Expert Opinion on Drug Safety最新文献_第8页

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-04-10 DOI: 10.1080/14740338.2025.2490847

Hanxu Zhang, Mengya Li, Wei Liu, Hengjie Yuan

{"title":"Dementia-related adverse events associated with direct oral anticoagulants use: a real-world, pharmacovigilance study based on the FAERS database.","authors":"Hanxu Zhang, Mengya Li, Wei Liu, Hengjie Yuan","doi":"10.1080/14740338.2025.2490847","DOIUrl":"https://doi.org/10.1080/14740338.2025.2490847","url":null,"abstract":"Background: Direct oral anticoagulants (DOACs) are commonly used to prevent and treat thromboembolic diseases. This study aimed to assess and compare dementia related adverse events (AEs) associated with DOACs.Research design and methods: AEs related to DOACs from January 2014 to June 2023 were extracted from the FDA Adverse Event Reporting System (FAERS) database. Disproportionality analysis methods, including reporting odds ratio (ROR), proportional reporting ratio, Bayesian Confidence Propagation Neural Network, and Multi-Item Gamma Poisson Shrinker, were used to evaluate the association between DOACs and dementia-related AEs.Results: There were 12,692,968 AEs reported in FAERS after deduplication. Among these, 165, 206, 1574, and 12 dementia-related AEs that were attributed to dabigatran, rivaroxaban, apixaban, and edoxaban, respectively. Apixaban showed the strongest association with dementia-related AEs (ROR 7.66, 95% confidence interval (CI) 7.27-8.06), while rivaroxaban had the lowest ROR (0.95, 95%CI 0.83-1.09). Women exhibited higher RORs for all DOACs, with apixaban showing the most significant correlation. Subgroup analysis indicated a significant link between apixaban and dementia, dementia Alzheimer's type and senile dementia.Conclusions: Apixaban appears most associated with dementia-related AEs among DOACs, whereas rivaroxaban poses a lower risk. Further research is needed to validate these findings through large-scale prospective studies.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-10"},"PeriodicalIF":3.0,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143993069","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Analysis of adverse events induced by fluconazole based on FAERS database. 基于FAERS数据库的氟康唑不良事件分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-04-10 DOI: 10.1080/14740338.2025.2490837

Tang Su, Li Jianglin, Su Si, Liu Xin

{"title":"Analysis of adverse events induced by fluconazole based on FAERS database.","authors":"Tang Su, Li Jianglin, Su Si, Liu Xin","doi":"10.1080/14740338.2025.2490837","DOIUrl":"10.1080/14740338.2025.2490837","url":null,"abstract":"Background: Fluconazole, a widely used antifungal agent, has been associated with various adverse events (AEs). This study aimed to analyze the safety profiles of fluconazole using the FDA Adverse Event Reporting System (FAERS) database to provide insights for its safe use.Research design and methods: Fluconazole-related AEs from 2004 to 2024Q2 were extracted from the FAERS database. The Reporting Odds Ratio (ROR) method was employed to detect and analyze safety signals. Additionally, the impact of COVID-19 on fluconazole safety was also examined.Results: A total of 7,720 AEs were identified, with 40.3% being serious. The most common AEs involved skin, gastrointestinal, and administration site reactions. High doses of fluconazole were linked to increased teratogenic risks. Weekly dosing regimens and doses below 200 mg/day were associated with fewer severe AEs. During the COVID-19 pandemic, there was a notable rise in reports of drug inefficacy and hepatic/renal damage. Additionally, 45 new adverse reactions were identified.Conclusions: The study highlights the importance of monitoring liver, kidney, and cardiovascular functions during fluconazole use, especially in high-risk populations. The findings underscore the need for careful dosing and consideration of drug interactions, particularly during the COVID-19 pandemic, to ensure safe and effective use of fluconazole.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-9"},"PeriodicalIF":3.0,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143810816","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Diarrhea-predominant irritable bowel syndrome treatment options eluxadoline, rifaximin, and alosetron: analysis of the FDA adverse event reporting system (FAERS) database. 腹泻为主的肠易激综合征治疗选择依洛沙多林、利福昔明和阿洛司琼：FDA不良事件报告系统（FAERS）数据库的分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-04-09 DOI: 10.1080/14740338.2025.2490841

