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What are the best antithrombotic prophylaxes following total knee arthroplasty? 全膝关节置换术后的最佳抗血栓预防措施是什么?
IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-11-01 Epub Date: 2024-09-30 DOI: 10.1080/14740338.2024.2411380
Filippo Migliorini, Nicola Maffulli
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引用次数: 0
Immune checkpoint inhibitors and neurotoxicity: a focus on diagnosis and management for a multidisciplinary approach. 免疫检查点抑制剂和神经毒性:多学科方法的诊断和管理重点。
IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-11-01 Epub Date: 2024-06-03 DOI: 10.1080/14740338.2024.2363471
Desirèe Speranza, Mariacarmela Santarpia, Francesco Luppino, Fausto Omero, Enrica Maiorana, Mariacarmela Cavaleri, Elena Sapuppo, Vincenzo Cianci, Alessia Pugliese, Vito Racanelli, Giulia Maria Camerino, Carmelo Rodolico, Nicola Silvestris

Introduction: Although immune checkpoint inhibitors (ICIs) have revolutionized cancer treatment, the consequential over activation of the immune system is often complicated by adverse events that can affect several organs and systems, including the nervous system. The precise pathophysiology underlying neurological irAEs (n-irAEs) is not completely known. Around 3.8% of patients receiving anti-CTLA-4 agents, 6.1% of patients receiving anti-PD-1/PD-L1, and 12% of patients receiving combination therapies have n-irAEs. Most n-irAEs are low-grade, while severe toxicities have rarely been reported. in this article, we performed an updated literature search on immuno-related neurotoxicity on main medical research database, from February 2017 to December 2023.

Areas covered: We have also compared the latest national and international guidelines on n-irAEs management with each other in order to better define patient management.

Expert opinion: A multidisciplinary approach appears necessary in the management of oncological patients during immunotherapy. Therefore, in order to better manage these toxicities, we believe that it is essential to collaborate with neurologists specialized in the diagnosis and treatment of n-irAEs, and that a global neurological assessment, both central and peripheral, is necessary before starting immunotherapy, with regular reassessment during treatment.

简介尽管免疫检查点抑制剂(ICIs)给癌症治疗带来了革命性的变化,但随之而来的免疫系统过度激活往往会因不良反应而变得复杂,这些不良反应可能会影响包括神经系统在内的多个器官和系统。神经系统不良反应(n-irAEs)的确切病理生理学尚不完全清楚。接受抗 CTLA-4 药物治疗的患者中约有 3.8%、接受抗 PD-1/PD-L1 治疗的患者中约有 6.1%、接受联合治疗的患者中约有 12% 出现了 n-irAEs。大多数 n-irAEs 是低级别的,而严重毒性很少见报道。在本文中,我们在主要医学研究数据库中进行了关于免疫相关神经毒性的最新文献检索,检索时间为 2017 年 2 月至 2023 年 12 月:我们还比较了最新的国家和国际 n-irAEs 管理指南,以便更好地确定患者管理方法:专家意见:在免疫治疗期间,对肿瘤患者的管理似乎需要采用多学科方法。因此,为了更好地处理这些毒性反应,我们认为有必要与擅长诊断和治疗 n-irAEs 的神经科医生合作,而且在开始免疫疗法之前有必要对中枢和外周神经系统进行全面评估,并在治疗期间定期进行复查。
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引用次数: 0
Adverse events of direct factor Xa inhibitors: a disproportionality analysis of the FAERS database. 直接 Xa 因子抑制剂的不良事件:FAERS 数据库的比例失调分析。
IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-11-01 Epub Date: 2024-06-18 DOI: 10.1080/14740338.2024.2368815
Yating Qian, Xinxia Zhao, Danyi Liu, Junting Liu, Zhongsheng Yue, Wei Liu

Objectives: Direct factor Xa inhibitors rivaroxaban, apixaban, and edoxaban, commonly used direct oral anticoagulant (DOAC), are widely used to prevent and treat stroke and venous thromboembolic events in patients with atrial fibrillation (AF). This study aimed to assess and compare reports of adverse events associated with rivaroxaban, apixaban, and edoxaban, including hemorrhagic and non-hemorrhagic events.

