Expert Opinion on Drug Safety最新文献_第2页

Adverse events associated with brolucizumab: a disproportionality analysis of the FDA adverse event reporting system (FAERS). 与博卢单抗相关的不良事件：美国食品药品管理局不良事件报告系统（FAERS）的比例失调分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2024-11-01 Epub Date: 2024-02-27 DOI: 10.1080/14740338.2024.2322712

Xiaomei Xiong, Xiuwen Zhang, Xiaoxia Li, Taomin Huang

{"title":"Adverse events associated with brolucizumab: a disproportionality analysis of the FDA adverse event reporting system (FAERS).","authors":"Xiaomei Xiong, Xiuwen Zhang, Xiaoxia Li, Taomin Huang","doi":"10.1080/14740338.2024.2322712","DOIUrl":"10.1080/14740338.2024.2322712","url":null,"abstract":"Background: The safety information of brolucizumab primarily comes from clinical trials experience. This study aimed to explore the ocular and systemic adverse events (AEs) associated with brolucizumab among real-world patients through data mining the FDA Adverse Event Reporting System (FAERS) database.Methods: AE reports submitted to the FAERS database between October 2019 and March 2023 were extracted. The reporting odds ratio was used to evaluate AE signals associated with brolucizumab.Results: There were 4,380,839 AE reports extracted from the FAERS database, and 3,313 of which were with brolucizumab as primary suspected. A total of 150 ocular AE signals were identified. Ninety-nine were known ocular AEs listed in brolucizumab' label, primarily including vision-related AEs, intraocular infections, and retinal disorders. Fifty-one were unexpected ocular AE signals, including keratic precipitates, retinal perivascular sheathing, dry eye, glaucoma, etc. Meanwhile, several serious systemic AE signals, including arterial thromboembolic events and rhinorrhea, were also identified.Conclusions: Several unexpected ocular and systemic AE signals associated with brolucizumab were identified through data mining of the FAERS database.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139971484","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

Correction. 更正。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2024-11-01 Epub Date: 2024-09-16 DOI: 10.1080/14740338.2024.2397893

引用次数: 0

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

Expert Opinion on Drug Safety Pub Date : 2024-11-01 Epub Date: 2024-09-30 DOI: 10.1080/14740338.2024.2411380

Filippo Migliorini, Nicola Maffulli

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

Expert Opinion on Drug Safety 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

{"title":"Immune checkpoint inhibitors and neurotoxicity: a focus on diagnosis and management for a multidisciplinary approach.","authors":"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","doi":"10.1080/14740338.2024.2363471","DOIUrl":"10.1080/14740338.2024.2363471","url":null,"abstract":"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.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141183991","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 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

Expert Opinion on Drug Safety 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

{"title":"Adverse events of direct factor Xa inhibitors: a disproportionality analysis of the FAERS database.","authors":"Yating Qian, Xinxia Zhao, Danyi Liu, Junting Liu, Zhongsheng Yue, Wei Liu","doi":"10.1080/14740338.2024.2368815","DOIUrl":"10.1080/14740338.2024.2368815","url":null,"abstract":"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.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141418500","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

Correction. 校正

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2024-11-01 Epub Date: 2023-10-17 DOI: 10.1080/14740338.2023.2271793

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

Expert Opinion on Drug Safety 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

{"title":"Infectious events in patients with alopecia areata treated with JAK inhibitors: low burden and minimal impact on persistence in treatment.","authors":"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","doi":"10.1080/14740338.2024.2348571","DOIUrl":"10.1080/14740338.2024.2348571","url":null,"abstract":"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.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140876247","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 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

Expert Opinion on Drug Safety Pub Date : 2024-11-01 Epub Date: 2024-10-04 DOI: 10.1080/14740338.2024.2410436

Cheng Zhong, Qi Zheng, Bin Zhao, Tao Ren

{"title":"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.","authors":"Cheng Zhong, Qi Zheng, Bin Zhao, Tao Ren","doi":"10.1080/14740338.2024.2410436","DOIUrl":"10.1080/14740338.2024.2410436","url":null,"abstract":"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.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142344391","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

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

Expert Opinion on Drug Safety Pub Date : 2024-11-01 Epub Date: 2024-10-01 DOI: 10.1080/14740338.2024.2410434

Zeping Yang, Kejing Tang, Jie Chen

{"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":"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.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":null,"pages":null},"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

Expert Opinion on Drug Safety Pub Date : 2024-11-01 Epub Date: 2024-10-01 DOI: 10.1080/14740338.2024.2409698

G Denas, G Santostasi, V Pengo

{"title":"The safety of available pharmacotherapy for stroke prevention in atrial fibrillation.","authors":"G Denas, G Santostasi, V Pengo","doi":"10.1080/14740338.2024.2409698","DOIUrl":"10.1080/14740338.2024.2409698","url":null,"abstract":"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.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142344395","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