A real-world data analysis of topotecan in the FDA Adverse Event Reporting System (FAERS) database

Yang, Haiyan; Zheng, Wei; Chen, Moliang; Zhang, Xiaohong; Cui, Wugeng; Zhao, Bin

doi:10.1080/17425255.2023.2219390

Cited by 11 publications

(4 citation statements)

References 21 publications

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“…FAERS database plays a significant function in the absence of clinical trials, especially when monitoring the long-term effects of drug therapies for chronic diseases like CVD becomes essential. The FAERS database gathers a variety of data on AEs and side effects associated with the usage of medicinal products, which is mostly submitted by drug manufacturers, with some data voluntarily submitted by drug users and other healthcare professionals ( Yu et al, 2021 ; Yang et al, 2023 ). By accessing publicly available FAERS data, we can identify ADRs associated with eplerenone, monitor the drug’s safety, and provide guidance for its usage.…”

Section: Discussionmentioning

confidence: 99%

Analysis of eplerenone in the FDA adverse event reporting system (FAERS) database: a focus on overall patient population and gender-specific subgroups

Guan,

Yang,

et al. 2024

Front. Pharmacol.

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Introduction: Eplerenone is approved for the treatment of hypertension as well as symptomatic heart failure with reduced ejection fraction (HFrEF) following an acute myocardial infarction. However, the adverse events (AEs) have not been systematically analyzed. The aim of this study was to identify adverse drug reactions (ADRs) related to eplerenone using the FDA Adverse Event Reporting System (FAERS) database. By identifying previously unreported AEs, the study could potentially contribute to updating the drug’s label.Methods: In order to find significant AEs, four algorithms, including Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN) and Empirical Bayesian Geometric Mean (EBGM), were used to analyze the signal strength of the ADRs connected to eplerenone that were gathered from the FAERS database over the previous 20 years.Results: From 2004Q1 to 2023Q4, a total of 20, 629, 811 reported cases were gathered from the FAERS database for this study. After processing the data and filtering, 1,874 case reports were analyzed. Of these cases, 1,070 AEs were identified, 128 of which were eplerenone-related ADRs. We investigated the occurrence of ADRs induced by eplerenone in 27 organ systems. Our study showed that the AEs listed in the medication’s package insert correspond with those listed in the literature, including hyperkalemia and increased creatinine. Additionally, the prescription label for eplerenone does not include all system organ class (SOC) terms, like Vascular disorders, hepatobiliary Disorders, etc.Discussion: The study used multiple algorithms to quantify the signal strength and then identified any previously unrecognized ADRs, further studies are needed to confirm the association of ADRs with eplerenone. The findings of this study may provide important insights into the safety profile of eplerenone, ensure that healthcare providers have up-to-date information about their potential risks and help guide them in the correct use of the drug.

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Section: Discussionmentioning

confidence: 99%

Analysis of eplerenone in the FDA adverse event reporting system (FAERS) database: a focus on overall patient population and gender-specific subgroups

Guan,

Yang,

et al. 2024

Front. Pharmacol.

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“…Reports were quantitatively assessed by signal detections, where a signal meant a drug-related AE. Researchers has begun to be analyzed on a variety of drugs and diseases using the FAERS database to find potential AEs that should be of particular concern, aiming to provide guidance on clinical medication and treatment ( Yang et al, 2023 ; Zhao et al, 2023 ).…”

Section: Introductionmentioning

confidence: 99%

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

Zhao,

Fu,

Cui

et al. 2024

Front. Pharmacol.

