Publication related to RSI or an RSI staff member
Systemic quinolones and risk of retinal detachment I: analysis of data from the US FDA adverse event reporting system.
Authors
- Taher, Mohamed Kadry, Taher MK, McLaughlin Centre for Population Health Risk Assessment, Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada.; School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON, Canada.; Risk Sciences International, Ottawa, ON, Canada.
- Alami, Abdallah, Alami A, Risk Sciences International, Ottawa, ON, Canada.
- Gravel, Christopher A, Gravel CA, McLaughlin Centre for Population Health Risk Assessment, Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada.; School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON, Canada.; Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, QC, Canada.
- Tsui, Derek, Tsui D, Risk Sciences International, Ottawa, ON, Canada.
- Bjerre, Lise M, Bjerre LM, School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON, Canada.; Department of Family Medicine, University of Ottawa, Ottawa, ON, Canada.; Institut Du Savoir Montfort, Ottawa, ON, Canada.
- Momoli, Franco, Momoli F, School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON, Canada.; Risk Sciences International, Ottawa, ON, Canada.; Children's Hospital of Eastern Ontario Research Institute, Ottawa, ON, Canada.
- Mattison, Donald, Mattison D, McLaughlin Centre for Population Health Risk Assessment, Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada.; School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON, Canada.; Risk Sciences International, Ottawa, ON, Canada.
- Krewski, Daniel, Krewski D, McLaughlin Centre for Population Health Risk Assessment, Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada.; School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON, Canada.; Risk Sciences International, Ottawa, ON, Canada.
YEAR OF PUBLICATION: 2022
SOURCE: Expert Opin Drug Saf. 2022 Feb;21(2):269-276. doi: 10.1080/14740338.2022.1993187. Epub 2021 Oct 24.
JOURNAL TITLE ABBREVIATION: Expert Opin Drug Saf
JOURNAL TITLE: Expert opinion on drug safety
ISSN: 1744-764X (Electronic) 1474-0338 (Linking)
VOLUME: 21
ISSUE: 2
PAGES: 269-276
PLACE OF PUBLICATION: England
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.
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.
LANGUAGE: eng
DATE OF PUBLICATION: 2022 Feb
DATE OF ELECTRONIC PUBLICATION: 20211024
DATE COMPLETED: 20220217
DATE REVISED: 20220430
MESH DATE: 2022/02/19 06:00
EDAT: 2021/10/14 06:00
STATUS: MEDLINE
PUBLICATION STATUS: ppublish
LOCATION IDENTIFIER: 10.1080/14740338.2022.1993187 [doi]
OWNER: NLM
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