Important Safety Information on KETEK (telithromycin) - For Health Professionals

Starting date:

August 30, 2007

Posting date:

September 5, 2007

Type of communication:

Dear Healthcare Professional Letter

Subcategory:

Drugs

Source of recall:

Health Canada

Audience:

Healthcare Professionals

Identification number:

RA-170001635

This is duplicated text of a letter from sanofi-aventis Canada Inc.

Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Health Canada Endorsed Important Safety Information on KETEK (telithromycin)

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).

KETEK^® is no longer approved for the treatment of bronchitis, sinusitis or tonsillitis/pharyngitis.

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:

sanofi-aventis Canada Inc.

2150 St. Elzear Blvd. West

Laval, Quebec

H7L 4A8

Toll-free telephone: 1-800-265-7927

Internet: www.sanofi-aventis.ca

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.

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.