The safety profile of the fluoroquinolones

Background: Premarketing trials showed the fluoroquinolone agents to have a favorable side-effect profile, with treatment-related adverse events compr ising gastrointestinal, central nervous system, and dermatologic effects th at were generally mild and reversible on cessation of treatment. However, p ostmarketing surveillance studies have identified severe adverse events, in cluding severe anaphylaxis, QTc-interval prolongation, and potential cardio toxicity, associated with 3 quinolone agents that either resulted in the re moval of the agent from the market (temafloxacin and grepafloxacin) or sign ificantly restricted its use due to substantial mortality and morbidity ass ociated with liver toxicity (trovafloxacin), To date, there have been no su ch significant adverse events associated with the older fluoroquinolone age nts, including ciprofloxacin, ofloxacin, norfloxacin, and levofloxacin, How ever, there are fewer data from postmarketing surveillance studies on the m ost recently approved agents, such as moxifloxacin and gatifloxacin, or age nts awaiting approval, such as gemifloxacin. Objective: This paper examines safety data from the premarketing trials and postmarketing surveillance studies of fluoroquinolones available in the Un ited States. Methods: A MEDLINE(R) search was performed to identify all English-language studies published since 1980 concerning the safely profiles of the fluoroq uinolones. Conclusion: The fluoroquinolone antibacterial agents offer broad-spectrum t herapy in patients with a variety of infections. Given similar spectra of a ctivity, the choice between quinolones may be based on differences in effic acy and safety or tolerability profiles. Most drug reactions involving thes e agents are minor and reversible on discontinuing treatment, but adverse e ffects can be associated with significant mortality and morbidity, as was s een in the case of trovafloxacin and temafloxacin.