Expert Opinion on Drug Safety最新文献_第5页

Hospital-wide interventions for reducing or preventing in-hospital prescribing errors: a scoping review. 减少或预防院内处方错误的全院干预措施：范围审查。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-05-01 Epub Date: 2025-02-25 DOI: 10.1080/14740338.2025.2467831

Rashudy Fatiha Mahomedradja, Steven Wang, Kim Catherina Eve Sigaloff, Jelle Tichelaar, Michiel Adriaan van Agtmael

{"title":"Hospital-wide interventions for reducing or preventing in-hospital prescribing errors: a scoping review.","authors":"Rashudy Fatiha Mahomedradja, Steven Wang, Kim Catherina Eve Sigaloff, Jelle Tichelaar, Michiel Adriaan van Agtmael","doi":"10.1080/14740338.2025.2467831","DOIUrl":"10.1080/14740338.2025.2467831","url":null,"abstract":"Introduction: Prescribing errors (PEs) in hospital care lead to patient harm, prolonged hospital stays, readmissions, and mortality. Despite interventions that successfully target 'high risk' populations in trials, PE rates remain largely unchanged in real-world settings. Existing studies often focus narrowly on specific populations, overlooking the wider complexities of hospital-wide prescribing. This scoping review evaluates interventions for adult inpatients to identify knowledge gaps in how to reduce in-hospital PEs.Methods: A systematic search of PubMed, EMBASE.com, and the Cochrane Library (inception to 13 December 2024) was conducted following PRISMA-ScR guidelines. Studies prospectively evaluating interventions reducing in-hospital PEs were eligible for inclusion; those focusing on specific drugs, wards or populations or lacking original data were excluded.Results: Fourteen studies met the inclusion criteria. Technological interventions, such as computerized order entry systems, accounted for 35.7% of the studies. Half addressed prescriber-related factors, such as inadequate drug knowledge and prescribing skills, while organizational factors were underexplored.Conclusion: Current interventions fail to address the underlying complexities, leaving critical gaps to decrease in-hospital PEs. To achieve sustainable PE reductions and improve patient safety, a multidisciplinary approach, standardized reporting, organizational reform, and a Safety-II perspective are essential.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"529-546"},"PeriodicalIF":3.0,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143457363","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

Pulmonary adverse events associated with monoclonal antibodies approved for multiple myeloma: a pharmacovigilance study based on the FDA adverse event reporting system. 批准用于多发性骨髓瘤的单克隆抗体相关的肺部不良事件：基于FDA不良事件报告系统的药物警戒研究

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-04-30 DOI: 10.1080/14740338.2025.2499218

Ting Liang, Limei Yan, Junfeng Li, Dongzheng Gai, Cong Xu

{"title":"Pulmonary adverse events associated with monoclonal antibodies approved for multiple myeloma: a pharmacovigilance study based on the FDA adverse event reporting system.","authors":"Ting Liang, Limei Yan, Junfeng Li, Dongzheng Gai, Cong Xu","doi":"10.1080/14740338.2025.2499218","DOIUrl":"https://doi.org/10.1080/14740338.2025.2499218","url":null,"abstract":"Background: The emergence of monoclonal antibodies has notably enhanced the outcomes for multiple myeloma. However, comprehensive assessment of monoclonal antibody-related pulmonary adverse events remains scarce.Research design and methods: This pharmacovigilance study analyzed adverse event data of monoclonal antibodies approved for myeloma from 1 January 2016, to 31 December 2023, using OpenVigil 2.1. Adverse event reports were classified based on the MedDRA v24.0 into five pulmonary SMQs: asthma/bronchospasm, infective pneumonia, interstitial lung disease, pulmonary hypertension, and respiratory failure. Disproportionality analyses were utilized to identify potential risk signals.Results: A total of 8,043,250 reports were extracted. Male patients and those aged ≥ 65 years were predominant. Hospitalization and death were common outcomes. Elranatamab had the highest risk for infective pneumonia, elotuzumab had the highest risk for interstitial lung disease, and isatuximab had the highest risk for respiratory failure. Significant associations were discovered between pulmonary adverse events and all five monoclonal antibodies. Viral pneumonia was most prevalent with daratumumab, fungal pneumonia was predominant with elotuzumab, and bacterial pneumonia was predominant with isatuximab, teclistamab, and elranatamab.Conclusions: This study summarized significant pulmonary adverse event signals associated with monoclonal antibodies approved for myeloma, emphasizing the significance of monitoring interstitial lung disease, respiratory failure, and infective pneumonia.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-6"},"PeriodicalIF":3.0,"publicationDate":"2025-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143999716","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

