Safety and Tolerability of Commonly Prescribed Oral Antibiotics for the Treatment of Respiratory Tract Infections
Section snippets
Fluoroquinolones
As a class, fluoroquinolones generally are well tolerated, with most AEs being mild-to-moderate in severity and self-limiting. This is borne out by a study of the fluoroquinolone levofloxacin, which has been shown to have a well-defined safety profile based on clinical trial experience (>7,000 patients) and clinical use over a period of 12 years.6 In clinical trials across a variety of infectious diseases—including respiratory tract, urinary tract, and skin infections—levofloxacin was at least
Macrolides
The older-generation macrolide erythromycin is associated with gastric distress in a significant number of patients.48 Furthermore, drug interactions with theophylline, carbamazepine, warfarin, cyclosporine, terfenadine, and digoxin limit the use of erythromycin.48 The newer macrolides azithromycin and clarithromycin are more stable than erythromycin; in addition, they are better absorbed and better tolerated.48 However, gastrointestinal intolerance and CNS AEs remain the primary AEs associated
Antimicrobial Safety Monitoring by Regulatory Agencies
Regulatory agencies in Europe and the US have developed specific procedures to assess the safety of antimicrobial agents during and after the drug approval process. The European Agency for the Evaluation of Medicinal Products (EMEA) is an organization of the European Union that evaluates the efficacy and safety of drugs. Serving functions similar to those served by the US FDA, EMEA reviews applications by European drug companies for marketing authorization. The agency continually monitors drug
Summary
This review summarized postmarketing surveillance information about medically significant AEs associated with commonly used oral antimicrobial agents used to treat respiratory tract infections. The various antimicrobial drug classes are associated with shared and unique drug-related AEs. The medically significant AEs associated with the fluoroquinolones and macrolides were evaluated by class. However, even within a single drug class, like the β-lactams, there can be significant differences in
Author Disclosures
The author of this article has disclosed the following industry relationships:
Hartmut Lode, MD, PhD, is a member of the Speakers' Bureaus of Astellas Pharma, Bayer-Schering Pharma, Janssen (a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.), Novartis Pharmaceuticals Corp., Pfizer Inc, sanofi-aventis, Theravance, and Wyeth; and has served as a consultant to Astellas Pharma, Bayer-Schering Pharma, Janssen (a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.), Novartis Pharmaceuticals
Acknowledgments
Medical writing support for the preparation of this article was provided by Ira Mills, PhD, and Craig Ornstein, PhD, of Embryon, LLC, A Division of Advanced Health Media, LLC (formerly Medesta Publications Group, A Business of Advogent).
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Statement of author disclosure: Please see the Author Disclosures section at the end of this article.