Methods: Reporting odds ratio (ROR), proportional reporting ratio (PRR), Medications and Health Care Products Regulatory Agency (MHRA), and the information component (IC) were used to perform a risk assessment of adverse event reports in the FDA Adverse Event Reporting System (FAERS) database for the years 2018-2022.

Results: Combined with disproportionality analysis in different backgrounds, the salient risks of the three-factor Xa inhibitors varied. Rivaroxaban had the most significant risk of hemorrhage, apixaban had a higher incidence and risk of death, cardiac and cerebral adverse events, and edoxaban showed a more prominent risk in the kidneys and urinary system.

Conclusion: Hemorrhage is a common risk with factor Xa inhibitors, with rivaroxaban being the most significant. Apixaban and edoxaban also showed significant association with non-hemorrhagic adverse events, and increased attention to non-hemorrhagic adverse events is needed in clinical use.

目的:直接Xa因子抑制剂利伐沙班、阿哌沙班和依度沙班是常用的直接口服抗凝剂(DOAC),被广泛用于预防和治疗心房颤动(房颤)患者的中风和静脉血栓栓塞事件。本研究旨在评估和比较利伐沙班、阿哌沙班和依度沙班的相关不良事件报告,包括出血和非出血事件:采用报告几率比(ROR)、比例报告比(PRR)、药品和保健品监管局(MHRA)以及信息组件(IC)对2018-2022年FDA不良事件报告系统(FAERS)数据库中的不良事件报告进行风险评估:结合不同背景下的比例失调分析,三因子Xa抑制剂的突出风险各不相同。利伐沙班的出血风险最为显著,阿哌沙班的死亡、心脑不良事件的发生率和风险较高,埃多沙班在肾脏和泌尿系统的风险更为突出.结论:结论:出血是Xa因子抑制剂的常见风险,其中利伐沙班的风险最大。阿哌沙班和埃多沙班与非出血不良事件也有显著关联,因此在临床应用中需要更加关注非出血不良事件。
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引用次数: 0
Correction. 校正
IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-11-01 Epub Date: 2023-10-17 DOI: 10.1080/14740338.2023.2271793
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引用次数: 0
Infectious events in patients with alopecia areata treated with JAK inhibitors: low burden and minimal impact on persistence in treatment. 接受 JAK 抑制剂治疗的斑秃患者中的感染事件:负担较轻,对持续治疗的影响很小。
IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-11-01 Epub Date: 2024-05-08 DOI: 10.1080/14740338.2024.2348571
Giacomo Caldarola, Lorenzo Maria Pinto, Francesco Bellinato, Nicoletta Bernardini, Elena Campione, Andrea Chiricozzi, Laura Colonna, Clara De Simone, Laura Diluvio, Paolo Gisondi, Enrico Matteini, Eleonora Tomassetti, Ersilia Tolino, Luca Bianchi, Ketty Peris

Background: Alopecia areata (AA) is a non-scarring disorder characterized by hair loss that greatly affects patients' quality of life and has a chronic, recurring course. This disease is marked by an inflammatory process, mainly on an autoimmune basis primarily regulated by Janus kinase (JAK).

Research design and methods: We conducted a retrospective study evaluating the safety of JAKi in a real-world setting in 91 AA patients, with a specific focus on the assessment of infectious events.

Results: Overall, 34 infectious events were observed in 28 patients (30.8%), among them 17 patients (60.7%) suspended treatment with JAKi until the infection was clinically resolved. Only in one case the infectious event led to a permanent discontinuation of the treatment. The data we observed in the study are consistent with results reported in clinical trials.

Conclusion: It can be stated that, during treatment with JAKi in AA patients, infectious events may occur, but in most cases these events are easily manageable and do not result in permanent discontinuation of the drug.

