Expert Opinion on Drug Safety最新文献_第6页

Rivaroxaban to reduce the risk of major cardiovascular events in patients with chronic coronary artery disease or peripheral artery disease: a narrative review.

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-03-01 Epub Date: 2025-03-12 DOI: 10.1080/14740338.2025.2462652

Toufik Abdul-Rahman, Poulami Roy, Ranferi Eduardo Herrera-Calderón, Jann Ludwig Mueller-Gomez, Marcos Lisbona-Buzali, Sebahat Ulusan, Wireko Andrew Awuah, Nataliia Kuchma, Nikhil Mehta, Ankit Agrawal, Ahmed Altibi, Rahul Gupta

{"title":"Rivaroxaban to reduce the risk of major cardiovascular events in patients with chronic coronary artery disease or peripheral artery disease: a narrative review.","authors":"Toufik Abdul-Rahman, Poulami Roy, Ranferi Eduardo Herrera-Calderón, Jann Ludwig Mueller-Gomez, Marcos Lisbona-Buzali, Sebahat Ulusan, Wireko Andrew Awuah, Nataliia Kuchma, Nikhil Mehta, Ankit Agrawal, Ahmed Altibi, Rahul Gupta","doi":"10.1080/14740338.2025.2462652","DOIUrl":"10.1080/14740338.2025.2462652","url":null,"abstract":"Background: Coronary Artery Disease (CAD) and Peripheral Artery Disease (PAD) are leading causes of morbidity and mortality. Despite medical advancements, patients remain at high risk for major adverse cardiovascular events (MACE) and major adverse limb events (MALE). Traditional anticoagulation strategies have shown limited efficacy. Rivaroxaban, an oral factor Xa inhibitor, has emerged as a potential alternative.Objectives: This review examines the role of rivaroxaban in reducing MACE and MALE in CAD and PAD patients, focusing on its pharmacology, efficacy, safety, and cost-effectiveness.Methods: A literature search was conducted in PubMed, Embase, and Scopus for studies on rivaroxaban's use in CAD and PAD.Results: The COMPASS trial demonstrated that rivaroxaban (2.5 mg twice daily) plus aspirin significantly reduced MACE and MALE but increased major bleeding. The COMPASS-LTOLE and VOYAGER PAD trials confirmed these findings. However, the COMMANDER HF trial found no benefit in heart failure patients without atrial fibrillation. Cost-effectiveness studies support rivaroxaban as a viable treatment strategy.Conclusion: Rivaroxaban plus aspirin effectively reduces thrombotic events in high-risk CAD and PAD patients. Despite an increased bleeding risk, its benefits outweigh the risks in selected populations. Future studies should explore personalized treatment approaches and long-term outcomes.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"261-271"},"PeriodicalIF":3.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143370731","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 event signals for alendronate based on the real-world data of FDA adverse event reporting system database. 基于 FDA 不良事件报告系统数据库的真实世界数据，挖掘和分析阿仑膦酸钠的不良事件信号。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-03-01 Epub Date: 2024-10-22 DOI: 10.1080/14740338.2024.2419995

Ziyi Zhao, Hongxiang Ji, Chenghao Zhang, Zhengdan Wang, Shengquan Ren, Chunlei Liu, Caifeng Wu, Jian Wang, Xiaoheng Ding

{"title":"Mining and analysis of adverse event signals for alendronate based on the real-world data of FDA adverse event reporting system database.","authors":"Ziyi Zhao, Hongxiang Ji, Chenghao Zhang, Zhengdan Wang, Shengquan Ren, Chunlei Liu, Caifeng Wu, Jian Wang, Xiaoheng Ding","doi":"10.1080/14740338.2024.2419995","DOIUrl":"10.1080/14740338.2024.2419995","url":null,"abstract":"Objective: Our study aims to assess alendronate-related adverse events (AEs) from the US FDA adverse event reporting system database.Methods: The AE data associated with alendronate between the first quarter of 2004 and the first quarter of 2024 were selected. Various signal quantification methods, including the ROR, PRR, BCPNN, and EBGM, were applied for analysis.Results: In 34,943 reports where alendronate was the primary suspected drug for the AE, 24 affected system organ classes and 1046 significant preferred terms were identified in this study. Several significant AEs beyond drug instructions with strong signals were determined, including low turnover osteopathy, fracture delayed union, fracture nonunion, loss of anatomical alignment after fracture reduction, fracture malunion, periprosthetic fracture, carotid bruit, oral fibroma, traumatic occlusion, and phlebolith. The median time to onset of alendronate-related AEs was 306 days (interquartile range [IQR] 12-1,461 days), and the majority of cases occurred 2 years later (18.80%) and within 30 days (14.49%).Conclusions: The current study detected multiple potential new AE signals for alendronate, and more clinical research is required to further validate our results and clarify their associations.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"297-304"},"PeriodicalIF":3.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142461470","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

