Expert Opinion on Drug Safety最新文献_第10页

Drug classes associated with the development of fulminant type 1 diabetes: a retrospective analysis using the FDA adverse event reporting system database. 与暴发性1型糖尿病相关的药物类别：使用FDA不良事件报告系统数据库的回顾性分析

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-04-01 Epub Date: 2025-01-21 DOI: 10.1080/14740338.2024.2448202

Yang Zhou, Yupeng Chen, Shan Zhang, Zhige Wen, Zifan Zhuang, Xinyao Liu, Qing Ni

{"title":"Drug classes associated with the development of fulminant type 1 diabetes: a retrospective analysis using the FDA adverse event reporting system database.","authors":"Yang Zhou, Yupeng Chen, Shan Zhang, Zhige Wen, Zifan Zhuang, Xinyao Liu, Qing Ni","doi":"10.1080/14740338.2024.2448202","DOIUrl":"10.1080/14740338.2024.2448202","url":null,"abstract":"Background: Fulminant type 1 diabetes mellitus (FT1DM) is a severe subtype of type 1 diabetes characterized by rapid onset, metabolic disturbances, and irreversible insulin secretion failure. Recent studies have suggested associations between FT1DM and certain medications, warranting further investigation.Objectives: This study aims to identify drugs associated with an increased risk of FT1DM using the FDA Adverse Event Reporting System (FAERS) database, evaluate reporting patterns, and provide actionable insights to reduce FT1DM occurrence and improve medication safety.Methods: A retrospective analysis of FAERS data from 2013 to 2023 was conducted. Drug names were standardized using text mining tools, and safety signals were evaluated using reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS).Results: A total of 706 FT1DM cases were identified, predominantly in older individuals and males. Nineteen drugs were implicated, including immune checkpoint inhibitors (nivolumab, ipilimumab, pembrolizumab, avelumab, durvalumab, atezolizumab), lenvatinib, eribulin, psychiatric drugs (atomoxetine, carbamazepine, lamotrigine), anti-infectives (sulfamethoxazole, trimethoprim, amoxicillin), and metabolic modulators (dapagliflozin, sitagliptin, hydrochlorothiazide, allopurinol).Conclusion: This study highlights drugs potentially triggering FT1DM and emphasizes the need for pharmacovigilance and glucose monitoring in patients treated with these medications.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"461-467"},"PeriodicalIF":3.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142964379","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

Comparison of the pharmacovigilance signals of cardiac and renal adverse events associated with sacubitril/valsartan and valsartan alone based on the FAERS database. 基于FAERS数据库的沙比利/缬沙坦与缬沙坦单用与心脏和肾脏不良事件相关的药物警戒信号比较

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-04-01 Epub Date: 2024-12-03 DOI: 10.1080/14740338.2024.2436100

Zhenhui Chen, Jingwen Li, Yan Zhou, Qining Qiu, Dapeng Yan, Gang Peng, Yongpei Xu, Yanrong Ye, Yun Shen

{"title":"Comparison of the pharmacovigilance signals of cardiac and renal adverse events associated with sacubitril/valsartan and valsartan alone based on the FAERS database.","authors":"Zhenhui Chen, Jingwen Li, Yan Zhou, Qining Qiu, Dapeng Yan, Gang Peng, Yongpei Xu, Yanrong Ye, Yun Shen","doi":"10.1080/14740338.2024.2436100","DOIUrl":"10.1080/14740338.2024.2436100","url":null,"abstract":"Background: In clinical practice, cardiovascular and renal safety profiles of sacubitril/valsartan, compared with those of valsartan alone, remain controversial. Therefore, we aimed to compare the pharmacovigilance signals related to cardiovascular and renal adverse events between sacubitril/valsartan and valsartan alone using the Food and Drug Administration Adverse Event Reporting System (FAERS) database.Research design and methods: Raw report data on cardiac and renal adverse events associated with sacubitril/valsartan and valsartan alone were retrieved from the FAERS database using preferred terms from the Medical Dictionary for Regulatory Activities. Preferred terms were mapped to System Organ Classes, and the time to onset of adverse events associated with sacubitril/valsartan and valsartan alone was calculated.Results: Most adverse events associated with sacubitril/valsartan occurred within the first month, whereas adverse events were more prevalent 6 months to 1 year after administration of valsartan alone. Adverse events reported for sacubitril/valsartan and valsartan alone included cardiac failure, cardiogenic shock, and ventricular fibrillation. Considering sacubitril/valsartan only, adverse events reported were renal impairment, renal failure, and acute kidney injury. For valsartan alone, adverse events reported included arrhythmia and angina pectoris.Conclusions: Sacubitril/valsartan carries a higher renal safety risk and lower cardiac safety risk than valsartan alone.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"445-452"},"PeriodicalIF":3.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142767592","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

