|
1
|
Lin TY, Wang JL, Wang GHM, Huang YY, Chen MC, Dong YH, Lo-Ciganic WH. Use of fluoroquinolones and risk of rhegmatogenous retinal detachment: a retrospective cohort study using two nationwide representative claims databases. Front Pharmacol 2024; 15:1414221. [PMID: 39723254 PMCID: PMC11668581 DOI: 10.3389/fphar.2024.1414221] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/08/2024] [Accepted: 11/12/2024] [Indexed: 12/28/2024] Open
Abstract
Background Although biological plausibility suggests that fluoroquinolones could lead to rhegmatogenous retinal detachment (RRD) through collagen degradation, real-world evidence on their relative risk of RRD is inconsistent, with limited information on absolute risk estimates. Objective The study aimed to estimate the RRD risk associated with fluoroquinolones versus other antibiotics with similar indications (i.e., comparison antibiotics). Methods We conducted a retrospective cohort study analyzing claims data from adult patients who initiated fluoroquinolones or amoxicillin/clavulanate or ampicillin/sulbactam or extended-spectrum cephalosporins using the Taiwan National Health Insurance Research Database (2009-2018) and the United States IBM MarketScan Database (2011-2020). Patients were followed for up to 90 days after cohort entry. For each country's data, after 1:1 propensity score (PS) matching, we used Cox regression models to estimate RRD risks, presented with hazard ratios (HR) with 95% confidence interval (95% CI). We used random-effects meta-analyses to derive pooled HRs across both counties. Results Of 24,172,032 eligible patients comprising 7,944,620 insured Taiwanese (mean age [SD], 46 [18] years; 45% male) and 16,227,412 United States commercially insured individuals (mean age [SD], 47 [16] years; 40% male), 10,137,468 patients initiated fluoroquinolones, 10,203,794 initiated amoxicillin/clavulanate or ampicillin/sulbactam, and 3,830,770 initiated extended-spectrum cephalosporins. After PS matching, similar RRD incidence rates were observed between fluoroquinolones and amoxicillin/clavulanate or ampicillin/sulbactam users (0.33 [95% CI, 0.19-0.56] versus 0.35 [95% CI, 0.26-0.46] per 1,000 person-years), yielding an HR of 0.97 (95% CI, 0.76-1.23). The RRD incidence rates were also similar comparing fluoroquinolones to extended-spectrum cephalosporins (0.36 [95% CI, 0.22-0.57] versus 0.34 [95% CI, 0.22-0.50] per 1,000 person-years; HR, 1.08 [95% CI, 0.92-1.27]). The comparative safety profiles remained consistent by country, various patient characteristic (e.g., diabetes or ophthalmic conditions), type of fluoroquinolones, follow-up duration, or treatment setting. Conclusion This large-scale study, leveraging real-world data from Taiwan and the United States, showed a low and comparable RRD risk among adults who initiated fluoroquinolones or other antibiotics with similar indications. This suggests that the RRD risk should not deter the use of fluoroquinolone when clinically indicated.
