Expert Opinion on Drug Safety最新文献_第9页

Why is pharmacovigilance essential for biosimilars? 为什么药物警戒对生物仿制药至关重要？

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-07-01 Epub Date: 2025-11-12 DOI: 10.1080/14740338.2025.2588599

Andrea Spini, Chiara Bellitto, Gianluca Trifirò

引用次数: 0

Cutaneous toxicity induced by antidepressants and second-generation antipsychotics in the United States food and drug administration adverse event reporting system. 美国食品和药物管理局不良事件报告系统中的抗抑郁药和第二代抗精神病药引起的皮肤毒性。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-07-01 Epub Date: 2024-12-17 DOI: 10.1080/14740338.2024.2443962

Yueyue Yuan, Mengting Shen, Chong Chen, Wensi Huang, Luyao He

{"title":"Cutaneous toxicity induced by antidepressants and second-generation antipsychotics in the United States food and drug administration adverse event reporting system.","authors":"Yueyue Yuan, Mengting Shen, Chong Chen, Wensi Huang, Luyao He","doi":"10.1080/14740338.2024.2443962","DOIUrl":"10.1080/14740338.2024.2443962","url":null,"abstract":"Background: Adverse cutaneous drug reactions have been reported with most drugs, including antidepressants (ADs) and second-generation antipsychotics (SGAs). The lack of extensive research on the relationship between ADs and SGAs, and cutaneous toxicity remains troubling. Our study aimed to assess the cutaneous toxicity of ADs and SGAs and provide valuable insights for clinical applications and scientific investigations.Research design and methods: We conduct a pharmacovigilance study based of the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database to analysis the relationship of ADs and SGAs and cutaneous adverse events. Reporting odds ratios (ROR) and information components (IC) were presented using statistical shrinkage transformation.Results: Comparing ACDRs to other ADRs, each AD (fluoxetine (ROR025 = 1.49), fluvoxamine (ROR025 = 1.14), paroxetine (ROR025 = 1.49), escitalopram (ROR025 = 1.79), sertraline (ROR025 = 1.44), venlafaxine (ROR025 = 1.46) and duloxetine (ROR025 = 1.69)) showed significantly more cases. There was no association between SGA and cutaneous toxicity. The spectrum displayed strong signals in duloxetine-induced genital ulceration (IC025 = 2.75) and amisulpride-induced conjunctivitis (IC025 = 2.56).Discussion: This study provides a valuable foundation for clinical practice and medication monitoring by thoroughly analyzing, methodically evaluating, and quantifying the potential dermal toxicity of ADs and SGAs.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1263-1269"},"PeriodicalIF":3.0,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142827943","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

Real-world safety evaluation of brivaracetam: insights from the US FDA Adverse Event Reporting System. 布瓦西坦的实际安全性评价：来自美国FDA不良事件报告系统的见解。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-07-01 Epub Date: 2025-02-01 DOI: 10.1080/14740338.2025.2460435

Zenan Meng, Xinzhi Li, Yue Liao, Feng Feng, Tingting Wang

{"title":"Real-world safety evaluation of brivaracetam: insights from the US FDA Adverse Event Reporting System.","authors":"Zenan Meng, Xinzhi Li, Yue Liao, Feng Feng, Tingting Wang","doi":"10.1080/14740338.2025.2460435","DOIUrl":"10.1080/14740338.2025.2460435","url":null,"abstract":"Background: Brivaracetam (BRV) is a novel drug for the treatment of epilepsy. This study aimed to detect and characterize adverse events (AEs) associated with BRV from the first quarter of 2016 to the second quarter of 2024 using the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database.Research design and methods: We utilized disproportionality analysis 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 assess the associations between reported AEs and BRV usage in the FAERS data.Results: A total of 1,781 adverse event reports were analyzed, with Brivaracetam as the primary suspected drug. We identified 13 positive system organ classes (SOCs) and 78 positive preferred term signals (PTs), with a particular focus on nervous system disorders, psychiatric disorders, and injury, poisoning, and procedural complications. Exposures related to injury, poisoning, and procedural complications during pregnancy and lactation showed positive signals, including exposure before pregnancy, during breastfeeding, and during pregnancy. These exposures warrant significant attention.Conclusions: Based on the FAERS database, we conducted a comprehensive analysis of AEs associated with BRV. This study aims to provide guidance for the clinical application of BRV in epilepsy treatment, thereby improving its safety.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1381-1388"},"PeriodicalIF":3.0,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143052125","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 Safety, Efficacy, and Clinical Use of Novel Once-Weekly Insulins in the Management of Diabetes. 新型每周一次胰岛素治疗糖尿病的安全性。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-07-01 Epub Date: 2025-11-27 DOI: 10.1080/14740338.2025.2593372

