Expert Opinion on Drug Safety最新文献_第4页

Updates on immunosuppressant safety and malignancy risk in patients with multiple sclerosis. 多发性硬化症患者免疫抑制剂安全性和恶性肿瘤风险的最新进展。

IF 3.1 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-08-21 DOI: 10.1080/14740338.2025.2543457

Gloria Dalla Costa, Giancarlo Comi

{"title":"Updates on immunosuppressant safety and malignancy risk in patients with multiple sclerosis.","authors":"Gloria Dalla Costa, Giancarlo Comi","doi":"10.1080/14740338.2025.2543457","DOIUrl":"https://doi.org/10.1080/14740338.2025.2543457","url":null,"abstract":"Introduction: Multiple sclerosis (MS) is a chronic, immune-mediated disease of the central nervous system, characterized by relapses or progressive neurological decline. Over recent decades, high-efficacy immunosuppressive therapies have dramatically reduced relapse rates and curtailed new MRI lesion activity in MS, but also raise safety concerns regarding infections, malignancy, and other serious adverse events.Areas covered: This review discusses immunosuppressants in MS, from older cytotoxic agents (azathioprine, cyclophosphamide, mitoxantrone) to newer therapies (cladribine, alemtuzumab, and anti-CD20 monoclonal antibodies). Key efficacy data are summarized, alongside risks of hematologic, hepatic, and autoimmune toxicities. Emerging evidence on malignancy risk is highlighted, including therapy-related acute leukemias (mitoxantrone), urothelial tumors (cyclophosphamide), and potential neoplasms linked to newer agents. Strategies for patient selection, screening, and long-term vigilance are examined to balance high-efficacy disease control with acceptable safety margins.Expert opinion: Immunosuppressants remain vital for certain MS phenotypes, especially those with highly active or refractory disease. Although novel agents offer more selective mechanisms, they still pose notable risks demanding careful monitoring and individualized care. Ongoing research, including predictive biomarkers and post-marketing surveillance, will refine patient selection and mitigate adverse events. With judicious use and robust safety protocols, clinicians can achieve durable disease control while minimizing long-term toxicities.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-17"},"PeriodicalIF":3.1,"publicationDate":"2025-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144948250","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 review of antithrombotic therapy options after left atrial appendage occlusion. 左心耳闭塞后抗血栓治疗方案的安全性评价。

IF 3.1 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-08-19 DOI: 10.1080/14740338.2025.2547007

Aanchal Sawhney, Rahul Gupta, Pranav Mahajan, Ankit Agrawal, Sergio Cossu, Dhanunjaya R Lakkireddy

{"title":"Safety review of antithrombotic therapy options after left atrial appendage occlusion.","authors":"Aanchal Sawhney, Rahul Gupta, Pranav Mahajan, Ankit Agrawal, Sergio Cossu, Dhanunjaya R Lakkireddy","doi":"10.1080/14740338.2025.2547007","DOIUrl":"10.1080/14740338.2025.2547007","url":null,"abstract":"Introduction: Left atrial appendage occlusion (LAAO) is a viable alternative to anticoagulation for treatment in patients with non-valvular atrial fibrillation (NVAF) who cannot tolerate anticoagulation. Post-procedure patients are generally prescribed oral anticoagulation (OAC) for 45 days, while the device is undergoing endothelialization, following which patients are continued on antiplatelet agents. Recommendations for antithrombotic agents following LAAO arrived by consensus, which are not tolerated by all patients.Areas covered: This review covers the safety profile of antithrombotic therapy options after LAAO. We discuss the side effect profiles including device-related thrombosis (DRT), bleeding, and thromboembolic events. The new randomized controlled trials and meta-analysis compared combinations of DOAC with single antiplatelet therapy (SAPT), dual antiplatelet therapy (DAPT), VKA, or only SAPT and studied the incidence of major bleeding, DRT, and thromboembolic events. This review is a comprehensive summary of different antithrombotic agents' combinations along with the duration recommendations and emphasizes the importance of a discussion among involved team members and patients.Expert opinion: In patients with NVAF undergoing LAAO, initial post-procedural antithrombotic monotherapy with DOAC is associated with low rates of thromboembolism, DRT, and major bleeding followed by DAPT. DAPT is associated with lower incidence of thromboembolic events in comparison to SAPT.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-10"},"PeriodicalIF":3.1,"publicationDate":"2025-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144821037","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

