Expert Opinion on Drug Safety最新文献_第2页

Psychedelics in psychiatry: comparative effectiveness, implementation, commercialization and safety lessons learned from intranasal esketamine. 精神病学中的致幻剂：鼻用艾氯胺酮的比较有效性、实施、商业化和安全性教训。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-09-01 DOI: 10.1080/14740338.2026.2726227

Roger S McIntyre

引用次数: 0

Novel insights into post-marketing AEs associated with bempedoic acid: a comprehensive analysis utilizing the FAERS database. 对与戊二甲酸相关的上市后ae的新见解：利用FAERS数据库的综合分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-09-01 Epub Date: 2025-02-19 DOI: 10.1080/14740338.2025.2468868

Xinzhe Wang, Yang Liu, Huawei Han, Jingyun Ma, Ningsheng Tian, Rui Zhu, Xiuwen Shi, Jing Jin, Huifang Zhou

{"title":"Novel insights into post-marketing AEs associated with bempedoic acid: a comprehensive analysis utilizing the FAERS database.","authors":"Xinzhe Wang, Yang Liu, Huawei Han, Jingyun Ma, Ningsheng Tian, Rui Zhu, Xiuwen Shi, Jing Jin, Huifang Zhou","doi":"10.1080/14740338.2025.2468868","DOIUrl":"10.1080/14740338.2025.2468868","url":null,"abstract":"Background: Bempedoic acid is a new drug for lowering low-density lipoprotein cholesterol. This study used the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database to retrospectively mine adverse events of oral bempedoic acid in the real world.Research design and methods: The FAERS database was searched to extract the adverse reactions of bempedoic acid from the third quarter of 2020 to the fourth quarter of 2023. After data standardization, the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS) methods were used to comprehensively evaluate the adverse reaction signals.Results: A total of 1091 adverse reaction reports were identified, and 70 adverse reaction terms were obtained, involving 22 system categories. According to the ROR signal ranking, the most affected System Organ Classes (SOCs) were \"musculoskeletal and connective tissue disorders,\"\"hepatobiliary disorders,\" and \"investigation.\" Preferred Terms (PTs) with high signal intensity had low density lipoprotein abnormality, elevated blood uric acid, biliary colic, etc. New adverse reaction signals such as esophageal spasm, angina, apathy were reported.Conclusions: This study provide support for clinical monitoring and risk identification of bempedoic acid.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1653-1660"},"PeriodicalIF":3.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143440397","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 disproportionality analysis of hydrocortisone-related adverse events: a real-world pharmacovigilance study using the FAERS database. 氢化可的松相关不良事件的歧化分析：使用FAERS数据库的现实世界药物警戒研究。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-09-01 Epub Date: 2025-04-07 DOI: 10.1080/14740338.2025.2487159

Xiaoyu Wang, Fan An, Xuelian Zhao, Benjun Wang, Liwei Yan, Weiwei Han

{"title":"A disproportionality analysis of hydrocortisone-related adverse events: a real-world pharmacovigilance study using the FAERS database.","authors":"Xiaoyu Wang, Fan An, Xuelian Zhao, Benjun Wang, Liwei Yan, Weiwei Han","doi":"10.1080/14740338.2025.2487159","DOIUrl":"10.1080/14740338.2025.2487159","url":null,"abstract":"Background: This study aims to systematically evaluate adverse events (AEs) associated with hydrocortisone through the FDA Adverse Event Reporting System (FAERS) database.Research designs: AE reports associated with hydrocortisone from Q1 2014 to Q4 2023 were extracted from the FAERS database. Multiple disproportionality analysis techniques, including Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayes Geometric Mean (EBGM), were employed for signal detection. In addition, we also analyzed the time to onset of AEs.Results: Analysis of 7,532 hydrocortisone-associated AEs from the FAERS database revealed significant signals across multiple system organ classes. The strongest associations were found in endocrine disorders (ROR: 13.39), ear and labyrinth disorders (ROR: 3.05), and immune system disorders (ROR: 2.17). Additionally, the study uncovered unexpected AEs such as splenic peliosis and lymphoid tissue hypoplasia. 63.9% of the AEs occurred within 7 days of treatment.Conclusions: Based on disproportionality analysis of FAERS data, this study provides new insights into the safety of hydrocortisone in the real-world setting. Future prospective studies should be conducted to validate the findings of this investigation.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1749-1758"},"PeriodicalIF":3.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143751483","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

Safeguarding drug safety in neonates: addressing the impact of in-hospital medication administration errors through prevention and standardization. 保障新生儿用药安全：通过预防和规范解决院内用药差错的影响。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-09-01 Epub Date: 2025-11-07 DOI: 10.1080/14740338.2025.2585069