背景:斑秃(AA)是一种以脱发为特征的非瘢痕性疾病,严重影响患者的生活质量,病程慢性,反复发作。这种疾病以炎症过程为特征,主要是受 Janus 激酶(JAK)调控的自身免疫性过程:我们进行了一项回顾性研究,评估了 JAKi 在真实世界环境中对 91 名 AA 患者的安全性,重点评估了感染事件:28名患者(30.8%)共发生了34起感染事件,其中17名患者(60.7%)暂停了JAKi治疗,直到感染得到临床缓解。只有一例患者因感染事件而永久停止了治疗。我们在研究中观察到的数据与临床试验报告的结果一致:可以说,AA患者在使用JAKi治疗期间可能会发生感染事件,但在大多数情况下,这些事件很容易控制,不会导致永久停药。
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引用次数: 0
A real-world pharmacovigilance study using disproportionality analysis of United States Food and Drug Administration Adverse Event Reporting System events for vinca alkaloids: comparing vinorelbine and Vincristine. 利用美国食品药品监督管理局不良事件报告系统对长春花生物碱事件进行比例失调分析的真实世界药物警戒研究:比较长春瑞滨和长春新碱。
IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-11-01 Epub Date: 2024-10-04 DOI: 10.1080/14740338.2024.2410436
Cheng Zhong, Qi Zheng, Bin Zhao, Tao Ren

Background: Vinca alkaloids are widely used in cancer treatment for their ability to target microtubule dynamics. While their efficacy in treating certain cancers is well-established, the full spectrum of their adverse event profiles remains an area of ongoing research.

Methods: We analyzed AEs related to vinorelbine and vincristine using a retrospective case/non-case approach with data from the FDA Adverse Event Reporting System (FAERS). We applied various algorithms to detect AE signals: the reporting odds ratio (ROR) and proportional reporting ratio (PRR) measured disproportionality and association strength; the Bayesian confidence propagation neural network (BCPNN) calculated the Information Component (IC) for associations against background rates; and the multi-item gamma Poisson shrinker (MGPS) yielded empirical Bayes geometric mean (EBGM) values, accounting for reporting variability.

Results: Both medications significantly involve the blood and lymphatic systems, with vinorelbine reporting 401 cases in this System Organ Class (SOC), exhibiting a ROR of 17.4, PRR of 12.4, IC of 3.63, and EBGM of 12.38. An intersection analysis of Preferred Terms (PTs) has uncovered previously unreported AEs shared by both drugs, including posterior reversible encephalopathy syndrome and inappropriate antidiuretic hormone secretion.

Conclusions: This analysis highlights the need for ongoing research of the risks associated with vinorelbine and vincristine.

背景:长春花生物碱因其靶向微管动力学的能力而被广泛用于癌症治疗。虽然它们治疗某些癌症的疗效已得到证实,但其不良反应的全貌仍是一个持续研究的领域:我们采用回顾性病例/非病例方法,利用美国食品药物管理局不良事件报告系统(FAERS)的数据分析了与长春瑞滨和长春新碱相关的不良事件。我们采用了多种算法来检测AE信号:报告几率比(ROR)和报告比例比(PRR)测量了比例失调和关联强度;贝叶斯置信度传播神经网络(BCPN)计算了与背景率关联的信息成分(IC);多项目伽马泊松收缩器(MGPS)得出了经验贝叶斯几何平均(EBGM)值,并考虑了报告的可变性:这两种药物均严重涉及血液和淋巴系统,其中长春瑞滨报告了 401 例该系统器官分类 (SOC),显示 ROR 为 17.4,PRR 为 12.4,IC 为 3.63,EBGM 为 12.38。对首选术语(PTs)的交叉分析发现了这两种药物以前未报告过的共同 AEs,包括后可逆性脑病综合征和抗利尿激素分泌不当:这项分析强调了对长春瑞滨和长春新碱相关风险进行持续研究的必要性。
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引用次数: 0
Post-marketing safety of tralokinumab: a real-world pharmacovigilance study based on the FDA adverse event reporting system. 曲妥珠单抗上市后的安全性:基于美国食品药品管理局不良事件报告系统的真实世界药物警戒研究。
IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-11-01 Epub Date: 2024-10-01 DOI: 10.1080/14740338.2024.2410434
Zeping Yang, Kejing Tang, Jie Chen

Background: Tralokinumab is a fully human IgG4 monoclonal antibody targeting IL-13, used for treating atopic dermatitis. This study analyzed tralokinumab-related adverse drug events by mining the Food and Drug Administration Adverse Event Reporting System (FAERS) database to provide a safety reference for clinical application.