Drug-induced noninfectious myocarditis: a disproportionality analysis of the FAERS database. 药物诱发的非感染性心肌炎：FAERS 数据库的比例失调分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-03-01 Epub Date: 2024-11-03 DOI: 10.1080/14740338.2024.2423679

Liyuan Yan, Guanqun Zheng

{"title":"Drug-induced noninfectious myocarditis: a disproportionality analysis of the FAERS database.","authors":"Liyuan Yan, Guanqun Zheng","doi":"10.1080/14740338.2024.2423679","DOIUrl":"10.1080/14740338.2024.2423679","url":null,"abstract":"Background: This investigation aims to identify and evaluate the most common and critical drugs associated with the risk of noninfectious myocarditis utilizing the US Food and Drug Administration Adverse Event Reporting System (FAERS) database.Methods: Data pertaining to noninfectious myocarditis from 2004 Q1 to 2024 Q2 were extracted. Following data standardization, multiple signal quantification techniques, including Reporting Odds Ratio (ROR) and Proportional Reporting Ratio, were employed for analysis.Results: The study identified a total of 10,763 adverse event reports associated with noninfectious myocarditis. Disproportionality analysis revealed that the top 5 drugs by ROR were phendimetrazine tartrate (ROR 104.64), trimethoprim + sulfamethoxazole (ROR 67.65), aldesleukin (ROR 52.67), mesalazine (ROR 49.73), and balsalazide disodium (ROR 45.26). Notably, among the 30 drugs with the strongest ROR signals, 8 drugs lacked myocarditis risk information in their package inserts.Conclusion: Through comprehensive analysis of the FAERS database, our study identified drugs with a strong signal for myocarditis that are not currently indicated on their labels. The findings suggest that the potential risk of myocarditis associated with these medications is significant and warrants close monitoring in clinical practice.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"345-353"},"PeriodicalIF":3.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142544569","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

Ocular adverse events associated with GLP-1 receptor agonists: a real-world study based on the FAERS database and network pharmacology. 与 GLP-1 受体激动剂相关的眼部不良事件：基于 FAERS 数据库和网络药理学的真实世界研究。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-03-01 Epub Date: 2024-11-07 DOI: 10.1080/14740338.2024.2419989

Zhan-Yang Luo, Xiang Li, Cui-Ting Chen, Hong-Hua Kang, Zhi-Jie Zhang, Dong Wang, Jing-Ru Gong

{"title":"Ocular adverse events associated with GLP-1 receptor agonists: a real-world study based on the FAERS database and network pharmacology.","authors":"Zhan-Yang Luo, Xiang Li, Cui-Ting Chen, Hong-Hua Kang, Zhi-Jie Zhang, Dong Wang, Jing-Ru Gong","doi":"10.1080/14740338.2024.2419989","DOIUrl":"10.1080/14740338.2024.2419989","url":null,"abstract":"Objective: This study evaluates the risk of ocular adverse events (AEs) associated with glucagon-like peptide-1 receptor agonists (GLP-1 RAs) using data from the FDA Adverse Event Reporting System (FAERS) and network pharmacology methods.Methods: FAERS data from 2004 to 2024 were analyzed for ocular AEs linked to GLP-1 RA treatments. Disproportionality analysis (Reporting Odds Ratio, ROR) was used to identify signals, and a drug-gene interaction network explored potential mechanisms.Results: Among 17,785,793 FAERS reports, semaglutide and lixisenatide were significantly associated with ocular AEs, with RORs of 1.25 (95% CI, 1.20-1.31) and 1.96 (95% CI, 1.70-2.27), respectively. Commonly reported AEs included blurred vision, visual impairment, and diabetic retinopathy, with some AEs occurring as early as 10 days after treatment initiation. Gene enrichment analysis highlighted potential links between GLP-1-related genes and ocular AEs.Conclusion: The widespread use of GLP-1 RAs has raised concerns regarding their ophthalmic safety. This study contributes new evidence from real-world data, suggesting that semaglutide and lixisenatide are associated with significant risks of ocular AEs. Further experimental studies are warranted to elucidate the underlying mechanisms and confirm these associations.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"287-296"},"PeriodicalIF":3.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142461473","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 aromatase inhibitors: an analysis of real-world datasets and drug-gene interaction network. 与芳香化酶抑制剂相关的不良事件：真实世界数据集和药物基因相互作用网络分析》。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-03-01 Epub Date: 2024-11-11 DOI: 10.1080/14740338.2024.2424443

