Expert Opinion on Drug Safety最新文献_第3页

Adverse drug reactions of intravesical instillation therapy for bladder cancer: based on FDA adverse event reporting system. 膀胱癌膀胱内灌注疗法的药物不良反应：基于美国食品及药物管理局不良事件报告系统。

IF 3.1 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-09-01 Epub Date: 2024-08-22 DOI: 10.1080/14740338.2024.2393283

Xiang Liu, Zixin Wang, Cong Peng, Jiaming Zhou, Minggen Chen, Longhua Luo, Xiang Sun

{"title":"Adverse drug reactions of intravesical instillation therapy for bladder cancer: based on FDA adverse event reporting system.","authors":"Xiang Liu, Zixin Wang, Cong Peng, Jiaming Zhou, Minggen Chen, Longhua Luo, Xiang Sun","doi":"10.1080/14740338.2024.2393283","DOIUrl":"10.1080/14740338.2024.2393283","url":null,"abstract":"Background: Intravesical chemotherapy and immunotherapy are common adjuvant treatments for non-muscle invasive bladder cancer post-surgery. Analyzing adverse events linked to these therapies, can assist in clinical decision-making and risk assessment.Study design and methods: Disproportionality analysis was conducted to analyze data from the Food and Drug Administration Adverse Event Reporting System database from the first quarter of 2004 to the first quarter of 2024, exploring potential positive signals between Bacillus Calmette-Guérin, mitomycin-C, epirubicin, gemcitabine, and adverse events.Results: The database retrieved 2018, 140, 31, and 85 adverse event reports associated with Bacillus Calmette-Guérin, mitomycin-C, epirubicin, and gemcitabine, respectively. Adverse reactions not mentioned in the label, such as aortic aneurysm and ocular congestion, were observed in preferred term level related to Bacillus Calmette-Guérin. Mitomycin-C exhibited specificity in skin and subcutaneous tissue diseases not reflected in the package insert. Gemcitabine-induced adverse drug reactions showed signals in vascular and lymphatic diseases meeting the screening criteria of all 4 indicators, with capillary leakage syndrome being the preferred term with the highest signal intensity.Conclusion: This study observed new adverse event signals, providing important assistance for drug selection in adjuvant therapy for non-muscle invasive bladder cancer postoperatively.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1095-1102"},"PeriodicalIF":3.1,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141999669","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

Cardiovascular adverse events associated with PARP inhibitors for ovarian cancer: a real world study (RWS) with Bayesian disproportional analysis based on the FDA adverse event reporting system (FAERS). 与治疗卵巢癌的 PARP 抑制剂相关的心血管不良事件：基于 FDA 不良事件报告系统 (FAERS) 的贝叶斯比例失调分析的真实世界研究 (RWS)。

IF 3.1 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-09-01 Epub Date: 2024-08-12 DOI: 10.1080/14740338.2024.2390640

Chenguang Yang, Xuan Song, Hongmei Sun, Xi Chen, Chengjiang Liu, Min Chen

{"title":"Cardiovascular adverse events associated with PARP inhibitors for ovarian cancer: a real world study (RWS) with Bayesian disproportional analysis based on the FDA adverse event reporting system (FAERS).","authors":"Chenguang Yang, Xuan Song, Hongmei Sun, Xi Chen, Chengjiang Liu, Min Chen","doi":"10.1080/14740338.2024.2390640","DOIUrl":"10.1080/14740338.2024.2390640","url":null,"abstract":"Background: To investigate the pharmacovigilance (PV) and make pairwise comparisons on reporting proportion, seriousness, and severity of outcomes of major adverse cardiovascular events (MACE) among poly(ADP-ribose) polymerase-inhibitors (PARPis) in treating ovarian cancer, fallopian tube carcinoma, and primary peritoneal cancer (collectively named EOC) from the US Food and Drug Administration Adverse Event Reporting System (FAERS).Research design and methods: Data on adverse cardiovascular events reports related to EOC treatment submitted to FAERS from the first quarter of 2015 to the second quarter of 2023 were harvested. Three PARPis were identified: olaparib, niraparib, and rucaparib.Results: Eventually, a total of 258,596 eligible records were enrolled with 12,331 reports including 5,292 reports of MACE and 7,039 reports of other cardiovascular events. For the primary composite endpoint, a PV signal associated with MACE was detected in niraparib (ROR = 1.12; IC025 = 0.03), whereas it was not detected in olaparib and rucaparib; For the secondary endpoint, PV signals associated with other cardiovascular events were detected in niraparib (ROR = 1.17;IC025 = 0.04), but not in olaparib and rucaparib.Conclusions: For EOC patients, close monitoring of blood pressure, heart rate, and coagulation function should be conducted when selecting niraparib for treatment.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1039-1046"},"PeriodicalIF":3.1,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141916495","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

