Health Canada
www.hc-sc.gc.ca
Common menu bar links
Important Safety Information on KETEK (telithromycin) - For Health Professionals
Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.
(PDF Version - 1445 K)Contact MHPD
The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.
This is duplicated text of a letter from sanofi-aventis Canada Inc.
Contact the company for a copy of any references, attachments or enclosures.
August 30, 2007
Dear Health Care Professional:
Subject: REMOVAL OF SINUSITIS, BRONCHITIS AND TONSILLITIS/PHARYNGITIS INDICATIONS FOR KETEK® (telithromycin)
Sanofi-aventis Canada Inc., in consultation with Health Canada, would like to inform you of changes important to the prescribing of KETEK® (telithromycin).
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® 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:
2150 St. Elzear Blvd. West
Laval, Quebec
H7L 4A8
Toll-free telephone: 1-800-265-7927
Internet:
www.sanofi-aventis.caAny 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.
For other inquiries 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
Sincerely,
original signed by
Franca Mancino, M. Sc.
Senior Director, Regulatory Affairs & Pharmacovigilance
sanofi-aventis Canada Inc.
