Health
FDA scraps 2 uses for telithromycin
NEWS IN BRIEF — Posted March 5, 2007
The antibiotic telithromycin, Ketek, no longer has Food and Drug Administration approval to treat sinusitis or exacerbations of chronic bronchitis linked to acute bacterial infection, according to statements issued Feb. 12 by the agency and the drug's manufacturer, Sanofi-Aventis.
The agency took this action because of data linking the drug to liver problems, loss of consciousness and visual disturbances that shift the risk-benefit balance against using it to treat these conditions.
This medication is still approved for mild to moderate community-acquired pneumonia but will have a new black-box warning and a patient medication guide.
Note: This item originally appeared at http://www.ama-assn.org/amednews/2007/03/05/hlbf0305.htm.