Expert Opinion on Drug Safety最新文献

Comparative analysis of cdki-related adverse events in older patients: a real-world data from the FDA adverse event reporting system database.

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-03-19 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":"https://doi.org/10.1080/14740338.2025.2464113","url":null,"abstract":"Background: 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 ananalysis of real-world data pertaining to the safety of older patients usingthe Adverse Event Reporting System (FAERS) database of the FDA.Researchdesign and methods: We performed adisproportionality analysis to evaluate CDKI-related adverse events (AEs) inolder adults administered abemaciclib, palbociclib, and ribociclib.Results: Data were from 2132, 36916, and 4328 casereports on abemaciclib, palbociclib, and ribociclib in older patients,respectively. Disproportionality analysis revealed 242, 295, and 439 drug-AEsignals. 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 thosein the drug instructions, such as nausea, neutropenia, and fatigue, for allCDKIs. Interstitial lung disease, thromboembolicevents, and cardiac toxicity were also noteworthy. Unexpected AE signals, suchas acute kidney injury, atrial fibrillation, and memory impairment associatedwith abemaciclib, ribociclib, and palbociclib, respectively, were identified.Conclusion: Our results aligned with clinicalobservations, emphasizing possible CDKI-related AEs. Conducting future clinicalresearch is essential to confirm AE-related differences among CDKIs in olderindividuals.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-03-19","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

Assessing adverse event burden in chronic lymphocytic leukemia treatment regimens: what's best for patient quality of life?

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-03-14 DOI: 10.1080/14740338.2025.2471508

Anna Korycka-Wołowiec, Dariusz Wołowiec, Hanna Ławnicka, Tadeusz Robak

{"title":"Assessing adverse event burden in chronic lymphocytic leukemia treatment regimens: what's best for patient quality of life?","authors":"Anna Korycka-Wołowiec, Dariusz Wołowiec, Hanna Ławnicka, Tadeusz Robak","doi":"10.1080/14740338.2025.2471508","DOIUrl":"10.1080/14740338.2025.2471508","url":null,"abstract":"Introduction: In recent years, chronic lymphocytic leukemia (CLL) treatment has changed dramatically. Chemoimmunotherapy with fludarabine/cladribine, cyclophosphamide, and rituximab have been almost completely replaced by targeted therapies with small molecules, such as Bruton's tyrosine kinase inhibitors or B-cell lymphoma 2 (BCL-2) antagonists. However, few studies have assessed the impact of novel therapies on patient quality of life (QoL).Areas covered: This article reviews the safety profile of new therapeutic options and their impact on the QoL of CLL patients. The MEDLINE database was searched for English language publications from 2010 through June 2024, including the Proceedings of the American Society of Hematology from over the past 5 years.Expert opinion: CLL is a clinically heterogenous disease predominantly affecting elderly patients. The variable clinical course of disease requires personalization and individualized treatment to achieve the optimal survival outcome and acceptable safety profile, especially in the case of poor prognosis. Clinical trials performed in the past decade indicate that novel drugs, used as a single agent or as part of a conventional chemotherapy, offer promise in minimalizing relapse rates, and may allow more effective and safer treatment options by reducing the risk of adverse events, especially cytopenias and infections.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-13"},"PeriodicalIF":3.0,"publicationDate":"2025-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143482572","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.

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":"Background: Selinexor is approved for the treatment of relapsed or refractory multiple myeloma. However, a comprehensive understanding of adverse events associated with selinexor is lacking.Methods: 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.Results: 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.Conclusions: 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.","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

Mining and analysis of amphotericin B adverse reaction signals: a real-world study based on the FAERS database.

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":"Background: 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.Research design and methods: 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.Results: 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.Conclusions: 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.","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

JAK inhibitors and pregnancy in autoimmune disease: safety insights from existing evidence.