A safety review of approved oral agents for treating type 2 diabetes and associated diseases in pregnant patients. 批准用于治疗妊娠患者2型糖尿病及相关疾病的口服药物的安全性审查

IF 3.1 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-08-13 DOI: 10.1080/14740338.2025.2545929

Damla N Costa, Rana Malek, Stephen N Davis

{"title":"A safety review of approved oral agents for treating type 2 diabetes and associated diseases in pregnant patients.","authors":"Damla N Costa, Rana Malek, Stephen N Davis","doi":"10.1080/14740338.2025.2545929","DOIUrl":"10.1080/14740338.2025.2545929","url":null,"abstract":"Introduction: Hyperglycemia in pregnancy, including gestational diabetes mellitus (GDM) and pregestational diabetes, significantly impacts maternal and neonatal outcomes, necessitating effective management strategies. Insulin is the first-line therapy; however, adherence barriers, cost, and route of administration challenges have driven interest in oral agents like metformin and glyburide. These agents offer practical alternatives but raise questions about long-term safety and fetal exposure.Areas covered: This review evaluates the pharmacokinetics, pharmacodynamics, and clinical outcomes of metformin and glyburide, focusing on their roles in GDM, pregestational diabetes, polycystic ovary syndrome (PCOS), and obesity. Maternal outcomes, neonatal impacts, and long-term offspring health were assessed to determine the safety of these therapies.Expert opinion: Metformin reduces insulin dependency and weight gain during pregnancy but raises concerns about short and long-term offspring impacts, such as increased SGA rates (22% vs. 5%), altered growth patterns, and offspring neurocognition. Glyburide is effective for glycemic control but carries higher neonatal hypoglycemia risks and lacks robust long-term safety data. Both agents hold promise as alternatives to insulin, particularly in resource-limited settings. However, further research is needed to address knowledge gaps, optimize their use, and ensure safe integration into clinical practice.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-18"},"PeriodicalIF":3.1,"publicationDate":"2025-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144798608","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

Artificial intelligence in pharmacovigilance signal management: a review of tools, implementations, research, and regulatory landscape. 药物警戒信号管理中的人工智能：对工具、实施、研究和监管环境的回顾。

IF 3.1 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-08-13 DOI: 10.1080/14740338.2025.2545926

Maria Antonietta Barbieri, Vera Battini, Carla Carnovale, Marianna Cocco, Despoina Georgia Papoutsi, Nicole Sonne Heckmann, Guojun Dong, Andrea Rossi, Simay Peker, Robbert P Van Manen, Sameer Thapar, Maurizio Sessa

{"title":"Artificial intelligence in pharmacovigilance signal management: a review of tools, implementations, research, and regulatory landscape.","authors":"Maria Antonietta Barbieri, Vera Battini, Carla Carnovale, Marianna Cocco, Despoina Georgia Papoutsi, Nicole Sonne Heckmann, Guojun Dong, Andrea Rossi, Simay Peker, Robbert P Van Manen, Sameer Thapar, Maurizio Sessa","doi":"10.1080/14740338.2025.2545926","DOIUrl":"10.1080/14740338.2025.2545926","url":null,"abstract":"Introduction: The integration of artificial intelligence (AI) into pharmacovigilance (PV) has advanced rapidly in recent years. AI tools have the potential to transform signal management by enabling faster and more accurate signal management and decision-making. However, the regulatory landscape governing these technologies remains complex.Areas covered: This article presents available AI tools for signal management, provides an overview of the regulatory landscape of these tools, and explores stakeholder perspectives on the challenges and opportunities posed by AI regulations. On 23 July 2024, we conducted a Google search of the top 2,000 results using the query 'AI pharmacovigilance service provider.' Two searches were performed in Ovid MEDLINE to identify articles published between 1 January 2022, and 23 July 2024, using ad hoc queries.Expert opinion: AI tools are now available to support all critical activities in signal management. However, regulatory discrepancies and variations persist across different regions. The findings underscore the urgent need for ongoing international collaboration to harmonize regulatory frameworks and ensure the safe and ethical implementation of AI in PV. As AI technologies continue to evolve, addressing these regulatory and operational challenges will be essential to fully realize their potential in enhancing drug safety and improving healthcare outcomes worldwide.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-16"},"PeriodicalIF":3.1,"publicationDate":"2025-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144798609","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