Reassessment of pioglitazone and bladder cancer based on FAERS database. 基于 FAERS 数据库对吡格列酮与膀胱癌的重新评估。

IF 3.1 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-09-01 Epub Date: 2024-09-20 DOI: 10.1080/14740338.2024.2390000

Hai-Yan Chen, Hui Zhao, Jun-Jie Yang, Qian Zhang, Ming-Ming Yan, Xiao-Yan Qiu

{"title":"Reassessment of pioglitazone and bladder cancer based on FAERS database.","authors":"Hai-Yan Chen, Hui Zhao, Jun-Jie Yang, Qian Zhang, Ming-Ming Yan, Xiao-Yan Qiu","doi":"10.1080/14740338.2024.2390000","DOIUrl":"10.1080/14740338.2024.2390000","url":null,"abstract":"Background: The association between pioglitazone (PLZ) and bladder cancer (BC) remains controversial in several randomized control trials, meta-analyses of multiple prospective studies, and large-scale observational studies.Research design and methods: Adverse event (AE) data from 1 January 2004 to 31 March 2024 were extracted from the Food and Drug Administration Adverse Event Reporting System (FAERS) database. Disproportionality analysis were applied to quantify the signals of PLZ related BC.Results: In total, 17,627,524 AE reports were recorded in the FAERS database, of which 1366 were PLZ-related BCs. More male than female patients were reported. The median age of patients was 70 years old. The peak in the annual report occurred in 2011. A total of 602 AEs reported time to onset (TTO) and the median TTO was 1023 days. In this study, BC and BC recurrence were strong signal, whereas BC stage 0 (with cancer in situ), stage ii and iii were weak signals.Conclusions: This study comprehensively demostrated the PLZ-induced risk of BC in patients with diabetes mellitus using the FAERS database. The results demonstrated that the patients treated with PLZ were more likely to develop BC. The male and aging attributed more cases to BC-related reports of PLZ treated patients.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1113-1120"},"PeriodicalIF":3.1,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142282662","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 burden of adverse drug reactions reported by patients in the Dutch ADR monitor: a proof of concept. 荷兰药物不良反应监测系统中患者报告的药物不良反应负担：概念验证。

IF 3.1 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-09-01 Epub Date: 2024-07-26 DOI: 10.1080/14740338.2024.2383707

Janneke M Quik, Helen R Gosselt, Jette A van Lint, Leanne J Kosse, Peter M Ten Klooster, Harald E Vonkeman, B J F van den Bemt, Naomi T Jessurun

{"title":"The burden of adverse drug reactions reported by patients in the Dutch ADR monitor: a proof of concept.","authors":"Janneke M Quik, Helen R Gosselt, Jette A van Lint, Leanne J Kosse, Peter M Ten Klooster, Harald E Vonkeman, B J F van den Bemt, Naomi T Jessurun","doi":"10.1080/14740338.2024.2383707","DOIUrl":"10.1080/14740338.2024.2383707","url":null,"abstract":"Background: We aimed to describe the burden of adverse drug reactions (ADRs) reported by patients participating in the Dutch ADR Monitor using a multifactorial burden measurement instrument.Methods: The Dutch ADR Monitor is a cohort event monitoring system that collects information on ADR experiences, including burden. This study includes the initial data (November 2022 until May 2023). Patients were asked if experienced ADRs impacted seven domains of burden: appearance, medical treatment, daily life, fatigue, physical consequences, mental consequences, and the course of ADRs. Burden was scored from 0 to 10 on impacted domains. The distributions of these burden scores were demonstrated in Likert plots. The burden between persistent and recurrent ADRs was compared.Results: Ninety-two patients reported 199 ADRs. Impacts on the domain fatigue and daily life were experienced most frequently, except for skin and subcutaneous tissue ADRs, where impacts on appearance and mental consequences were experienced most frequently. Fatigue was considered the most burdensome domain. No difference in burden was found between persistent (median = 7, IQR = 4) and recurrent ADRs (median = 6, IQR = 4, p = 0.59).Conclusions: This is the first study investigating burden of ADRs on seven domains in patients with chronic diseases. Impact on the domain fatigue was considered most burdensome.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1023-1033"},"PeriodicalIF":3.1,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141758088","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 evaluation of adverse drug reactions for tenofovir alafenamide and tenofovir disoproxil fumarate using the FAERS Database: a disproportionality analysis. 使用 FAERS 数据库对替诺福韦-阿拉非那胺和富马酸替诺福韦二吡呋酯的药物不良反应进行比较评估：比例失调分析。