The Impact of Medication Regimen Complexity Score on Multi-Organ Dysfunction and Clinical Outcomes in Critically Ill Patients: A Cohort Study. 用药方案复杂性评分对危重患者多器官功能障碍和临床结局的影响：一项队列研究。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-04-30 DOI: 10.1080/14740338.2025.2497395

Kholoud Al Aamer, Khalid Al Sulaiman, Ohoud Aljuhani, Sarah Alshehri, Abdulmajeed M Alshehri, Lina Aldawood, Asmahan AlQurashi, Khuld Aloufi, Lamyaa Kassem, Shahad Nazel, Khalid Albarqi, Alawi S Alsaeedi, Shaden Alonazi, Afnan Alqahtani, Munirah Alhmoud, Majidah Aljohani, Qasem A Bahri, Abdulaziz Alanazi, Saud Jassar, Bader Alnasser, Razan Alqadi, Amal Alqumia, Hasan M Al-Dorzi

{"title":"The Impact of Medication Regimen Complexity Score on Multi-Organ Dysfunction and Clinical Outcomes in Critically Ill Patients: A Cohort Study.","authors":"Kholoud Al Aamer, Khalid Al Sulaiman, Ohoud Aljuhani, Sarah Alshehri, Abdulmajeed M Alshehri, Lina Aldawood, Asmahan AlQurashi, Khuld Aloufi, Lamyaa Kassem, Shahad Nazel, Khalid Albarqi, Alawi S Alsaeedi, Shaden Alonazi, Afnan Alqahtani, Munirah Alhmoud, Majidah Aljohani, Qasem A Bahri, Abdulaziz Alanazi, Saud Jassar, Bader Alnasser, Razan Alqadi, Amal Alqumia, Hasan M Al-Dorzi","doi":"10.1080/14740338.2025.2497395","DOIUrl":"https://doi.org/10.1080/14740338.2025.2497395","url":null,"abstract":"Background: Evidence is limited on the utilization of the Medication Regimen Complexity - Intensive Care Unit (MRC-ICU) scores for predicting clinical outcomes in critically ill patients. Therefore, this study aims to examine the impact of the MRC-ICU score on clinical outcomes for critically ill patients.Research design and methods: A single-center retrospective cohort study included adult ICU patients admitted for >72 hours between January and December 2021. Patients were categorized into two groups based on MRC-ICU scores assessed within 24 hours of ICU admission. The primary endpoint was the Multiorgan Dysfunction (MOD) score at 72 hours of ICU admission. Other clinical outcomes were considered secondary.Results: Of the 1406 patients included, 718 had an MRC-ICU score of nine or higher. Patients with MRC-ICU scores ≥9 had significantly higher MOD scores at 72 hours (median 5 vs 3, p < 0.001), longer hospital LOS, and higher mortality rates in crude analyses. Regression analysis showed a significant association between MRC-ICU score and MOD score at day 3 of ICU admission (coefficient: 0.49, 95% CI 0.07 to 0.92, p = 0.02). However, no significant differences were observed with ICU-LOS, vasopressor-free days, or mortality.Conclusions: Higher MRC-ICU scores might be linked to worse clinical outcomes, including greater organ dysfunction, and longer hospital stay.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-7"},"PeriodicalIF":3.0,"publicationDate":"2025-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143985375","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 analysis of compounded GLP-1 receptor agonists: a pharmacovigilance study using the FDA adverse event reporting system. 复合GLP-1受体激动剂的安全性分析：使用FDA不良事件报告系统的药物警戒研究。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-04-29 DOI: 10.1080/14740338.2025.2499670

Kenneth L McCall, Keri A Mastro Dwyer, Ryan T Casey, Tasnia N Samana, Ewa K Sulicz, Susannah Y Tso, Emma R Yalanzhi, Brian J Piper

