The Pharmaceutical Journal
Vol 278 No 7446 p390
7 April 2007

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Telithromycin (Ketek)
• Summary of product characteristics (PDF 170K)
• Questions and answers on the review (PDF 40K)

EMEA orders revision of telithromycin indications

Telithromycin (Ketek; sanofi-aventis) should only be used to treat cases of bronchitis, sinusitis and tonsillitis/pharyngitis caused by bacterial strains that are suspected or proven to be resistant to macrolide and beta-lactam antibiotics, the European Medicines Agency (EMEA) has recommended, following a review by its Committee for Medicinal Products for Human Use (CHMP).

The CHMP began its review of the safety and effectiveness of telithromycin in January 2006, responding to reports of the drug causing serious liver impairment. The product’s summary of product characteristics was updated to include stronger warnings about severe liver reactions to the drug, and a contraindication for patients with a history of serious liver disorders. In January this year the CHMP requested further information from the manufacturer to undertake a safety assessment of its approved indications. The indication for telithromycin for the treatment of adults with mild to moderate community-acquired pneumonia remains unchanged.

The CHMP stipulates that warnings about visual effects and transient loss of consciousness associated with the drug should be strengthened and that telithromycin use be contraindicated for patients with myasthenia gravis.