EMEA restricts use of Sanofi-Aventis' Ketek

The European Medicines Agency (EMEA) has recommended restrictions on the use of French drug major Sanofi-Aventis' Ketek (telithromycin) in three of its four approved indications. For the treatment of bronchitis, sinusitis and tonsillitis/pharyngitis, the drug should only be used for infections caused by bacterial strains that are suspected or proven to be resistant to or cannot be treated with macrolide or beta-lactam antibiotics, the EMEA noted, but did not recommend restrictions for the remaining indication: the treatment of community-acquired pneumonia.

The Agency's Committee for Medicinal Products for Human Use (CHMP) also recommended the contraindication of the use of Ketek 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 after reports of severe liver toxicity emerged last year (Marketletter July 10, 2006).

As part of the CHMP review, several updates relating to the safety of Ketek were made to the Product Information during 2006. 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. However, its use is associated with a greater risk of certain side effects, some of which may be serious. These include a worsening of myasthenia gravis (which can be life-threatening), transient loss of consciousness and temporary visual disturbances. The Committee concluded that the benefits of Ketek continue to outweigh its risks in the treatment of the three restricted indications, if used in accordance with the updated product information.