Expert Opinion on Drug Safety最新文献

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Risk of respiratory, thoracic, and mediastinal disorders associated with endothelin receptor antagonists and prostacyclin-related drugs in pulmonary hypertension: a disproportionality analysis based on FAERS. 肺动脉高压患者与内皮素受体拮抗剂和前列环素相关药物相关的呼吸、胸腔和纵隔疾病的风险:基于FAERS的歧化分析
IF 3 3区 医学
Expert Opinion on Drug Safety Pub Date : 2025-04-01 Epub Date: 2024-12-03 DOI: 10.1080/14740338.2024.2436077
Fengjie Tang, Qihuan Ma, Yinghong Liu, Xiaojuan Yang
{"title":"Risk of respiratory, thoracic, and mediastinal disorders associated with endothelin receptor antagonists and prostacyclin-related drugs in pulmonary hypertension: a disproportionality analysis based on FAERS.","authors":"Fengjie Tang, Qihuan Ma, Yinghong Liu, Xiaojuan Yang","doi":"10.1080/14740338.2024.2436077","DOIUrl":"10.1080/14740338.2024.2436077","url":null,"abstract":"<p><strong>Background: </strong>Adverse drug events (ADEs) for endothelin receptor antagonists (ERAs) and prostacyclin-related drugs (PRDs) have been reported in clinical trials, but large-scale, real-world evaluations for respiratory, thoracic, and mediastinal disorders (RTMD) remain scarce.</p><p><strong>Methods: </strong>A pharmacovigilance analysis of the FAERS database (Q1 2004~Q2 2024) used the reporting odds ratio (ROR) method for disproportionality analysis to assess the adverse drug events (ADEs) of ERAs and PRDs in pulmonary arterial hypertension, focusing on risks related to RTMD.</p><p><strong>Results: </strong>Reports of ADEs for ERAs (bosentan, ambrisentan, and macitentan) were 15,286, 36795, and 17,497, respectively, and for PRDs (epoprostenol, treprostinil, iloprost, and selexipag) were 5,477, 57265, 3,247, and 5,504. Females exceeded males, with most cases in adults. The top PTs for ERAs were death, dyspnea, and pneumonia, with bosentan linked to liver impairment. PRDs commonly cause headaches, flushing, hypotension, edema, and fluid retention. Dyspnea was the most reported RTMD risk for all drugs, and nasal congestion was noted for all. Selexipag had the fewest RTMD-related PTs, and iloprost had the strongest signal for hemoptysis.</p><p><strong>Conclusion: </strong>The analysis highlights the RTMD risks of ERAs and PRDs in treating PH and underscores the need for careful monitoring of ADEs to ensure their safe and effective use in clinical practice.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"487-498"},"PeriodicalIF":3.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142767606","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
Role of gliflozins on hepatocellular carcinoma progression: a systematic synthesis of preclinical and clinical evidence. 格列净对肝细胞癌进展的作用:临床前和临床证据的系统综合。
IF 3 3区 医学
Expert Opinion on Drug Safety Pub Date : 2025-04-01 Epub Date: 2024-12-25 DOI: 10.1080/14740338.2024.2447057
Livia Basile, Rossella Cannarella, Paolo Magni, Rosita A Condorelli, Aldo E Calogero, Sandro La Vignera
{"title":"Role of gliflozins on hepatocellular carcinoma progression: a systematic synthesis of preclinical and clinical evidence.","authors":"Livia Basile, Rossella Cannarella, Paolo Magni, Rosita A Condorelli, Aldo E Calogero, Sandro La Vignera","doi":"10.1080/14740338.2024.2447057","DOIUrl":"10.1080/14740338.2024.2447057","url":null,"abstract":"<p><strong>Introduction: </strong>The risk of HCC is twice as high in diabetic patients compared to non-diabetic ones, suggesting that diabetes advances carcinogenesis in the liver through a variety of mechanisms. Sodium-glucose cotransporter 2 inhibitors (SGLT2i) have been shown to improve liver outcomes, emerging as promising agents to treat hepatocellular carcinoma (HCC) in patients with type 2 diabetes mellitus (T2DM).</p><p><strong>Methods: </strong>We searched PubMed and Scopus databases for articles presenting an association between SGLT2is and HCC to explore the putative mechanisms of action underlying the anti-proliferative activity of SGLT2is.</p><p><strong>Results: </strong>A total of 24 articles were selected for inclusion, of which 14 were preclinical and 10 were clinical. Preclinical studies were mainly focused on canagliflozin, used alone or in combination with other drugs.</p><p><strong>Conclusions: </strong>Overall, canagliflozin had a negative effect on HCC cell proliferation by interfering with glucose-dependent and independent metabolic pathways, negatively impacting angiogenesis, and inducing apoptosis in in-vitro cell models. In-vivo, a protective effect on hepatic steatosis and fibrosis and HCC development has been reported. Human studies showed a lower risk of developing HCC in patients on SGLT2is. However, this is supported by retrospective cohort studies. Clinical trials are needed to confirm the causal relationship between SGLT2i administration and HCC development.