Michael B Andrews, Douglas G Adler

{"title":"Diarrhea-predominant irritable bowel syndrome treatment options eluxadoline, rifaximin, and alosetron: analysis of the FDA adverse event reporting system (FAERS) database.","authors":"Michael B Andrews, Douglas G Adler","doi":"10.1080/14740338.2025.2490841","DOIUrl":"10.1080/14740338.2025.2490841","url":null,"abstract":"Background: Adverse events (AEs) suspected to be associated with the three FDA approved medications (eluxadoline, rifaximin, and alosetron) for diarrhea-predominant irritable bowel syndrome (IBS-D) were examined.Research design and methods: We analyzed all reports in the FDA Adverse Event Reporting System (FAERS) database from each medication's date of FDA approval through 30 June 2024. Reports were excluded if they contained other suspected medications or had a reason for use outside of IBS and/or diarrhea.Results: Eluxadoline was associated with 1,002 AEs, most commonly abdominal pain (n = 257, 17.0%) and uniquely pancreatitis (n = 174, 11.5%) and sphincter of Oddi dysfunction (n = 39, 2.6%). Rifaximin was associated with 652 AEs, most commonly abdominal pain (n = 64, 7.6%) and uniquely C.difficile and bacterial overgrowth (n = 3, 0.4% each). Alosetron was associated with 3,832AEs, most commonly constipation (n = 2,007, 23.1%) and uniquely colitis (n = 235,2.7%), ischemic colitis (n = 140, 1.6%), obstruction (n = 110, 1.3%), and perforation (n = 26, 0.3%).Conclusions: Our analysis of the FAERS database showed frequent reports of abdominal pain, constipation, and nausea/vomiting related to the three FDA approved medications for IBS-D. Each raised concerns for distinct and serious AEs including pancreatitis (eluxadoline), C.difficile infection (rifaximin), ischemic colitis (alosetron), and intestinal obstruction/perforation (alosetron).","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-7"},"PeriodicalIF":3.0,"publicationDate":"2025-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143803013","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

A real-world disproportionality analysis of cidofovir from the FDA Adverse Event Reporting System (FAERS) database. 来自FDA不良事件报告系统（FAERS）数据库的西多福韦的现实世界歧化分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-04-09 DOI: 10.1080/14740338.2025.2490271

Chengzhi Liu, Xinyu Wang, Chuanlie Zhou, Xusheng Cao

{"title":"A real-world disproportionality analysis of cidofovir from the FDA Adverse Event Reporting System (FAERS) database.","authors":"Chengzhi Liu, Xinyu Wang, Chuanlie Zhou, Xusheng Cao","doi":"10.1080/14740338.2025.2490271","DOIUrl":"10.1080/14740338.2025.2490271","url":null,"abstract":"Background: Cidofovir, an antiviral drug used to treat cytomegalovirus retinitis in AIDS patients. While effective against several viruses, cidofovir's nephrotoxicity and other adverse events (AEs) limit its broader use. This study aims to evaluate the AE profile of cidofovir using data from the FAERS database.Research design and methods: An analysis of FAERS data from the first quarter of 2004 to the fourth quarter of 2023 was performed. Signal detection was conducted using four algorithms: ROR, PRR, BCPNN, and EBGM. Data were categorized by system organ classes (SOCs) and preferred terms (PTs), and the strength of association between cidofovir and AEs was assessed.Results: 1,874 AE reports involving 1,266 patients were identified. 'Renal and urinary disorders,' 'Infections and infestations,' and 'Immune system disorders' were the most frequently reported SOCs, with the highest signal detected for 'Renal and urinary disorders.' Off-label use was the most common PT, highlighting the importance of controlling the indication of medication in clinical practice.Conclusion: This study identified significant signals related to cidofovir, suggesting that clinicians should carefully monitor patients, especially when using cidofovir for off-label purposes to mitigate potential risk outcomes. Further research is needed to optimize the safe and effective use of cidofovir.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-9"},"PeriodicalIF":3.0,"publicationDate":"2025-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143795001","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Exploration of cardiac adverse events associated with relugolix and degarelix: a multi-center pharmacovigilance study based on the FAERS database. 探索与雷鲁高利和德格雷利克斯相关的心脏不良事件：基于FAERS数据库的多中心药物警戒研究。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-04-08 DOI: 10.1080/14740338.2025.2488239

