Cited by A real-world disproportionality analysis of colchicine: data mining of the public version of FDA Adverse Event Reporting System

Analysis of ADR reports of cetuximab based on the FDA adverse event reporting system database DOI

Shuai Zhao,

Yan Wang,

Xiaoli Deng

et al.

Scientific Reports, Journal Year: 2025, Volume and Issue: 15(1)

Published: Feb. 3, 2025

Language: Английский

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Suicidal thoughts and behaviors associated with fluoroquinolone antibiotics: a real-world pharmacovigilance analysis DOI

Lijuan Yang, Congqin Chen,

Lingqing Ding

et al.

Frontiers in Pharmacology, Journal Year: 2025, Volume and Issue: 16

Published: April 25, 2025

Objective This study aimed to systematically and scientifically investigate the potential associations between use of fluoroquinolone antibiotics (ciprofloxacin, levofloxacin, moxifloxacin, ofloxacin, norfloxacin, delafloxacin) suicidal thoughts behaviors using data from Food Drug Administration Adverse Event Reporting System (FAERS) database. Methods The FAERS database was queried first quarter 2004 fourth 2023. Disproportionality analysis conducted reporting odds ratio (ROR) empirical Bayes geometric mean (EBGM). Results A total 737 cases associated with fluoroquinolones (FQs) were reported in during period. Overall, FQs did not demonstrate a disproportionate increase overall (ROR: 0.74, 95% CI: 0.69–0.79, P < 0.001; EBGM05: 0.69). Stratified analyses revealed no safety signals for either females or males. However, subgroup by age groups demonstrated slightly elevated RORs <18 years group 1.51, 1.05–2.19, = 0.03) 18–24 2.31, 1.75–3.06, 0.001), although EBGM05s values remained below two both populations. No significant observed other groups. Conclusion does indicate an signal at present. Subgroup slight group; however, detected based on these Further comprehensive prospective studies are necessary confirm validate findings.

Language: Английский

Citations

Adverse drug reaction signals mining comparison of amiodarone and dronedarone: a pharmacovigilance study based on FAERS DOI

Ye Xu, Bin Zhao, HE Li-qun

et al.

Frontiers in Pharmacology, Journal Year: 2024, Volume and Issue: 15

Published: Oct. 22, 2024

Background Amiodarone and dronedarone are both class III antiarrhythmic medications used to treat arrhythmias. The objective of this study was enhance the current understanding adverse drug reaction (ADR) associated with amiodarone by employing data mining methods on U.S. Food Drug Administration Adverse Event Reporting System (FAERS), providing a reference for safe reasonable clinical use. Methods ADR records were selected searching FAERS database from 2011 Q3 2023 Q3. disproportionality analysis algorithms, including Odds Ratio (ROR), Proportional (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), Empirical Geometric Mean (EBGM), detect signals amiodarone-related dronedarone-related ADRs. profiles categorized organ toxicity compared through Z-test Fisher exact test. Results 9,295 reports specifically mentioned use 2,485 among 9,972,109 reports, majority ADRs occurring in males over 60 years old. United States responsible highest proportion reported Significant system classes (SOC) included Cardiac disorders, Respiratory, thoracic mediastinal Investigations, etc. At preferred terms (PTs) level, more frequent interaction (n = 856), hyperthyroidism 758), dyspnoea 607), while atrial fibrillation 371), 204), blood creatinine increased 123). Notably, unexpected ADRs, electrocardiogram T wave alternans 16; EBGM05 231.27), accessory cardiac pathway 11; 140), thyroiditis 178; 125.91) amiodarone, ablation 31.86), cardioversion 7; 22.69), dysphagia 47; 3.6) dronedarone, uncovered instructions. also revealed significant differences showing higher proportions but lower thyroid amiodarone. Conclusion These findings underscore significance vigilantly monitoring comprehending potential risks linked dronedarone. New discovered clear thorough these drugs, which is essential clinicians ensure

Language: Английский

Citations

A real-world disproportionality analysis of Amiodarone: data mining of the public version of FDA adverse event reporting system DOI

Ye Xu, Bin Zhao, HE Li-qun

et al.

Research Square (Research Square), Journal Year: 2024, Volume and Issue: unknown

Published: May 15, 2024

Abstract Background: Amiodarone is a class III antiarrhythmic medication used to treat arrhythmias for decades. The objective of this study was enhance the current understanding adverse events (AEs) associated with Amiodarone by employing data mining methods on US Food and Drug Administration Adverse Event Reporting System (FAERS). Methods: The AE records were selected searching FDA database from September 2014 2023. disproportionality analysis algorithms, including reporting odds ratio (ROR), proportional (PRR), Bayesian confidence propagation neural network (BCPNN) empirical Bayes geometric mean (EBGM) detected signals Amiodarone-related events. Results: Among 8,595,344 reports, 7,841 specifically mentioned use, majority AEs occurring in males over 60 years old. United States responsible highest proportion reported AEs. Reports severe outcomes, hospitalization, life-threatening death, notable. Significant system organ classes (SOC) included “Cardiac disorders” (SOC: 10007541), “Respiratory, thoracic mediastinal 10038731), “Metabolism nutrition 10027433), etc. significant then mapped preferred terms such as “myxoedema coma” (n=108, EBGM05=499.73), “thyrotoxic crisis” (n=97, EBGM05=194.83), “mitochondrial aspartate aminotransferase increased ” (n=8，EBGM05=186.19)，which have emerged usually patients Amiodarone. Of note, unexpected AEs, “thyroiditis” (n=161, EBGM05=127), “electrocardiogram T wave alternans” (n=13, EBGM05=236.29) “iodine overload” (n=5, EBGM05=152.03), uncovered label. Conclusions: These findings underscore significance vigilantly monitoring comprehending potential risks linked use. Unexpected discovered made thorough drug, which essential clinicians ensure safe use

Language: Английский

Citations

Postmarketing Safety Surveillance of Topiramate: A Signal Detection and Analysis Study Based on the FDA Adverse Event Reporting System Database DOI

Kai Lin,

Mengjiao He,

Zuoqi Ding

et al.

Journal of Evidence-Based Medicine, Journal Year: 2024, Volume and Issue: 17(4), P. 795 - 807

Published: Dec. 1, 2024

This study aims to investigate the occurrence of adverse events associated with topiramate by analyzing data from FDA Adverse Event Reporting System. The goal is provide a basis for safe clinical use topiramate.

Language: Английский

Citations

A real-world disproportionality analysis of colchicine: data mining of the public version of FDA Adverse Event Reporting System DOI

Ye Xu, Zhiguo Dai, Guilong Tian

et al.

Expert Opinion on Drug Safety, Journal Year: 2024, Volume and Issue: unknown, P. 1 - 8

Published: Dec. 12, 2024

Colchicine is widely used for gout and familial Mediterranean fever (FMF) has cardiovascular benefits. However, it linked to various adverse drug reactions (ADRs). This study aimed analyze colchicine-related ADRs using FAERS data safer clinical use.

Language: Английский

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