Fluoroquinolone-associated tendon-rupture

A summary of reports in the Food and Drug Administrations adverse event reporting system

Rasha M. Arabyat, Dennis W. Raisch*, June M McKoy, Charles L. Bennett

*Corresponding author for this work

Research output: Contribution to journalReview article

33 Citations (Scopus)

Abstract

Objective: To review and summarize reports of tendon rupture associated with each fluoroquinolone (FQ) currently marketed in the United States (US), as reported to the FDAs Adverse Event Reporting System (FAERS).Methods: FAERS data were reviewed for reports of tendon rupture associated with each FQ from their respective approval date through September 2012. Disproportional reporting signal detection was estimated using empirical Bayes geometric mean (EBGM) with 95% confidence intervals (CI).Results: There were 2495 FAERs reports of tendon rupture associated with currently approved FQs. Most FAERS reports were associated with levofloxacin (n = 1555) followed by ciprofloxacin (n = 606) and moxifloxacin (n = 230). Signal detection results for FQs were as follows: levofloxacin (EBGM = 55.2, 95% CI = 52.3 - 58.0), ciprofloxacin (EBGM = 20.0, 95% CI = 18.2 - 21.6), moxifloxacin (EBGM = 13.3, 95% CI = 11.7 - 15.1), norfloxacin (EBGM = 9.6, 95% CI = 6.5 - 13.5), ofloxacin (EBGM = 8.2, 95%CI = 6.3 - 10.2) and gemifloxacin (EBGM = 1.9, 95% CI = 0.7 - 4.5). The mean age of affected individuals was 59.6 ± 5.1 years. Corticosteroids were administered concomitantly with FQs in 21.2% of cases.Conclusion: As noted in boxed warnings, FQ use is associated with increased tendon rupture risk. Risk factors for FQ associated tendon rupture include use in the elderly, and in patients with concomitant corticosteroids. Further monitoring may be needed due to antibiotic overuse and marketing of newer FQs.

Original languageEnglish (US)
Pages (from-to)1653-1660
Number of pages8
JournalExpert Opinion on Drug Safety
Volume14
Issue number11
DOIs
StatePublished - Nov 2 2015

Fingerprint

Fluoroquinolones
United States Food and Drug Administration
Tendons
Rupture
Confidence Intervals
Levofloxacin
Ciprofloxacin
Adrenal Cortex Hormones
Drug Labeling
Norfloxacin
Ofloxacin
Marketing
Information Systems
Research Design
Anti-Bacterial Agents

Keywords

  • adverse events
  • fluoroquinolones
  • pharmacovigilance
  • tendon rupture

ASJC Scopus subject areas

  • Pharmacology (medical)

Cite this

@article{8d91e4b6a90f48f4b5984b24837b5394,
title = "Fluoroquinolone-associated tendon-rupture: A summary of reports in the Food and Drug Administrations adverse event reporting system",
abstract = "Objective: To review and summarize reports of tendon rupture associated with each fluoroquinolone (FQ) currently marketed in the United States (US), as reported to the FDAs Adverse Event Reporting System (FAERS).Methods: FAERS data were reviewed for reports of tendon rupture associated with each FQ from their respective approval date through September 2012. Disproportional reporting signal detection was estimated using empirical Bayes geometric mean (EBGM) with 95{\%} confidence intervals (CI).Results: There were 2495 FAERs reports of tendon rupture associated with currently approved FQs. Most FAERS reports were associated with levofloxacin (n = 1555) followed by ciprofloxacin (n = 606) and moxifloxacin (n = 230). Signal detection results for FQs were as follows: levofloxacin (EBGM = 55.2, 95{\%} CI = 52.3 - 58.0), ciprofloxacin (EBGM = 20.0, 95{\%} CI = 18.2 - 21.6), moxifloxacin (EBGM = 13.3, 95{\%} CI = 11.7 - 15.1), norfloxacin (EBGM = 9.6, 95{\%} CI = 6.5 - 13.5), ofloxacin (EBGM = 8.2, 95{\%}CI = 6.3 - 10.2) and gemifloxacin (EBGM = 1.9, 95{\%} CI = 0.7 - 4.5). The mean age of affected individuals was 59.6 ± 5.1 years. Corticosteroids were administered concomitantly with FQs in 21.2{\%} of cases.Conclusion: As noted in boxed warnings, FQ use is associated with increased tendon rupture risk. Risk factors for FQ associated tendon rupture include use in the elderly, and in patients with concomitant corticosteroids. Further monitoring may be needed due to antibiotic overuse and marketing of newer FQs.",
keywords = "adverse events, fluoroquinolones, pharmacovigilance, tendon rupture",
author = "Arabyat, {Rasha M.} and Raisch, {Dennis W.} and McKoy, {June M} and Bennett, {Charles L.}",
year = "2015",
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Fluoroquinolone-associated tendon-rupture : A summary of reports in the Food and Drug Administrations adverse event reporting system. / Arabyat, Rasha M.; Raisch, Dennis W.; McKoy, June M; Bennett, Charles L.