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"413-426"},"PeriodicalIF":3.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142876373","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 : 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":"https://doi.org/10.1080/14740338.2025.2487142","url":null,"abstract":"<p><strong>Background: </strong><i>Clostridium difficile</i> 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.</p><p><strong>Research design and methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-4"},"PeriodicalIF":3.0,"publicationDate":"2025-03-31","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
Infection toxicity assessment of tumor necrosis factor α inhibitors in the treatment of IBD: a real-world study based on the US food and drug administration adverse events reporting system (FAERS). 肿瘤坏死因子α抑制剂治疗IBD的感染毒性评估:基于美国食品和药物管理局不良事件报告系统(FAERS)的现实世界研究。
IF 3 3区 医学
Expert Opinion on Drug Safety Pub Date : 2025-03-30 DOI: 10.1080/14740338.2025.2486309
Qian Cheng, Zeyu Yao, Xuan Shi, Shupeng Zou, Yazheng Zhao, Mengling Ouyang, Minghui Sun
{"title":"Infection toxicity assessment of tumor necrosis factor α inhibitors in the treatment of IBD: a real-world study based on the US food and drug administration adverse events reporting system (FAERS).","authors":"Qian Cheng, Zeyu Yao, Xuan Shi, Shupeng Zou, Yazheng Zhao, Mengling Ouyang, Minghui Sun","doi":"10.1080/14740338.2025.2486309","DOIUrl":"https://doi.org/10.1080/14740338.2025.2486309","url":null,"abstract":"<p><strong>Background: </strong>Tumor necrosis factor α (TNF-α) inhibitors are widely used to treat inflammatory bowel disease (IBD), but systematic risk assessment of infectious toxicity is still lacking.</p><p><strong>Research design and methods: </strong>We used disproportional analysis to calculate infection-related risk signals for four TNF-α inhibitors and compared them with infection-related signals for seven other therapies.</p><p><strong>Results: </strong>There were 55,379 reports of infection-related adverse events (AEs) with TNF-α inhibitors as a 'primary suspect (PS)' therapy. The median time to onset of infection-related AEs was 113 days (interquartile range [IQR] 14-612). TNF-α inhibitors present the strongest infectious toxic signal than interleukin 12/23 (IL-12/23) inhibitors, integrin blockers, Jak inhibitors, and S1P receptor modulator. Compared with infliximab, certolizumab pegol, and adalimumab, golimumab showed the strongest signal. The strongest signal corresponding to appendicitis, pulmonary tuberculosis, pneumonia, sepsis, urinary tract infection, otitis media and herpes zoster is golimumab, infliximab, golimumab, natalizumab, certolizumab pegol, infliximab, and infliximab.</p><p><strong>Conclusions: </strong>Compared with other control therapies, TNF-α inhibitors have the strongest infectious toxicity signal. Compared with other TNF-α inhibitors, golimumab has the strongest infectious toxicity signal. When using TNF-α inhibitors to treat IBD, infection-related AEs should be vigilant.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-8"},"PeriodicalIF":3.0,"publicationDate":"2025-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143742689","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 : 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":"<p><strong>Background: </strong>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).</p><p><strong>Research design and methods: </strong>Disproportionality analysis employing reporting odds ratios (RORs) was conducted to detect AP signals in ICI-treated patients compared to the entire FAERS database.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-9"},"PeriodicalIF":3.0,"publicationDate":"2025-03-29","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
Post-marketing safety associated with sodium zirconium cyclosilicate: a pharmacovigilance study based on the FDA reporting system. 与环硅酸锆钠相关的上市后安全性:基于FDA报告系统的药物警戒研究。
IF 3 3区 医学
Expert Opinion on Drug Safety Pub Date : 2025-03-29 DOI: 10.1080/14740338.2025.2486310
Jiankang Chen, Zuzhuang Lu, Honghong Luo, Tiaomin Wang, Xiaoying Qin