Meina Lv, Jianhui Chen, Bin Zheng, Bijuan Lin, Maobai Liu

{"title":"Exploration of cardiac adverse events associated with relugolix and degarelix: a multi-center pharmacovigilance study based on the FAERS database.","authors":"Meina Lv, Jianhui Chen, Bin Zheng, Bijuan Lin, Maobai Liu","doi":"10.1080/14740338.2025.2488239","DOIUrl":"10.1080/14740338.2025.2488239","url":null,"abstract":"Background: Relugolix and degarelix are gonadotropin-releasing hormone antagonist. However, the cardiac safety of relugolix and degarelix in the real world remains uncertain. The purpose of this study was to explore the potential association of relugolix and degarelix with cardiac adverse events (AEs).Methods: We queried the FAERS database and selected AE reports with relugolix or degarelix as the first suspected drug for analysis. Reporting odds ratio (ROR) and empirical Bayes geometric mean (EBGM) were used to quantify the association between relugolix and degarelix and cardiac AEs.Results: A total of 5,598 and 372 AEs were reported for relugolix and degarelix, respectively, with 235 and 56 being cardiac AEs. The cardiac AEs associated with relugolix and degarelix predominantly occurred in elderly patients (>65 years). Disproportionality analysis showed that relugolix was significantly associated with electrocardiogram/heart rate abnormality and palpitations, with the strongest signal for electrocardiogram abnormality (ROR = 77.54, EBGM = 68.64). While degarelix was significantly associated with cardiac failure, myocardial Infarction, and arrhythmia, with cardiac failure showing the strongest signal (ROR = 8.62, EBGM = 97.71).Conclusions: There are differences in the types of cardiac adverse events induced by relugolix and degarelix. Clinicians should consider their differences and enhanced electrocardiogram monitoring when prescribing GnRH antagonists to their patients.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-8"},"PeriodicalIF":3.0,"publicationDate":"2025-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143771758","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

A disproportionality analysis of hydrocortisone-related adverse events: a real-world pharmacovigilance study using the FAERS database. 氢化可的松相关不良事件的歧化分析：使用FAERS数据库的现实世界药物警戒研究。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-04-07 DOI: 10.1080/14740338.2025.2487159

Xiaoyu Wang, Fan An, Xuelian Zhao, Benjun Wang, Liwei Yan, Weiwei Han

{"title":"A disproportionality analysis of hydrocortisone-related adverse events: a real-world pharmacovigilance study using the FAERS database.","authors":"Xiaoyu Wang, Fan An, Xuelian Zhao, Benjun Wang, Liwei Yan, Weiwei Han","doi":"10.1080/14740338.2025.2487159","DOIUrl":"10.1080/14740338.2025.2487159","url":null,"abstract":"Background: This study aims to systematically evaluate adverse events (AEs) associated with hydrocortisone through the FDA Adverse Event Reporting System (FAERS) database.Research designs: AE reports associated with hydrocortisone from Q1 2014 to Q4 2023 were extracted from the FAERS database. Multiple disproportionality analysis techniques, including Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayes Geometric Mean (EBGM), were employed for signal detection. In addition, we also analyzed the time to onset of AEs.Results: Analysis of 7,532 hydrocortisone-associated AEs from the FAERS database revealed significant signals across multiple system organ classes. The strongest associations were found in endocrine disorders (ROR: 13.39), ear and labyrinth disorders (ROR: 3.05), and immune system disorders (ROR: 2.17). Additionally, the study uncovered unexpected AEs such as splenic peliosis and lymphoid tissue hypoplasia. 63.9% of the AEs occurred within 7 days of treatment.Conclusions: Based on disproportionality analysis of FAERS data, this study provides new insights into the safety of hydrocortisone in the real-world setting. Future prospective studies should be conducted to validate the findings of this investigation.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-10"},"PeriodicalIF":3.0,"publicationDate":"2025-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143751483","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Analysis of diroximel fumarate data for patients with relapsing forms of multiple sclerosis using related adverse events from the FDA adverse reporting system. 利用FDA不良反应报告系统的相关不良事件分析复发型多发性硬化症患者的富马酸地洛昔美尔数据。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-04-03 DOI: 10.1080/14740338.2025.2488318