Mining and analysis of adverse events associated with aducanumab: a real-world study using FDA Adverse Event Reporting System database. 挖掘和分析与aducanumab相关的不良事件：使用FDA不良事件报告系统数据库的真实世界研究。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-04-01 Epub Date: 2025-01-02 DOI: 10.1080/14740338.2024.2448205

Shuangshuang Wu, Yiming Qi, Cheng Jiang, Junxian Zheng

{"title":"Mining and analysis of adverse events associated with aducanumab: a real-world study using FDA Adverse Event Reporting System database.","authors":"Shuangshuang Wu, Yiming Qi, Cheng Jiang, Junxian Zheng","doi":"10.1080/14740338.2024.2448205","DOIUrl":"10.1080/14740338.2024.2448205","url":null,"abstract":"Background: Aducanumab, a monoclonal antibody, received approval for the treatment of Alzheimer's disease in 2021. However, it remains controversial over the security of this drug. In this study, aducanumab-related adverse events (AEs) were evaluated through data mining based on the FDA Adverse Event Reporting System (FAERS) database.Research design and methods: The AE reports induced by aducanumab as the primary suspected drug were extracted from the FAERS database. The clinical characteristics of aducanumab-associated reports were analyzed. The potential new AE signals of aducanumab were explored using four disproportionality analysis methods. Furthermore, the difference in aducanumab-associated AE signals was investigated concerning sex, age, weight, dose, onset time, and continent.Results: In total, 328 reports and 793 AEs associated with aducanumab were identified. Six new AEs were identified. No significant sex and weight difference in aducanumab-related signals was found. Notably, nervous system disorders, especially 'amyloid related imaging abnormality-edema/effusion' and 'amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits,' were more frequently to be reported within 121-240 days, particularly in Europe.Conclusions: This study contributes real-world evidence regarding the safety of aducanumab.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"469-478"},"PeriodicalIF":3.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142893401","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

Disproportionality analysis of adverse events associated with asfotase alfa: a post-marketing study using the FDA Adverse Event Reporting System. 与asfotase alfa相关的不良事件的比例分析：使用FDA不良事件报告系统进行的上市后研究。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-04-01 Epub Date: 2024-11-27 DOI: 10.1080/14740338.2024.2433566

Wang Wen, Wang Zhe, Chen Qianxiu, Sun Haixia, Fu Zongchao, Han Jing, Lv Hao

{"title":"Disproportionality analysis of adverse events associated with asfotase alfa: a post-marketing study using the FDA Adverse Event Reporting System.","authors":"Wang Wen, Wang Zhe, Chen Qianxiu, Sun Haixia, Fu Zongchao, Han Jing, Lv Hao","doi":"10.1080/14740338.2024.2433566","DOIUrl":"10.1080/14740338.2024.2433566","url":null,"abstract":"Background: Asfotase alfa (AA) is an FDA-approved enzyme replacement therapy for hypophosphatasia (HPP). Limited real-world data on its adverse events (AEs) exist. This study evaluates AA-related AEs using the U.S. FDA's Adverse Event Reporting System (FAERS) database.Methods: Reports for AA were extracted from FAERS and analyzed per FDA guidelines. AEs were categorized using MedDRA version 26.1. Disproportionality analysis was conducted using the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and empirical Bayes geometric mean (EBGM) algorithms. Time-to-onset (TTO) was calculated, with a Weibull shape parameter test to assess risk over time.Results: Out of 13,702,373 reports, 5,040 AA-related AEs were identified, with 198 significant preferred terms (PTs). Common AEs included injection site reactions and pain, with additional PTs for ear/labyrinth disorders and infections. The median onset for 234 AEs with reported times was 170 days (IQR 18-390 days). No significant differences in AEs were found across gender or age groups.Conclusion: Most AEs align with known data, but newly identified ear/labyrinth disorders and infections require further investigation to enhance AA's safety profile.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"435-443"},"PeriodicalIF":3.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142738912","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

Is Duchenne gene therapy a suitable treatment despite its immunogenic class effect? 尽管杜氏基因疗法具有免疫原性作用，但它是一种合适的治疗方法吗？

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-04-01 Epub Date: 2024-12-31 DOI: 10.1080/14740338.2024.2447072

