Expert Opinion on Drug Safety最新文献

Trends in the use of sodium-glucose cotransporter-2 inhibitors and characteristics of adverse event reporting in patients with heart failure in Japan: reports from the medical administration database and the adverse event reporting database. 日本心力衰竭患者使用钠-葡萄糖共转运蛋白-2抑制剂的趋势和不良事件报告的特征：来自医疗管理数据库和不良事件报告数据库的报告

IF 3.1 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-07-31 DOI: 10.1080/14740338.2025.2539543

Kazuya Sato, Kei Kawada, Tomoaki Ishida, Toru Kubo, Miyata Koji, Fuka Aizawa, Kenta Yagi, Yuki Izawa-Ishizawa, Takahiro Niimura, Mitsuhiro Goda, Keisuke Ishizawa

{"title":"Trends in the use of sodium-glucose cotransporter-2 inhibitors and characteristics of adverse event reporting in patients with heart failure in Japan: reports from the medical administration database and the adverse event reporting database.","authors":"Kazuya Sato, Kei Kawada, Tomoaki Ishida, Toru Kubo, Miyata Koji, Fuka Aizawa, Kenta Yagi, Yuki Izawa-Ishizawa, Takahiro Niimura, Mitsuhiro Goda, Keisuke Ishizawa","doi":"10.1080/14740338.2025.2539543","DOIUrl":"10.1080/14740338.2025.2539543","url":null,"abstract":"Background: Heart failure (HF) is a global health issue with a high prevalence in aging populations. Sodium-glucose cotransporter-2 (SGLT2) inhibitors reduce HF-related hospitalizations and mortality; however, their adverse drug events (ADEs) require further evaluation.Research design and methods: Using the Japan Medical Data Center and Japanese Adverse Drug Event Report (JADER) databases, we analyzed prescribing trends and ADE risk factors. Multivariate logistic regression assessed associations between patient characteristics and ADEs, adjusting for age, sex, medication use, and comorbidities. Decision tree analyses stratified ADE risks.Results: SGLT2 inhibitor prescriptions increased from 1.63% (2018) to 9.08% (2022), with a notable rise in 2021. JADER analysis showed an increasing number of ADE reports, primarily dehydration, urinary tract infections, and renal impairment. Decision tree analyses identified risk factors: dehydration (age ≥80 years, tolvaptan use), urinary tract infection (female sex, renal dysfunction), and renal impairment (angiotensin receptor-neprilysin inhibitor use, history of renal dysfunction).Conclusions: Personalized risk assessment and monitoring are crucial for optimizing SGLT2 inhibitor therapy, particularly in older patients with HF and renal impairment.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-11"},"PeriodicalIF":3.1,"publicationDate":"2025-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144715058","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

COVID-19 vaccine safety studies- the need for a third group for extended monitoring. COVID-19疫苗安全性研究——需要第三组进行延长监测。

IF 3.1 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-07-30 DOI: 10.1080/14740338.2025.2542249

Upinder Kaur, Sankha Shubhra Chakrabarti

{"title":"COVID-19 vaccine safety studies- the need for a third group for extended monitoring.","authors":"Upinder Kaur, Sankha Shubhra Chakrabarti","doi":"10.1080/14740338.2025.2542249","DOIUrl":"https://doi.org/10.1080/14740338.2025.2542249","url":null,"abstract":"Introduction: Studies assessing COVID-19 vaccine effectiveness have generally categorized individuals into 'vaccinated' and 'unvaccinated' groups. Long-term safety studies are sparse and have usually compared adverse events with background rates. Studies on timing of COVID-19 vaccination as a determinant of long COVID have provided variable results, while there is scarce data on timing of vaccination as a determinant of adverse events.Areas covered: We discuss some of our observations as well as the global evidence on the timing of COVID-19 vaccination as a determinant of long-COVID and adverse events. This special report is hypothesis-generating and aims to propose a conceptual framework and not establish causality.Expert opinion: We propose an alternative classification strategy for COVID-19 vaccinees, with special emphasis on individuals who received any dose of vaccination after recovering from natural COVID-19, i.e. the 'vaccine-after-COVID' (VAC) group. These individuals should be followed up for an extended period through multicentric and database studies. This may help in understanding the long-term safety of COVID-19 vaccines and the natural course of long COVID. Immunological characteristics of this group should also be scrutinized. The evidence gained might be useful in planning vaccination policies in the event of future pandemics.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144752824","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

