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

ABSTRACT

Background

Quinolones comprise a class of antibiotics that are globally preferred for treating a wide range of bacterial infections due to their potency, broad coverage, favorable pharmacologic profile, and mostly mild to moderate adverse reactions. Spontaneous reports on adverse drug events (ADE) and data from some pharmacoepidemiologic studies have raised concerns regarding quinolones and risk of retinal detachment (RD). This study examined ADE reports submitted to FDA adverse event reporting system (FAERS) for evidence on quinolone-associated RD risk.

Research design and methods

We identified all RD reports in FAERS between 2010–2019. We compared ADE signals between quinolones and selected medications that were previously associated with RD, and with reference medications not known to cause RD. For signal detection, we used two techniques: the proportional reporting ratio (PRR) and multi-item gamma Poisson shrinker (MGPS), which are known for their higher sensitivity and specificity for ADE signal detection, respectively.

Results

Moxifloxacin showed a positive and significant PRR signal for RD [PRR: 2.54 (1.60, 4.04)], and a marginally significant EBGM signal [EBGM: 2.21 (1.41, 3.02)].

Conclusion

Moxifloxacin is the only quinolone showing a positive disproportionality signal for RD. Further epidemiologic research is needed to clarify the association between moxifloxacin and RD risk.

KEYWORDS:

• Drug safety
• FAERS
• FDA adverse event reporting system
• pharmacovigilance
• quinolones
• retinal detachment

Disclosure statement

No potential conflict of interest was reported by the author(s).

Author contributions

The primary author, Mohamed Taher, designed and implemented this study including statistical analysis, interpretation of findings and drafting of this manuscript. Christopher Gravel, Abdallah Alami, and Derek Tsui contributed to statistical analysis, as well as critical review and approval of this manuscript. Lise Bjerre, Franco Momoli, Donald Mattison and Daniel Krewski provided guidance and feedback on all aspects of the study, as well as critical review and approval of the manuscript.

Data availability statement

Raw data used for this manuscript were extracted from FDA FAERS Quarterly Data Extract Files, which can be downloaded from the US Food & Drug Administration (FDA) website: https://fis.fda.gov/extensions/FPD-QDE-FAERS/FPD-QDE-FAERS.html.

Notes

1. EBGM: The Empirical Bayesian Geometric Mean value calculated by the MGPS method

Additional information

Funding

This research was supported in part with funding from the McLaughlin Centre for Population Health Risk Assessment at the University of Ottawa. D. Krewski is the Natural Sciences and Engineering Research Council of Canada Chair in Risk Science at the University of Ottawa.