Methods: Adverse drug event reports from Q1 2022 to Q2 2024 were extracted from the FAERS database. After standardizing the data, various signal detection methods were used for analysis, including ROR, PRR, BCPNN, and MGPS.

Results: A total of 1,820 reports of adverse events (AEs) with tralokinumab as the primary suspected drug were identified. 70 preferred terms (PTs) met the criteria across four signal detection methods, involving 11 system organ classes (SOCs). These included known adverse reactions like conjunctivitis and injection site reactions, and signals not previously reported in clinical trials, such as eye pruritus, dry eye, eye swelling, pneumonia pneumococcal, and cutaneous T-cell lymphoma. Most AEs occurred within one month of initiating tralokinumab treatment.

Conclusions: Based on the FAERS database, this study comprehensively and systematically analyzed AE signals in tralokinumab treatment. The results enhance the understanding of tralokinumab's safety and serve as valuable references for reducing the risk of adverse reactions during clinical use.

背景介绍曲洛单抗是一种靶向IL-13的全人源IgG4单克隆抗体,用于治疗特应性皮炎。本研究通过挖掘美国食品和药物管理局不良事件报告系统(FAERS)数据库,对曲洛单抗相关药物不良事件进行分析,为临床应用提供安全性参考:方法:从FAERS数据库中提取2022年第一季度至2024年第二季度的药物不良事件报告。方法:从 FAERS 数据库中提取 2022 年第一季度至 2024 年第二季度的药物不良事件报告,对数据进行标准化处理后,采用多种信号检测方法进行分析,包括 ROR、PRR、BCPNN 和 MGPS:结果:共发现 1,820 份以曲妥珠单抗为主要可疑药物的不良事件 (AE) 报告。在四种信号检测方法中,有 70 个首选术语 (PT) 符合标准,涉及 11 个系统器官类别 (SOC)。其中包括结膜炎和注射部位反应等已知不良反应,以及以前在临床试验中未报告过的信号,如眼睛瘙痒、干眼症、眼睛肿胀、肺炎球菌肺炎和皮肤 T 细胞淋巴瘤。大多数AE发生在开始曲妥珠单抗治疗的一个月内:本研究基于 FAERS 数据库,全面系统地分析了曲妥珠单抗治疗中的 AE 信号。结论:这项研究基于 FAERS 数据库,全面系统地分析了曲妥珠单抗治疗过程中的不良反应信号,其结果加深了人们对曲妥珠单抗安全性的理解,对降低临床使用过程中的不良反应风险具有重要参考价值。
{"title":"Post-marketing safety of tralokinumab: a real-world pharmacovigilance study based on the FDA adverse event reporting system.","authors":"Zeping Yang, Kejing Tang, Jie Chen","doi":"10.1080/14740338.2024.2410434","DOIUrl":"10.1080/14740338.2024.2410434","url":null,"abstract":"<p><strong>Background: </strong>Tralokinumab is a fully human IgG4 monoclonal antibody targeting IL-13, used for treating atopic dermatitis. This study analyzed tralokinumab-related adverse drug events by mining the Food and Drug Administration Adverse Event Reporting System (FAERS) database to provide a safety reference for clinical application.</p><p><strong>Methods: </strong>Adverse drug event reports from Q1 2022 to Q2 2024 were extracted from the FAERS database. After standardizing the data, various signal detection methods were used for analysis, including ROR, PRR, BCPNN, and MGPS.</p><p><strong>Results: </strong>A total of 1,820 reports of adverse events (AEs) with tralokinumab as the primary suspected drug were identified. 70 preferred terms (PTs) met the criteria across four signal detection methods, involving 11 system organ classes (SOCs). These included known adverse reactions like conjunctivitis and injection site reactions, and signals not previously reported in clinical trials, such as eye pruritus, dry eye, eye swelling, pneumonia pneumococcal, and cutaneous T-cell lymphoma. Most AEs occurred within one month of initiating tralokinumab treatment.</p><p><strong>Conclusions: </strong>Based on the FAERS database, this study comprehensively and systematically analyzed AE signals in tralokinumab treatment. The results enhance the understanding of tralokinumab's safety and serve as valuable references for reducing the risk of adverse reactions during clinical use.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1439-1446"},"PeriodicalIF":3.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142344394","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
The safety of available pharmacotherapy for stroke prevention in atrial fibrillation. 预防心房颤动中风的现有药物疗法的安全性。
IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-11-01 Epub Date: 2024-10-01 DOI: 10.1080/14740338.2024.2409698
G Denas, G Santostasi, V Pengo

Introduction: Oral anticoagulant drugs reduce the risk of stroke associated with atrial fibrillation. Vitamin K antagonists, gold standard therapy for decades, have been deposed by the direct oral anticoagulants that exhibit superior safety profiles. However, hemorrhagic complications remain a major concern to anticoagulation.

