Expert Opinion on Drug Safety最新文献

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Associations of acute kidney injury with oral anticoagulants: a disproportionality analysis of the Food and Drug Administration Adverse Event Reporting System (FAERS) database. 急性肾损伤与口服抗凝剂的关系:食品和药物管理局不良事件报告系统(FAERS)数据库的歧化分析。
IF 3 3区 医学
Expert Opinion on Drug Safety Pub Date : 2026-07-01 Epub Date: 2025-02-02 DOI: 10.1080/14740338.2025.2461203
Hehe Bai, Jinping Wang, Xiaojing Nie, Huan Li, Li Ma, Xiaonian Han, Lirong Peng
{"title":"Associations of acute kidney injury with oral anticoagulants: a disproportionality analysis of the Food and Drug Administration Adverse Event Reporting System (FAERS) database.","authors":"Hehe Bai, Jinping Wang, Xiaojing Nie, Huan Li, Li Ma, Xiaonian Han, Lirong Peng","doi":"10.1080/14740338.2025.2461203","DOIUrl":"10.1080/14740338.2025.2461203","url":null,"abstract":"<p><strong>Objective: </strong>The FDA Adverse Event Reporting System (FAERS) was used to evaluate the associations between oral anticoagulants (OACs) and acute kidney injury (AKI).</p><p><strong>Methods: </strong>Disproportionality analysis was applied to data in the FAERS database from January 2004 to December 2023 to detect adverse events (AEs) for various OACs. The adjusted reporting odds ratios (RORs) calculated using multiple logistic regression were used to explore the risk factors for OACs-associated AKI.</p><p><strong>Results: </strong>The crude RORs for the associations of AKI with warfarin, rivaroxaban, dabigatran, apixaban, and edoxaban were 1.35, 2.14, 2.98, 1.33, and 3.56, respectively. The risk of OACs-associated AKI was affected by age and sex, being higher in those aged 65 years and males. The adjusted RORs for rivaroxaban, dabigatran, apixaban, and edoxaban were 1.26, 1.67, 0.65, and 2.06, respectively.Nearly 50% of AKI cases occurred within the first 2 months, and each OAC was of the early-failure type. Hospitalization and mortality rates for AKI patients after OACs were 45.53% and 22.98%, respectively.</p><p><strong>Conclusions: </strong>The study revealed a strong association between AKI and OACs, emphasizing the need for regular renal function monitoring , especially in elderly male patients. Further in-depth research is needed to confirm these exploratory findings.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1361-1370"},"PeriodicalIF":3.0,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143064346","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
From black box to clear box: explainable AI for next-gen pharmacovigilance. 从黑箱到清箱:用于下一代药物警戒的可解释人工智能。
IF 3 3区 医学
Expert Opinion on Drug Safety Pub Date : 2026-07-01 Epub Date: 2026-02-11 DOI: 10.1080/14740338.2026.2628822
Nirmala Suryadevara, Vishnu Priya, Sanjay Sharma
{"title":"From black box to clear box: explainable AI for next-gen pharmacovigilance.","authors":"Nirmala Suryadevara, Vishnu Priya, Sanjay Sharma","doi":"10.1080/14740338.2026.2628822","DOIUrl":"10.1080/14740338.2026.2628822","url":null,"abstract":"<p><strong>Introduction: </strong>Pharmacovigilance (PV) plays a vital role in post-marketing surveillance of drug safety; however, traditional methods are hindered by underreporting, data heterogeneity, and delayed signal detection. Artificial Intelligence (AI) has been increasingly employed to overcome these shortcomings through automation, advanced pattern recognition, and multimodal fusion of patient data.</p><p><strong>Areas covered: </strong>The regulatory acceptance of these systems rests on explainability, transparency, and auditability, which necessitate the inclusion of explainable AI (XAI) methods. This review thoroughly examines the international regulatory environment for AI in PV and suggests using Shapley Additive Explanations (SHAP) and Local Interpretable Model-Agnostic Explanations (LIME) to build regulatory trust. Research materials, including official guidelines and publications, were systematically sourced from authoritative regulatory websites in the US, Europe, and India, as well as from major academic databases such as Google Scholar, ScienceDirect, and PubMed.</p><p><strong>Expert guidance: </strong>The EU AI Act classifies PV algorithms as 'high-risk,' imposing strict requirements for human oversight and transparency, aligning with the FDA's GMLP and India's Responsible AI principles. The review emphasizes traceability and governance, recommending convergence with human oversight into a regulatory-fit XAI framework to maximize safety signal detection and foster international trust in AI-based decision-making.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1229-1243"},"PeriodicalIF":3.0,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146124321","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 assessment of constipation drugs: a real-world pharmacovigilance study based on FAERS database. 便秘药物上市后安全性评估:基于FAERS数据库的真实世界药物警戒研究