Giva Sheiniz, Naomi McCallion, Karel Allegaert, Fiona O'Brien

引用次数: 0

Diarrhea-predominant irritable bowel syndrome treatment options eluxadoline, rifaximin, and alosetron: analysis of the FDA adverse event reporting system (FAERS) database. 腹泻为主的肠易激综合征治疗选择依洛沙多林、利福昔明和阿洛司琼：FDA不良事件报告系统（FAERS）数据库的分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-09-01 Epub Date: 2025-04-09 DOI: 10.1080/14740338.2025.2490841

Michael B Andrews, Douglas G Adler

{"title":"Diarrhea-predominant irritable bowel syndrome treatment options eluxadoline, rifaximin, and alosetron: analysis of the FDA adverse event reporting system (FAERS) database.","authors":"Michael B Andrews, Douglas G Adler","doi":"10.1080/14740338.2025.2490841","DOIUrl":"10.1080/14740338.2025.2490841","url":null,"abstract":"Background: Adverse events (AEs) suspected to be associated with the three FDA approved medications (eluxadoline, rifaximin, and alosetron) for diarrhea-predominant irritable bowel syndrome (IBS-D) were examined.Research design and methods: We analyzed all reports in the FDA Adverse Event Reporting System (FAERS) database from each medication's date of FDA approval through 30 June 2024. Reports were excluded if they contained other suspected medications or had a reason for use outside of IBS and/or diarrhea.Results: Eluxadoline was associated with 1,002 AEs, most commonly abdominal pain (n = 257, 17.0%) and uniquely pancreatitis (n = 174, 11.5%) and sphincter of Oddi dysfunction (n = 39, 2.6%). Rifaximin was associated with 652 AEs, most commonly abdominal pain (n = 64, 7.6%) and uniquely C.difficile and bacterial overgrowth (n = 3, 0.4% each). Alosetron was associated with 3,832AEs, most commonly constipation (n = 2,007, 23.1%) and uniquely colitis (n = 235,2.7%), ischemic colitis (n = 140, 1.6%), obstruction (n = 110, 1.3%), and perforation (n = 26, 0.3%).Conclusions: Our analysis of the FAERS database showed frequent reports of abdominal pain, constipation, and nausea/vomiting related to the three FDA approved medications for IBS-D. Each raised concerns for distinct and serious AEs including pancreatitis (eluxadoline), C.difficile infection (rifaximin), ischemic colitis (alosetron), and intestinal obstruction/perforation (alosetron).","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1785-1791"},"PeriodicalIF":3.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143803013","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 acute pancreatitis caused by immune checkpoint inhibitors: a pharmacovigilance analysis of the FDA adverse event reporting system (FAERS) database. 与免疫检查点抑制剂引起的急性胰腺炎相关的不良事件：对FDA不良事件报告系统（FAERS）数据库的药物警戒分析

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-09-01 Epub Date: 2025-03-29 DOI: 10.1080/14740338.2025.2486311

Lihua Tong, Yanling Yuan, Wanming He, Wen Yang, Xingxi Pan

{"title":"Adverse events associated with acute pancreatitis caused by immune checkpoint inhibitors: a pharmacovigilance analysis of the FDA adverse event reporting system (FAERS) database.","authors":"Lihua Tong, Yanling Yuan, Wanming He, Wen Yang, Xingxi Pan","doi":"10.1080/14740338.2025.2486311","DOIUrl":"10.1080/14740338.2025.2486311","url":null,"abstract":"Background: The precise incidence of immune-related adverse events (irAEs) remains unclear. This pharmacovigilance study investigated acute pancreatitis (AP) associated with immune checkpoint inhibitors (ICIs) using real-world data from the FDA Adverse Event Reporting System (FAERS).Research design and methods: Disproportionality analysis employing reporting odds ratios (RORs) was conducted to detect AP signals in ICI-treated patients compared to the entire FAERS database.Results: A total of 152,042 individual patients were included in the dataset from which we identified a cohort of 921 acute pancreatitis adverse events (AEs). The severe outcome of acute pancreatitis was death, with a rate of 13.6% (125/921). Immune checkpoint inhibitor (ICI)-related acute pancreatitis AEs were classified into two categories (pancreatitis and immune-mediated pancreatitis) based on the type of adverse event observed. ICI treatments were significantly correlated with the risk of ICIs-induced acute pancreatitis (AP) but varied among different drugs. The median time to AP onset was 57 days, with events occurring throughout the first year post-ICI initiation.Conclusions: Our findings provide an enhanced understanding of potential acute pancreatitis related adverse events and provide actionable insights for the early detection and management of ICI related pancreatic adverse events.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1711-1719"},"PeriodicalIF":3.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143729516","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 drug reactions linked to fidaxomicin: insights from a retrospective analysis of the FAERS database. 与非达霉素相关的药物不良反应：来自FAERS数据库回顾性分析的见解。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-09-01 Epub Date: 2025-03-31 DOI: 10.1080/14740338.2025.2487142