Suspected statin-related adverse drug reactions: analysis of spontaneous reports in Hubei Province, China (2014-2022). 疑似他汀类药物不良反应：湖北省2014-2022年自发报告分析

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-07-28 DOI: 10.1080/14740338.2025.2536343

Haochengyi Wang, Hongyu Bi, Xiaofang Shangguan, Zherui Chen, Rui Huang, Xianglong Chen, Yuanxuan Cai

{"title":"Suspected statin-related adverse drug reactions: analysis of spontaneous reports in Hubei Province, China (2014-2022).","authors":"Haochengyi Wang, Hongyu Bi, Xiaofang Shangguan, Zherui Chen, Rui Huang, Xianglong Chen, Yuanxuan Cai","doi":"10.1080/14740338.2025.2536343","DOIUrl":"10.1080/14740338.2025.2536343","url":null,"abstract":"Introduction: Statins, some of the most widely prescribed medications for the treatment of cardiovascular diseases, cause common and serious adverse drug reactions (ADRs). However, studies of statin-related ADRs in the Chinese population are lacking.Research design and methods: ADR reports of statins collected by the Hubei Adverse Drug Reaction Monitoring Center from 2014 to 2022 were analyzed. Statin safety was described using descriptive analysis and three signal mining methods: reporting odds ratio, proportional reporting ratio, and a combined standard method.Results: ADRs were common in individuals aged 50-79 years. Most administration routes are oral. ADR reports of atorvastatin and rosuvastatin were numerous and serious. The reports mainly consisted of gastrointestinal disorders, hepatobiliary disorders. Three signal mining algorithms generated 91 identical drug - event combination signals, including 23 off-label ADRs.Conclusions: Atorvastatin was associated with a higher number of ADR reports and a higher proportion of serious ADRs than the other statins. Atorvastatin may cause off-label ADRs such as back pain, increased blood bilirubin, bone pain, hemorrhage, hepatic failure, and hepatocellular injury. Drug instructions should be enriched for better labeling of ADRs.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-8"},"PeriodicalIF":3.0,"publicationDate":"2025-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144642184","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

Peripheral neuropathies induced by BRAF+MEK inhibitor combinations: a real-world study based on FAERS database 2011-2022. BRAF+MEK抑制剂联合诱导的周围神经病变：基于FAERS数据库2011-2022的现实世界研究

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-07-09 DOI: 10.1080/14740338.2025.2529428

Yuting Wang, Jingping Zheng, Zhenpo Zhang, Haiyan Mai, Ling Su

{"title":"Peripheral neuropathies induced by BRAF+MEK inhibitor combinations: a real-world study based on FAERS database 2011-2022.","authors":"Yuting Wang, Jingping Zheng, Zhenpo Zhang, Haiyan Mai, Ling Su","doi":"10.1080/14740338.2025.2529428","DOIUrl":"10.1080/14740338.2025.2529428","url":null,"abstract":"Background: BRAF/MEK inhibitors (BRAFi+MEKi) like may cause peripheral neuropathies (PN). This study analyzes FAERS data to assess PN signals across BRAFi+MEKi combinations.Research design and methods: Disproportionality analysis was conducted to quantify the signals of BRAFi+MEKi-associated PN on FAERS database from January 2011 to December 2022. Additionally, we examined the onset times and prognosis of BRAFi+MEKi-associated PN.Results: A total of 268 reports of BRAFi+MEKi-associated PN were identified in the study, with a median age range of 60.00 to 69.00 years. All three combination therapies exhibited positive signals for PN, and notably, Encorafenib and Binimetinib (E+B) displayed the strongest association with PN (ROR 3.05[2.47,3.76], IC1.57[1.26]). The associations between PN and different BRAFi+MEKi combinations remained persisted in the gender and age stratification analysis, with all three combination therapies showing an elevated number of disproportionality signals in males compared to females.Conclusion: According to our findings, BRAFi+MEKi-associated PN tends to occur several months after initiation and may lead to serious outcomes. Male sex is more likely to be a risk factor associated with PN. Prompt identification and intervention for BRAFi+MEKi-associated PN are crucial, and additional fundamental research is required to validate the underlying mechanism as observed in our study.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-8"},"PeriodicalIF":3.0,"publicationDate":"2025-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144559642","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