IF 3 3区 医学
Expert Opinion on Drug Safety Pub Date : 2026-07-01 Epub Date: 2025-02-18 DOI: 10.1080/14740338.2025.2467829
Wenyu Zhang, Hui Wang, Shiwei Yang, Xue Pang, Wenqi Hu, Guang Zhang, Xuezhi Xin
{"title":"Post-marketing safety assessment of constipation drugs: a real-world pharmacovigilance study based on FAERS database.","authors":"Wenyu Zhang, Hui Wang, Shiwei Yang, Xue Pang, Wenqi Hu, Guang Zhang, Xuezhi Xin","doi":"10.1080/14740338.2025.2467829","DOIUrl":"10.1080/14740338.2025.2467829","url":null,"abstract":"<p><strong>Background: </strong>Laxatives are widely used in the treatment of constipation, but they also have brought many adverse reactions to patients.</p><p><strong>Methods: </strong>We conducted a pharmacovigilance analysis based on the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database to analyze the adverse events of six constipation drugs (linaclotide, lubiprostone, prucalopride, naloxegol, naldemedine, and plecanatide) and to search for clinically meaningful adverse reaction signals. We used disproportionality analysis as the main analysis method to detect pharmacovigilance signals, which includes Frequentist methods and Bayesian methods.</p><p><strong>Results: </strong>Among the reports of the six drugs, more adverse reactions were reported from females than males, and the number of adverse reactions reported was higher in the group of 60-89 years. Linaclotide had the lowest proportion of serious adverse event reports (4.38%), while naldemedine had the highest proportion of serious adverse event reports (25.57%). According to the classification of system organ classification (SOC), the number of gastrointestinal adverse events (<i>N</i> = 8321) was the largest.</p><p><strong>Conclusions: </strong>The adverse reactions of constipation drugs were mainly gastrointestinal symptoms such as diarrhea, abdominal pain and abdominal distension. Linaclotide has the highest safety, and more studies are needed to analyze the cardiovascular safety of lubiprostone.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1279-1289"},"PeriodicalIF":3.0,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143413756","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 of edaravone in real-world use: analysis based on FDA adverse event reporting system. 依达拉奉在实际应用中的安全性:基于FDA不良事件报告系统的分析。
IF 3 3区 医学
Expert Opinion on Drug Safety Pub Date : 2026-07-01 Epub Date: 2025-02-25 DOI: 10.1080/14740338.2025.2470874
Tao Peng, Nan Hu, Lan Huang, Yalong Kang, Yongmei Yan, Hui Zhang, Dongping Wan, Xiaxia Jin, Yifan Yang
{"title":"Safety of edaravone in real-world use: analysis based on FDA adverse event reporting system.","authors":"Tao Peng, Nan Hu, Lan Huang, Yalong Kang, Yongmei Yan, Hui Zhang, Dongping Wan, Xiaxia Jin, Yifan Yang","doi":"10.1080/14740338.2025.2470874","DOIUrl":"10.1080/14740338.2025.2470874","url":null,"abstract":"<p><strong>Background: </strong>Edaravone is a novel free radical scavenger utilized to treat amyotrophic lateral sclerosis (ALS). However, long-term safety data remain limited.</p><p><strong>Research design and methods: </strong>Adverse event reports related to edaravone from the second quarter of 2017 to the second quarter of 2024 were extracted from the US Food and Drug Administration (FDA) Adverse Event Reporting System database (FAERS). Disproportionality analysis was conducted utilizing the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS) algorithms.</p><p><strong>Results: </strong>A total of 3,149 adverse event reports related to edaravone were analyzed. The most common adverse reactions included systemic disorders and administration site reactions, nervous system disorders, respiratory system disorders, and surgical and medical procedures. New adverse reaction signals included disseminated intravascular coagulation, gastric fistula, sputum retention, excessive salivation, fractures, elevated cystatin C. The median onset time for adverse events was 43 days (interquartile range: 7-173 days).</p><p><strong>Conclusion: </strong>This study confirmed previously reported adverse events and identified several new ones associated with edaravone. These findings provide valuable insights for optimizing ALS patient management and highlight the need for further research into the mechanisms of these adverse reactions.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1299-1307"},"PeriodicalIF":3.0,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143467539","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