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Background: Everolimus is an inhibitor of the mammalian target of rapamycin and is used to treat various tumors. The presented study aimed to evaluate the Everolimus-associated adverse events (AEs) through data mining of the US Food and Drug Administration Adverse Event Reporting System (FAERS).Methods: The AE records were selected by searching the FDA Adverse Event Reporting System database from the first quarter of 2009 to the first quarter of 2022. Potential adverse event signals were mined using the disproportionality analysis, including reporting odds ratio the proportional reporting ratio the Bayesian confidence propagation neural network and the empirical Bayes geometric mean and MedDRA was used to systematically classify the results.Results: A total of 24,575 AE reports of Everolimus were obtained using data from the FAERS database, and Everolimus-induced AEs occurrence targeted 24 system organ classes after conforming to the four algorithms simultaneously. The common significant SOCs were identified, included benign, malignant and unspecified neoplasms, reproductive system and breast disorders, etc. The significant AEs were then mapped to preferred terms such as stomatitis, pneumonitis and impaired insulin secretion, which have emerged in the study usually reported in patients with Everolimus. Of note, unexpected significant AEs, including biliary ischaemia, angiofibroma, and tuberous sclerosis complex were uncovered in the label.Conclusion: This study provided novel insights into the monitoring, surveillance, and management of adverse drug reaction associated with Everolimus. The outcome of serious adverse events and the corresponding detection signals, as well as the unexpected significant adverse events signals are worthy of attention in order to improving clinical medication safety during treatment of Everolimus.

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“…14 As the largest pharmacovigilance database globally, FAERS serves as a valuable tool for identifying AEs associated with medication use. 15,16 This study aimed to analyze data from the FAERS database and perform post-marketing surveillance to assess the AEs linked with sildenafil.…”

Section: Introductionmentioning

confidence: 99%

“…The FDA Adverse Event Reporting System (FAERS) database is a publicly available voluntary reporting system that contains a wide range of records documenting adverse drug incidents reported by medical practitioners, pharmacists, manufacturers, and other individuals 14 . As the largest pharmacovigilance database globally, FAERS serves as a valuable tool for identifying AEs associated with medication use 15,16 . This study aimed to analyze data from the FAERS database and perform post‐marketing surveillance to assess the AEs linked with sildenafil.…”

Section: Introductionmentioning

confidence: 99%

A real‐world pharmacovigilance study of FDA adverse event reporting system events for sildenafil

Wang,

Zhao,

Yang

et al. 2023

Andrology

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BackgroundSildenafil, a selective inhibitor of phosphodiesterase type 5 (PDE5), is widely used for the treatment of erectile dysfunction (ED). However, the safety profile of sildenafil, including adverse event (AEs), requires comprehensive evaluation.MethodsThis retrospective pharmacovigilance study aimed to evaluate AEs linked to sildenafil by analyzing data sourced from the FDA Adverse Event Reporting System (FAERS) database. A case/non‐case design was utilized, and various algorithms including the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN), and the multiitem gamma Poisson shrinker (MGPS) were employed to measure the signals indicating the presence of sildenafil‐related AEs.ResultsAmong 339,230 reports, 33,692 specifically mentioned sildenafil use. Most of AEs occurred in males over 60 years old. The United States accounted for the highest proportion of reported AEs. Severe outcomes, including death, disability, and life‐threatening events, were reported. Significant system organ class (SOC) included “Reproductive system and breast disorders” (SOC: 10038604), “Neoplasms benign, malignant and unspecified” (SOC: 10038738), “Vascular disorders” (SOC: 10047065), and “Blood and lymphatic system disorders” (SOC: 10005329). Noteworthy preferred terms (PTs) associated with sildenafil included “Vision blurred,” “Flushing,” “sudden hearing loss,” “Painful erection,” and “Priapism.” Unexpected AEs, such as “Malignant melanoma,” “Pulmonary hypertension,” “Malignant melanoma in situ,” “Pulmonary arterial hypertension,” “Metastatic malignant melanoma,” “Malignant melanoma stage III,” “Malignant melanoma stage II,” “Acquired hemophilia,” “Aortic dissection rupture,” and “Intracranial artery dissection” were also identified.ConclusionsThese findings emphasize the importance of monitoring and understanding the potential risks associated with sildenafil. Further investigation is warranted to validate these associations and address previously unrecognized safety concerns.

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A real-world data analysis of topotecan in the FDA Adverse Event Reporting System (FAERS) database

Cited by 11 publications

References 21 publications

Analysis of eplerenone in the FDA adverse event reporting system (FAERS) database: a focus on overall patient population and gender-specific subgroups

Analysis of eplerenone in the FDA adverse event reporting system (FAERS) database: a focus on overall patient population and gender-specific subgroups

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

A real‐world pharmacovigilance study of FDA adverse event reporting system events for sildenafil

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