Annie Tang, Toshifumi Yokota

{"title":"Is Duchenne gene therapy a suitable treatment despite its immunogenic class effect?","authors":"Annie Tang, Toshifumi Yokota","doi":"10.1080/14740338.2024.2447072","DOIUrl":"10.1080/14740338.2024.2447072","url":null,"abstract":"Introduction: Duchenne muscular dystrophy (DMD) is a severe X-linked disorder characterized by progressive muscle weakness and eventual death due to cardiomyopathy or respiratory complications. Currently, there is no cure for DMD, with standard treatments primarily focusing on symptom management. Using immunosuppressive measures and optimized vector designs allows for gene therapies to better address the genetic cause of the disease.Areas covered: This review evaluates the efficacy and safety of emerging DMD gene therapies as of 2024. It also discusses the potential of utrophin upregulation, gene editing, and truncated dystrophin as therapeutic strategies. It highlights safety concerns associated with these therapies, including adverse events and patient deaths. A comprehensive overview of developments covers topics such as CRISPR-Cas9 therapies, micro-dystrophin, and the potential delivery of full-length dystrophin.Expert opinion: The FDA's recent approval of delandistrogene moxeparvovec (Elevidys) underscores the promise of gene replacement therapies for DMD patients. Understanding the mechanisms behind the adverse effects and excluding patients with specific pathogenic variants may enhance the safety profiles of these therapies. CRISPR/Cas9 therapies, while promising, face significant regulatory and safety challenges that hinder their clinical application. Optimal DMD therapies should target both skeletal and cardiac muscles to be effective.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"395-411"},"PeriodicalIF":3.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142885302","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

Safety profile of isocitrate dehydrogenase inhibitors in cancer therapy: a pharmacovigilance study of the FDA Adverse Event Reporting System. 异柠檬酸脱氢酶抑制剂在癌症治疗中的安全性：FDA不良事件报告系统的药物警戒研究。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-04-01 Epub Date: 2025-01-01 DOI: 10.1080/14740338.2024.2448210

Yiming Fu, Ruxue Lv, Ruizhen Li, Wenjie Li, Zhaoze Guo

{"title":"Safety profile of isocitrate dehydrogenase inhibitors in cancer therapy: a pharmacovigilance study of the FDA Adverse Event Reporting System.","authors":"Yiming Fu, Ruxue Lv, Ruizhen Li, Wenjie Li, Zhaoze Guo","doi":"10.1080/14740338.2024.2448210","DOIUrl":"10.1080/14740338.2024.2448210","url":null,"abstract":"Background: Isocitrate dehydrogenase (IDH) inhibitors hold promise for IDH-mutated cancer patients and demonstrated favorable clinical efficacy. Nonetheless, a comprehensive understanding of the associated toxicities of IDH inhibitors remains notably lacking.Research design and methods: This pharmacovigilance analysis utilized the FDA Adverse Event Reporting System (FAERS) database to assess notable adverse events (AEs) attributed to IDH inhibitors (enasidenib and ivosidenib) from January 2018 to December 2023.Results: In the FAERS database, 2,905 enasidenib-associated and 1,289 ivosidenib-related AEs records were identified, respectively. The toxicity profiles of IDH1 and IDH2 inhibitors exhibited notable similarities. The most commonly significant system-organ classes induced by IDH inhibitors encompassed general disorders and administration site conditions, investigations, gastrointestinal disorders, and infections and infestations. The most common AEs included nausea, fatigue, diarrhea, decreased appetite, decreased platelet count, fever, pneumonia, weakness, sepsis, constipation, vomiting, rash, and reduced hemoglobin levels. Notably, temporal analysis of AEs shows enasidenib and ivosidenib have median onset times of 137 and 75 days, with distinct initial peak frequencies.Conclusion: The reversible nature of the toxicities associated with IDH inhibitors underscores their promise as a therapeutic agent with a favorable safety profile.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"479-486"},"PeriodicalIF":3.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142893402","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

Risk of acute kidney injury in patients receiving vancomycin and concomitant piperacillin-tazobactam or carbapenem: a multicenter, retrospective cohort study. 接受万古霉素和哌拉西林-他唑巴坦或碳青霉烯类药物治疗的患者发生急性肾损伤的风险：一项多中心回顾性队列研究。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-04-01 Epub Date: 2024-08-19 DOI: 10.1080/14740338.2024.2393263

Dong Wu, Xiaowu Wang, Guangli Li, Xiuli Chai, Shaobo Guo, Lulu Zhou, Xiaojuan Wang