Could anticholinergics accelerate ALS progression? A critical perspective on drug safety and disease vulnerability. 抗胆碱能药物会加速ALS的进展吗?对药物安全和疾病脆弱性的关键观点。
IF 3 3区 医学
Expert Opinion on Drug Safety Pub Date : 2026-06-30 DOI: 10.1080/14740338.2026.2687628
Tiffany R Price, Chia-Yuan Chang, Kirya Skinner, Michael Dinneny, Parmida Nafezi, Lisa Kuramoto, Mary A De Vera, Neil R Cashman, Jacquelyn J Cragg
{"title":"Could anticholinergics accelerate ALS progression? A critical perspective on drug safety and disease vulnerability.","authors":"Tiffany R Price, Chia-Yuan Chang, Kirya Skinner, Michael Dinneny, Parmida Nafezi, Lisa Kuramoto, Mary A De Vera, Neil R Cashman, Jacquelyn J Cragg","doi":"10.1080/14740338.2026.2687628","DOIUrl":"10.1080/14740338.2026.2687628","url":null,"abstract":"<p><strong>Introduction: </strong>Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disorder with limited treatment options and diverse symptoms necessitating active management. Anticholinergic medications are frequently used in ALS care, particularly for sialorrhea and mood disturbances. Their cumulative effects, termed anticholinergic burden, may pose underrecognized risks in this neurologically vulnerable population. This review highlights a plausible safety signal and outlines priorities for future research.</p><p><strong>Areas covered: </strong>This narrative review synthesizes evidence from non-ALS populations reporting associations between higher anticholinergic burden and cognitive decline, respiratory complications, functional deterioration, and mortality. Evidence was identified through targeted PubMed/MEDLINE and Embase searches with reference chaining, emphasizing recent and seminal studies. Mechanistic overlap with ALS pathophysiology, including neuromuscular junction disruption, impaired cholinergic signaling, and neuroinflammation, supports biological plausibility for harm. Current ALS guidelines do not address cumulative anticholinergic exposure, leaving clinicians without a framework for evaluating risk or deprescribing.</p><p><strong>Expert opinion: </strong>This article proposes a testable hypothesis that anticholinergic burden may represent a clinically relevant yet unmeasured risk factor in ALS. Emerging pharmacoepidemiologic methods and validated burden tools offer approaches to quantify exposure and evaluate relationships with ALS outcomes, supporting safer symptomatic management. Prioritizing longitudinal studies and integrating burden assessment into multidisciplinary care may help clarify risk.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-16"},"PeriodicalIF":3.0,"publicationDate":"2026-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148351431","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 teprotumumab-trbw, the first and only FDA-approved treatment for thyroid-associated ophthalmopathy. teprotumumab-trbw的安全性概况,FDA批准的第一种也是唯一一种治疗甲状腺眼病的药物。
IF 3 3区 医学
Expert Opinion on Drug Safety Pub Date : 2026-06-24 DOI: 10.1080/14740338.2026.2690266
Terry J Smith
{"title":"Safety profile of teprotumumab-trbw, the first and only FDA-approved treatment for thyroid-associated ophthalmopathy.","authors":"Terry J Smith","doi":"10.1080/14740338.2026.2690266","DOIUrl":"10.1080/14740338.2026.2690266","url":null,"abstract":"<p><strong>Introduction: </strong>Teprotumumab (Tepezza), a monoclonal antibody targeting the insulin-like growth factor 1 receptor (IGF-IR), was approved in January 2020 by the US Food and Drug Administration for treatment of thyroid-associated ophthalmopathy (TAO). The drug was found to be effective and generally well-tolerated in two registered clinical trials and subsequent post-marketing trials.