Areas covered: We searched available data in the literature to review the current knowledge on the safety profiles of available anticoagulants.

Expert opinion: Despite a relevant leap forward with the introduction of DOACs, safety concerns persist in some fields of the current pharmacotherapy for stroke prevention in atrial fibrillation. In-depth knowledge of the safety profile of available anticoagulants and dealing with safety issues in patient subgroups is of utmost importance. Bleeding risk scores should not be dichotomously used to decide anticoagulation treatment but rather to promote shared decision, identify and correct modifiable risk factors, and set monitoring frequency. Additional issues that wait to be investigated in order to improve the safety of therapy include circulating levels of direct oral anticoagulants and anticoagulation in patient sub-groups: very elderly, frail, those with advanced kidney or liver disease, and so on. Safety may be improved from the in-depth knowledge of safety concerns and therapeutic options.

介绍:口服抗凝药物可降低与心房颤动相关的中风风险。维生素 K 拮抗剂是数十年来的金标准疗法,如今已被安全性更高的直接口服抗凝剂所取代。然而,出血性并发症仍然是抗凝治疗的一个主要问题:我们搜索了文献中的可用数据,回顾了目前关于现有抗凝剂安全性的知识:专家观点:尽管随着 DOACs 的问世实现了相关的飞跃,但目前预防心房颤动卒中的药物治疗在某些领域仍存在安全性问题。深入了解现有抗凝药物的安全性概况以及处理患者亚群的安全性问题至关重要。不应将出血风险评分二分法用于决定抗凝治疗,而应促进共同决策、识别和纠正可改变的风险因素并设定监测频率。为提高治疗的安全性,还有其他问题有待研究,包括直接口服抗凝剂的循环水平和患者亚群的抗凝治疗:高龄、体弱、晚期肝肾疾病患者等。通过深入了解安全问题和治疗方案,可以提高安全性。
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引用次数: 0
Comprehensive evaluation of leuprorelin-associated adverse events: insights from FDA adverse event reporting system. 对利普瑞林相关不良事件的全面评估:美国食品药品管理局不良事件报告系统的启示。
IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-31 DOI: 10.1080/14740338.2024.2423680
Xiao Tang, Fuchun Zheng, Zifang Ma, Huilong Shen, Zhijun Yao

Background: Leuprorelin, a gonadotropin-releasing hormone agonist, is widely used to treat hormone-related disorders. This study aims to explore and analyze the safety profile of leuprorelin by examining adverse event reports from the FDA Adverse Event Reporting System (FAERS) database.

Methods: This study conducted a retrospective pharmacovigilance analysis using FAERS data from Q1 2004 to Q1 2024. Adverse drug events (ADEs) related to leuprorelin were identified and categorized by system organ class and specific adverse events. Statistical methods such as Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayesian Geometric Mean (EBGM) were used to detect safety signals.

Results: A total of 63,928 ADE reports implicated leuprorelin, with 500 preferred terms and 25 system organ classes showing significant disproportionality. Notable rare ADEs identified were bulbospinal muscular atrophy congenital (n = 26; ROR 1282.72, PRR 1282.52, IC 7.91, EBGM 241.28), follicular cystitis (n = 3; ROR 126.84, PRR 126.84, IC 6.48, EBGM 89.09), and anaplastic meningioma (n = 3; ROR 46.73, PRR 46.73, IC 5.34, EBGM 40.5).

Conclusion: Most findings were expected, but new signals like follicular cystitis, previously unreported, emerged. Further studies are essential to validate these findings, crucial for clinical monitoring and risk identification of leuprorelin.