IF 3.1 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-09-01 Epub Date: 2024-08-19 DOI: 10.1080/14740338.2024.2391496

Meng Zhu, Lingjuan Jia, Yike Wang, Yongsheng Zhang, Shengxia Lv

{"title":"Comparative evaluation of adverse drug reactions for tenofovir alafenamide and tenofovir disoproxil fumarate using the FAERS Database: a disproportionality analysis.","authors":"Meng Zhu, Lingjuan Jia, Yike Wang, Yongsheng Zhang, Shengxia Lv","doi":"10.1080/14740338.2024.2391496","DOIUrl":"10.1080/14740338.2024.2391496","url":null,"abstract":"Background: Tenofovir alafenamide (TAF) and tenofovir disoproxil fumarate (TDF) are widely used nucleoside reverse transcriptase inhibitors (NRTIs), necessitating a thorough understanding of their safety profiles to ensure optimal patient care and treatment adherence.Methods: We employed statistical methods including the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-Item Gamma Poisson Shrinker (MGPS) to compare and evaluate the safety profiles of these NRTIs.Results: TAF was significantly associated with weight increase (ROR: 6.43; 95% CI: 5.93-6.96) and specific psychiatric disorders. TDF showed a notable signal for renal disorders and product-related issues, including product dose omission (ROR: 3.53; 95% CI: 3.22-3.87). Additionally, the study highlighted differences in safety signals related to pregnancy outcomes, with TAF having a higher ROR for maternal exposure (ROR: 7.83; 95% CI: 7.06-8.69) and TDF for fetal exposure (ROR: 4.51; 95% CI: 3.93-5.18), underscoring the need for cautious use in pregnant women. The comparative analysis also identified signals for osteonecrosis (ROR: 108.81; 95% CI: 106.25-111.43) and bone loss (ROR: 714; 95% CI: 685.49-743.68) for TAF and TDF, respectively, highlighting the importance of bone health considerations in treatment plans.Conclusion: These findings underscore the importance of personalized antiviral therapy and patient safety.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1073-1082"},"PeriodicalIF":3.1,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141916496","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

Analysis of lumateperone data for patients with schizophrenia using related adverse events from the FDA adverse reporting system. 利用美国食品及药物管理局不良反应报告系统中的相关不良事件，分析精神分裂症患者服用鲁马培龙的数据。

IF 3.1 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-09-01 Epub Date: 2024-08-28 DOI: 10.1080/14740338.2024.2392869

Shengzhu Sun, Ying Zhang, Hongyun Wu, Wei Peng

{"title":"Analysis of lumateperone data for patients with schizophrenia using related adverse events from the FDA adverse reporting system.","authors":"Shengzhu Sun, Ying Zhang, Hongyun Wu, Wei Peng","doi":"10.1080/14740338.2024.2392869","DOIUrl":"10.1080/14740338.2024.2392869","url":null,"abstract":"Background: Our study utilized the U.S. Food and Drug Administration's Adverse Event Reporting System (FAERS) to analyze and study the adverse event (AEs) signals of second-generation antipsychotic drug lumateperone, providing a reference for clinical safety monitoring in the treatment of schizophrenia.Methods: The International Dictionary of Medical Terminology (version 26.0) was used to standardize the preferred system organ category (SOC) and preferred terminology (PT) for adverse drug events (ADE) data related to lumateperone. ADE signals were classified and described using four algorithms: reporting odds ratios (ROR), proportional reporting ratios (PRR), Bayesian confidence-propagation neural network (BCPNN) and Multinomial gamma-poisson shrinkage (MGPS).Result: Among the 2542 case reports collected from the FAERS database, 1762 reports with lumateperone as a 'principal suspect(PS)' AEs were identified. Lumateperone-induced AEs occurred in 26 system organ categories (SOC). A total of 118 significant disproportionate preferred terms (PTs) meeting the requirements of 4 algorithms were retained, and unexpected major events, such as burning sensation, tremor, migraine etc. may also occur. The median time to onset of lumateperone-related adverse events was 9 days (interquartile range [IQR] 2-31.25 days), and most AEs occurred within the first 10 days and 1 month after initiation of lumateperone therapy.Conclusion: Our research may provide a better understanding of the potential adverse events that may be caused by lumateperone and those not recorded in the drug instructions, providing valuable signals for clinical use.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1083-1093"},"PeriodicalIF":3.1,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142079765","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 3.1 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-09-01 Epub 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 of current strategies to manage moderate to severe pain in patients with endometriosis. 当前治疗子宫内膜异位症患者中至重度疼痛策略的安全性。