</p><p><strong>Areas covered: </strong>A search of PubMed and other databases of medical and scientific literature was conducted. Key search terms included 'teprotumumab,' 'Tepezza,' 'thyroid-associated ophthalmopathy treatment,' and 'Graves' disease treatment.' Two adverse events (AEs), auditory abnormalities and hyperglycemia, were the focus of this review. As of 7 December 2025, 392 citations were identified in PubMed using teprotumumab as the search term. Of these, 29 publications primarily reported AEs or safety concerns associated with teprotumumab. The two most consequential AEs, hearing dysfunction and hyperglycemia, were identified in phase 2 and phase 3 clinical trials.</p><p><strong>Expert opinion: </strong>Teprotumumab, the only FDA-approved therapy for TAO, is generally effective. It has been associated with several side effects; the most concerning are hearing dysfunction and hyperglycemia. Due diligence in pretreatment, intra-treatment and post-treatment monitoring is essential. Detailed benefit-risk analysis should be shared with all patients for whom use of the drug is being considered.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-12"},"PeriodicalIF":3.0,"publicationDate":"2026-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148249897","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 systematic review and meta-analysis of safety and efficacy parameters of sotatercept in the therapy of pulmonary arterial hypertension. 索他塞普治疗肺动脉高压的安全性和有效性参数的系统回顾和荟萃分析。
IF 3.1 3区 医学
Expert Opinion on Drug Safety Pub Date : 2026-06-09 DOI: 10.1080/14740338.2026.2685360
Siddhartha Dutta, Rima Shah, Shubha Singhal, Mamta Singh, Sagar Dholariya, Shalini Chawla, Chandan Katoch
{"title":"A systematic review and meta-analysis of safety and efficacy parameters of sotatercept in the therapy of pulmonary arterial hypertension.","authors":"Siddhartha Dutta, Rima Shah, Shubha Singhal, Mamta Singh, Sagar Dholariya, Shalini Chawla, Chandan Katoch","doi":"10.1080/14740338.2026.2685360","DOIUrl":"10.1080/14740338.2026.2685360","url":null,"abstract":"<p><strong>Introduction: </strong>Pulmonary arterial hypertension (PAH) has responded favorably to the new fusion protein named sotatercept. This study aimed to evaluate the safety and efficacy of sotatercept in PAH.</p><p><strong>Methods: </strong>The online databases like PubMed/Medline, Cochrane Library, and ClinicalTrials.gov were searched until 15 September 2024 for studies comparing sotatercept to placebo using keywords such as \"sotatercept, pulmonary arterial hypertension, and 'fusion protein.'</p><p><strong>Results: </strong>Of the 213 titles searched, after removing duplicates, 142 studies were evaluated for eligibility. Two RCTs were finally included. Subgroup analysis was conducted for the two doses (0.7 mg/kg and 0.3 mg/kg). In the safety analysis, there were no significant differences in total adverse events [RR = 1.03 (0.95, 1.12), I<sup>2</sup> = 0, <i>p</i> = 0.50], serious adverse events [RR = 0.96 (0.38, 2.42), I<sup>2</sup> = 56, <i>p</i> = 0.93], and mortality [RR = 0.39 (0.01, 11.81), I<sup>2</sup> = 61%, <i>p</i> = 0.59]. However, a significant difference was observed with non-serious adverse events [RR = 1.15 (1.03-1.30), I<sup>2</sup> = 0%, <i>p</i> = 0.02], telangiectasia [RR = 3.34 (1.26-8.83), <i>p</i> = 0.02], thrombocytopenia [RR = 3.69 (1.23-11.0), I<sup>2</sup> = 0%, <i>p</i> = 0.02] and epistaxis [RR = 5.58 (2.20-14.13), <i>p</i> = 0.0003]. No significant difference was observed with headache, nasopharyngitis, hypotension, neutropenia, nausea, diarrhea, rash, anemia, and dizziness. A significant change was observed with the majority of efficacy parameters, like Pro BNP [MD = -1150.38 (-1846.44, -454.32), I<sup>2</sup> = 79, <i>p</i> = 0.001], pulmonary vascular resistance [MD = -234.40 (-325.30, -143.51), I<sup>2</sup> = 72, <i>p</i> < 0.00001], pulmonary arterial wedge pressure (<i>p</i> = 0.007) and improvement in WHO functional class [OR = 3.23 (1.25, 8.34), I<sup>2</sup> = 61, <i>p</i> = 0.02].</p><p><strong>Conclusion: </strong>This study demonstrates that sotatercept is more effective than placebo in treating PAH and has a fair safety profile.</p><p><strong>Clinicaltrial.gov: </strong>Identifier numbers: NCT04576988 and NCT03496207 PROSPERO: CRD42024534695.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-13"},"PeriodicalIF":3.1,"publicationDate":"2026-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148162490","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
Tirzepatide data: safety first is safety always! 替西肽数据:安全永远第一!