{"title":"Post-marketing safety associated with sodium zirconium cyclosilicate: a pharmacovigilance study based on the FDA reporting system.","authors":"Jiankang Chen, Zuzhuang Lu, Honghong Luo, Tiaomin Wang, Xiaoying Qin","doi":"10.1080/14740338.2025.2486310","DOIUrl":"10.1080/14740338.2025.2486310","url":null,"abstract":"<p><strong>Background: </strong>Sodium zirconium cyclosilicate (SZC) is a novel oral therapy for hyperkalemia with limited adverse reactions documented on its label. Accordingly, the objective of this study was to investigate real-world adverse events (AEs) associated with SZC using the FDA Adverse Event Reporting System (FAERS).</p><p><strong>Research design and methods: </strong>Relevant data regarding SZC were extracted from FAERS, and signal detection was conducted using four distinct algorithms. The Weibull shape parameter characterized the AE onset time. Kaplan-Meier analysis was used to evaluate the cumulative incidence of AEs associated with SZC.</p><p><strong>Results: </strong>Among 8,846,085 case reports recorded in the FAERS database, 1,160 SZC-related AEs were identified. Beyond AEs, such as hypokalemia, edema, constipation, and ileus, listed on the SZC label, 26 additional positive risk signals were not stated, including X-ray gastrointestinal tract abnormal, cardiac failure, and aspiration pneumonia. The median onset time of SZC-related AEs was 42 days. Furthermore, AEs differed between male and female patients.</p><p><strong>Conclusions: </strong>This study confirmed SZC label safety warnings and identified new AEs, offering insights for clinical monitoring of SZC.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-8"},"PeriodicalIF":3.0,"publicationDate":"2025-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143729531","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
Comparative analysis of CDKI-related adverse events in older patients: a real-world data from the FDA adverse event reporting system database. 老年患者cdki相关不良事件的比较分析:来自FDA不良事件报告系统数据库的真实数据。
IF 3 3区 医学
Expert Opinion on Drug Safety Pub Date : 2025-03-21 DOI: 10.1080/14740338.2025.2464113
Qiongtong Fang, Fuqiang Huang, Huibin Zhao, Jiabi Liang, Yishen Chen, Xinrong Wu, Meirong Zhang, Wenji Luo
{"title":"Comparative analysis of CDKI-related adverse events in older patients: a real-world data from the FDA adverse event reporting system database.","authors":"Qiongtong Fang, Fuqiang Huang, Huibin Zhao, Jiabi Liang, Yishen Chen, Xinrong Wu, Meirong Zhang, Wenji Luo","doi":"10.1080/14740338.2025.2464113","DOIUrl":"10.1080/14740338.2025.2464113","url":null,"abstract":"<p><strong>Background: </strong>Cyclin-dependent kinase 4 and 6 inhibitors (CDKIs) are effective and safe against advanced and metastatic breast cancer; however, limited information is available for older patients. We conducted an analysis of real-world data pertaining to the safety of older patients using the Adverse Event Reporting System (FAERS) database of the FDA.</p><p><strong>Research design and methods: </strong>We performed a disproportionality analysis to evaluate CDKI-related adverse events (AEs) in older adults administered abemaciclib, palbociclib, and ribociclib.</p><p><strong>Results: </strong>Data were from 2132, 36916, and 4328 case reports on abemaciclib, palbociclib, and ribociclib in older patients, respectively. Disproportionality analysis revealed 242, 295, and 439 drug-AE signals. The numbers of system organ classes (SOC) for abemaciclib, palbociclib, and ribociclib were 25, 27, and 26, respectively. We found several expected AE signals consistent with those in the drug instructions, such as nausea, neutropenia, and fatigue, for all CDKIs. Interstitial lung disease, thromboembolic events, and cardiac toxicity were also noteworthy. Unexpected AE signals, such as acute kidney injury, atrial fibrillation, and memory impairment associated with abemaciclib, ribociclib, and palbociclib, respectively, were identified.</p><p><strong>Conclusion: </strong>Our results aligned with clinical observations, emphasizing possible CDKI-related AEs. Conducting future clinical research is essential to confirm AE-related differences among CDKIs in older individuals.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-10"},"PeriodicalIF":3.0,"publicationDate":"2025-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143662513","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Mining and analysis of amphotericin B adverse reaction signals: a real-world study based on the FAERS database. 两性霉素B不良反应信号的挖掘和分析:基于FAERS数据库的现实世界研究。
IF 3 3区 医学
Expert Opinion on Drug Safety Pub Date : 2025-03-12 DOI: 10.1080/14740338.2025.2468856
Siqi Wang, Yimei Cheng, Xing Wang, Qian Wang
