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

Taher, Mohamed Kadry; Alami, Abdallah; Gravel, Christopher A.; Tsui, Derek; Bjerre, Lise M.; Momoli, Franco; Mattison, Donald R.; Krewski, Daniel

doi:10.1080/14740338.2022.1993187

Cited by 6 publications

(4 citation statements)

References 42 publications

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“…Moreover, a study examining the adverse drug event reports submitted to FAERS found a positive association of Moxifloxacin with RRD. 53 Conversely, other studies including a nationwide, registerbased cohort study from Denmark, 54 two case-control analyses from USA, 55,56 a retrospective cohort study using The Health Improvement Network database, 57 a self-controlled case series study of data from Hong Kong Clinical Data Analysis and Reporting System Database and Taiwan National Health Insurance Research Database, 58 a nested casecontrol study of Korean National Health Insurance Service National Sample Cohort data, 59 and a nested case-control study of electronic health records 60 found no association between oral FQ use and retinal detachment. In addition, few systematic reviews and meta-analyses [61][62][63] did not also find any association of development of RRD with the use of systemic FQs.…”

Section: Retinal Detachmentmentioning

confidence: 99%

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Overview of Tendinopathy, Peripheral Neuropathy, Aortic Aneurysm, and Hypoglycemia Caused by Fluoroquinolones

Balasubramanian,

Maideen,

Narayanaswamy

2024

Ibnosina Journal of Medicine and Biomedical Sciences

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Background Fluoroquinolones (FQs) are widely used in the management of several bacterial infections including urinary tract infections (UTIs), upper respiratory tract infections (URTIs), lower respiratory tract infections (LRTIs), skin and soft tissue, gastrointestinal tract infections (GITIs), and many other infections. Objective This review article focuses on some serious side effects notified by United States Food and Drug Administration (US FDA) in different warning statements. Methods The literature was searched, in databases such as Medline/PubMed/PMC, Google Scholar, Science Direct, Ebsco, Scopus, Web of science, Embase, and reference lists to identify publications relevant to the serious side effects associated with the use of FQs. Results Several epidemiological studies and meta-analyses have documented the occurrence of serious side effects of FQs including tendinopathy, peripheral neuropathy, aortic aneurysm/dissection, hypoglycemia, QT prolongation, retinal detachment, and worsening of myasthenia gravis. Conclusion The clinicians should be aware of serious side effects of FQs. The US FDA and European Medicines Agency recommend against the use of FQs as first-line therapies to treat infections such as acute sinusitis, acute bronchitis, and uncomplicated UTIs, as the risks outweigh the benefits. The risk of incidence of serious side effects of FQs is higher among patients with advanced age, renal insufficiency, and certain concomitant medications. To avoid occurrence of any serious side effects of FQs, the clinicians should prefer non-FQ antibacterial drugs to manage uncomplicated UTIs, respiratory tract infections, and other infections for which alternatives available.

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Section: Retinal Detachmentmentioning

confidence: 99%

“…Moreover, a study examining the adverse drug event reports submitted to FAERS found a positive association of Moxifloxacin with RRD. 53…”

Section: Retinal Detachmentmentioning

confidence: 99%

Overview of Tendinopathy, Peripheral Neuropathy, Aortic Aneurysm, and Hypoglycemia Caused by Fluoroquinolones

Balasubramanian,

Maideen,

Narayanaswamy

2024

Ibnosina Journal of Medicine and Biomedical Sciences

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“…No evidence was found regarding FQs regimens associated with retinal detachment in patients with no history of eye diseases. Additionally, Taher et al [ 221 ] identified all retinal detachment reported in the FDA adverse event reporting system (2010–2019 period). Two methods were used for analysis: the proportional reporting ratio and the multi-item gamma Poisson shrinker.…”

Section: Side-effects Of Fqs and Underlying Mechanismsmentioning

confidence: 99%

Overview of Side-Effects of Antibacterial Fluoroquinolones: New Drugs versus Old Drugs, a Step Forward in the Safety Profile?