IF 3.1 3区 医学
Expert Opinion on Drug Safety Pub Date : 2026-06-02 DOI: 10.1080/14740338.2026.2681511
Miodrag Janić, Syed Arman Rabbani, Mohamed El-Tanani, Imran Rangraze, Andrej Janež, Viviana Maggio, Manfredi Rizzo
{"title":"Tirzepatide data: safety first is safety always!","authors":"Miodrag Janić, Syed Arman Rabbani, Mohamed El-Tanani, Imran Rangraze, Andrej Janež, Viviana Maggio, Manfredi Rizzo","doi":"10.1080/14740338.2026.2681511","DOIUrl":"10.1080/14740338.2026.2681511","url":null,"abstract":"<p><strong>Introduction: </strong>Tirzepatide, a dual GIP and GLP-1 receptor agonist, offers unprecedented efficacy for type 2 diabetes and obesity. Due to its rapid global adoption, understanding its complete safety spectrum is urgently needed to guide responsible prescribing and mitigate public health risks.</p><p><strong>Areas covered: </strong>A literature search was conducted using PubMed and other public databases available to evaluate current evidence on the efficacy, safety, and metabolic impact of tirzepatide. The research discussed encompasses clinical trials and real-world data detailing the glycemic and weight reduction benefits of the drug. We examine its overall tolerability, covering common gastrointestinal events, including its high comparative risk for severe gastrointestinal events and treatment discontinuation, rare risks such as gallbladder and thyroid disorders, and the complex impact of the drug on skeletal muscle mass.</p><p><strong>Expert opinion: </strong>While tirzepatide represents a paradigm shift in metabolic therapy, clinical management must evolve toward precision phenotyping to individualize patient risk-benefit trajectories. Future research must prioritize long-term functional outcomes to ensure that disease-modifying benefits are not offset by treatment-induced sarcopenia.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-10"},"PeriodicalIF":3.1,"publicationDate":"2026-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148041675","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 impact of the COVID-19 pandemic on adverse events associated with ACEIs and ARBs: a real-world analysis using the FDA adverse event reporting system. COVID-19大流行对与acei和arb相关的不良事件的影响:使用FDA不良事件报告系统的现实世界分析。
IF 3.1 3区 医学
Expert Opinion on Drug Safety Pub Date : 2026-06-01 Epub Date: 2025-02-13 DOI: 10.1080/14740338.2025.2465865
Hui Qiu, Li He, Jianzhu Zhou, Zeying Feng, Ling Ye, Tong Li, Xin Huang, Longjian Huang, Chengjun Guo, Shaojun Chen, Chengxian Guo
{"title":"The impact of the COVID-19 pandemic on adverse events associated with ACEIs and ARBs: a real-world analysis using the FDA adverse event reporting system.","authors":"Hui Qiu, Li He, Jianzhu Zhou, Zeying Feng, Ling Ye, Tong Li, Xin Huang, Longjian Huang, Chengjun Guo, Shaojun Chen, Chengxian Guo","doi":"10.1080/14740338.2025.2465865","DOIUrl":"10.1080/14740338.2025.2465865","url":null,"abstract":"<p><strong>Background: </strong>During the 2019 coronavirus disease (COVID-19) pandemic, although patients were advised to continue using angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs), it remains unclear whether the pandemic influenced the occurrence of adverse reactions to these drugs. This study aims to analyze and compare changes in ACEIs and ARBs adverse events before and during the COVID-19 pandemic, exploring its potential impact on the safety of these medications.</p><p><strong>Methods: </strong>We used real-world data to explore the impact of the COVID-19 pandemic on adverse events related to ACEIs and ARBs.</p><p><strong>Results: </strong>During the pandemic, ACEI-related adverse events (70 cases) and ARB-related adverse events (7 cases) showed increased reporting rates and RORs, with a notable rise in ACEI-related ear and labyrinth disorders. Additionally, 170 new adverse event signals were detected for ACEIs (8 with significantly increased risk) and 191 signals for ARBs (2 with significantly increased risk).</p><p><strong>Conclusions: </strong>This study, based on real-world data, revealed significant signals indicating that ACEI use during the COVID-19 pandemic may have increased the risk of renal adverse events and ear labyrinth diseases. The study emphasized the need for increased caution when using ACEIs and ARBs during the pandemic.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1197-1206"},"PeriodicalIF":3.1,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143382030","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
Updated insights on levetiracetam-associated severe cutaneous adverse reactions: a real-world pharmacovigilance analysis. 关于左乙拉西坦相关严重皮肤不良反应的最新见解:现实世界药物警戒分析。
IF 3.1 3区 医学
Expert Opinion on Drug Safety Pub Date : 2026-06-01 Epub Date: 2025-02-20 DOI: 10.1080/14740338.2025.2468351
Zhanshen Wu, Yang Zhao, Xiangyu Zhang, Yanyan Li
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