Jing-Ya Yang, Sheng-Zhu Sun, Yi-Yan Sun, Tian-Qi Zuo, Xiao-Tong Li, Lei-Yong Zhao, Hong-Yun Wu, Wei Peng

{"title":"Analysis of diroximel fumarate data for patients with relapsing forms of multiple sclerosis using related adverse events from the FDA adverse reporting system.","authors":"Jing-Ya Yang, Sheng-Zhu Sun, Yi-Yan Sun, Tian-Qi Zuo, Xiao-Tong Li, Lei-Yong Zhao, Hong-Yun Wu, Wei Peng","doi":"10.1080/14740338.2025.2488318","DOIUrl":"10.1080/14740338.2025.2488318","url":null,"abstract":"Background: Diroximel fumarate (DRF) is an oral fumarate used to treat relapsing forms of multiple sclerosis (RMS). This study comprehensively analyzed the adverse events (AEs) associated with DRF for treating RMS based on data from the FDA Adverse Event Reporting System (FAERS) database.Research design and methods: This study collected data on AEs associated with DRF treatment of RMS from the FAERS database between 2019 and 2024. We used reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS) for signal detection.Results: This study collected 7,944,554 AE reports, of which 7,868 were associated with DRF. A total of 120 preferred terms (PTs) were included in the analysis, relating to 27 system organ classes (SOCs). This study identified several clinically significant new potential AEs, including decreased immune responsiveness (n = 26, ROR 4.45, PRR 4.45, IC 2.15, EBGM 4.43), female breast cancer (n = 50, ROR 4.07, PRR 4.07, IC 2.02, EBGM 4.05), transient blindness (n = 19, ROR 7.27, PRR 7.26, IC 2.85, EBGM 7.21) and others.Conclusions: Our study identified several potentially important AEs that were not mentioned in the DRF instructions. However, further epidemiologic studies are needed to validate these findings.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-8"},"PeriodicalIF":3.0,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143763306","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Influence factors of metronidazole-related CNS disorders: an analysis of the Japan adverse drug event report and FDA adverse event reporting system. 甲硝唑相关中枢神经系统疾病的影响因素：日本不良事件报告与FDA不良事件报告制度分析

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-04-03 DOI: 10.1080/14740338.2025.2486308

Keisuke Takada, Yuki Enoki, Masaru Samura, Yuki Igarashi, Kazuaki Taguchi, Koji Tanikawa, Kazuaki Matsumoto

{"title":"Influence factors of metronidazole-related CNS disorders: an analysis of the Japan adverse drug event report and FDA adverse event reporting system.","authors":"Keisuke Takada, Yuki Enoki, Masaru Samura, Yuki Igarashi, Kazuaki Taguchi, Koji Tanikawa, Kazuaki Matsumoto","doi":"10.1080/14740338.2025.2486308","DOIUrl":"10.1080/14740338.2025.2486308","url":null,"abstract":"Background: Metronidazole (MNZ) can be administered for various infections. The impact of comorbidities/concomitant drugs on MNZ-induced central nervous system (CNS) disorders remains unclear.Research design and methods: We assessed the risk of metronidazole-related CNS disorders using the Japan Adverse Drug Event Report (JADER, May 2023) and the US Food and Drug Administration Adverse Event Reporting System (FAERS, Q1 2023), excluding comorbidities/concomitant drugs. Clonazepam and diazepam were evaluated as potential prophylactics based on the efficacy of benzodiazepines for MNZ-related CNS disorders. Reporting odds ratios (ROR) and 95% confidence intervals (CI) were calculated. Additionally, sensitivity analysis by sex and age was conducted.Results: The ROR (95% CI) of CNS disorders associated with MNZ in JADER and FAERS were 3.16 (2.69-3.72) and 1.69 (1.64-1.73), respectively. MNZ was significantly related to CNS disorders after excluding comorbidities (brain/spinal cord or liver abscesses) and concomitant drugs (glucocorticoids, antiepileptic, antiparkinson, and schizophrenia drugs). In sensitivity analysis, MNZ was significantly related to CNS disorders, despite sex and age. The ROR in the concomitant with clonazepam (CZP) was 0.70 (0.53-0.92) in FAERS.Conclusion: MNZ may be associated with CNS disorders, even if comorbidities/concomitant drugs that are potential risk factors for CNS disorders are excluded. Additionally, CZP may suppress CNS disorders.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-7"},"PeriodicalIF":3.0,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143751694","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Adverse event signal analysis of type Ib MET tyrosine kinase inhibitors based on food and drug administration adverse event reporting system. 基于食品药品监督管理不良事件报告系统的Ib型MET酪氨酸激酶抑制剂不良事件信号分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-04-03 DOI: 10.1080/14740338.2025.2487158