Collapse
Affiliation(s)
- Ting-Yu Lin
- Department of Pharmacy, College of Pharmaceutical Sciences, National Yang Ming Chiao Tung University, Taipei, Taiwan
- Department of Pharmacy Administration, Chang Gung Medical Foundation, Taoyuan City, Taiwan
| | - Jiun-Ling Wang
- Department of Internal Medicine, National Cheng Kung University Hospital, Tainan, Taiwan
- Department of Medicine, College of Medicine, National Cheng Kung University, Tainan, Taiwan
| | - Grace Hsin-Min Wang
- Department of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, FL, United States
| | - Yu-Yun Huang
- Department of Ophthalmology, Taipei Veterans General Hospital, Taipei, Taiwan
| | - Ming-Ching Chen
- Department of Pharmacy, College of Pharmaceutical Sciences, National Yang Ming Chiao Tung University, Taipei, Taiwan
| | - Yaa-Hui Dong
- Department of Pharmacy, College of Pharmaceutical Sciences, National Yang Ming Chiao Tung University, Taipei, Taiwan
- Institute of Public Health, School of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan
| | - Wei-Hsuan Lo-Ciganic
- Division of General Internal Medicine, Department of Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, PA, United States
- Center for Pharmaceutical Policy and Prescribing, University of Pittsburgh, Pittsburgh, PA, United States
- Center for Clinical Artificial Intelligence, University of Pittsburgh, Pittsburgh, United States
- North Florida/South Georgia Veterans Health System Geriatric Research Education and Clinical Center, Gainesville, FL, United States
| |
Collapse
|
|
2
|
Mitrani-Gold FS, Ju S, Drysdale M, Schultze A, Mu G, Logie J. Risk of collagen-related disorders and neurological events among patients with uncomplicated urinary tract infection following short treatment with fluoroquinolones: a cohort study. Antimicrob Agents Chemother 2024; 68:e0069024. [PMID: 39470200 PMCID: PMC11619313 DOI: 10.1128/aac.00690-24] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/10/2024] [Accepted: 09/18/2024] [Indexed: 10/30/2024] Open
Abstract
Studies of fluoroquinolone (FQ) safety across indications show increased collagen/neurological adverse event (AE) risk, yet patients still receive FQs for uncomplicated urinary tract infections (uUTIs). This retrospective, cohort study investigated the risk of collagen/neurological AEs of special interest (AESIs) with short-term FQ use versus standard-of-care antibiotics (trimethoprim-sulfamethoxazole [SXT], nitrofurantoin [NTF]) among female outpatients with uUTIs. This study was conducted between December 2009 and 2019 using Optum's de-identified Clinformatics Data Mart Database. Adjusted absolute risks were calculated for composite/collagen/neurological AESIs (Kaplan-Meier cumulative hazards, after applying stabilized inverse probability of treatment weighting [sIPTW]). Adjusted hazard ratios were generated (sIPTW Cox proportional hazard modeling). Overall, 954,777 patients were included: FQ (n = 386,537 [40.5%]); SXT (n = 237,120 [24.8%]); NTF (n = 314,585 [32.9%]). Adjusted absolute risk range for collagen/neurological AESIs was <1%-4.5%. The hazard (95% CI) of tendon rupture was 25% higher with FQ versus SXT (1.25 [1.00-1.57]; P = 0.0497). Patients receiving FQ had lower hazard of neurological (0.95 [0.93-0.97]; P < 0.0001), central nervous system (0.85 [0.80-0.89]; P < 0.0001), and peripheral nervous system (0.96 [0.93-0.98]; P = 0.0016) AESIs versus NTF. Following a short treatment duration, FQs were associated with increased risk of tendon rupture versus SXT and reduced risk (adjusted hazard ratios) of neurological AESI versus NTF. Individual patient risk and consequences for known uncommon, yet serious, AEs need to inform appropriate antibiotic choice in treating uUTIs. Patient profile, efficacy, microbiome impact, safety, and surveillance should inform antibiotic selection for uUTI management, in accordance with guidelines.
Collapse
Affiliation(s)
| | | | - Myriam Drysdale
- London School of Hygiene and Tropical Medicine, London, United Kingdom
| | - Anna Schultze
- London School of Hygiene and Tropical Medicine, London, United Kingdom
| | - George Mu
- GSK, Collegeville, Pennsylvania, USA
| | | |
Collapse
|
|
3
|
Systemic quinolones and risk of retinal detachment III: a nested case-control study using a US electronic health records database. Eur J Clin Pharmacol 2022; 78:1019-1028. [PMID: 35290480 PMCID: PMC9107393 DOI: 10.1007/s00228-021-03260-4] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/05/2021] [Accepted: 11/25/2021] [Indexed: 11/23/2022]
Abstract
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. Supplementary Information The online version contains supplementary material available at 10.1007/s00228-021-03260-4.
