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Image header Agence Europe
Europe Daily Bulletin No. 9400
Contents Publication in full By article 22 / 29
GENERAL NEWS / (eu)/medicines

03/04/2007 (Agence Europe) - The European Medicines Agency (EMEA) has recommended new restrictions on the use of Ketek by the laboratory Sanofi-Aventis. At the end of its meeting on 19-22 March, EMEA declared that in the indications for bronchitis, sinusitis and tonsillitis/pharyngitis, telithromycin should only be used for infections caused by bacterial strains that are suspected or proven to be resistant to or which cannot be treated with macrolide or beta-lactam antibiotics. These restrictions do not apply to the treatment of community-acquired pneumonia. The Agency's Committee for Medicinal Products for Human Use (CHMP) also recommended the contra-indication of the use of Ketek in patients with myasthenia gravis (chronic and rapid muscle weakness). The agency is supporting strengthened warnings on transient loss of consciousness and effects on vision. This drug has been subject to a comprehensive review since January 2006, following reports of severe liver injuries in patients.

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