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. 2008 May;17(5):523-32.
doi: 10.1002/pds.1547.

Adverse events associated with prolonged antibiotic use

Sharon B Meropol  1 , K Arnold Chan, Zhen Chen, Jonathan A Finkelstein, Sean Hennessy, Ebbing Lautenbach, Richard Platt, Stephanie D Schech, Deborah Shatin, Joshua P Metlay
Affiliations

Adverse events associated with prolonged antibiotic use

Sharon B Meropol et al. Pharmacoepidemiol Drug Saf. 2008 May.

Abstract

Purpose: The Infectious Diseases Society of America and US CDC recommend 60 days of ciprofloxacin, doxycycline, or amoxicillin for anthrax prophylaxis. It is not possible to determine severe adverse drug event (ADE) risks from the few people thus far exposed to anthrax prophylaxis. This study's objective was to estimate risks of severe ADEs associated with long-term ciprofloxacin, doxycycline, and amoxicillin exposure using three large databases: one electronic medical record (General Practice Research Database) and two claims databases (UnitedHealthcare, HMO Research Network).

Methods: We include office visit, hospital admission and prescription data for 1/1/1999-6/30/2001. Exposure variable was oral antibiotic person-days (pds). Primary outcome was hospitalization during exposure with ADE diagnoses: anaphylaxis, phototoxicity, hepatotoxicity, nephrotoxicity, seizures, ventricular arrhythmia, or infectious colitis.

Results: We randomly sampled 999,773, 1047,496, and 1819,004 patients from Databases A, B, and C respectively. 33,183 amoxicillin, 15,250 ciprofloxacin and 50,171 doxycycline prescriptions continued > or =30 days. ADE hospitalizations during long-term exposure were not observed in Database A. ADEs during long-term amoxicillin were seen only in Database C with 5 ADEs or 1.2(0.4-2.7) ADEs/100,000 pds exposure. Long-term ciprofloxacin showed 3 and 4 ADEs with 5.7(1.2-16.6) and 3.5(1.0-9.0) ADEs/100,000 pds in Databases B and C, respectively. Only Database B had ADEs during long-term doxycycline with 3 ADEs or 0.9(0.2-2.6) ADEs/100,000 pds. For most events, the incidence rate ratio, comparing >28 versus 1-28 pds exposure was <1, showing limited evidence for cumulative dose-related ADEs from long-term exposure.

Conclusions: Long-term amoxicillin, ciprofloxacin, and doxycycline appear safe, supporting use of these medications if needed for large-scale post-exposure anthrax prophylaxis.

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Conflict of interest statement

Potential conflicts of interest:

Dr. Meropol has served as a consultant for Wyeth Pharmaceuticals and is supported, in part by an educational grant from Amgen. Dr. Hennessy has served as a consultant for Sanofi-Aventis and performed legal consulting regarding an antibiotic not related to this study. Dr. Lautenbach has received research grants from Merck & Co., Inc. and has served as a consultant for Ortho McNeil and Bristol-Myers-Squibb. Dr. Platt has had research support and/or consulted for the following: America’s Health Insurance Plans, Agency for Healthcare Research, and Quality, Centers for Disease Control and Prevention, Crohn’s and Colitis Foundation of America, Food and Drug Administration, GlaxoSmithKline, Massachusetts Department of Public Health, National Cancer Institute, National Heart, Lung and Blood Institute, National Institute of Allergy and Infectious Disease, National Institute of Diabetes, Digestive and Kidney Disease, National Institute of General Medical Sciences, National Committee for Quality Assurance, Parke Davis, Pfizer, Robert Wood Johnson Foundation, Sanofi-Aventis, Sanofi-Pasteur, SmithKlineBeecham, Tap Pharmaceuticals, and Wyeth. The remaining authors have nothing to declare.

Figures

Figure
Figure
Distribution of Drug Exposure Time for Each Antibiotic Drug
Figure
Figure
Distribution of Drug Exposure Time for Each Antibiotic Drug
See this image and copyright information in PMC

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