背景:亮丙瑞林是一种促性腺激素释放激素激动剂,被广泛用于治疗激素相关疾病。本研究旨在通过研究美国食品药品管理局不良事件报告系统(FAERS)数据库中的不良事件报告,探讨和分析亮丙瑞林的安全性:本研究利用2004年第一季度至2024年第一季度的FAERS数据进行了回顾性药物警戒分析。按照系统器官类别和具体不良事件对与亮普瑞林相关的药物不良事件(ADEs)进行了识别和分类。采用比例报告率 (PRR)、报告几率比 (ROR)、贝叶斯置信度传播神经网络 (BCPNN) 和经验贝叶斯几何平均 (EBGM) 等统计方法检测安全信号:共有 63,928 例 ADE 报告涉及亮丙瑞林,其中 500 个首选术语和 25 个系统器官类别显示出明显的不相称性。值得注意的罕见ADE是先天性球海绵状肌萎缩症(n = 26;ROR 1282.72,PRR 1282.52,IC 7.91,EBGM 241.28)、滤泡性膀胱炎(n = 3;ROR 126.84,PRR 126.84,IC 6.48,EBGM 89.09)和无细胞脑膜瘤(n = 3;ROR 46.73,PRR 46.73,IC 5.34,EBGM 40.5):大多数发现都在预料之中,但也出现了一些新的信号,如以前未报道过的滤泡性膀胱炎。进一步的研究对验证这些发现至关重要,这些发现对利普瑞林的临床监测和风险识别至关重要。
{"title":"Comprehensive evaluation of leuprorelin-associated adverse events: insights from FDA adverse event reporting system.","authors":"Xiao Tang, Fuchun Zheng, Zifang Ma, Huilong Shen, Zhijun Yao","doi":"10.1080/14740338.2024.2423680","DOIUrl":"10.1080/14740338.2024.2423680","url":null,"abstract":"<p><strong>Background: </strong>Leuprorelin, a gonadotropin-releasing hormone agonist, is widely used to treat hormone-related disorders. This study aims to explore and analyze the safety profile of leuprorelin by examining adverse event reports from the FDA Adverse Event Reporting System (FAERS) database.</p><p><strong>Methods: </strong>This study conducted a retrospective pharmacovigilance analysis using FAERS data from Q1 2004 to Q1 2024. Adverse drug events (ADEs) related to leuprorelin were identified and categorized by system organ class and specific adverse events. Statistical methods such as Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayesian Geometric Mean (EBGM) were used to detect safety signals.</p><p><strong>Results: </strong>A total of 63,928 ADE reports implicated leuprorelin, with 500 preferred terms and 25 system organ classes showing significant disproportionality. Notable rare ADEs identified were bulbospinal muscular atrophy congenital (<i>n</i> = 26; ROR 1282.72, PRR 1282.52, IC 7.91, EBGM 241.28), follicular cystitis (<i>n</i> = 3; ROR 126.84, PRR 126.84, IC 6.48, EBGM 89.09), and anaplastic meningioma (<i>n</i> = 3; ROR 46.73, PRR 46.73, IC 5.34, EBGM 40.5).</p><p><strong>Conclusion: </strong>Most findings were expected, but new signals like follicular cystitis, previously unreported, emerged. Further studies are essential to validate these findings, crucial for clinical monitoring and risk identification of leuprorelin.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-10"},"PeriodicalIF":3.0,"publicationDate":"2024-10-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142521486","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 events associated with carbamazepine: a pharmacovigilance study using the FDA Adverse Event Reporting System. 与卡马西平相关的不良事件:使用美国食品药物管理局不良事件报告系统进行的药物警戒研究。
IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-25 DOI: 10.1080/14740338.2024.2416926
Shulan Huang, Hanlin Dong, Dongqiang Luo, Jiazhen Jiang, Manting Liu, Jiayu Wu, Xiangyun Dou, Siyuan Zhou

Introduction: Carbamazepine (CBZ) is a commonly used antiseizures medications (ASM), but its adverse drug reactions (ADRs) can impact the successful management of epilepsy. There are currently limited systematic studies on ADRs related to CBZ, necessitating further investigation.