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

引用次数: 0

Safety assessment of esomeprazole: real-world adverse event signal mining and analysis based on FAERS database. 埃索美拉唑的安全性评估：基于 FAERS 数据库的真实世界不良事件信号挖掘与分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-03-08 DOI: 10.1080/14740338.2025.2473636

Bojing Wang, Shu Huang, Shiqi Li, Yaqi Deng, Ziyan Li, Yizhou Wang, Xiaomin Shi, Wei Zhang, Lei Shi, Xiaowei Tang

{"title":"Safety assessment of esomeprazole: real-world adverse event signal mining and analysis based on FAERS database.","authors":"Bojing Wang, Shu Huang, Shiqi Li, Yaqi Deng, Ziyan Li, Yizhou Wang, Xiaomin Shi, Wei Zhang, Lei Shi, Xiaowei Tang","doi":"10.1080/14740338.2025.2473636","DOIUrl":"10.1080/14740338.2025.2473636","url":null,"abstract":"Background: Esomeprazole holds a significant position in the treatment of acid-related diseases. However, as with all drugs, it may also carry some potential risk of adverse effects. This study aims to further evaluate the safety of esomeprazole for clinical use.Research design and methods: The data of esomeprazole-related adverse events was extracted from the FAERS database from the first quarter of 2004 to the first quarter of 2024 and used Reporting Odds Ratios (ROR), Proportional Reporting Ratios (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayes Geometric Mean(EBGM) for data mining.Results: A total of 67,712 esomeprazole-related adverse events were extracted from the FAERS database, involving 27 system organ class. The frequency of renal and urinary occurrence was the highest, and the signal was the strongest. Additionally, we detected 324 preferred terms: rebound acid hypersecretion, nephrogenic anemia, and hyperparathyroidism secondary showed significant high signal strength. In the elderly, adverse events were concentrated in the gastrointestinal disorders system, and the most common adverse events were dyspepsia and hyponatremia. Unexpected adverse events, such as vomiting, acute kidney injury, and anaphylactic reaction occurred in children.Conclusions: We discovered some new and special esomeprazole-related adverse events, raising awareness of the safety of esomeprazole and further helping to mitigate associated risks.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-9"},"PeriodicalIF":3.0,"publicationDate":"2025-03-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143522972","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 monitoring of tirzepatide: a pharmacovigilance study based on the FAERS database.

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-03-08 DOI: 10.1080/14740338.2025.2468860

Han Chen, Yuhang Ding, Yongqi Shan

{"title":"Post-marketing safety monitoring of tirzepatide: a pharmacovigilance study based on the FAERS database.","authors":"Han Chen, Yuhang Ding, Yongqi Shan","doi":"10.1080/14740338.2025.2468860","DOIUrl":"10.1080/14740338.2025.2468860","url":null,"abstract":"Objective: To explore adverse drug events (ADEs) associated with tirzepatide using real-world data from the U.S. Food and Drug Administration's Adverse Event Reporting System (FAERS) database to guide its safe management.Methods: ADE reports from the second quarter of 2022 to the fourth quarter of 2023 were analyzed using the Reporting Odds Ratio (ROR) and Bayesian Confidence Propagation Neural Network (BCPNN) methods. Gender-specific differences and reporting biases were also assessed.Results: Among 25,212 tirzepatide-related ADE reports, 101 significant ADE signals across 15 system organ classifications were identified. Common ADEs included nausea (n = 3030, ROR 5.38) and vomiting (n = 1147, ROR 3.44). Previously unreported ADEs included eructation (n = 500, ROR 46.56), gastroesophageal reflux disease (n = 191, ROR 3.24), injection site hemorrhage (n = 1610, ROR 27.8), and increased blood glucose (n = 641, ROR 6.22). Women reported more injection-site reactions, while men experienced more gastrointestinal issues. Weibull analysis indicated a median ADE onset time of 23 days (IQR: 6-90 days).Conclusion: This pharmacovigilance study identified both known and novel ADEs of tirzepatide, highlighting gender differences and reporting biases. Close monitoring and further research are needed to ensure its safe use.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-9"},"PeriodicalIF":3.0,"publicationDate":"2025-03-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143556224","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

Drug-associated pancreatic cancer: insights from real-world pharmacovigilance and network pharmacology.