Parth Patel, Mohamad Ayman Ebrahim, Douglas G Adler

{"title":"Adverse drug reactions linked to fidaxomicin: insights from a retrospective analysis of the FAERS database.","authors":"Parth Patel, Mohamad Ayman Ebrahim, Douglas G Adler","doi":"10.1080/14740338.2025.2487142","DOIUrl":"10.1080/14740338.2025.2487142","url":null,"abstract":"Background: Clostridium difficile infection is a leading healthcare-associated infection, and fidaxomicin is recommended as a first-line treatment. Although generally well-tolerated, post-marketing surveillance of fidaxomicin's safety profile is necessary given its increased utilization.Research design and methods: This study utilized the FDA Adverse Event Reporting System to analyze adverse drug reactions potentially linked to fidaxomicin use from January 2011 to June 2024. Data were extracted on patient demographics, reported ADRs, and outcomes. Descriptive statistics were used to analyze the ADR reports.Results: A total of 1,187 reports of ADRs were analyzed, including 122 deaths (10.3%), 187 hospitalizations (15.8%), and 17 disabilities (1.4%). The most commonly reported ADRs were gastrointestinal (33%) in nature. Neurological ADRs accounted for 6% of reports, with dizziness and headache being the most prevalent. Psychiatric ADRs such as insomnia and anxiety were reported in 2.8% of cases, with more than half considered serious. Cardiovascular ADRs, though infrequent (2.2%), were largely severe, with heart failure and arrhythmias being the most common.Conclusion: While fidaxomicin is generally well-tolerated, our study identified rare but serious neuropsychiatric and cardiovascular ADRs. Further research is needed to investigate these effects and ensure informed, shared decision-making between prescribers and patients.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1771-1774"},"PeriodicalIF":3.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143751676","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

Update of safety profile of levonorgestrel: a disproportionality analysis based on FAERS from 2004 to 2023. 左炔诺孕酮安全性概况的更新：2004 - 2023年基于FAERS的歧化分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-09-01 Epub Date: 2025-03-03 DOI: 10.1080/14740338.2025.2472908

Wujiang Lai, Jiemei Liang, Ying Xiang, Qinqin Hu, Jinfa Huang, Milin Chen, Xiting Chen, Bin Sun, Qian Yang, Kaixian Deng

{"title":"Update of safety profile of levonorgestrel: a disproportionality analysis based on FAERS from 2004 to 2023.","authors":"Wujiang Lai, Jiemei Liang, Ying Xiang, Qinqin Hu, Jinfa Huang, Milin Chen, Xiting Chen, Bin Sun, Qian Yang, Kaixian Deng","doi":"10.1080/14740338.2025.2472908","DOIUrl":"10.1080/14740338.2025.2472908","url":null,"abstract":"Background: Levonorgestrel has been utilized in emergency contraception (EC) and for endometrial conditions. While abnormal uterine bleeding is a recognized adverse event (AE), other potential AEs remain undocumented.Research design and methods: Safety data for levonorgestrel were acquired from the United States FDA Adverse Event Reporting System (FAERS) database, covering the period from the first quarter (Q1) of 2004 to the fourth quarter (Q4) of 2023. A disproportionality analysis was conducted to assess the association between levonorgestrel and AEs.Results: A total of 136,168 AEs associated with levonorgestrel were reported. 106 preferred terms (PTs) and 2 system organ class (SOCs) met the criteria established by four algorithms. The identified PTs were vaginal hemorrhage, irregular menstruation, genital hemorrhage and so on. The SOCs encompassed reproductive system and breast disorders, as well as pregnancy, puerperium, and perinatal conditions.Conclusions: Although most findings align with the existing drug inserts for levonorgestrel, several novel AEs were identified in our study. Therefore, ongoing monitoring of this drug is essential and its safety profile should be updated regularly to enhance clinical practice regulation.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1685-1693"},"PeriodicalIF":3.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143491445","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

Safe prescribing of antihypertensive drugs in the elderly and managing the risk of adverse events. 老年人抗高血压药物的安全处方和不良事件的风险管理。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-09-01 Epub Date: 2026-04-04 DOI: 10.1080/14740338.2026.2653753

