Expert Opinion on Drug Safety最新文献_第4页

Drug-associated pancreatic cancer: insights from real-world pharmacovigilance and network pharmacology. 药物相关性胰腺癌：来自现实世界药物警戒和网络药理学的见解。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-09-01 Epub Date: 2025-03-06 DOI: 10.1080/14740338.2025.2469273

Hao Xie, Qiang Xu, Bin Zhao, Wenming Wu

{"title":"Drug-associated pancreatic cancer: insights from real-world pharmacovigilance and network pharmacology.","authors":"Hao Xie, Qiang Xu, Bin Zhao, Wenming Wu","doi":"10.1080/14740338.2025.2469273","DOIUrl":"10.1080/14740338.2025.2469273","url":null,"abstract":"Background: Pancreatic cancer's high mortality rate necessitates our study, which aims to identify potential risk drugs and speculate on the underlying mechanisms.Research design and methods: All pertinent reports from the FDA Adverse Event Reporting System database were extracted. The disproportionality analysis was used in signal detection and data on patient age, sex, weight, time to onset were collected. Seven databases were retrieved for network pharmacology. AutoDock Vina 1.1.2 was for molecular docking.Results: Signals were detected among 397 drugs with pancreatic cancer report ≥3. Except 4 antineoplastic agents, only 24 drugs indicated pancreatic cancer signals in 33,948 reports including 4 dipeptidyl peptidase-4 (DPP-4) inhibitors, 3 glucagon-like peptide-1 (GLP-1) analogues, 5 compound hypoglycemic agents, 3 hypotensive agents, ranitidine, pancrelipase, fondaparinux, naldemedine, daprodustat, megestrol acetate, leuprorelin, lecanemab, and lorcaserin. Pancreatic cancer more occurred after the age of 45, with a higher proportion among male. Weight with GLP-1 analogues (median, 91 kg), and compound hypoglycemic agents (median, 82 kg) was heavier (p < 0.01). GLP1R (glucagon-like peptide 1 receptor) for GLP-1 analogues, and PTEN (phosphatase and tensin homolog) for metformin might be a potential cause of pancreatic cancer.Conclusion: Clinicians providing these therapies should stay vigilant to detect pancreatic cancer early.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1673-1683"},"PeriodicalIF":3.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143572565","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 and pharmacological analysis of sulfasalazine based on the FDA adverse event reporting system (FAERS) database. 基于FDA不良事件报告系统（FAERS）数据库的磺胺氮嗪药物警戒研究和药理学分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-09-01 Epub Date: 2025-05-05 DOI: 10.1080/14740338.2025.2488241

Dandan Guo, Bufu Tang, Peng Luo, Jian Zhang, Lvdan Deng, Sentao Fu, Zhijun Shen, Qing Li, Zhao Xie, Na Hang, Hongjie Fan, Ling Wang

{"title":"A real-world pharmacovigilance study and pharmacological analysis of sulfasalazine based on the FDA adverse event reporting system (FAERS) database.","authors":"Dandan Guo, Bufu Tang, Peng Luo, Jian Zhang, Lvdan Deng, Sentao Fu, Zhijun Shen, Qing Li, Zhao Xie, Na Hang, Hongjie Fan, Ling Wang","doi":"10.1080/14740338.2025.2488241","DOIUrl":"10.1080/14740338.2025.2488241","url":null,"abstract":"Objective: The purpose of this study was to use the FDA Adverse Event Reporting System (FAERS) to detect and identify adverse events (AEs) related to sulfasalazine to provide a reference for clinical use.Methods: Four algorithms (ROR, PRR, BCPNN and EBGM) were used to detect sulfasalazine-correlated AE signals in real data to calculate the signals associated with sulfasalazine-related AEs.Results: During the study period, FAERS was used to extract a total of 91,509 sulfasalazine-related (SASP-related) adverse event reports. In total, 6830 sulfasalazine adverse event signals were found, involving 23 organ systems. The analysis revealed several common adverse reactions; the most common were dizziness, malaise, asthenia, decreased appetite, rash, and anemia, and these adverse reactions are listed on the warning label for sulfasalazine. It is worth noting that in our study, in the preferred term (PT), we also found some reactions that were not mentioned on the warning label, such as blurred vision and cardiac failure.Conclusion: This study revealed potential new AEs resulting from sulfasalazine, and further studies are needed to confirm these new AEs.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1775-1783"},"PeriodicalIF":3.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144062437","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 event signal analysis of type Ib MET tyrosine kinase inhibitors based on food and drug administration adverse event reporting system. 基于食品药品监督管理不良事件报告系统的Ib型MET酪氨酸激酶抑制剂不良事件信号分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-09-01 Epub Date: 2025-04-03 DOI: 10.1080/14740338.2025.2487158

