FDA Advisory Committee Recommends New Limits and Warnings for Ketek
Two FDA advisory committees agreed on December 15, 2006, that the antibiotic Ketek (telithromycin) should have new black box warnings added to its label about several serious side effects which have been associated with it. "Black box" is the strongest warning the FDA can mandate. Further, the committees recommended that Ketek be limited to second-line therapy for community-acquired pneumonia only, rather than allowing it to be prescribed for acute bacterial bronchitis and acute bacterial sinusitis for which it's currently approved.
Continue reading "FDA Advisory Committee Recommends New Limits and Warnings for Ketek" »