Exploring tumor lysis syndrome linked to immune checkpoint inhibitors: insights from the FAERS pharmacovigilance database. 探索与免疫检查点抑制剂相关的肿瘤溶解综合征：来自FAERS药物警戒数据库的见解。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-07-09 DOI: 10.1080/14740338.2025.2527406

Yanling Yuan, Wanming He, Lihua Tong, Mindong Liu, Wubing Tang, Wen Yang, Xingxi Pan

{"title":"Exploring tumor lysis syndrome linked to immune checkpoint inhibitors: insights from the FAERS pharmacovigilance database.","authors":"Yanling Yuan, Wanming He, Lihua Tong, Mindong Liu, Wubing Tang, Wen Yang, Xingxi Pan","doi":"10.1080/14740338.2025.2527406","DOIUrl":"10.1080/14740338.2025.2527406","url":null,"abstract":"Background: The increasing use of immune checkpoint inhibitors (ICIs) has raised concerns about immune-related adverse events (irAEs), including tumor lysis syndrome(TLS), traditionally linked to cytotoxic chemotherapy. This study investigates the association between ICIs and TLS, analyzing clinical characteristics, treatment regimens, and outcomes.Research design and methods: ICIs-associated TLS cases reported in the FDA Adverse Event Reporting System (FAERS) from Q1 2011 to Q1 2024 were analyzed. Disproportionality analysis and Weibull shape parameter (WSP) modeling were used to assess reporting trends and onset patterns.Results: Among 364 TLS cases, anti-PD-1 were most frequently implicated (n = 210), followed by anti-PD-L1 (n = 109) and anti-CTLA-4 (n = 45). Combination therapies accounted for 61.0% of cases, with distinct disease distributions: dual ICIs in melanoma (36.36%), ICIs plus chemotherapy in lung cancer (47.37%), and ICIs plus antiangiogenic therapy in hepatocellular carcinoma (59.14%). The median onset time was 9 days (IQR: 3-23.75), with WSP analysis indicating an early failure pattern (β = 0.75, 95% CI: 0.66-0.85).Conclusions: ICIs are significantly associated with TLS, particularly in combination regimens, necessitating early risk identification and close monitoring. Given the rising use of ICIs, proactive management and ongoing pharmacovigilance are essential to mitigate severe outcomes.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-11"},"PeriodicalIF":3.0,"publicationDate":"2025-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144552787","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 letrozole in the real world: a disproportionality analysis of FAERS database and systematic review of case reports. 来曲唑在现实世界中的安全性：对FAERS数据库的不相称性分析和对病例报告的系统回顾。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-07-09 DOI: 10.1080/14740338.2025.2527964

Chunsu Liang, Yizhou Zhang, Pengjiao An, Wei Zuo, Bo Zhang

{"title":"Safety profile of letrozole in the real world: a disproportionality analysis of FAERS database and systematic review of case reports.","authors":"Chunsu Liang, Yizhou Zhang, Pengjiao An, Wei Zuo, Bo Zhang","doi":"10.1080/14740338.2025.2527964","DOIUrl":"10.1080/14740338.2025.2527964","url":null,"abstract":"Background: Letrozole is an aromatase inhibitor for breast cancer. Most of the safety data of letrozole came from clinical trials, while real-world information is insufficient.Research design and methods: FAERS data were analyzed using OpenVigil 2 for disproportionality signals. A systematic review of PubMed, Embase, and CINAHL identified letrozole-related ADR case reports, evaluated by Naranjo Scale.Results: The analysis of FAERS (2004 Q1-2023 Q4) identified 1,165 ADR signals from 29,631 cases, with general disorders, gastrointestinal, and musculoskeletal connective tissue disorders being the most frequent system organ classes (SOCs). Fatigue (3,431 cases), nausea (2,421), diarrhea (1,943), arthralgia (1,756), and alopecia (1,640) were the top reported signals. Novel signals included nitrituria and retinal phototoxicity, with 14 SOCs identified in the top 20 high-PRR signals. The systematic review included 45 cases from 40 publications, with skin/subcutaneous (13 cases) and musculoskeletal disorders (9 cases) most common. Notably, 26.67% of ADRs (12/45) were unreported in labeling, including rhabdomyolysis, systemic sclerosis, and acute kidney injury.Conclusions: Clinicians need to pay attention to rhabdomyolysis when letrozole combined with catecholaminergic agents. Patient education on urine output monitoring is essential due to potential kidney injury. Bone marrow suppression and reproductive toxicity risks require clinical attention.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-11"},"PeriodicalIF":3.0,"publicationDate":"2025-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144539752","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 issues of tofacitinib in rheumatoid arthritis patients: real-world pharmacovigilance. 托法替尼在类风湿关节炎患者中的安全性问题：现实世界的药物警戒。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-07-06 DOI: 10.1080/14740338.2025.2527386

