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

Frontiers in Pharmacology, Год журнала: 2025, Номер 16

Опубликована: Март 18, 2025

Tyrosine kinase inhibitors (TKIs) are the preferred targeted therapy for advanced gastrointestinal stromal tumors (GIST). Ripretinib, first tyrosine switch control inhibitor, has not yet been extensively studied long-term safety in large populations. This study evaluates Ripretinib-related adverse events (AEs) real-world applications by analyzing data from FDA's Adverse Event Reporting System (FAERS). To quantify signals of AEs, we employed several disproportionality analyses: Odds Ratio (ROR), Proportional (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS). In FAERS database, out 7,064,646 reports, 3,161 were identified as related to Ripretinib with 438 significant terms. The most common reactions tiredness, hair loss, nausea, constipation, diarrhea, loss appetite, palmar-plantar erythrodysesthesia syndrome, vomiting. These align medication instructions reports corresponding clinical trials. Notably, label includes unexpected AEs such "hepatic neoplasm", "hair texture abnormal", "metastases liver" "red blood cell count decreased". median onset time was 99 days, an interquartile range 27-245 days. Most cases (26.74%, n = 165) occurred within month administration. Our findings observations. We novel signatures indicating that prospective studies necessary confirm these clarify their implications. results could provide valuable evidence guide further on Ripretinib.

Язык: Английский

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Association of PI3K/AKT/mTOR Pathway with Cancer and Its Therapeutic Implications

Опубликована: Янв. 1, 2025

Язык: Английский

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

Frontiers in Pharmacology, Год журнала: 2025, Номер 16

Опубликована: Апрель 25, 2025

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. The FAERS database was queried first quarter 2004 fourth 2023. Disproportionality analysis conducted reporting odds ratio (ROR) empirical Bayes geometric mean (EBGM). 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. does indicate an signal at present. Subgroup slight group; however, detected based on these Further comprehensive prospective studies are necessary confirm validate findings.

Язык: Английский

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Nephrotoxicity of direct factor Xa inhibitors: a pharmacovigilance study using real-world data from the Federal Adverse Event Reporting System database

Postgraduate Medical Journal, Год журнала: 2025, Номер unknown

Опубликована: Май 13, 2025

Abstract Background Factor Xa inhibitors (FXaIs) may induce nephrotoxicity despite their FDA approval for thrombotic diseases, which has raised concerns due to its severe consequences. This study utilizes the FAERS database assess potential link between direct FXaIs and nephrotoxicity. Methods Data from database, spanning third quarter of 2011 fourth 2023, were used perform a disproportionality analysis on Apixaban, Edoxaban, Rivaroxaban. Disproportionality statistical processing conducted using R software. Results Descriptive revealed that males individuals aged 65–85 are more susceptible nephrotoxic adverse events. The indicated all three drugs associated with acute renal failure renovascular disorders, Edoxaban showing strongest correlation. Conclusions quantitatively analysed relative risk reactions FXaIs, emphasizing importance function monitoring these medications. results indicate significant association nephrotoxicity, necessitating closer attention use recommending additional tests drug concentration testing high-risk patients.

Язык: Английский

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Uncovering safety signals of duloxetine: Real-world evidence from the FAERS database

Journal of Affective Disorders, Год журнала: 2025, Номер unknown, С. 119517 - 119517

Опубликована: Май 1, 2025

Язык: Английский

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Gastrointestinal adverse events associated with SNRIs: A FAERS-based pharmacovigilance study

Journal of Affective Disorders, Год журнала: 2025, Номер 387, С. 119484 - 119484

Опубликована: Май 27, 2025

Язык: Английский

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

Frontiers in Pharmacology, Год журнала: 2024, Номер 15

Опубликована: Окт. 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

Язык: Английский

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

Research Square (Research Square), Год журнала: 2024, Номер unknown

Опубликована: Май 15, 2024

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

Язык: Английский

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

Expert Opinion on Drug Safety, Год журнала: 2024, Номер unknown, С. 1 - 8

Опубликована: Дек. 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.

Язык: Английский

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

Journal of Evidence-Based Medicine, Год журнала: 2024, Номер 17(4), С. 795 - 807

Опубликована: Дек. 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.

Язык: Английский

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