title: Preclinical safety evaluation of moxifloxacin, a novel fluoroquinolone.
abstract: The toxicity of moxifloxacin (BAY 12-8039), a novel fluoroquinolone with a broad spectrum of antibacterial activity, was evaluated in a comprehensive programme of toxicological studies that included single and multiple dose toxicity studies in rats, mice, dogs and monkeys, reproductive system toxicity studies in rats and monkeys and in-vitro and in-vivo mutagenicity assays. Although moxifloxacin is not intended for long-term clinical use, an accelerated bioassay in target organs to assess carcinogenesis was performed in rats. In addition to the routine toxicological programme required for the development of a drug intended for short-term administration, a major part of the preclinical programme for moxifloxacin comprised studies designed specifically to address the safety issues known to be features of fluoroquinolones, i.e. adverse effects on the central nervous and cardiovascular systems, phototoxicity, arthrotoxicity and oculotoxicity. The results of the toxicological investigations confirmed that the safety profile of moxifloxacin is comparable to those of other fluoroquinolones.
authors.affiliation: Institute of Toxicology, PH-Product Development, Bayer AG, Wuppertal, Germany.
authors.forename: E
authors.initials: E
authors.lastname: von Keutz
authors.forename: G
authors.initials: G
authors.lastname: Schlüter
mesh_terms: D000818:Animals; D000890:Anti-Infective Agents / Q000009:adverse effects*; D001372:Aza Compounds; D004285:Dogs; D005069:Evaluation Studies as Topic; D024841:Fluoroquinolones; D008252:Macaca fascicularis; D051379:Mice; D000077266:Moxifloxacin; D009152:Mutagenicity Tests; D011804:Quinolines; D051381:Rats
chemical_list: D000890:Anti-Infective Agents; D001372:Aza Compounds; D024841:Fluoroquinolones; D011804:Quinolines; D000077266:Moxifloxacin