Rusu

Arbănași

et al. 2023

Pharmaceutics

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Antibacterial fluoroquinolones (FQs) are frequently used in treating infections. However, the value of FQs is debatable due to their association with severe adverse effects (AEs). The Food and Drug Administration (FDA) issued safety warnings concerning their side-effects in 2008, followed by the European Medicine Agency (EMA) and regulatory authorities from other countries. Severe AEs associated with some FQs have been reported, leading to their withdrawal from the market. New systemic FQs have been recently approved. The FDA and EMA approved delafloxacin. Additionally, lascufloxacin, levonadifloxacin, nemonoxacin, sitafloxacin, and zabofloxacin were approved in their origin countries. The relevant AEs of FQs and their mechanisms of occurrence have been approached. New systemic FQs present potent antibacterial activity against many resistant bacteria (including resistance to FQs). Generally, in clinical studies, the new FQs were well-tolerated with mild or moderate AEs. All the new FQs approved in the origin countries require more clinical studies to meet FDA or EMA requirements. Post-marketing surveillance will confirm or infirm the known safety profile of these new antibacterial drugs. The main AEs of the FQs class were addressed, highlighting the existing data for the recently approved ones. In addition, the general management of AEs when they occur and the rational use and caution of modern FQs were outlined.

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“…This study comprises one of a comprehensive, three-part examination of the association between systemic quinolones and risk of RD, which has been conducted in response to the heightened scientific and regulators' safety concerns. The first part examines evidence from the FDA adverse drug event reporting system (FAERS) [53] to flag any disproportionality in voluntary reporting of possible quinolone-linked RD incidents beyond what would be normally expected (hypothesis generating). The verification of this association (hypothesis testing) is accomplished in the second part [54] (involving an analysis of clinical trial data) and the third part (current study), which examines data from a major database that includes electronic health records (EHR) of inpatients of more than 500 hospitals in the USA.…”

Section: Introductionmentioning

confidence: 99%

Systemic quinolones and risk of retinal detachment III: a nested case–control study using a US electronic health records database

Taher

Crispo

Fortin

et al. 2022

Eur J Clin Pharmacol

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Background Quinolones are popular antibiotics that are known for their potency, broad coverage, and reasonable safety. Concerns have been raised about a possible association between quinolones and retinal detachment (RD). Methods We conducted a nested case–control study using electronic health records (EHR) from the Health Facts® Database. The initial cohort included all patients who were admitted between 2000 and 2016, with no history of eye disease, and had a minimum medical history of one year. Eligible cases comprised inpatients who were first admitted with a primary diagnosis of RD between 2010 and 2015. Each eligible case was matched without replacement to five unique controls by sex, race, age, and period-at-risk. We used conditional logistic regression to calculate RD risk, adjusting for exposure to other medications, and major risk factors. Results We identified 772 cases and 3860 controls. Whereas our primary analysis of all subjects revealed no quinolone-associated RD risk, elevated but non-significant risks were noted in African Americans (ciprofloxacin and levofloxacin), those aged 56–70 years old (moxifloxacin), and women (ciprofloxacin). Conclusion Our study did not identify an elevated RD risk within 30 days following systemic administration of quinolone antibiotics. Suggestions of increased risk observed in some population subgroups warrant further investigation.

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

Cited by 6 publications

References 42 publications

Overview of Tendinopathy, Peripheral Neuropathy, Aortic Aneurysm, and Hypoglycemia Caused by Fluoroquinolones

Overview of Tendinopathy, Peripheral Neuropathy, Aortic Aneurysm, and Hypoglycemia Caused by Fluoroquinolones

Overview of Side-Effects of Antibacterial Fluoroquinolones: New Drugs versus Old Drugs, a Step Forward in the Safety Profile?

Systemic quinolones and risk of retinal detachment III: a nested case–control study using a US electronic health records database

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