FDA Panel Urges Limits on Telithromycin (KETEK)
The FDA advisory panel has concluded that telithromycin (KETEK) should not be sold to patients with sinusitis or bronchitis. It could still be used for mild to moderate pneumonia.
FDA panel backs limiting telithromycin (KETEK) uses
Telithromycin (KETEK) is approved for acute bacterial bronchitis and acute bacterial sinusitis as well as for community-acquired pneumonia. In June 2006, the FDA changed its label to add a warning about hepatoxicity following four reported deaths and one live transplant. After reviewing information about liver failure, blurred vision, loss of consciousness and other problems reported in some users, the FDA panel said that telithromycin (KETEK) should be limited to treatment in the mild to moderate community acquired pneumonia (CAP). The panel members voted 17-2 against allowing the manufacturer of telithromycin (KETEK) to keep promoting the drug for acute exacerbation of chronic bronchitis (AECB) and acute bacterial sinusitis. The 13 panel members also indicated they favored adding a black box warning on its label. The FDA will make the final decision, but the agency usually takes the advice of its advisory panels.
For additional information regarding the Joint Meeting of the Anti-Infective Drug Advisory Committee and the Drug Safety and Risk Management Advisory Committee, please visit the FDA Website.
Source : http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4266b1-00-index.htm