KETEK(R) to treat bronchitis, sinusitis,
     tonsillitis or pharyngitis (sore throat).
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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
erythromycin).
    
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 www.sanofi-aventis.ca 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
addresses:

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

     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
     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://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_guide-ldir_e.html
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     Sincerely,

     original signed by

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

 

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/For further information: Health Canada: Marketed Health Products
Directorate (MHPD), MHPD_DPSC@hc-sc.gc.ca, (613) 954-6522, Fax: (613)
952-7738/


 

Posted: September 2007


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