Healthcare Industry News:  sanofi-aventis 

Biopharmaceuticals

 News Release - October 4, 2006

Important safety information about KETEK (telithromycin)

LAVAL, QC, Oct. 4 (Healthcare Sales & Marketing Network) - sanofi-aventis Canada Inc., in consultation with Health Canada, has provided new safety information regarding the antibiotic, KETEK (telithromycin) tablets to healthcare professionals through a Dear Doctor letter and to Canadian consumers via a public information notice (available on the Health Canada website: http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/index_e.html). The following information was obtained from worldwide reports of side effects received from health care professionals and consumers. Some patients have experienced liver problems during or following treatment with Ketek. Rare cases of severe liver injury have been reported and have, in isolated cases, resulted in death. In patients with myasthenia gravis (a neuromuscular disease), reports have also included a sudden worsening of symptoms and life-threatening breathing trouble and death. Fainting has also been reported in some patients taking Ketek.

Before using Ketek, patients should discuss with their doctor if they have liver disease or a past history of liver disease or have ever had jaundice while taking KETEK, myasthenia gravis, or the experience of fainting after taking any medication. It should not be used if patients have ever had an allergic reaction to Ketek or to any macrolide-type of antibiotic. To minimize potential adverse reactions, Ketek should always be taken per approved indications, in accordance with prescribing information, and not used when contraindicated.

Patients experiencing side effects with Ketek, or any medication, should consult a health professional and are encouraged to report these experiences to the manufacturer of the product or to Health Canada.

Ketek has been available in Canada since 2003 and is used for the treatment of some types of pneumonia, exacerbation of chronic bronchitis, throat infections and sinus infections. Patients who have been prescribed Ketek and are not suffering side effects should continue taking their medicine, unless otherwise directed by their health care provider.

For further information

Joelle Sissmann, Sanofi aventis Canada Inc., (514) 904-2667, (877) 904-2667


Source: sanofi-aventis

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