Siddhant Passey, Maheen Erum, Nandan Patel, Shrey Chopra, Hritvik Jain, Jagriti Jha, Tyler Kingma, Obada Kholoki, Ashwin Pillai, Sai Vikram Alampoondi Venkataramanan, Wilbert Aronow

{"title":"Safe prescribing of antihypertensive drugs in the elderly and managing the risk of adverse events.","authors":"Siddhant Passey, Maheen Erum, Nandan Patel, Shrey Chopra, Hritvik Jain, Jagriti Jha, Tyler Kingma, Obada Kholoki, Ashwin Pillai, Sai Vikram Alampoondi Venkataramanan, Wilbert Aronow","doi":"10.1080/14740338.2026.2653753","DOIUrl":"10.1080/14740338.2026.2653753","url":null,"abstract":"Introduction: Older patients with hypertension have unique clinical challenges based on age-related physiological changes, multimorbidity, and vulnerability to drug side effects. The 2017 American College of Cardiology/American Heart Association guidelines propose initiating antihypertensive therapy at a systolic blood pressure threshold of 130 mm Hg for non-institutionalized ambulatory adults over the age of 65. They also recommended individualized treatment for adults with advanced frailty or high risk of adverse events.Areas covered: This article reviews evolving paradigms and strategies in blood pressure therapy in elderly individuals, based on shifting the approach from stringent treatment targets toward individualized management. Step-care management is one such strategy that involves prudent introduction of low doses of antihypertensives with regular follow-up to avoid side effects. Deprescribing is increasingly being promoted as a key intervention in reducing polypharmacy and maximizing safety in at-risk groups of patients.Expert opinion: There is an increased need to incorporate frailty and functional assessments into routine practice and clinical trials. Despite growing evidence, there are still implementation challenges such as insufficient robust long-term data for frail populations. Pragmatic trials, adoption of digital solutions, and implementation of individualized goals must be the targets of future research.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1629-1640"},"PeriodicalIF":3.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147591118","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 celecoxib associated with the central nervous system and cancer: a disproportionality analysis of the FDA adverse event reporting system. 塞来昔布与中枢神经系统和癌症相关的不良事件：FDA不良事件报告系统的歧化分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-09-01 Epub Date: 2025-04-02 DOI: 10.1080/14740338.2025.2487140

Yikuan Du, Mengting Zhang, Mianhai Chen, Mianda Hu, Wenqi Zeng, Xiaolin Cai, Weichui Zhang, Jinfeng Zhu, Mingjun Zhong, Yi Liu, Chun Yang

{"title":"Adverse events of celecoxib associated with the central nervous system and cancer: a disproportionality analysis of the FDA adverse event reporting system.","authors":"Yikuan Du, Mengting Zhang, Mianhai Chen, Mianda Hu, Wenqi Zeng, Xiaolin Cai, Weichui Zhang, Jinfeng Zhu, Mingjun Zhong, Yi Liu, Chun Yang","doi":"10.1080/14740338.2025.2487140","DOIUrl":"10.1080/14740338.2025.2487140","url":null,"abstract":"Background: Celecoxib is now clinically recognized as a candidate for treating various neurological disorders and cancers. The recent emergence of some serious adverse reactions is concerning.Research design and methods: We carried out data mining on the FDA Adverse Event Reporting System (FAERS) for adverse events (AEs) with celecoxib as the main suspect drug and conducted a disproportionality analysis.Results: 111,155,092 AE reports were extracted from FAERS, and 32,841 AEs with celecoxib as the primary suspected drug were identified. Celecoxib AEs were predominantly reported in cardiac disorders (n = 9602) and nervous system disorders (n = 4045). Cerebrovascular accident (n = 3109, PRR = 3.24) ranked second in the number of reports and cerebrovascular disorder (n = 265, PRR = 5.06) ranked second in signal intensity, was described as rare in the instructions. Nine unexpected and serious AEs were discovered, such as Stevens-Johnson syndrome (n = 175, IC025 = 1.7), breast disease male (n = 4, IC025 = 1.54), and squamous cell carcinoma of the head and neck (n = 4, IC025 = 0.96). At 200 mg, celecoxib was more linked to musculoskeletal and connective AEs; At 400 mg, it was more linked to neurological and cardiovascular AEs.Conclusions: Unexpected AEs of celecoxib in neurological diseases and cancer have been identified, offering valuable insights for monitoring and risk assessment in future clinical applications.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1759-1770"},"PeriodicalIF":3.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143751691","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