Si-Qi Zhang, Shujing Jia, Xiang Li, Rui-Rui Hu, Zhanyang Luo, Junhai Wang, Hongyan Xi

{"title":"Adverse events associated with aromatase inhibitors: an analysis of real-world datasets and drug-gene interaction network.","authors":"Si-Qi Zhang, Shujing Jia, Xiang Li, Rui-Rui Hu, Zhanyang Luo, Junhai Wang, Hongyan Xi","doi":"10.1080/14740338.2024.2424443","DOIUrl":"10.1080/14740338.2024.2424443","url":null,"abstract":"Background: Aromatase inhibitors (AIs) are commonly used to treat postmenopausal hormone receptor positive breast cancer, but there is currently a lack of comprehensive safety reports on AIs in large-scale cohorts.Research design and methods: We conducted a retrospective pharmacovigilance survey based on the FDA Adverse Event Reporting System, retrieving relevant reports from the 2004 to the 2023, aiming to conduct a comprehensive comparative analysis of adverse reactions associated with AIs. In addition, we elucidated the potential toxicological mechanisms of AIs related adverse events through functional enrichment analysis.Results: A total of 7,933 adverse event reports related to AIs were collected, and there were 642 positive signals at the preferred term level. The top three signal intensities for anastrozole are: antiphospholipid syndrome, plantar fasciitis and autoimmune pancreatitis. The top three signal intensities for letrozole are: androgenetic alopecia and myosclerosis, pneumonic herpes virus. The top three signal intensities for exemestane are: infection reactivation, thyroxine free decreased and dilatation atrial. In terms of onset time, letrozole has the earliest onset time overall, followed by exemestane, and finally anastrozole.Conclusions: Our research corroborates the typical adverse events linked to AIs while highlighting potential safety concerns in their real-world clinical application.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"315-324"},"PeriodicalIF":3.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142575642","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

Effects of nirmatrelvir/ritonavir (Paxlovid) on the nervous system: analysis on adverse events released by FDA.

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-02-27 DOI: 10.1080/14740338.2025.2471509

Caixia Gao, Zhihui Liu, Zhen Zou, Lejiao Mao, Jun Zhang

{"title":"Effects of nirmatrelvir/ritonavir (Paxlovid) on the nervous system: analysis on adverse events released by FDA.","authors":"Caixia Gao, Zhihui Liu, Zhen Zou, Lejiao Mao, Jun Zhang","doi":"10.1080/14740338.2025.2471509","DOIUrl":"10.1080/14740338.2025.2471509","url":null,"abstract":"Background: Nirmatrelvir/ritonavir, commonly known as Paxlovid, is one of the main drugs used to treat COVID-19. Neurological disorders are among the adverse drug reactions (ADRs) linked to Paxlovid, yet comprehensive data-mining studies based on real-world neurological adverse events induced by Paxlovid are lacking.Methods: It is an observational study, to reduce the risk of bias affected by COVID-19 disease, our study included only patients with COVID-19 disease. In this case, disproportionate analysis is performed using the Report Odds Ratio (ROR) and its 95% Confidence Interval (CI).Results: We screened and compared all medications associated with COVID-19 (N = 439) and found that 22 of these were linked to neurological adverse reactions. Paxlovid was associated with a threefold greater number of neurological adverse events compared to all other drugs combined (N = 11,792), with a strong signal value (ROR = 2.27).Conclusions: Compared to all other COVID-19-related drugs, Paxlovid has the highest number and stronger signal value for neurologic-related adverse reactions. Clinicians should pay special attention to female patients taking Paxlovid within the first 30 days, monitoring for symptoms such as dysgeusia, ageusia, headache, and anosmia. In addition, headache and anosmia are not uncommon occurrences as mentioned in the instructions and should be noted.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-8"},"PeriodicalIF":3.0,"publicationDate":"2025-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143514945","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 comprehensive exploration of adverse reactions to lapatinib: a disproportionate analysis based on the FAERS database.