{"title":"Safety analysis of compounded GLP-1 receptor agonists: a pharmacovigilance study using the FDA adverse event reporting system.","authors":"Kenneth L McCall, Keri A Mastro Dwyer, Ryan T Casey, Tasnia N Samana, Ewa K Sulicz, Susannah Y Tso, Emma R Yalanzhi, Brian J Piper","doi":"10.1080/14740338.2025.2499670","DOIUrl":"https://doi.org/10.1080/14740338.2025.2499670","url":null,"abstract":"Background: This study evaluated the safety of compounded glucagon-like peptide-1 receptor agonists (GLP-1 RAs) compared to non-compounded formulations using the U.S. FDA Adverse Event Reporting System (FAERS).Research design and methods: A retrospective analysis of FAERS from 2018 to 2024 examined adverse events (AEs), medication errors, and product quality issues for liraglutide, semaglutide, and tirzepatide. Reporting odds ratios (RORs) with 95% confidence intervals were calculated with adjustment using logistic regression.Results: Of the 81,078 GLP-1 RA reports in the FAERS database, 707 involved compounded products. Compounded formulations demonstrated higher RORs for abdominal pain (2.84 [2.29, 3.49]), diarrhea (1.59 [1.25, 1.99]), nausea (1.27 [1.05, 1.52]), suicidality (6.34, [4.32, 8.99]), and cholecystitis (3.39, [1.61, 6.31]). Compounded products showed higher RORs of preparation errors (48.92 [12.63, 189.6]), prescribing errors (4.46, [2.49, 7.98]), contamination (19.00, [4.24, 85.03]), and compounding/manufacturing issues (8.51, [5.17, 14.0]), while lower odds of administration (0.29 [0.16, 0.53]) and dosing errors (0.24, [0.17, 0.32]). The hospitalization odds were higher for compounded products (2.35 [1.94, 2.83]).Conclusions: Compounded GLP-1 RAs may be associated with a higher odds of AEs, safety concerns, and product quality issues compared to non-compounded products. These findings underscore the importance of cautious prescribing, rigorous quality standards, and enhanced patient monitoring.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-8"},"PeriodicalIF":3.0,"publicationDate":"2025-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143994605","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

Allergy-like nocebo events reported with COVID-19 vaccines: a case control study. COVID-19疫苗报告的过敏样反安慰剂事件：一项病例对照研究

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-04-29 DOI: 10.1080/14740338.2025.2497397

Virginie Bres, Najah Ben Fadhel, Raphael Trouillet, Guillaume Broc, Anca Chiriac, Jean-Luc Faillie

{"title":"Allergy-like nocebo events reported with COVID-19 vaccines: a case control study.","authors":"Virginie Bres, Najah Ben Fadhel, Raphael Trouillet, Guillaume Broc, Anca Chiriac, Jean-Luc Faillie","doi":"10.1080/14740338.2025.2497397","DOIUrl":"https://doi.org/10.1080/14740338.2025.2497397","url":null,"abstract":"Background: Allergy-like symptoms after COVID-19 vaccination are frequently reported, though true allergic reactions are rare. Clinical trials suggest many reported symptoms may reflect nocebo effects. This study aimed to characterize nocebo responses and identify associated factors.Research design and methods: A case-control study was conducted using pharmacovigilance records and a cross-sectional questionnaire. Cases were defined as patients reporting allergy-like symptoms without anaphylaxis; controls reported reactogenicity or localized reactions. Data on demographics, medical history, vaccinations, and psychological factors were analyzed using multivariate logistic regression to identify risk factors associated with nocebo effects.Results: Among 1038 participants, 320 were nocebo cases and 718 were controls. Cases frequently reported cutaneous (71.8%) and respiratory (38.8%) symptoms, with 43.4% occurring after the first dose. Nocebo responses were positively associated with a history of allergy (OR 1.78, 95% CI: 1.32-2.4) and COMIRNATY vaccine (OR 1.60, 95% CI: 1.20-2.14), and negatively correlated with perceived vaccine effectiveness (OR 0.93, 95% CI: 0.88-0.98).Conclusions: The nocebo effect appears to differ by vaccine type and is more common in individuals with a history of allergy and lower perceived vaccine effectiveness. While further research is needed to validate these findings, this underscores the importance of clear, evidence-based communication to reduce nocebo responses.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-9"},"PeriodicalIF":3.0,"publicationDate":"2025-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143981445","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

Nephrotoxicity risks of colistin-combination therapy: a USFDA adverse event reporting system analysis using disproportionality and interaction assessment. 粘菌素联合治疗的肾毒性风险：使用歧化和相互作用评估的USFDA不良事件报告系统分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-04-29 DOI: 10.1080/14740338.2025.2499672