{"title":"Risk of acute kidney injury in patients receiving vancomycin and concomitant piperacillin-tazobactam or carbapenem: a multicenter, retrospective cohort study.","authors":"Dong Wu, Xiaowu Wang, Guangli Li, Xiuli Chai, Shaobo Guo, Lulu Zhou, Xiaojuan Wang","doi":"10.1080/14740338.2024.2393263","DOIUrl":"10.1080/14740338.2024.2393263","url":null,"abstract":"Background: Vancomycin (VAN) is empirically used with other broad-spectrum antibiotics, such as piperacillin-tazobactam (PTZ) or carbapenem (CBP). However, conflicting literature on the rates of acute kidney injury (AKI) of VAN with PTZ has been reported.Research design and methods: A multicenter, retrospective cohort study of the risk of AKI was conducted in patients receiving VAN and concomitant PTZ or CBP from January 2019 and June 2023.Results: In total, 514 eligible patients were included. AKI occurred in a total of 91 patients (17.70%). The prevalence of AKI was significantly higher in the VAN+PTZ group than in the VAN+CBP group (23.37% vs 15.27%, p = 0.028). The survival curves depicting the time to AKI showed the increased incidence and more rapid onset of AKI among patients in the VAN+PTZ group compared to those of the VAN+CBP group (HR 2.186, 95%CI 1.351-3.538, p = 0.0015). VAN+PTZ was associated with a consistently higher AKI rate over VAN+CBP (HR 1.762, 95%CI 1.111-2.795, p = 0.0161) throughout the 14-day combination therapy. VAN with concomitant PTZ, duration of combination therapy ≤ 4 days and VAN trough concentration > 20 mg/L were independent risk factors associated with AKI.Conclusion: The prevalence of AKI was found to be higher in patients receiving VAN+PTZ therapy compared to those receiving VAN+CBP therapy based on creatinine-defined AKI.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"499-506"},"PeriodicalIF":3.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141999670","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 reactions associated with SSRIs and PD-1/PD-L1 inhibitors: a disproportionality analysis of the FDA Adverse Event Reporting System. 与SSRIs和PD-1/PD-L1抑制剂相关的不良反应：FDA不良事件报告系统的歧化分析

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-04-01 Epub Date: 2025-01-01 DOI: 10.1080/14740338.2024.2446426

Jiaqi Dong, Mingyue Liu, Suning Li, Siqi Zhang, Pengbin Fu, Mengya Liu, Shasha Jin, Chunliang Fan, Mingzhu Fang, Liang Wu, Zhe Li

{"title":"Adverse reactions associated with SSRIs and PD-1/PD-L1 inhibitors: a disproportionality analysis of the FDA Adverse Event Reporting System.","authors":"Jiaqi Dong, Mingyue Liu, Suning Li, Siqi Zhang, Pengbin Fu, Mengya Liu, Shasha Jin, Chunliang Fan, Mingzhu Fang, Liang Wu, Zhe Li","doi":"10.1080/14740338.2024.2446426","DOIUrl":"10.1080/14740338.2024.2446426","url":null,"abstract":"Background: Selective serotonin reuptake inhibitors (SSRIs) are the primary choice for antidepressant therapy in cancer patients with depression. Programmed death-1 and programmed cell death-ligand 1 (PD-1/PD-L1) play a critical role in immune checkpoint inhibitors. To date, there have been no studies reporting adverse events (AEs) associated with the real-world use of PD-1/PD-L1 inhibitors-SSRIs combination.Research design and methods: This study included a comprehensive evaluation of AE cases covered PD-1/PD-L1 inhibitors-SSRIs combination (first quarter of 2004 to second quarter of 2024) using the FDA Adverse Event Reporting System (FAERS) database, and compared with the use of PD-1/PD-L1 inhibitors or SSRIs alone.Results: By extracting a total of 807 reports of related AEs, the combination therapy was associated with a distinct AE profile characterized by an increased incidence of immune-related and systemic disorders, as well as a higher signal for adverse pregnancy and perinatal outcomes.Conclusions: This study represents the largest report to date on PD-1/PD-L1 inhibitors-SSRIs -related AEs, providing valuable insights into the potential side effects of SSRIs for cancer patients with depression. Clinicians should exercise caution when prescribing SSRIs alongside PD-1/PD-L1 inhibitors, particularly in vulnerable populations such as pregnant women and those with significant comorbidities.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"453-460"},"PeriodicalIF":3.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142876310","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

