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Systemic quinolones and risk of retinal detachment I: analysis of data from the US FDA adverse event reporting system

Mohamed Kadry Taher1,2,3, Abdallah Alami3, Christopher A Gravel1,2,4

  • 1McLaughlin Centre for Population Health Risk Assessment, Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada.

Expert Opinion on Drug Safety
|October 13, 2021
PubMed
Abstract

Insights

Moxifloxacin, a quinolone antibiotic, showed a potential link to retinal detachment (RD) in a safety analysis. Further research is needed to confirm this association and understand the risks of quinolone use.

Area of Science:

  • Pharmacovigilance and Drug Safety
  • Ophthalmology
  • Infectious Diseases

Background:

  • Quinolones are widely used antibiotics with a generally favorable safety profile.
  • Concerns exist regarding a potential association between quinolone use and retinal detachment (RD).
  • This study investigated adverse drug event (ADE) reports to assess quinolone-associated RD risk.

Purpose of the Study:

  • To evaluate the association between quinolone antibiotics and the risk of retinal detachment (RD).
  • To analyze spontaneous adverse drug event (ADE) reports for signals of quinolone-associated RD.

Main Methods:

  • Retrospective analysis of retinal detachment (RD) reports in the FDA Adverse Event Reporting System (FAERS) from 2010-2019.
  • Utilized proportional reporting ratio (PRR) and multi-item gamma Poisson shrinker (MGPS) for ADE signal detection.
  • Compared quinolone ADE signals against medications with known and unknown associations with RD.

Main Results:

  • Moxifloxacin demonstrated a significant positive proportional reporting ratio (PRR) signal for RD (PRR: 2.54).
  • A marginally significant Empirical Bayes Geometric Mean (EBGM) signal was also observed for moxifloxacin and RD (EBGM: 2.21).
  • No other quinolone showed a significant disproportionality signal for RD.

Conclusions:

  • Moxifloxacin emerged as the sole quinolone exhibiting a positive signal for RD in this analysis.
  • The findings suggest a potential association between moxifloxacin and an increased risk of retinal detachment.
  • Further epidemiological studies are warranted to definitively establish the relationship between moxifloxacin and RD risk.
Keywords:
Drug safetyFAERSFDA adverse event reporting systempharmacovigilancequinolonesretinal detachment

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