Kannan Sridharan

{"title":"Nephrotoxicity risks of colistin-combination therapy: a USFDA adverse event reporting system analysis using disproportionality and interaction assessment.","authors":"Kannan Sridharan","doi":"10.1080/14740338.2025.2499672","DOIUrl":"https://doi.org/10.1080/14740338.2025.2499672","url":null,"abstract":"Background: Colistin, a last-resort antimicrobial, is often used in combination with other drugs to treat multidrug-resistant infections, but its nephrotoxic potential raises concerns, especially in combination therapies.Research design and methods: A retrospective analysis was performed on 29,163,222 reports from the USFDA Adverse Event Reporting System (AERS), identifying 125 reports meeting inclusion criteria for acute renal failure (ARF) associated with colistin-antimicrobial combinations. Disproportionality analysis using frequentists and Bayesian techniques were employed to evaluate ARF risk. Drug interaction and clinical outcomes were assessed using the Interaction-Adjusted SignalScores (INTSS) and mortality data, respectively.Results: The results showed significantly higher ARF risk for colistin combinations with ceftazidime, vancomycin, meropenem, and tigecycline, with particularly strong signals observed for colistin-ceftazidime combinations, corroborated by INTSS. Mortality rates were paradoxically higher in patients receiving colistin without nephrotoxic antimicrobials. Comprehensive signal detection metrics highlighted a consistent ARF risk for several other antimicrobial combinations. Clinical outcomes analysis revealed a complex relationship between combination therapy choices and patient mortality.Conclusion: Colistin combinations with certain antimicrobials, especially ceftazidime, vancomycin, and tigecycline, carry significantly higher nephrotoxicity risks, warranting careful clinical consideration. Rigorous renal monitoring protocols are essential in managing these therapies, particularly in critically ill patients.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-10"},"PeriodicalIF":3.0,"publicationDate":"2025-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143984769","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

Identifying signals of disproportionate reporting for calcitonin gene-related peptide inhibitors: real-world evidence from the FDA adverse event reporting system. 识别降钙素基因相关肽抑制剂不成比例报告的信号：来自FDA不良事件报告系统的真实证据。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-04-28 DOI: 10.1080/14740338.2025.2497394

Nai Lee, Jihoon Ok, Yonghoon Kwon, Su-Jin Rhee, Yun Kim

{"title":"Identifying signals of disproportionate reporting for calcitonin gene-related peptide inhibitors: real-world evidence from the FDA adverse event reporting system.","authors":"Nai Lee, Jihoon Ok, Yonghoon Kwon, Su-Jin Rhee, Yun Kim","doi":"10.1080/14740338.2025.2497394","DOIUrl":"https://doi.org/10.1080/14740338.2025.2497394","url":null,"abstract":"Background: Calcitonin gene-related peptide (CGRP) inhibitors have been FDA-approved for migraine prophylaxis and relief. However, their safety profile remains uncertain. This study analyzes adverse events (AEs) and signals of disproportionate reporting (SDRs) using the FDA Adverse Event Reporting System (FAERS).Research design and methods: We analyzed FAERS reports from approval through Q2 2023, standardizing terms using preferred terminology and system organ class (SOCs) classifications. Disproportionality analyses (ROR, PRR, IC) identified SDRs and inclusion in FDA prescribing information was reviewed. Additional analyses included comparisons with other migraine drugs, indication-based sensitivity analyses and causality assessment using the Bradford Hill framework.Results: Galcanezumab showed strong signals for underdose (ROR 47.4; 95% CI 43.79-51.3), alopecia (5.72; 5.09-6.43), and constipation (6.01; 5.35-6.75), while fremanezumab exhibited notable associations with alopecia (6.9; 5.72-8.33) and weight increased (6.34; 5.18-7.76). Among gepants, rimegepant was linked to somnolence (4.52; 3.57-5.73) and dizziness (3.73; 3.15-4.42) and atogepant showed a strong signal for therapy interruption (16.58; 12.86-21.38).Conclusions: This study highlights CGRP inhibitor-associated AEs, underscoring the need for clinical monitoring and risk identification. Early detection of AEs and SDRs can inform protective measures to enhance patient safety.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-10"},"PeriodicalIF":3.0,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143975604","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

Non-melanoma skin cancer and other adverse events resulting from antihypertensive drug use: what do we know? 抗高血压药物使用导致的非黑色素瘤皮肤癌和其他不良事件：我们知道什么？