Yi Zeng, Jiazhen Jiang, Dongqiang Luo, Bohui Zheng, Manting Liu, Shulan Huang, Jiayu Wu, Xiangyun Dou, Siyuan Zhou

{"title":"Safety issues of tofacitinib in rheumatoid arthritis patients: real-world pharmacovigilance.","authors":"Yi Zeng, Jiazhen Jiang, Dongqiang Luo, Bohui Zheng, Manting Liu, Shulan Huang, Jiayu Wu, Xiangyun Dou, Siyuan Zhou","doi":"10.1080/14740338.2025.2527386","DOIUrl":"10.1080/14740338.2025.2527386","url":null,"abstract":"Background: Tofacitinib is the first oral tsDMARD approved for the treatment of rheumatoid arthritis, often used as monotherapy or in combination with conventional synthetic DMARDs. However, its safety profile has yet to be systematically evaluated. Our study is the largest pharmacovigilance analysis of real-world data on the safety of tofacitinib.Methods: Using the FAERS database (from Q1 2012 to Q1 2024), we extracted reports where tofacitinib was the primary suspect, conducting subgroup analyses stratified by gender and age. Positive signals were assessed through disproportionality analysis (criteria: ROR, PRR, BCPNN, and EBGM), identifying common ADRs across five subgroups. Further, we extracted reports with complete information on confounding factors (age, gender, weight, report time) for multivariate logistic regression to evaluate the independent effects of the intersecting ADRs.Results: Our study reveals that, beyond known adverse reactions (such as upper respiratory tract infections and nasopharyngitis), tofacitinib is associated with numerous unreported adverse reactions, including systemic infections, tumor progression, and thrombotic risks. Many of these adverse reactions exhibit significant variability across different AD populations.Conclusions: Enhanced monitoring is recommended for RA patients, especially those with comorbid malignancies, cardiovascular events, or infection risks, during tofacitinib therapy.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-15"},"PeriodicalIF":3.0,"publicationDate":"2025-07-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144527094","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

Enhancing therapeutic strategies and drug development for patients with kidney disease. 加强肾脏疾病患者的治疗策略和药物开发。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-07-04 DOI: 10.1080/14740338.2025.2525970

Yik Pui Tsang, Kayenat S Aryeh, Kai Wang, Jonathan Himmelfarb, Catherine K Yeung, Edward J Kelly

{"title":"Enhancing therapeutic strategies and drug development for patients with kidney disease.","authors":"Yik Pui Tsang, Kayenat S Aryeh, Kai Wang, Jonathan Himmelfarb, Catherine K Yeung, Edward J Kelly","doi":"10.1080/14740338.2025.2525970","DOIUrl":"10.1080/14740338.2025.2525970","url":null,"abstract":"Introduction: Kidney diseases, including chronic kidney disease and acute kidney injury, pose major global health challenges due to their high prevalence and impact on morbidity and mortality. Despite medical advances, there remains an urgent need for improved drug development and therapeutic strategies to treat these conditions.Areas covered: This review examines how renal transporters influence drug handling, highlighting the impact of altered transporter function on toxin accumulation, organ injury, and systemic toxicity. We also address pharmacokinetic and pharmacodynamic changes in kidney diseases, recent advances in preclinical models like microphysiological systems, emerging therapies, and biomarkers for early detection and monitoring.Expert opinion: A robust understanding of transporter function and disease-specific pharmacokinetic shifts is crucial for optimizing drug development. While MPS show promise in predicting drug responses and nephrotoxicity by more accurately simulating human kidney physiology, current hurdles include complexity, cost, and scalability. Emerging biomarkers require stringent validation to ensure specificity and reliability in kidney disease. Targeting transporters offers novel therapeutic and drug repurposing opportunities. Moving forward, refining and validating these models and biomarkers, alongside patient-tailored therapies, will improve personalized medicine and management. Attentive integration of these innovations could significantly reduce morbidity and improve outcomes worldwide for patients with kidney disease.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-26"},"PeriodicalIF":3.0,"publicationDate":"2025-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12285105/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144495429","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Use of medroxyprogesterone acetate and risk of meningiomas: a comparative safety study. 使用醋酸甲孕酮和脑膜瘤的风险：一项比较安全性研究。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-07-03 DOI: 10.1080/14740338.2025.2526787