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-02-26 DOI: 10.1080/14740338.2025.2471515

Yao Zhou, Jie Gong, Xianguang Deng, Lele Shen, Anqi Ge, Hongqiao Fan, Jie Ling, Shiting Wu, Lifang Liu

{"title":"A comprehensive exploration of adverse reactions to lapatinib: a disproportionate analysis based on the FAERS database.","authors":"Yao Zhou, Jie Gong, Xianguang Deng, Lele Shen, Anqi Ge, Hongqiao Fan, Jie Ling, Shiting Wu, Lifang Liu","doi":"10.1080/14740338.2025.2471515","DOIUrl":"10.1080/14740338.2025.2471515","url":null,"abstract":"Background: Lapatinib, an FDA-approved tyrosine kinase inhibitor, treats HER2+ advanced/metastatic breast cancer. This study comprehensively analyzed its adverse reaction profile using FDA Adverse Event Reporting System (FAERS) to guide clinical use.Research design and methods: Adverse event (AE) reports for lapatinib from the second quarter of 2007 to the second quarter of 2024 in FAERS were analyzed using Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Multi-item Gamma Poisson Shrinkage (MGPS) and Bayesian Confidence Propagation Neural Network (BCPNN) to identify AE signals.Results: Among 8300 AE reports, females (91.47%) and ages 40-59.9 (33.71%) were predominant. 20 system organ classifications (SOCs) were affected, with gastrointestinal disorders (ROR = 3.46) and skin disorders (ROR = 2.47) most significant. Based on the PT level, a total of 111 PTs were analyzed that met the four algorithms, including typical AEs such as diarrhea (n = 3410), vomiting (n = 856), and rash (n = 856), as well as some rare AEs that were not prompted by the drug inserts, such as neutropenia (n = 252), pericardial effusion (n = 43), lymphedema (n = 20). The majority of lapatinib-associated AEs had onset within 30 days (51%).Conclusions: Lapatinib has a generally favorable safety profile, but gastrointestinal toxicity and dermatotoxicity require close monitoring to prevent serious AEs.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-10"},"PeriodicalIF":3.0,"publicationDate":"2025-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143476049","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

Review of studies evaluating the effectiveness of risk minimization measures for oncology medicinal products registered in the European Medicines Agency (HMA-EMA) catalogue: findings and lessons learned.

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-02-26 DOI: 10.1080/14740338.2025.2471530

Jorge Monteiro, Diogo Almeida, João Paulo Fernandes, Bruno Sepodes, Carla Torre

{"title":"Review of studies evaluating the effectiveness of risk minimization measures for oncology medicinal products registered in the European Medicines Agency (HMA-EMA) catalogue: findings and lessons learned.","authors":"Jorge Monteiro, Diogo Almeida, João Paulo Fernandes, Bruno Sepodes, Carla Torre","doi":"10.1080/14740338.2025.2471530","DOIUrl":"10.1080/14740338.2025.2471530","url":null,"abstract":"Background: Risk management in oncology is critical due to toxicity, narrow therapeutic windows, and strict dosing schedules. This study analyzed post-authorization studies from the HMA-EMA Real-World Data Catalogues evaluating the effectiveness of risk minimization measures (RMM) for oncology medicines.Research design and methods: We reviewed all RMM effectiveness studies registered in the HMA-EMA RWD Catalogues until February 2024, focusing on medicines classified under ATC codes 'L' and 'V10' for oncological conditions. Data from protocols and reports were analyzed, including study design, population, objectives, RMM types, process and outcomes indicators and reported effectiveness.Results: Out of 1,280 records, 21 studies met the inclusion criteria. Most studies (81%) were cross-sectional surveys, 57% targeted healthcare professionals, and 86% used primary data. Additional RMMs were evaluated in 81% of studies. Process indicators were assessed in nearly all studies, but only 5% included outcome indicators. Of the 15 studies with available results, 60% were deemed effective, 27% inconclusive, and 13% ineffective by the sponsors.Conclusions: Future studies should set success thresholds in advance, use a dual evidence approach to measure outcomes, and consider new methods to increase participant numbers. Feasibility assessments prior to conducting studies are essential for achieving meaningful objectives in oncology risk management.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-12"},"PeriodicalIF":3.0,"publicationDate":"2025-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143482573","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 surveillance of Amivantamab: a real world study based on the FDA adverse event reporting system.