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-04-27 DOI: 10.1080/14740338.2025.2498615

Beatrice Nardone, Dennis P West

引用次数: 0

The safety analysis of lurasidone based on the real-world data of FAERS database. 基于FAERS数据库真实数据的鲁拉西酮安全性分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-04-27 DOI: 10.1080/14740338.2025.2498054

Ziyi Luo, Mengting Zhang, Weijian Liang, Mianda Hu, Yunze Jiang, Xi Lei, Zhenjie Wang, Jinfeng Zhu, Yikuan Du, Yi Liu, Chun Yang

{"title":"The safety analysis of lurasidone based on the real-world data of FAERS database.","authors":"Ziyi Luo, Mengting Zhang, Weijian Liang, Mianda Hu, Yunze Jiang, Xi Lei, Zhenjie Wang, Jinfeng Zhu, Yikuan Du, Yi Liu, Chun Yang","doi":"10.1080/14740338.2025.2498054","DOIUrl":"https://doi.org/10.1080/14740338.2025.2498054","url":null,"abstract":"Background: To assess lurasidone's real-world safety via retrospective analysis of post-marketing adverse reactions.Research design and methods: Signal mining was carried out by retrieving the adverse events (AEs) associated with lurasidone from the FDA Adverse Event Reporting System (FAERS) database spanning from the first quarter of 2011 to the fourth quarter of 2023. Disproportionality analyses including Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and empirical Bayesian geometric mean (EBGM) were used to assess the presence of significant associations between lurasidone and AEs.Results: From the 10,176,406 reports collected in the FAERS database, a total of 12,451 reports of lurasidone-related AEs were identified, which focused on Psychiatric disorders (n = 8950), notably, akathisia and parkinsonian rest tremor are strongly associated with lurasidone; Breast engorgement, galactorrhea, breast discharge, and umbilical cord around neck and new ocular AEs including oculogyric crisis, excessive eye blinking, and blepharospasm, have not been mentioned in the specification. The most common and most severe PT reported was off-label use, followed by suicidal ideation.Conclusions: This study reveals known and unexpected AEs about lurasidone, related to the eye, lactating women and life-threatening threats, and underscores the need for ongoing post-marketing surveillance of lurasidone.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-11"},"PeriodicalIF":3.0,"publicationDate":"2025-04-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143990937","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 safety analysis of baloxavir marboxil and oseltamivir based on the FAERS database. 基于FAERS数据库的baloxavir marboxil和oseltamivir安全性比较分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-04-24 DOI: 10.1080/14740338.2025.2495854

Yingqiu Tu, Xin Lai, Qing Wan, Tiantian Xu

{"title":"Comparative safety analysis of baloxavir marboxil and oseltamivir based on the FAERS database.","authors":"Yingqiu Tu, Xin Lai, Qing Wan, Tiantian Xu","doi":"10.1080/14740338.2025.2495854","DOIUrl":"https://doi.org/10.1080/14740338.2025.2495854","url":null,"abstract":"Background: This study aimed to analyze adverse drug events (ADEs) of oseltamivir or baloxavir marboxil monotherapy using the Food and Drug Administration Adverse Event Reporting System (FAERS) database, providing a valuable reference for clinical drug safety.Research design and methods: FAERS data for oseltamivir and baloxavir marboxil from their market approval in the United States until the third quarter of 2023 were retrieved. Signal detection was performed using the reporting odds ratio (ROR) and proportional reporting ratio (PRR) methods. ADEs were classified according to the System Organ Class (SOC) in the Medical Dictionary for Regulatory Activities (MedDRA) version 25.0.Results: A total of 1,727 and 12,607 ADE reports were retrieved for baloxavir marboxil and oseltamivir, respectively, involving 17 and 26 SOC categories. Baloxavir marboxil demonstrated a strong association with ischemic colitis, melena, delirium febrile, enterocolitis, febrile convulsion, and altered state of consciousness. Oseltamivir exhibited a strong association with pathological personality, thinking abnormal, agitation, abnormal behavior, somnambulism, delirium febrile, and spinal cord hemorrhage.Conclusions: When using oseltamivir and baloxavir marboxil clinically, attention should be paid not only to common ADEs but also to those not mentioned on the drug label.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-13"},"PeriodicalIF":3.0,"publicationDate":"2025-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143981795","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