Areas covered: Using the FDA Adverse Event Reporting System (FAERS) database , we extracted reports where CBZ was the primary suspect, conducting subgroup analyses stratified by sex and age. Four risk signal detection methods ROR, PRR, BCPNN, and EGBM were employed to systematically analyze the ADRs associated with CBZ.

Expert opinion: In the epilepsy population, ADRs related to CBZ often involve examinations, hereditary disorders, and infections. Subgroup analysis showed differences in ADR signals among male, female, elderly, and young patients. Human Herpesvirus 6 Infection and Dermatitis Exfoliative were consistent CBZ-induced ADRs, unaffected by age or sex. The study also identified previously overlooked ADRs such as bone metabolism abnormalities, ocular toxicity, and ototoxicity. Many ADRs linked to CBZ remain underreported. It is crucial to enhance monitoring and information dissemination about CBZ use in epileptic patients. Adjusting medication regimens for high-risk individuals, potentially incorporating acupuncture, traditional Chinese medicine, or alternative anti-seizure medications, should be considered when necessary.

简介:卡马西平(CBZ)是一种常用的抗癫痫药物(ASM),但其药物不良反应(ADRs)会影响癫痫的成功治疗。目前关于 CBZ 相关药物不良反应的系统研究还很有限,因此有必要进行进一步调查:利用美国食品药物管理局不良事件报告系统(FAERS)数据库,我们提取了以 CBZ 为主要可疑药物的报告,并按性别和年龄进行了亚组分析。我们采用了四种风险信号检测方法 ROR、PRR、BCPNN 和 EGBM,对与 CBZ 相关的 ADR 进行了系统分析:在癫痫人群中,与CBZ相关的ADR通常涉及检查、遗传性疾病和感染。亚组分析显示,男性、女性、老年和年轻患者的ADR信号存在差异。人类疱疹病毒 6 感染和剥脱性皮炎是 CBZ 引起的一致的 ADR,不受年龄或性别的影响。研究还发现了以前被忽视的 ADR,如骨代谢异常、眼毒性和耳毒性。许多与 CBZ 相关的 ADR 仍未得到充分报告。加强对癫痫患者使用 CBZ 的监测和信息传播至关重要。必要时,应考虑调整高危人群的用药方案,并可能结合针灸、传统中药或替代抗癫痫药物。
{"title":"Adverse events associated with carbamazepine: a pharmacovigilance study using the FDA Adverse Event Reporting System.","authors":"Shulan Huang, Hanlin Dong, Dongqiang Luo, Jiazhen Jiang, Manting Liu, Jiayu Wu, Xiangyun Dou, Siyuan Zhou","doi":"10.1080/14740338.2024.2416926","DOIUrl":"https://doi.org/10.1080/14740338.2024.2416926","url":null,"abstract":"<p><strong>Introduction: </strong>Carbamazepine (CBZ) is a commonly used antiseizures medications (ASM), but its adverse drug reactions (ADRs) can impact the successful management of epilepsy. There are currently limited systematic studies on ADRs related to CBZ, necessitating further investigation.</p><p><strong>Areas covered: </strong>Using the FDA Adverse Event Reporting System (FAERS) database , we extracted reports where CBZ was the primary suspect, conducting subgroup analyses stratified by sex and age. Four risk signal detection methods ROR, PRR, BCPNN, and EGBM were employed to systematically analyze the ADRs associated with CBZ.</p><p><strong>Expert opinion: </strong>In the epilepsy population, ADRs related to CBZ often involve examinations, hereditary disorders, and infections. Subgroup analysis showed differences in ADR signals among male, female, elderly, and young patients. Human Herpesvirus 6 Infection and Dermatitis Exfoliative were consistent CBZ-induced ADRs, unaffected by age or sex. The study also identified previously overlooked ADRs such as bone metabolism abnormalities, ocular toxicity, and ototoxicity. Many ADRs linked to CBZ remain underreported. It is crucial to enhance monitoring and information dissemination about CBZ use in epileptic patients. Adjusting medication regimens for high-risk individuals, potentially incorporating acupuncture, traditional Chinese medicine, or alternative anti-seizure medications, should be considered when necessary.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-13"},"PeriodicalIF":3.0,"publicationDate":"2024-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142497751","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
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Expert Opinion on Drug Safety
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