Safety assessment of cabozantinib in patients with renal cell carcinoma: retrospective pharmacovigilance study based on FAERS database. 卡博替尼对肾细胞癌患者的安全性评估：基于FAERS数据库的回顾性药物警戒研究。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-04-01 Epub Date: 2024-11-17 DOI: 10.1080/14740338.2024.2429475

Zhipeng Wang, Fuchun Zheng, Liangwei Wan, Lei Zhang, Situ Xiong, Sheng Li, Chen Wang, Xiaoqiang Liu, Jun Deng

{"title":"Safety assessment of cabozantinib in patients with renal cell carcinoma: retrospective pharmacovigilance study based on FAERS database.","authors":"Zhipeng Wang, Fuchun Zheng, Liangwei Wan, Lei Zhang, Situ Xiong, Sheng Li, Chen Wang, Xiaoqiang Liu, Jun Deng","doi":"10.1080/14740338.2024.2429475","DOIUrl":"10.1080/14740338.2024.2429475","url":null,"abstract":"Objective: This study was designed to conduct data mining through the Food and Drug Administration Adverse Event Reporting System (FAERS) to assess adverse events (AEs) associated with cabozantinib in the treatment of renal cell carcinoma.Methods: Reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS) algorithms were used to detect drug-related AEs signals from reporting data in FAERS database from 2016 to 2024.Results: A total of 32,129 AE reports identifying cabozantinib as a 'primary suspect' were retrieved from the FAERS database. Among them, there were 21,549 reports of renal cell carcinoma as an indication. AEs induced by cabozantinib were observed in 23 system organ classes (SOCs). 215 AE signals were detected in 16 SOCs after four algorithms were simultaneously met. Among them, signals related to gastrointestinal disorders, general disorders and administration site conditions, and skin and subcutaneous tissue disorders were the most common. Of note, the median time to onset of AEs was 38 days (interquartile range (IQR) 14-116 days).Conclusion: This study provides new insights into the monitoring, surveillance, and management of cabozantinib-related adverse drug reactions and provides a comprehensive long-term post-marketing safety assessment of cabozantinib.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"427-433"},"PeriodicalIF":3.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142638438","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

Risk of respiratory, thoracic, and mediastinal disorders associated with endothelin receptor antagonists and prostacyclin-related drugs in pulmonary hypertension: a disproportionality analysis based on FAERS. 肺动脉高压患者与内皮素受体拮抗剂和前列环素相关药物相关的呼吸、胸腔和纵隔疾病的风险：基于FAERS的歧化分析

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-04-01 Epub Date: 2024-12-03 DOI: 10.1080/14740338.2024.2436077

Fengjie Tang, Qihuan Ma, Yinghong Liu, Xiaojuan Yang

{"title":"Risk of respiratory, thoracic, and mediastinal disorders associated with endothelin receptor antagonists and prostacyclin-related drugs in pulmonary hypertension: a disproportionality analysis based on FAERS.","authors":"Fengjie Tang, Qihuan Ma, Yinghong Liu, Xiaojuan Yang","doi":"10.1080/14740338.2024.2436077","DOIUrl":"10.1080/14740338.2024.2436077","url":null,"abstract":"Background: Adverse drug events (ADEs) for endothelin receptor antagonists (ERAs) and prostacyclin-related drugs (PRDs) have been reported in clinical trials, but large-scale, real-world evaluations for respiratory, thoracic, and mediastinal disorders (RTMD) remain scarce.Methods: A pharmacovigilance analysis of the FAERS database (Q1 2004~Q2 2024) used the reporting odds ratio (ROR) method for disproportionality analysis to assess the adverse drug events (ADEs) of ERAs and PRDs in pulmonary arterial hypertension, focusing on risks related to RTMD.Results: Reports of ADEs for ERAs (bosentan, ambrisentan, and macitentan) were 15,286, 36795, and 17,497, respectively, and for PRDs (epoprostenol, treprostinil, iloprost, and selexipag) were 5,477, 57265, 3,247, and 5,504. Females exceeded males, with most cases in adults. The top PTs for ERAs were death, dyspnea, and pneumonia, with bosentan linked to liver impairment. PRDs commonly cause headaches, flushing, hypotension, edema, and fluid retention. Dyspnea was the most reported RTMD risk for all drugs, and nasal congestion was noted for all. Selexipag had the fewest RTMD-related PTs, and iloprost had the strongest signal for hemoptysis.Conclusion: The analysis highlights the RTMD risks of ERAs and PRDs in treating PH and underscores the need for careful monitoring of ADEs to ensure their safe and effective use in clinical practice.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"487-498"},"PeriodicalIF":3.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142767606","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