Aventis’ proposed Ketek labeling
Executive Summary
Aventis is adding a precaution to its proposed labeling for Ketek (telithromycin) following reports of exacerbation of symptoms in patients already diagnosed with myasthenia gravis being treated with the antibiotic. The company is responding to FDA requests for "additional analyses and information" outlined in the agency's Jan. 24 "approvable" letter for Ketek (1"The Pink Sheet" Feb. 10, In Brief). Ten cases of exacerbated myasthenia gravis have been reported; Aventis is also sending "Dear Healthcare Professional" letters...