Junyu Wang, Rong Ma, Binbin Qu, Xiangpeng Li

{"title":"Adverse event signal analysis of type Ib MET tyrosine kinase inhibitors based on food and drug administration adverse event reporting system.","authors":"Junyu Wang, Rong Ma, Binbin Qu, Xiangpeng Li","doi":"10.1080/14740338.2025.2487158","DOIUrl":"10.1080/14740338.2025.2487158","url":null,"abstract":"Background: Type Ib MET Tyrosine Kinase Inhibitors (TKIs), such as capmatinib, tepotinib, and savolitinib, are used to treat MET-amplified and MET exon 14 deletion mutant non-small cell lung cancer. This pharmacovigilance study analyzed data from the FDA Adverse Event Reporting System (FAERS) between September 2014 and March 2024 to assess adverse events (AEs) for these FDA-approved drugs.Research design and methods: We conducted a systematic search of AEs using MedDRA SMQs by SOC and PT, and performed disproportionality analysis to identify safety signals, calculating ROR, PRR, EBGM, and IC.Results: The analysis identified significant safety signals: capmatinib showed signals for ear and labyrinth disorders, neoplasms, general disorders, and hepatobiliary disorders; tepotinib for renal and urinary disorders, ear and labyrinth disorders, metabolism and nutrition disorders, and general disorders; savolitinib for hepatobiliary disorders. Key PT signals included protein deficiency, scrotal edema, and chylothorax for capmatinib; edema and decreased blood albumin for tepotinib; and abnormal hepatic function for savolitinib.Conclusion: The study highlights differences in the safety profiles of Type Ib MET TKIs, underscoring the need for further regulatory review and possible updates to product labels to better inform clinicians and patients.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1739-1748"},"PeriodicalIF":3.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143771742","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

Influence factors of metronidazole-related CNS disorders: an analysis of the Japan adverse drug event report and FDA adverse event reporting system. 甲硝唑相关中枢神经系统疾病的影响因素：日本不良事件报告与FDA不良事件报告制度分析

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-09-01 Epub Date: 2025-04-03 DOI: 10.1080/14740338.2025.2486308

Keisuke Takada, Yuki Enoki, Masaru Samura, Yuki Igarashi, Kazuaki Taguchi, Koji Tanikawa, Kazuaki Matsumoto

{"title":"Influence factors of metronidazole-related CNS disorders: an analysis of the Japan adverse drug event report and FDA adverse event reporting system.","authors":"Keisuke Takada, Yuki Enoki, Masaru Samura, Yuki Igarashi, Kazuaki Taguchi, Koji Tanikawa, Kazuaki Matsumoto","doi":"10.1080/14740338.2025.2486308","DOIUrl":"10.1080/14740338.2025.2486308","url":null,"abstract":"Background: Metronidazole (MNZ) can be administered for various infections. The impact of comorbidities/concomitant drugs on MNZ-induced central nervous system (CNS) disorders remains unclear.Research design and methods: We assessed the risk of metronidazole-related CNS disorders using the Japan Adverse Drug Event Report (JADER, May 2023) and the US Food and Drug Administration Adverse Event Reporting System (FAERS, Q1 2023), excluding comorbidities/concomitant drugs. Clonazepam and diazepam were evaluated as potential prophylactics based on the efficacy of benzodiazepines for MNZ-related CNS disorders. Reporting odds ratios (ROR) and 95% confidence intervals (CI) were calculated. Additionally, sensitivity analysis by sex and age was conducted.Results: The ROR (95% CI) of CNS disorders associated with MNZ in JADER and FAERS were 3.16 (2.69-3.72) and 1.69 (1.64-1.73), respectively. MNZ was significantly related to CNS disorders after excluding comorbidities (brain/spinal cord or liver abscesses) and concomitant drugs (glucocorticoids, antiepileptic, antiparkinson, and schizophrenia drugs). In sensitivity analysis, MNZ was significantly related to CNS disorders, despite sex and age. The ROR in the concomitant with clonazepam (CZP) was 0.70 (0.53-0.92) in FAERS.Conclusion: MNZ may be associated with CNS disorders, even if comorbidities/concomitant drugs that are potential risk factors for CNS disorders are excluded. Additionally, CZP may suppress CNS disorders.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1731-1737"},"PeriodicalIF":3.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143751694","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

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

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

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