Ketek

Ketek

Ketek has been linked to hepatitis and liver damage resulting in liver transplants and death.

Ketek or telithromycin tablets is a ketolide antibiotic.

Ketek has been used in infections of the lungs, sinus, and throat.

It also has adverse effects on the heart. If you have a disease called myasthenia gravis, Ketek may worsen your symptoms.

Serious side effects of Ketek are:

jaundice (yellowing of the skin and/or eyes)

redness, blistering, peeling or loosening of the skin, including inside the mouth

severe or watery diarrhea or persistent diarrhea

skin rash, itching

swelling of tongue or throat

difficult breathing

fainting spells

eye problems such as blurred vision, difficulty focusing, and objects doubled

vomiting

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.

If you or someone you know became seriously ill after being prescribed this antibiotic, please contact us