{"title":"Mining and analysis of amphotericin B adverse reaction signals: a real-world study based on the FAERS database.","authors":"Siqi Wang, Yimei Cheng, Xing Wang, Qian Wang","doi":"10.1080/14740338.2025.2468856","DOIUrl":"10.1080/14740338.2025.2468856","url":null,"abstract":"<p><strong>Background: </strong>Invasive fungal infections (IFIs) have become an increasingly serious public health problem. Amphotericin B (AmB) remains the important component in the treatment of IFIs. But its clinical application is limited due to its adverse reactions.</p><p><strong>Research design and methods: </strong>In this study we mined the adverse drug event signals of AmB based on the Food and Drug Administration Adverse Event Reporting System (FAERS) from the first quarter of 2004 to the third quarter of 2023, using the Reported Odds Ratio, Proportional Reporting Ratio, Bayesian Confidence Propagation Neural Network and Multi-item Gamma Poisson Shrinker methods to provide a reference for the safe clinical use.</p><p><strong>Results: </strong>A total of 3597 adverse event (AE) reports for the primary suspect drug AmB were obtained, involving 22 system organ classes (SOCs), 1355 AEs. Patients aged 18-60 (47.93%) and female patients (53.82%) were at a higher risk of AEs with AmB. High risk signals in the report include hypokalemia, pyrexia, chill, renal failure. Additional high risk signals not mentioned in the instructions conclude respiratory failure, tachycardia, deafness.</p><p><strong>Conclusions: </strong>Mining the adverse reaction signal study of AmB based on the FAERS database provides support for the clinical monitoring and risk identification of this drug.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-8"},"PeriodicalIF":3.0,"publicationDate":"2025-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143604445","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 assessment of selinexor: a real-world pharmacovigilance study. selinexor的安全性评估:一项真实世界的药物警戒研究。
IF 3 3区 医学
Expert Opinion on Drug Safety Pub Date : 2025-03-12 DOI: 10.1080/14740338.2024.2442021
Wei Zhang, Kai Tao, Bin Zeng, Linghui Deng, Ping Lu, Ting Niu, Shi Qiu, Lu Yang
{"title":"Safety assessment of selinexor: a real-world pharmacovigilance study.","authors":"Wei Zhang, Kai Tao, Bin Zeng, Linghui Deng, Ping Lu, Ting Niu, Shi Qiu, Lu Yang","doi":"10.1080/14740338.2024.2442021","DOIUrl":"10.1080/14740338.2024.2442021","url":null,"abstract":"<p><strong>Background: </strong>Selinexor is approved for the treatment of relapsed or refractory multiple myeloma. However, a comprehensive understanding of adverse events associated with selinexor is lacking.</p><p><strong>Methods: </strong>Clinical trials of selinexor in patients with multiple myeloma were reviewed. We investigated selinexor-related adverse events through data of the US Food and Drug Administration Adverse Event Reporting System (FAERS). The disproportionality analysis was conducted. Four algorithms were employed to evaluate the signals of adverse events. The adverse effects of selinexor combined with dexamethasone were compared with bortezomib and dexamethasone. Sensitivity analysis was performed to exclude consumer-reported adverse events. The onset of adverse reactions were calculated.</p><p><strong>Results: </strong>A total of 1,698 reports related with selinexor from FAERS were identified. 6 significant system organ class and 42 significant preferred terms (PTs) were found. Unexpected significant adverse events including mania, acute kidney injury, orthostatic hypotension, and embolisms were identified. 14 PTs reported significant signals in treatment of selinexor combined dexamethasone compared with traditional treatment of bortezomib and dexamethasone. 45.2% of adverse events occurred within the first month of starting selinexor.</p><p><strong>Conclusions: </strong>Comprehensive analyses of selinexor related adverse events are helpful for clinical detection of adverse events and timely intervention, advancing selinexor's therapeutic progress in future treatment.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-9"},"PeriodicalIF":3.0,"publicationDate":"2025-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143188815","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
JAK inhibitors and pregnancy in autoimmune disease: safety insights from existing evidence. 自身免疫性疾病中JAK抑制剂和妊娠:来自现有证据的安全性见解
IF 3 3区 医学
Expert Opinion on Drug Safety Pub Date : 2025-03-10 DOI: 10.1080/14740338.2025.2476021
Hanjing Huang, Yunuo Wang, Luyao Han, Yuanhao Wu, Chen Li
{"title":"JAK inhibitors and pregnancy in autoimmune disease: safety insights from existing evidence.","authors":"Hanjing Huang, Yunuo Wang, Luyao Han, Yuanhao Wu, Chen Li","doi":"10.1080/14740338.2025.2476021","DOIUrl":"10.1080/14740338.2025.2476021","url":null,"abstract":"","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-3"},"PeriodicalIF":3.0,"publicationDate":"2025-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143585316","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
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