Understanding the risk of pneumonia in elderly individuals with schizophrenia receiving antipsychotic treatment. 了解接受抗精神病药物治疗的老年精神分裂症患者肺炎的风险。

IF 3.1 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-08-12 DOI: 10.1080/14740338.2025.2547008

Seetal Dodd, Alison R Yung, Michael Berk

引用次数: 0

Prevention and detection of hydroxychloroquine-induced retinopathy in patients with systemic autoimmune diseases. 系统性自身免疫性疾病患者羟氯喹所致视网膜病变的预防与检测。

IF 3.1 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-08-07 DOI: 10.1080/14740338.2025.2544044

Ko Eun Kim, Seong Joon Ahn

{"title":"Prevention and detection of hydroxychloroquine-induced retinopathy in patients with systemic autoimmune diseases.","authors":"Ko Eun Kim, Seong Joon Ahn","doi":"10.1080/14740338.2025.2544044","DOIUrl":"10.1080/14740338.2025.2544044","url":null,"abstract":"Introduction: Hydroxychloroquine (HCQ) is prescribed in systemic autoimmune diseases for disease-modifying benefits. However, long-term HCQ use can cause irreversible retinal toxicity.Areas covered: Key articles were identified through searches of publications in PubMed and Embase from January 2000 to May 2025. Data indicate that retinopathy risk is low during the first 5-10 years of therapy but rises with longer exposure. High daily dose ( >5 mg/kg real weight), long-term use ( >5 years), renal impairment, and tamoxifen use are key risk factors. Guidelines emphasize weight-based dosing (≤5 mg/kg/day) and regular ophthalmologic screening. The American Academy of Ophthalmology (AAO) recommends baseline fundus exam and annual screening after 5 years of HCQ use if no high-risk features, using spectral-domain optical coherence tomography (SD-OCT) and automated visual fields as primary tests. Four recommended screening modalities by AAO and Royal College of Ophthalmologists include SD-OCT, fundus autofluorescence, automated visual fields, and multifocal electroretinography.Expert opinion: Despite advancements in understanding and detecting HCQ retinopathy, challenges remain in defining a truly safe dose, achieving early detection, and ensuring adherence to screening guidelines. Ongoing research into imaging biomarkers, genetic susceptibility, and AI-driven tools aims to enhance early detection and personalize screening, ultimately improving outcomes and reducing vision loss.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-13"},"PeriodicalIF":3.1,"publicationDate":"2025-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144783899","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

Statement of retraction: clinical adverse events to letairis: a real-world drug safety study based on FDA Adverse Event Reporting System (FAERS). 撤回声明：临床不良事件：一项基于FDA不良事件报告系统（FAERS）的真实世界药物安全性研究。

IF 3.1 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-08-07 DOI: 10.1080/14740338.2025.2542063

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 : 2025-08-03 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":"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":"1-7"},"PeriodicalIF":3.1,"publicationDate":"2025-08-03","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

The association between ketamine and esketamine and suicidality: reports to the Food And Drug Administration Adverse Event Reporting System (FAERS). 氯胺酮和艾司氯胺酮与自杀之间的关联：向食品药品管理局不良事件报告系统（FAERS）提交的报告。

