EMEA Strengthens Warnings for Ketek

The European Medicines Agency (EMEA) has recommended restrictions on the use of sanofi-aventis' antibiotic Ketek for three of its four approved indications. For the treatment of bronchitis, sinusitis and tonsillitis, Ketek should only be used for infections caused by bacterial strains that are resistant to or cannot be treated with macrolide or beta-lactam antibiotics. No such restrictions are recommended for the other indication, community-acquired pneumonia.

The EMEA's Committee for Medicinal Products for Human Use (CHMP) also recommended the contraindication of the use of Ketek (telithromycin) in patients with myasthenia gravis and strengthened warnings on transient loss of consciousness and effects on vision. The CHMP has been carrying out a comprehensive review of the safety and effectiveness of Ketek since January 2006 following reports of severe liver injuries.

As part of this review several updates relating to the safety of Ketek were made to the product information last year. These included strengthening the warnings on serious liver reactions and contraindicating the use of the medicine in patients with a previous history of serious liver disorders.

In January 2007 the CHMP requested updated information from the marketing authorization holder for Ketek to allow a comprehensive assessment of the benefits and risks in each of the medicine's approved indications. The committee finalized the review at its March meeting, concluding that the effectiveness of Ketek has been demonstrated in the approved indications. The committee concluded that the benefits of Ketek continue to outweigh its risks if used in accordance with the updated product information.