Collapse
|
|
4
|
Leonova MV. Collagen-associated side effects of fluoroquinolones: aneurysm and aortic dissection (systematic review). CONSILIUM MEDICUM 2022. [DOI: 10.26442/20751753.2022.1.201380] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/22/2022] Open
Abstract
Well known for fluoroquinolones cause the development of collagen-associated side effects tendopathies with the risk of tendon rupture and retinal detachment, which is associated with the damaging effect and degradation of type I and type III collagen. The aorta is also rich in collagen type I and type III up to 8090%, which has the potential to play a role in the development of aortopathies in cases of fluoroquinolone use. Since 2015, the first publications of research results on the collagen-associated effect of fluoroquinolones on the development of aneurysm and aortic dissection, often called aortopathy, began to appear. A systematic review of observational studies and 5 meta-analyzes of the development of a novel side effect of fluoroquinolones is presented. An absolute incidence of this side effect of 1.1% and a twofold increased relative risk of developing aneurysm/aortic dissection (RR 2.042.23), aortic aneurysm (RR 1.742.83), and aortic dissection (RR 1.882.79). When analyzing age subgroups, an increase in the risk of aneurysm/aortic dissection was noted already from the age of 35 years and was more significant in elderly patients (over 65 years). Analisys of the course duration of fluoroquinolone use (314 days or 14 days) was carried out in two studies and showed an increase in the risk of aneurysm/aortic dissection with increasing duration of fluoroquinolone therapy (RR 1.72 versus RR 1.92). The risk of developing a fluoroquinolone-associated aortopathy was highest during the first 30 days after the course use of fluoroquinolones, with a slight decrease within 6090 days after the course. The signal was confirmed by the FDA pharmacovigilance system (USA) during the analysis of cases of aneurysm/aortic dissection against the background of fluoroquinolones use. International regulatory authorities (FDA and EMA) have announced official documents warning of an increased incidence of rare but serious cases of aortic dissection or ruptured aortic aneurysm with oral fluoroquinolones. Fluoroquinolones should not be given to patients at increased risk unless other treatment options are available. The increased risk category includes patients with a history of aortic or other blood vessel aneurysm, high blood pressure, and the elderly.
Collapse
|
|
5
|
Zhang J, Zhang Z. Fluoroquinolones increase the risk of aortic aneurysm and dissection: A protocol for meta-analysis. Medicine (Baltimore) 2021; 100:e28081. [PMID: 34941048 PMCID: PMC8702248 DOI: 10.1097/md.0000000000028081] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/09/2021] [Accepted: 11/15/2021] [Indexed: 01/05/2023] Open
Abstract
BACKGROUND Fluoroquinolones have been associated with collagen degradation, raising safety concerns related to more serious collagen disorders with use of these antibiotics, including aortic aneurysm and dissection. We performed this protocol for meta-analysis to examine the relationship between fluoroquinolone therapy and the risk of developing aortic aneurysm and dissection. METHODS This study will be designed following the guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols statement guidelines. Studies were identified through systematic searches in November 2021 with no restrictions on date and time, and publication status using the following bibliographic databases: Embase, Medline, PubMed, Web of Science, Science Direct, and the Cochrane Library. The risk of bias of included studies were estimated by taking into consideration the characteristics including random sequence generation, allocation concealment, blinding of patients, blinding of outcome assessment, completeness of outcome data, selective reporting and other bias by Cochrane Collaboration's tool. Data synthesis and analyses were performed using Stata version 10.0 software. RESULTS The results of this systematic review and meta-analysis will be published in a peer-reviewed journal. CONCLUSION Use of fluoroquinolones may be associated with an increased risk of aortic aneurysm and dissection. While these were rare events, physicians should be aware of this possible drug safety risk associated with fluoroquinolone therapy. OPEN SCIENCE FRAMEWORK REGISTRATION NUMBER https://doi.org/10.17605/OSF.IO/ZKE3Y10.17605/OSF.IO/UP3BA.