IF 3.1 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-08-01 Epub Date: 2024-06-21 DOI: 10.1080/14740338.2024.2368827

Roger S McIntyre, Rodrigo B Mansur, Joshua D Rosenblat, Kayla M Teopiz, Angela T H Kwan

{"title":"The association between ketamine and esketamine and suicidality: reports to the Food And Drug Administration Adverse Event Reporting System (FAERS).","authors":"Roger S McIntyre, Rodrigo B Mansur, Joshua D Rosenblat, Kayla M Teopiz, Angela T H Kwan","doi":"10.1080/14740338.2024.2368827","DOIUrl":"10.1080/14740338.2024.2368827","url":null,"abstract":"Introduction: Replicated evidence indicates that ketamine and esketamine reduce measures of suicidality in persons with treatment-resistant depression (TRD). It remains uncertain whether individuals experience worsening of preexisting suicidality with either agent.Research design and methods: The Food and Drug Administration Adverse Event Reporting System (FAERS) database was searched from 1970 and 2019 to 30 September 2023 for reports of suicidal ideation, depression suicidal, suicidal behavior, suicidal attempt, and completed suicide in association with ketamine and esketamine exposure, respectively. We present reporting odds ratios (ROR) significance was determined when the lower limit of the 95% confidence interval (CI) exceeded 1.0. Lithium was used as the control agent.Results: Observed a higher ROR for suicidal ideation (ROR 7.58, 95% CI 6.34-9.07) and depression suicidal (ROR 14.19, 95% CI 1.80-112.07) with esketamine. Significantly lower RORs were observed for suicide attempt with ketamine (ROR 0.15, 95% CI 0.11-0.21) and esketamine (ROR 0.57, 95% CI 0.48-0.67).Conclusions: Mixed RORs across aspects of suicidality were observed with ketamine and esketamine. Limitations of the FAERS database prevent any determination of causal effects new onset suicidality to either agent. The lower RORs for suicide attempt with ketamine and esketamine is noted but cannot be interpreted as a direct therapeutic effect.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"909-914"},"PeriodicalIF":3.1,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141330704","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 brexanolone in the FAERS database: real adverse event analysis and discussion of side effects. FAERS 数据库中的布雷克诺龙安全性评估：真实不良事件分析和副作用讨论。

IF 3.1 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-08-01 Epub Date: 2024-08-02 DOI: 10.1080/14740338.2024.2387316

Liuyin Jin, Kaixia Yang, Xiping Wu, Jing Zhang

{"title":"Safety assessment of brexanolone in the FAERS database: real adverse event analysis and discussion of side effects.","authors":"Liuyin Jin, Kaixia Yang, Xiping Wu, Jing Zhang","doi":"10.1080/14740338.2024.2387316","DOIUrl":"10.1080/14740338.2024.2387316","url":null,"abstract":"Background: Postpartum depression (PPD) is linked to hormonal changes. Brexanolone, the first FDA-approved drug for PPD, is a potential treatment. This study analyzes Brexanolone's safety using the FAERS database, highlighting its adverse effects and potential risk factors.Methods: We analyzed FAERS data from Q3 2019 to Q3 2023, evaluating adverse reactions to Brexanolone. The analysis includes demographics, reporting regions, reporter identities, and types of adverse reactions.Results: Most reports are from the United States, with consumers and physicians as primary reporters. Adverse reactions mainly involve severe systemic diseases, administration site reactions, injuries, intoxication, operational complications, and mental disorders. Specific adverse reactions include incorrect drug monitoring, PPD, intrusive thoughts, delayed treatment efficacy, sedation complications, product discontinuation, misuse, infusion site leakage and pain, and medication errors.Conclusion: The study confirms known safety information about Brexanolone and provides comprehensive data for medical practices and public health decisions. However, relying on spontaneous reports may introduce biases and incomplete information. Continued monitoring and reporting of adverse reactions to newer drugs like Brexanolone remain crucial.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"983-989"},"PeriodicalIF":3.1,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141874561","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