Sinusitis: February 2007 Archives

FDA: New Limits to Ketek Use

ketekFebruary 13, 2007 — Multiple label revisions for telithromycin (Ketek tablets, made by Sanofi-Aventis) include removal of its approval for 2 of its 3 indications, according to the US Food and Drug Administration (FDA).

The risks of telithromycin for the treatment of acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis have been found to outweigh the benefits, the FDA said in an alert sent yesterday from MedWatch, the FDA's safety information and adverse event reporting program.

Other label changes include a boxed warning stating that use of telithromycin is contraindicated in patients with myasthenia gravis, and a strengthened warning section regarding the risk for adverse events such as visual disturbances and loss of consciousness; the risk for hepatotoxicity was previously emphasized in June 2006.