Collapse
Affiliation(s)
- Jiawei Zhang
- Department of Vascular Surgery, The First Hospital of China Medical University, Liaoning, China
| | - Zhe Zhang
- Operating Room, The First Hospital of China Medical University, Liaoning, China
| |
Collapse
|
|
6
|
Abstract
Fluoroquinolones are broad-spectrum antibiotics with good oral bioavailability. They are used for the treatment of a wide variety of infections, but there are restrictions on prescribing these drugs. Epidemiological studies have reported an increased risk of rare adverse effects. These include tendinopathy and tendon rupture, peripheral neuropathy and aortic aneurysm. Safe prescribing of fluroquinolones requires recognition of patients with risk factors for toxicity. Prompt drug discontinuation is recommended in the event of an adverse reaction. Practising antimicrobial stewardship by prescribing fluoroquinolones only when alternative drugs are unavailable is also key to limiting adverse events and antibiotic resistance.
Collapse
Affiliation(s)
- Diva Baggio
- Malignant Haematology and Stem Cell Transplantation Service, Alfred Health.,General Medicine Unit, Alfred Health.,Central Clinical School, Monash University.,Melbourne
| | - Michelle R Ananda-Rajah
- Malignant Haematology and Stem Cell Transplantation Service, Alfred Health.,General Medicine Unit, Alfred Health.,Central Clinical School, Monash University.,Melbourne
| |
Collapse
|
|
7
|
Taher MK, Alami A, Gravel CA, Tsui D, Bjerre LM, Momoli F, Mattison D, Krewski D. Systemic quinolones and risk of retinal detachment I: analysis of data from the US FDA adverse event reporting system. Expert Opin Drug Saf 2021; 21:269-276. [PMID: 34641748 DOI: 10.1080/14740338.2022.1993187] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/20/2022]
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.
Collapse
Affiliation(s)
- Mohamed Kadry Taher
- 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
| | | | - Christopher A Gravel
- 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
| | - Derek Tsui
- Risk Sciences International, Ottawa, ON, Canada
| | - Lise M Bjerre
- 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
| | - Franco Momoli
- 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
| | - Donald Mattison
- 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
| | - Daniel Krewski
- 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
| |
Collapse
|
|
8
|
Barberán J, Barberán LC, de la Cuerda A. [Safety in the selection of oral antibiotic treatment in community infections, beyond COVID-19]. REVISTA ESPANOLA DE QUIMIOTERAPIA : PUBLICACION OFICIAL DE LA SOCIEDAD ESPANOLA DE QUIMIOTERAPIA 2021; 34:289-297. [PMID: 34319057 PMCID: PMC8329570 DOI: 10.37201/req/087.2021] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Subscribe] [Scholar Register] [Indexed: 12/19/2022]
Abstract
Los antibióticos orales son uno de los fármacos más utilizados en la comunidad. Sus efectos adversos son generalmente poco frecuentes y leves, e incluyen toxicidad e interacciones medicamentosas. El mecanismo de producción es variado y no siempre bien conocido. El conocimiento de los efectos adversos con relevancia clínica puede permitir hacer un uso más juicioso de los antibióticos basados en el principio primero no hacer daño, primun non nocere. En esta revisión exploramos los principales efectos adversos de los antibióticos orales con énfasis en los β-lactámicos, macrólidos y fluoroquinolonas.