IF 3 3区医学

Expert Opinion on Drug Safety Pub 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":"https://doi.org/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":"1-11"},"PeriodicalIF":3.0,"publicationDate":"2025-03-06","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

Drug-induced hyperacusis: a disproportionality analysis of the FAERS database.

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-03-06 DOI: 10.1080/14740338.2025.2471516

HuaJie Lin, Qianqian Wang, Haiting Liu, Yong Tang

{"title":"Drug-induced hyperacusis: a disproportionality analysis of the FAERS database.","authors":"HuaJie Lin, Qianqian Wang, Haiting Liu, Yong Tang","doi":"10.1080/14740338.2025.2471516","DOIUrl":"https://doi.org/10.1080/14740338.2025.2471516","url":null,"abstract":"Background: Hyperacusis is a non-negligible clinical condition, but reports related to drug-induced hyperacusis are rare. The aim of this study was to investigate the risk of drug-induced hyperacusis and to identify the top drugs that can cause hyperacusis through the FAERS database.Research design and methods: We used the search term 'hyperacusis' to query all reports of hyperacusis in the FAERS database from 2004(Q1) to 2023(Q4), and extracted, cleaned, mined, and analyzed the data to retrieve the top medications that cause hyperacusis.Result: A total of 2937 unduplicated reports of hyperacusis were found, and the top 10 drugs among them were screened. 6 of them had positive results for all 4 calculations, which was regarded as a strong signal. The likelihood of drug-induced hyperacusis varied considerably between sexes, with females being approximately 2.5 times more likely than males to develop druginduced hyperacusis.Conclusion: By analyzing the FAERS database, we listed drugs with strong hyperacusis that were not suggested on the label and analyzed that the cause of hyperacusis by these drugs is likely to be related to altered levels of 5-HT in the organism. Women are more likely than men to develop pharmacologic hyperacusis.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143566563","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

Incidence and risk of drug-induced interstitial lung disease associated with anti-neoplastic drugs.

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-03-03 DOI: 10.1080/14740338.2025.2472918

Il-Hyung Hwang, Seung Hyeun Lee, Hankil Lee

{"title":"Incidence and risk of drug-induced interstitial lung disease associated with anti-neoplastic drugs.","authors":"Il-Hyung Hwang, Seung Hyeun Lee, Hankil Lee","doi":"10.1080/14740338.2025.2472918","DOIUrl":"10.1080/14740338.2025.2472918","url":null,"abstract":"Background: To evaluate the incidence and risk of drug-induced interstitial lung disease (DIILD) associated with anti-neoplastic drugs among patients with cancer in Korea.Research design and methods: This nested case-control study included 457,685 patients diagnosed with cancer and treated with anti-neoplastic drugs from a retrospective nationwide population-based cohort between 2017 and 2021. The incidence rate of DIILD and the risks of DIILD by anti-neoplastic drug categories were analyzed.Results: Among 270,595 patients, 2,634 developed ILD, resulting in an incidence rate of 4.12 per 1,000 person-years (95% confidence interval (CI): 3.97-4.28). DIILD was more prevalent in men, older patients, and those with a history of pulmonary disease or lung cancer. In a multivariable conditional logistic regression analysis, immune checkpoint inhibitors (odds ratio (OR): 2.37; 95%CI: 1.48-3.78), mammalian target of rapamycin inhibitors (OR: 9.79; 95%CI: 5.20-18.45), antibody-drug conjugates (OR: 7.99; 95%CI: 3.24-19.74), cyclin-dependent kinase 4/6 inhibitors (OR: 2.28; 95%CI: 1.26-4.12), and any combination of different drug categories (OR: 1.93; 95%CI: 1.21-3.09) were associated with an increased risk of DIILD.Conclusion: Our findings suggest that the risk of incident DIILD depends on the category of anti-neoplastic drugs. Patients with identified risk factors and treated with these drugs should be monitored closely.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-9"},"PeriodicalIF":3.0,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143500117","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