IF 3.1 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-08-25 DOI: 10.1080/14740338.2025.2547017

Simone Ferrero, Fabio Barra, Giulia Vatteroni, Francesco Paolo Rosato, Giulio Evangelisti, Michele Paudice, Valerio Gaetano Vellone

{"title":"Safety of current strategies to manage moderate to severe pain in patients with endometriosis.","authors":"Simone Ferrero, Fabio Barra, Giulia Vatteroni, Francesco Paolo Rosato, Giulio Evangelisti, Michele Paudice, Valerio Gaetano Vellone","doi":"10.1080/14740338.2025.2547017","DOIUrl":"10.1080/14740338.2025.2547017","url":null,"abstract":"Introduction: Medical therapy is crucial in the long-term management of endometriosis, and its clinical efficacy must be balanced with a favorable safety profile.Areas covered: This review aims to provide a comprehensive overview of available drugs for the treatment of endometriosis, with an emphasis on their safety. A literature search was conducted using MEDLINE. EMBASE. and the Cochrane Library. Reference lists of relevant articles and recent book chapters were also examined.Expert opinion: First-line therapies include combined contraceptives and progestins, both effective in reducing pain. Combined contraceptives commonly cause breakthrough bleeding, nausea, headaches, breast tenderness, and libido changes. Progestins may lead to depression, decreased libido, weight gain, breast tenderness, and lipid alterations. Gonadotropin-releasing hormone agonists are second-line options but are limited by hypoestrogenic side effects, including vasomotor symptoms, urogenital atrophy, and bone mineral density (BMD) loss. Add-back therapy with norethindrone acetate or low-dose combined contraceptives mitigates these effects. GnRH antagonists provide immediate suppression without flare-up and may improve adherence; however, hot flushes and BMD loss remain concerns. While all hormonal therapies are suppressive rather than curative, optimizing safety and tolerability is essential for sustained use and symptom control.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-14"},"PeriodicalIF":3.1,"publicationDate":"2025-08-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144816135","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

Efficacy and tolerability of bimekizumab within patients with moderate-to-severe plaque psoriasis: learnings from real world evidence. 比美珠单抗在中重度斑块性银屑病患者中的疗效和耐受性：来自现实世界证据的学习

IF 3.1 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-08-25 DOI: 10.1080/14740338.2025.2553058

Matteo Megna, Daniele Cecere, Michela D'Agostino, Nello Tommasino, Giuseppe Lauletta, Valeria Esposito, Mariateresa Bianco, Luca Potestio

{"title":"Efficacy and tolerability of bimekizumab within patients with moderate-to-severe plaque psoriasis: learnings from real world evidence.","authors":"Matteo Megna, Daniele Cecere, Michela D'Agostino, Nello Tommasino, Giuseppe Lauletta, Valeria Esposito, Mariateresa Bianco, Luca Potestio","doi":"10.1080/14740338.2025.2553058","DOIUrl":"https://doi.org/10.1080/14740338.2025.2553058","url":null,"abstract":"Introduction: Bimekizumab is the latest biologics approved for the management of moderate-to-severe plaque psoriasis. Its unique mechanism of action simultaneously inhibition of interleukin (IL)17A and IL17F] offers a potentially deeper suppression of cutaneous immune activation compared to selective IL17A inhibition alone. While clinical trials demonstrated excellent results in terms of efficacy and safety, real-world data are mandatory to assess its performance in broader patient populations, including those excluded from trials.Areas covered: This narrative review summarizes findings from real-life studies on bimekizumab in moderate-to-severe plaque psoriasis. Extensive literature research was conducted on the main databases, including PubMed, Embase, Ovid, Scopus, Google Scholar and the Cochrane Library, until April 2025.Expert opinion: Bimekizumab has rapidly gained relevance as a highly effective and fast-acting option in psoriasis management, with durable outcomes across heterogeneous patient profiles. The emerging number of real-world evidence reinforces its value in routine practice and supports its positioning as a valuable weapon among the armamentarium of biological therapies.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-12"},"PeriodicalIF":3.1,"publicationDate":"2025-08-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144948267","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

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