In: Expert Opinion on Drug Safety, Vol. 14, No. 11, 02.11.2015, p. 1653-1660.

Research output: Contribution to journalReview article

TY - JOUR

T1 - Fluoroquinolone-associated tendon-rupture

T2 - A summary of reports in the Food and Drug Administrations adverse event reporting system

AU - Arabyat, Rasha M.

AU - Raisch, Dennis W.

AU - McKoy, June M

AU - Bennett, Charles L.

PY - 2015/11/2

Y1 - 2015/11/2

N2 - Objective: To review and summarize reports of tendon rupture associated with each fluoroquinolone (FQ) currently marketed in the United States (US), as reported to the FDAs Adverse Event Reporting System (FAERS).Methods: FAERS data were reviewed for reports of tendon rupture associated with each FQ from their respective approval date through September 2012. Disproportional reporting signal detection was estimated using empirical Bayes geometric mean (EBGM) with 95% confidence intervals (CI).Results: There were 2495 FAERs reports of tendon rupture associated with currently approved FQs. Most FAERS reports were associated with levofloxacin (n = 1555) followed by ciprofloxacin (n = 606) and moxifloxacin (n = 230). Signal detection results for FQs were as follows: levofloxacin (EBGM = 55.2, 95% CI = 52.3 - 58.0), ciprofloxacin (EBGM = 20.0, 95% CI = 18.2 - 21.6), moxifloxacin (EBGM = 13.3, 95% CI = 11.7 - 15.1), norfloxacin (EBGM = 9.6, 95% CI = 6.5 - 13.5), ofloxacin (EBGM = 8.2, 95%CI = 6.3 - 10.2) and gemifloxacin (EBGM = 1.9, 95% CI = 0.7 - 4.5). The mean age of affected individuals was 59.6 ± 5.1 years. Corticosteroids were administered concomitantly with FQs in 21.2% of cases.Conclusion: As noted in boxed warnings, FQ use is associated with increased tendon rupture risk. Risk factors for FQ associated tendon rupture include use in the elderly, and in patients with concomitant corticosteroids. Further monitoring may be needed due to antibiotic overuse and marketing of newer FQs.

AB - Objective: To review and summarize reports of tendon rupture associated with each fluoroquinolone (FQ) currently marketed in the United States (US), as reported to the FDAs Adverse Event Reporting System (FAERS).Methods: FAERS data were reviewed for reports of tendon rupture associated with each FQ from their respective approval date through September 2012. Disproportional reporting signal detection was estimated using empirical Bayes geometric mean (EBGM) with 95% confidence intervals (CI).Results: There were 2495 FAERs reports of tendon rupture associated with currently approved FQs. Most FAERS reports were associated with levofloxacin (n = 1555) followed by ciprofloxacin (n = 606) and moxifloxacin (n = 230). Signal detection results for FQs were as follows: levofloxacin (EBGM = 55.2, 95% CI = 52.3 - 58.0), ciprofloxacin (EBGM = 20.0, 95% CI = 18.2 - 21.6), moxifloxacin (EBGM = 13.3, 95% CI = 11.7 - 15.1), norfloxacin (EBGM = 9.6, 95% CI = 6.5 - 13.5), ofloxacin (EBGM = 8.2, 95%CI = 6.3 - 10.2) and gemifloxacin (EBGM = 1.9, 95% CI = 0.7 - 4.5). The mean age of affected individuals was 59.6 ± 5.1 years. Corticosteroids were administered concomitantly with FQs in 21.2% of cases.Conclusion: As noted in boxed warnings, FQ use is associated with increased tendon rupture risk. Risk factors for FQ associated tendon rupture include use in the elderly, and in patients with concomitant corticosteroids. Further monitoring may be needed due to antibiotic overuse and marketing of newer FQs.

KW - adverse events

KW - fluoroquinolones

KW - pharmacovigilance

KW - tendon rupture

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