Collapse
Affiliation(s)
- J Barberán
- José Barberán, Servicio de Medicina Interna - Enfermedades infecciosas Hospital Universitario HM Montepríncipe. Universidad San Pablo CEU, Madrid, Spain.
| | | | | |
Collapse
|
|
9
|
Abstract
OBJECTIVE The aim of this study was to investigate risk factors for retinal detachment or tear (RD/T), and follow up two studies that found increased risk from work-related heavy lifting. METHODS We conducted a case-control study including 200 cases of RD/T and 415 controls. Participants completed a questionnaire covering general health, vision, and physical exertion. Multiple logistic regression and propensity score matching was used to control confounding and estimate independent effects. RESULTS RD/T risk was increased by one lifting measure: current regular lifting of more than 30 lbs (>13.6 kg). In the population aged less than 65 years, the odds ratio comparing those with/without heavy lifting was 1.81, 95% confidence interval = 1.08 to 3.04. CONCLUSION Occupational heavy lifting may represent a risk factor for RD/T, but further research is needed in populations with frequent heavy physical exertion to more precisely quantify the risk.
Collapse
|
|
10
|
Gatti M, Bianchin M, Raschi E, De Ponti F. Assessing the association between fluoroquinolones and emerging adverse drug reactions raised by regulatory agencies: An umbrella review. Eur J Intern Med 2020; 75:60-70. [PMID: 31983604 DOI: 10.1016/j.ejim.2020.01.009] [Citation(s) in RCA: 25] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/03/2019] [Revised: 01/11/2020] [Accepted: 01/15/2020] [Indexed: 12/16/2022]
Abstract
BACKGROUND Regulatory agencies warned against fluoroquinolones for the management of minor infections because of the risk of emerging adverse events (collagen-associated adverse events, neuropsychiatric toxicity and long-term disability). We aimed to assess quality and credibility of evidence as well as causality regarding these putative associations. METHODS MEDLINE, Scopus, Web of Science and PROSPERO were searched, from inception to August 2019, for systematic reviews with meta-analyses investigating emerging adverse events. Two investigators extracted data to grade quality (through validated AMSTAR-2 tool), rank credibility of the evidence (convincing, highly suggestive, suggestive, weak) through adapted criteria including E-value calculation, and assess causality (Hill's criteria). RESULTS Seven systematic reviews of observational studies providing 16 risk estimates [seven, five and four, respectively, for aortic aneurysm/dissection (AAD), retinal detachment (RD) and any tendon disorders (ATD)] met inclusion criteria. No systematic reviews with meta-analysis investigating the risk of neuropsychiatric toxicity or long-term disability were found. The associations between fluoroquinolones and AAD/ATD showed highly suggestive credibility and were supported by strong evidence of causality (double increased risk, especially within first 2 months of treatment). Conflicting data concerning the emergence of RD were retrieved, resulting in weak evidence of causality. Quality of the evidence ranged from high to low for AAD, from moderate to critically low for RD, and it was moderate for ATD. CONCLUSION Our analysis supports credible, plausible and highly suggestive associations with AAD (rare occurrence but strong causality) and ATD. Limitations of both umbrella reviews and observational evidence should be considered.
Collapse
Affiliation(s)
- Milo Gatti
- Department of Medical and Surgical Sciences, Alma Mater Studiorum, University of Bologna, Via Irnerio 48, 40126, Bologna, Italy
| | - Matteo Bianchin
- Department of Medical and Surgical Sciences, Alma Mater Studiorum, University of Bologna, Via Irnerio 48, 40126, Bologna, Italy
| | - Emanuel Raschi
- Department of Medical and Surgical Sciences, Alma Mater Studiorum, University of Bologna, Via Irnerio 48, 40126, Bologna, Italy.
