Important Safety Information on KETEK^® (telithromycin) - sanofi-aventis Canada Inc.

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Contact: Marketed Health Products Directorate (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.
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Public Communication
Health Canada Endorsed Important Safety Information on
KETEK^® (telithromycin)

September 5, 2007

Dear Sir/Madam,

Subject: Updated Information on the antibiotic KETEK^® (telithromycin)

Sanofi-aventis Canada Inc., in consultation with Health Canada, would like to inform Canadian consumers of important new changes regarding the antibiotic KETEK^® (telithromycin).

Do not take the antibiotic KETEK^® 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^® should no longer be prescribed or used to treat bronchitis, sinusitis, tonsillitis/pharyngitis (sore throat). If you are prescribed KETEK^® for any of these conditions, ask your doctor about using other antibiotics instead.

KETEK^® can still be used to treat community-acquired pneumonia ("CAP"). Before taking KETEK^®, discuss the possible side effects with your doctor, such as liver injury, fainting and difficulty seeing properly.

You should not take KETEK^® 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^® or macrolide antibiotics (such as clarithromycin (Biaxin^®), azithromycin (Zithromax^TM) or erythromycin).

Complete product information will be available in the official Canadian Product Monograph for KETEK^® (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^® should be reported to sanofi-aventis Canada Inc. or Health Canada at the following addresses:

Sincerely,

Original signed by

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