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-02-26 DOI: 10.1080/14740338.2025.2471512

Xiang Fu, Dongqiang Zeng, Min Li, Jianhua Wu, Yufan Yang, Qianqian Mao, Wenjun Qiu, Xiatong Huang, Yiran Fang, Luyang Jiang, Panwei Hu, Jiani Wu, Wangjun Liao

{"title":"Post-marketing safety surveillance of Amivantamab: a real world study based on the FDA adverse event reporting system.","authors":"Xiang Fu, Dongqiang Zeng, Min Li, Jianhua Wu, Yufan Yang, Qianqian Mao, Wenjun Qiu, Xiatong Huang, Yiran Fang, Luyang Jiang, Panwei Hu, Jiani Wu, Wangjun Liao","doi":"10.1080/14740338.2025.2471512","DOIUrl":"10.1080/14740338.2025.2471512","url":null,"abstract":"Background: Amivantamab stands as the pioneering bispecific antibody that targets both EGFR and MET, utilized in the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR ex20ins mutations. Nevertheless, a thorough assessment of its safety characteristics in the real-world remains unknown.Research design and methods: The adverse event (AE) reports were collected through a search of the FDA Adverse Event Reporting System (FAERS) database spanning from 2019 Q1 to 2024 Q1, and then disproportionality analysis was utilized.Results: Totally, 9,252,269 AE reports were obtained from the FAERS database, with 893 reports of amivantamab classified as primary suspect AEs. Amivantamab-related AEs were distributed in 23 organ systems, and 87 significant preferred terms (PTs) met the reporting odds ratio criteria. Novel significant AEs were detected, and the median time to onset of amivantamab-associated AEs was 43 days. In subgroup analysis, a higher proportion of patients who were male, over 65 years, and with pneumonitis or pneumonia were reported in the death cases. We also found that AEs may vary between intravenous and subcutaneous administration.Conclusions: This investigation offered novel prospects for monitoring and addressing undesirable medication effects associated with amivantamab, which might improve the clinical medication safety.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-9"},"PeriodicalIF":3.0,"publicationDate":"2025-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143500119","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 inclisiran: a real-world pharmacovigilance study of FDA adverse event reporting system (FAERS).

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-02-25 DOI: 10.1080/14740338.2025.2468855

Bing Li, Yan Chen, Yongyi Zhang, Mengying Qian, Qing Shan, Jiao Qian, Jinmin Guo

{"title":"Adverse events associated with inclisiran: a real-world pharmacovigilance study of FDA adverse event reporting system (FAERS).","authors":"Bing Li, Yan Chen, Yongyi Zhang, Mengying Qian, Qing Shan, Jiao Qian, Jinmin Guo","doi":"10.1080/14740338.2025.2468855","DOIUrl":"10.1080/14740338.2025.2468855","url":null,"abstract":"Objective: To gain an improved comprehension of inclisiran safety in real-world settings by data mining from FAERS.Methods: Data were gathered between 1 December 2020 and 31 December 2023. The Medical Dictionary for Regulatory Activities (MedDRA) corresponding preferred term (PT) and system organ class (SOC) were used to categorize adverse medication reactions in AE reports (AERs). By using reported odds ratio (ROR) method, positive signals were identified.Results: There were 2,652 reports of inclisiran, and 150 of those AEs had significant disproportionality. Among the 44 PTs with moderate clinical priority, 35 PTs were discovered on the medicine label, including 12 IMEs and 2 DMEs. Of note, 9 PTs were unanticipated AEs that were not discovered in the medication label or reported clinical studies, such as movement disorder (ROR: 3.05; 95%CI: 1.73,5.37), aphonia (ROR: 3.77; 95%CI: 1.79,7.91), and pulmonary congestion (ROR: 3.47; 95%CI: 1.44,8.34). Inclisiran was found to be related to 12 serious AEs. The median TTO of 1896 cases was 13.5 (IQR 0-100) days.Conclusion: We identified not only known AEs, but also new AE signals such as movement disorder. However, signals does not reveal actual risk, prospective clinical trials are still required to verify their causal connection.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-12"},"PeriodicalIF":3.0,"publicationDate":"2025-02-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143467509","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