Drug Safety

, Volume 32, Issue 5, pp 359–378 | Cite as

Safety Profile of the Respiratory Fluoroquinolone Moxifloxacin

Comparison with Other Fluoroquinolones and Other Antibacterial Classes
  • Françoise Van Bambeke
  • Paul M. Tulkens
Leading Article

Abstract

Moxifloxacin, a fluoroquinolone with potent activity against respiratory pathogens, is approved and considered as an alternative to β-lactams and macrolides for the treatment of acute bacterial sinusitis and lower respiratory tract infections. In this review, we critically examine its safety profile in comparison with other fluoroquinolones and other antibacterial classes sharing similar indications. Data were extracted from published clinical trials, meta-analyses, postmarketing studies, spontaneous report systems and case reports for rare effects.

Global analysis did not reveal significantly higher incidences of drug-related adverse effects than for comparators. Tendon rupture was infrequent with moxifloxacin, including when used in elderly patients with chronic obstructive pulmonary disease. Severe toxic cutaneous reactions and allergies were very rare. Phototoxicity and CNS adverse effects were less common than with other fluoroquinolones. Although causing a 4–7 msec corrected QT interval prolongation, severe cardiac toxicity was neither seen in large cohorts or clinical trials nor reported to pharmacovigilance systems. Hepatotoxicity was not different from what was observed for other fluoroquinolones (excluding trovafloxacin) and less frequent than reported for amoxicillin-clavulanic acid or telithromycin.

The data show that using moxifloxacin, in its accepted indications and following the corresponding guidelines, should not be associated with an excessive incidence of drug-related adverse reactions, provided the clinician takes care in identifying patients with known risk factors and pays due attention to the contraindications and warnings mentioned in the labelling.

Notes

Acknowledgements

We thank Professor P. Ball (School of Biomedical Sciences, St Andrews University, St Andrews, Fife, UK) for critical reading of this review. Françoise Van Bambeke is Maître de recherches of the Belgian FondsdelaRecherche Scientifique. Both authors are members of the Belgian Advisory Board of Bayer-Belgium. No sources of funding were used to assist in the preparation of this review.

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Copyright information

© Adis Data Information BV 2009

Authors and Affiliations

  • Françoise Van Bambeke
    • 1
  • Paul M. Tulkens
    • 1
  1. 1.Unité de pharmacologie cellulaire et moléculaire & Centre de Pharmacie CliniqueLouvain Drug Research Institute, Université catholique de LouvainBrusselsBelgium

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