Safety profile of oral and intravenous moxifloxacin: cumulative data from clinical trials and postmarketing studies

Clinical Therapeutics
Peter BallRobert Owens

Abstract

The established safety profile of the fluoroquinolones has been disrupted in the past decade by the detection of low-frequency but potentially serious adverse events that have led to the license suspension, voluntary withdrawal, or restricted use of specific members of the class. Moxifloxacin is a broad-spectrum, advanced-generation fluoroquinolone that has potent activity against respiratory tract infections in adults in both oral and IV formulations. The goal of this article was to provide an overview of the cumulative safety data on both oral and IV moxifloxacin, including data from the most recent clinical trials and postmarketing studies. Data from clinical trials of moxifloxacin were captured from an electronic database maintained by the manufacturer. Safety data for oral moxifloxacin were obtained from 30 Phase II/III comparator studies (n = 7,368 moxifloxacin, n = 5,687 comparators), 1 Phase IV study (n = 18,374), and 4 postmarketing observational studies (n = 27,756). Safety data for IV moxifloxacin were obtained from 2 Phase III comparator studies (n = 550 maxifloxacin, n = 579 comparators). In addition, pharmacokinetic data were reviewed. In Phase II/III comparator studies, gastrointestinal complaints were the most c...Continue Reading

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