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| |  Ketek (telithromycin) No Longer Approved in Canada for Treatment of Bronchitis, Sinusitis or Tonsillitis/Pharyngitis OTTAWA, CANADA -- September 5, 2007 -- Upon review of the available safety information, including reported cases of severe liver injury, Health Canada has determined that the benefit-risk profile for Ketek® (telithromycin) no longer supports its use for the treatment of acute exacerbation of chronic bronchitis (AECB), acute bacterial sinusitis (ABS) or tonsillitis/pharyngitis. These indications will be removed from the label. Ketek® continues to be indicated only for the treatment of community-acquired pneumonia (CAP) of mild to moderate severity due to Streptococcus pneumoniae, (including multi-drug resistant isolates [MDRSP]), Haemophilus influenzae, Moraxella catarrhalis, Chlamydophila (Chlamydia) pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, and Staphylococcus aureus for patients 18 years old and older. Complete product information will be available in a revised version of the official Canadian Product Monograph. Revisions will include new contraindications against the use of Ketek® for patients with myasthenia gravis, or with a history of hepatitis and/or jaundice associated with any macrolide antibiotic. Labelling will also be strengthened regarding hepatotoxicity, visual disturbances and loss of consciousness. 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 hepatic events, exacerbations of myasthenia gravis, visual disturbances, syncope or other serious or unexpected adverse reactions in patients receiving Ketek® should be reported to sanofi-aventis Canada Inc. or Health Canada at the following addresses: sanofi-aventis Canada Inc. Any suspected adverse reaction can also be reported to: 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. For other inquiries related to this communication, please contact Health Canada at:
SOURCE: Health Canada
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