Connor Frey, Mohit Sodhi, Mostafa Fatehi, Abbas Kezouh, Mahyar Etminan

{"title":"Use of medroxyprogesterone acetate and risk of meningiomas: a comparative safety study.","authors":"Connor Frey, Mohit Sodhi, Mostafa Fatehi, Abbas Kezouh, Mahyar Etminan","doi":"10.1080/14740338.2025.2526787","DOIUrl":"10.1080/14740338.2025.2526787","url":null,"abstract":"Background: Medroxyprogesteroneacetate (MPA), a widely used hormonal contraceptive, has been associated with increased risk of meningiomas. However, the risk of meningiomas associated with MPA compared to oral contraceptives containing ethinylestradiol-levonorgestrel (EE-LNG) remains unclear. This study aimed to evaluate the relative risk of meningiomas in women using MPA versus EE-LNG.Research design and methods: A nested case-control study was conducted using the PharMetrics Plus database (2006-2020). The cohort included new users of MPA and EE-LNG. Incident meningioma cases were matched to controls based on age and calendar time. Conditional logistic regression was used to account for confounders, including prior radiotherapy, hormonal contraceptive use, and obesity.Main outcome measures: The primary outcome was the incidence rate ratio (IRR) of meningiomas in MPA users compared to EE-LNG users.Results: Among women using MPA for more than one year, the adjusted IRR for meningiomas was 3.55 (95% CI: 1.85-6.85), indicating a significantly higher risk compared to EE-LNG users.Conclusions: MPAuse is linked to a substantially increased risk of meningiomas, underscoring the importance of assessing its long-term use. Further research is warranted to confirm these findings and guide clinical practice.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-4"},"PeriodicalIF":3.0,"publicationDate":"2025-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144527095","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

Evaluating safety risks of ischaemic colitis with taxanes: a disproportionality analysis based on FDA adverse event Reporting system. 评价紫杉烷类药物治疗缺血性结肠炎的安全风险：基于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 : 2025-07-02 DOI: 10.1080/14740338.2025.2529429

Yufang Liao, Yanbin Zeng, Xiaorong Su, Wanlong Lin, Xiuxian Lin, Lizhu Weng, Jianhui Yang, Wei Zhuang, Junyan Wu

{"title":"Evaluating safety risks of ischaemic colitis with taxanes: a disproportionality analysis based on FDA adverse event Reporting system.","authors":"Yufang Liao, Yanbin Zeng, Xiaorong Su, Wanlong Lin, Xiuxian Lin, Lizhu Weng, Jianhui Yang, Wei Zhuang, Junyan Wu","doi":"10.1080/14740338.2025.2529429","DOIUrl":"https://doi.org/10.1080/14740338.2025.2529429","url":null,"abstract":"Background: Ischaemic colitis (IC) is a rare yet serious gastrointestinal condition, increasingly reported in patients receiving taxanes-based chemotherapy. So far, the correlation between the two remains unclear. The aim of this study is to assess the safety concerns associated with taxanes use in relation to IC.Research design and methods: Disproportionality analyses (Reporting Odds Ratio [ROR], Proportional Reporting Ratio [PRR], Bayesian Confidence Propagation Neural Network [BCPNN], Multi-item gamma Poisson Shrinker [MGPS]) were conducted using the FDA Adverse Event Reporting System (FAERS, 2005 Q1-2023 Q2).Results: Significant IC signals were detected across taxanes: paclitaxel (ROR 4.07, PRR 4.07, BCPNN 2.02, MGPS 4.05), nab-paclitaxel (ROR 2.99, PRR 2.99, BCPNN 1.58, MGPS 2.98,), and docetaxel (ROR 3.63, PRR 3.63, BCPNN 1.85, MGPS 3.59). Reports were predominantly from Japan and the U.S.A. with IC developing within 16 days in half of the patients.Conclusion: Taxanes may substantially increase IC risk, necessitating vigilant gastrointestinal monitoring and characterization of high-risk populations. Further clinical validation is required to confirm these findings.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144539751","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