| | - Fabrizio De Ponti
- Department of Medical and Surgical Sciences, Alma Mater Studiorum, University of Bologna, Via Irnerio 48, 40126, Bologna, Italy
| |
Collapse
|
|
11
|
Yu X, Jiang DS, Wang J, Wang R, Chen T, Wang K, Cao S, Wei X. Fluoroquinolone Use and the Risk of Collagen-Associated Adverse Events: A Systematic Review and Meta-Analysis. Drug Saf 2020; 42:1025-1033. [PMID: 31077091 DOI: 10.1007/s40264-019-00828-z] [Citation(s) in RCA: 23] [Impact Index Per Article: 4.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/29/2022]
Abstract
INTRODUCTION It has been suggested that fluoroquinolone antibiotics increase the risk of developing collagen-associated adverse events such as aortic dissection and aortic aneurysm. These are life-threatening emergencies that need to be prevented. OBJECTIVES We performed this systematic review to clarify the association between fluoroquinolones and three collagen-associated adverse events: aortic aneurysm or aortic dissection, retinal detachment, and tendon disorders. METHODS We searched PubMed, Embase, and Scopus for observational studies up to January 2019. Cohort and case-control studies were included if they reported data on the risk of collagen-related adverse events associated with fluoroquinolone exposure versus no exposure. We assessed the quality of the included studies using the Newcastle-Ottawa Scale. Effect statistics were pooled using random-effects models. Sensitivity and subgroup analyses were performed to identify any source of heterogeneity. RESULTS After screening 2729 citations, we included 22 observational studies (12 cohort studies and ten case-control studies) with 19,207,552 participants. Current use of fluoroquinolones was significantly associated with aortic aneurysm and aortic dissection (odds ratio [OR] 2.20; 95% confidence interval [CI] 1.92-2.52), tendon disorders (OR 1.89; 95% CI 1.53-2.33), and retinal detachment (sensitivity analysis, OR 1.25; 95% CI 1.01-1.53). Past fluoroquinolone use (> 30 and ≤ 365 days) was associated with retinal detachment (OR 1.27; 95% CI 1.09-1.47). CONCLUSIONS Fluoroquinolone use incurs a risk of developing three collagen-associated diseases (aortic aneurysm or aortic dissection, retinal detachment, and tendon disorders). Patients at an increased risk of collagen-associated diseases should not use fluoroquinolones unless no other options are available.
Collapse
Affiliation(s)
- Xinyu Yu
- Division of Cardiothoracic and Vascular Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China
| | - Ding-Sheng Jiang
- Division of Cardiothoracic and Vascular Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.,Key Laboratory of Organ Transplantation, Ministry of Education, Wuhan, China.,NHC Key Laboratory of Organ Transplantation, Wuhan, China.,Key Laboratory of Organ Transplantation, Chinese Academy of Medical Sciences, Wuhan, China
| | - Jing Wang
- Division of Cardiothoracic and Vascular Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China
| | - Rui Wang
- Division of Cardiothoracic and Vascular Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China
| | - Taiqiang Chen
- Division of Cardiothoracic and Vascular Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China
| | - Kan Wang
- Division of Cardiothoracic and Vascular Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China
| | - Shiyi Cao
- School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.
| | - Xiang Wei
- Division of Cardiothoracic and Vascular Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China. .,Key Laboratory of Organ Transplantation, Ministry of Education, Wuhan, China. .,NHC Key Laboratory of Organ Transplantation, Wuhan, China. .,Key Laboratory of Organ Transplantation, Chinese Academy of Medical Sciences, Wuhan, China.
| |
Collapse
|
|
12
|
Penedones A, Alves C, Batel Marques F. A comparison between two recommendations to conduct and report systematic reviews on drug's safety. Syst Rev 2019; 8:238. [PMID: 31619279 PMCID: PMC6796334 DOI: 10.1186/s13643-019-1167-5] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/21/2019] [Accepted: 09/21/2019] [Indexed: 12/23/2022] Open
Abstract
BACKGROUND Several recommendations are available to conduct and report a systematic review of adverse drug reactions. This study is aimed at identifying and comparing the methodologies of the two most commonly used recommendations to conduct and report systematic reviews on drug's safety. METHODS Two systematic reviews were conducted following the recommendations "Cochrane Handbook for Systematic Reviews of Interventions" and "Systematic Reviews' Centre for Reviews and Dissemination guidance for undertaking reviews in healthcare." The methods of each recommendation were characterized, and the results and the discussion of each systematic review were also evaluated. RESULTS The methodologies of both recommendations are similar. The review question was structured. Both recommendations suggest to include pre- and post-marketing data. The recommended data sources differed and, consequently, the results of the systematic reviews (37 vs. 35 studies). Other aspects of search literature were identical. Different tools are suggested to evaluate the methodological quality of the included studies. For case reports, both recommendations only report some questions that may be helpful to assess risk of bias. The reporting of the results and discussion is also identical for both recommendations. CONCLUSIONS Few methodological differences were observed between the analyzed recommendations to conduct a systematic review on drug's safety. Combining their methods into a single and recognized recommendation could be of great value.