Junyu Wang, Rong Ma, Binbin Qu, Xiangpeng Li

{"title":"Adverse event signal analysis of type Ib MET tyrosine kinase inhibitors based on food and drug administration adverse event reporting system.","authors":"Junyu Wang, Rong Ma, Binbin Qu, Xiangpeng Li","doi":"10.1080/14740338.2025.2487158","DOIUrl":"https://doi.org/10.1080/14740338.2025.2487158","url":null,"abstract":"Background: Type Ib MET Tyrosine Kinase Inhibitors (TKIs), such as capmatinib, tepotinib, and savolitinib, are used to treat MET-amplified and MET exon 14 deletion mutant non-small cell lung cancer. This pharmacovigilance study analyzed data from the FDA Adverse Event Reporting System (FAERS) between September 2014 and March 2024 to assess adverse events (AEs) for these FDA-approved drugs.Research design and methods: We conducted a systematic search of AEs using MedDRA SMQs by SOC and PT, and performed disproportionality analysis to identify safety signals, calculating ROR, PRR, EBGM, and IC.Results: The analysis identified significant safety signals: capmatinib showed signals for ear and labyrinth disorders, neoplasms, general disorders, and hepatobiliary disorders; tepotinib for renal and urinary disorders, ear and labyrinth disorders, metabolism and nutrition disorders, and general disorders; savolitinib for hepatobiliary disorders. Key PT signals included protein deficiency, scrotal edema, and chylothorax for capmatinib; edema and decreased blood albumin for tepotinib; and abnormal hepatic function for savolitinib.Conclusion: The study highlights differences in the safety profiles of Type Ib MET TKIs, underscoring the need for further regulatory review and possible updates to product labels to better inform clinicians and patients.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-10"},"PeriodicalIF":3.0,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143771742","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Real-world data analysis of topotecan in combination with Bevacizumab or CycloPhosphamide in the FDA adverse event reporting system (FAERS) database. FDA不良事件报告系统（FAERS）数据库中拓扑替康联合贝伐单抗或环磷酰胺的真实数据分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-04-02 DOI: 10.1080/14740338.2025.2488240

Huihui Chen, Guobiao Zhuang, Shihao Hong, Jing Wu

{"title":"Real-world data analysis of topotecan in combination with Bevacizumab or CycloPhosphamide in the FDA adverse event reporting system (FAERS) database.","authors":"Huihui Chen, Guobiao Zhuang, Shihao Hong, Jing Wu","doi":"10.1080/14740338.2025.2488240","DOIUrl":"https://doi.org/10.1080/14740338.2025.2488240","url":null,"abstract":"Background: The main purpose of this study is to observe and detect adverse reactions to the combination of topotecan, bevacizumab and cyclophosphamide, to learn more about possible adverse drug reactions (ADRs) and to help doctors make the right medication decisions and treatment plans.Research design and methods: Adverse event signals were detected and quantified using data from the U.S. Food and Drug Administration's Adverse Event Reporting System using reporting ratios, proportions of reports (PRR), Bayesian Confidence Propagation Neural Networks (BCPN), and empirical Bayesian Geometric Mean (EBGM). Subgroup analyses were performed to compare adverse events associated with topotecan alone.Results: The analysis of FAERS data revealed a total of 1,789 primary suspected adverse events (PS AEs) linked to topotecan. The Weibull shape parameter (β) for females was lower than for males across all age groups, indicating a potentially higher susceptibility to the adverse effects of topotecan in female patients.Conclusions: This study proved several expected and new adverse drug reactions associated with the combination of topotecan, bevacizumab, and cyclophosphamide. While some ADRs, such as neutropenia and anemia, align with the known adverse profile of topotecan, the detection of novel signals, including potential gender-based differences in drug response, warrants further investigation.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-12"},"PeriodicalIF":3.0,"publicationDate":"2025-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143763307","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0