Collapse
Affiliation(s)
- Ana Penedones
- Centre for Health Technology Assessment and Drug Research (CHAD), Association for Innovation and Biomedical Research on Light and Image (AIBILI), Azinhaga Sta. Comba, Celas, 3000-548 Coimbra, Portugal
- Laboratory of Social Pharmacy and Public Health, School of Pharmacy, University of Coimbra, Coimbra, Portugal
| | - Carlos Alves
- Centre for Health Technology Assessment and Drug Research (CHAD), Association for Innovation and Biomedical Research on Light and Image (AIBILI), Azinhaga Sta. Comba, Celas, 3000-548 Coimbra, Portugal
- Laboratory of Social Pharmacy and Public Health, School of Pharmacy, University of Coimbra, Coimbra, Portugal
| | - Francisco Batel Marques
- Centre for Health Technology Assessment and Drug Research (CHAD), Association for Innovation and Biomedical Research on Light and Image (AIBILI), Azinhaga Sta. Comba, Celas, 3000-548 Coimbra, Portugal
- Laboratory of Social Pharmacy and Public Health, School of Pharmacy, University of Coimbra, Coimbra, Portugal
| |
Collapse
|
|
13
|
Silva JT, San-Juan R, Fernández-Ruiz M, Aguado JM. Fluoroquinolones for the treatment of latent Mycobacterium tuberculosis infection in liver transplantation. World J Gastroenterol 2019; 25:3291-3298. [PMID: 31341356 PMCID: PMC6639553 DOI: 10.3748/wjg.v25.i26.3291] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/18/2019] [Revised: 05/30/2019] [Accepted: 06/08/2019] [Indexed: 02/06/2023] Open
Abstract
Solid organ transplantation (SOT) is the best treatment option for end-stage organ disease. Newer immunosuppressive agents have reduced the incidence of graft rejection but have increased the risk of infection, particularly due to the reactivation of latent infections due to opportunistic agents such as Mycobacterium tuberculosis. Active tuberculosis (TB) after SOT is a significant cause of morbidity and mortality. Most cases of posttransplant TB are secondary to reactivation of latent tuberculosis infection (LTBI) due to the effects of long-term immunosuppressive therapy. Risk minimization strategies have been developed to diagnose LTBI and initiate treatment prior to transplantation. Isoniazid with vitamin B6 supplementation is the treatment of choice. However, liver transplantation (LT) candidates and recipients have an increased risk of isoniazid-induced liver toxicity, leading to lower treatment completion rates than in other SOT populations. Fluoroquinolones (FQs) exhibit good in vitro antimycobacterial activity and a lower risk of drug-induced liver injury than isoniazid. In the present review, we highlight the disease burden posed by posttransplant TB and summarize the emerging clinical evidence supporting the use of FQs for the treatment of LTBI in LT recipients and candidates.
Collapse
Affiliation(s)
- Jose Tiago Silva
- Unit of Infectious Diseases, Hospital Universitario “12 de Octubre”, Instituto de Investigación Hospital “12 de Octubre” (imas12), School of Medicine, Universidad Complutense, Madrid 28041, Spain
| | - Rafael San-Juan
- Unit of Infectious Diseases, Hospital Universitario “12 de Octubre”, Instituto de Investigación Hospital “12 de Octubre” (imas12), School of Medicine, Universidad Complutense, Madrid 28041, Spain
| | - Mario Fernández-Ruiz
- Unit of Infectious Diseases, Hospital Universitario “12 de Octubre”, Instituto de Investigación Hospital “12 de Octubre” (imas12), School of Medicine, Universidad Complutense, Madrid 28041, Spain
| | - José María Aguado
- Unit of Infectious Diseases, Hospital Universitario “12 de Octubre”, Instituto de Investigación Hospital “12 de Octubre” (imas12), School of Medicine, Universidad Complutense, Madrid 28041, Spain
| |
Collapse
|
|
14
|
Choi SY, Lim HA, Yim HW, Park YH. Administration of oral fluoroquinolone and the risk of rhegmatogenous retinal detachment: A nationwide population-based study in Korea. PLoS One 2018; 13:e0195563. [PMID: 29649310 PMCID: PMC5896937 DOI: 10.1371/journal.pone.0195563] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/30/2018] [Accepted: 03/23/2018] [Indexed: 01/02/2023] Open
Abstract
PURPOSE To investigate the association between oral fluoroquinolones (FQ) and the risk of rhegmatogenous retinal detachment (RRD) using a nationwide population-based study in Korea, designed to control for time-related bias. METHODS As a nested case-control study within a cohort, the KNHIS-NSC 2002-2013 (Korean National Health Insurance Service National Sample Cohort) data used for the investigation. The subjects who visited an ophthalmologist were included in a cohort. Subjects with infectious ocular diseases, severe ocular trauma, and congenital diseases were excluded. Within the cohort, subjects who underwent surgery for RRD were defined as cases, and controls were matched by age group, sex, and cohort entry date using an incidence density sampling method. After investigating the exposure to oral FQ, the odds ratio was calculated by the FQ exposure rate of both groups and adjusted by the confounding factors of demography, health service utilization, and comorbidities. RESULTS A total of 1,151 subjects in the case group and 11,470 subjects in the control group were included. There were intergroup differences in household income, numbers of ophthalmologic visits and drug prescriptions, events of intraocular surgeries, and prevalence of diabetes and degenerative myopia (all P's<0.05). The crude odds ratio of the total group was 1.06 (P = 0.53, 95% CI 0.88-1.28), and the odds ratio adjusted for all pre-defined confounders was 1.00 (P = 0.99, 95% CI 0.81-1.24). The crude and adjusted odds ratios were not showed statistical significance (all P's>0.05). CONCLUSIONS By the nested case-control design, this study showed that oral administration of FQ was not associated with the increased risk of development of RRD.
Collapse
Affiliation(s)
- Seung Yong Choi
- Department of Ophthalmology and Visual Science, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea
| | - Hyun-A. Lim
- Department of Preventive Medicine, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea
| | - Hyeon Woo Yim
- Department of Preventive Medicine, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea
| | - Young-Hoon Park
- Department of Ophthalmology and Visual Science, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea
- Catholic Institute for Visual Science, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea
| |
Collapse
|
|
15
|
Forooghian F. The importance of validation in ophthalmic medical claims database research. Can J Ophthalmol 2017; 52:143-144. [PMID: 28457280 DOI: 10.1016/j.jcjo.2016.12.005] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/06/2016] [Accepted: 12/23/2016] [Indexed: 10/20/2022]
|
|
16
|
Farioli A, Kriebel D, Mattioli S, Kjellberg K, Hemmingsson T. Occupational lifting and rhegmatogenous retinal detachment: a follow-up study of Swedish conscripts. Occup Environ Med 2017; 74:489-495. [DOI: 10.1136/oemed-2016-104172] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/28/2016] [Revised: 01/30/2017] [Accepted: 02/06/2017] [Indexed: 01/06/2023]
|