Amanda DeLuca, Ashley Schultz, Hannah Ofori, Viviana Maggio, Manfredi Rizzo, Ali A Rizvi

{"title":"The Safety, Efficacy, and Clinical Use of Novel Once-Weekly Insulins in the Management of Diabetes.","authors":"Amanda DeLuca, Ashley Schultz, Hannah Ofori, Viviana Maggio, Manfredi Rizzo, Ali A Rizvi","doi":"10.1080/14740338.2025.2593372","DOIUrl":"10.1080/14740338.2025.2593372","url":null,"abstract":"Introduction: Insulin remains the mainstay of diabetes management. Once weekly insulins (OWI) being investigated as viable options for both type 1 and type 2 diabetes. Less frequent dosing and better pharmacokinetic profile with these products hold the promise for improved patient adherence and enhanced efficacy in everyday practice.Areas covered: We conducted a biomedical literature review of the PubMed database from 2009 to 2025. This narrative review summarizes the characteristics, advantages, and drawbacks of the two OWI products on the market and in development, namely insulin icodec and insulin efsitora. We review the published data with an emphasis on the safety of these when compared with daily long-acting insulin in insulin-treated and insulin-naïve patients with diabetes.Expert opinion: The available data for OWI thus far points to similar adherence, acceptability, and efficacy when compared to once-daily insulin. OWI use was associated with comparable lowering of glycosylated hemoglobin and achievement of glycemic targets, potentially widening the treatment options for individuals with diabetes. However, increased risks of hypoglycemia and weight gain were seen in some studies. The clinical concerns regarding hypoglycemia led the U.S. regulatory agency to vote against recommending approval of icodec for use in patients with type 1 diabetes.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1213-1227"},"PeriodicalIF":3.0,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145603274","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 real‑world pharmacovigilance study of raloxifene based on the FDA adverse event reporting system (FAERS). 基于 FDA 不良事件报告系统 (FAERS) 的雷洛昔芬真实世界药物警戒研究。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-07-01 Epub Date: 2024-12-18 DOI: 10.1080/14740338.2024.2443960

Hao Liu, Wei Yan, Di Luo, Jinsong Li, Dezhi Yan

{"title":"A real‑world pharmacovigilance study of raloxifene based on the FDA adverse event reporting system (FAERS).","authors":"Hao Liu, Wei Yan, Di Luo, Jinsong Li, Dezhi Yan","doi":"10.1080/14740338.2024.2443960","DOIUrl":"10.1080/14740338.2024.2443960","url":null,"abstract":"Background: Raloxifene was approved for the treatment of postmenopausal osteoporosis; however, its safety profile remains inadequately understood. This study aimed to evaluate the safety signals associated with raloxifene.Research design and methods: Adverse events (AEs) related to raloxifene, spanning from the first quarter of 2004 to the fourth quarter of 2023, were extracted from the FDA Adverse Event Reporting System (FAERS) database. A disproportionality analysis was conducted using several methods, including the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayes Geometric Mean (EBGM).Results: The analysis yielded 7 229 reports related to raloxifene across 19 277 AEs. A total of 217 significantly disproportionate signals were identified, including muscle spasms and hot flashes. Notably, the study also uncovered novel AEs, including eye conditions like cataracts and macular degeneration, as well as gynecological issues like uterine polyps and hemorrhage. Additionally, the analysis confirmed that pulmonary embolism and deep vein thrombosis were the two most prevalent thromboembolic AEs.Conclusion: Our study reaffirmed some existing safety information regarding raloxifene while also unveiling novel risk signals. The findings provided crucial insights to enhance the rational use of the drug and inform safety regulatory strategies.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1253-1261"},"PeriodicalIF":3.0,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142845927","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

What's in a name? What shall we call xanomeline-trospium combination? 名字里有什么？我们该怎么称呼xanomeline-trospium ？

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-07-01 Epub Date: 2025-11-12 DOI: 10.1080/14740338.2025.2588631

Leslie Citrome

引用次数: 0

Post-marketing safety of pimavanserin: a real-world pharmacovigilance study based on the FDA adverse event reporting system (FAERS). 匹马色林上市后安全性：基于FDA不良事件报告系统（FAERS）的真实世界药物警戒研究

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-07-01 Epub Date: 2025-02-01 DOI: 10.1080/14740338.2025.2460444

Dong Liu, Xueni Zhang, Haiyan Xu

{"title":"Post-marketing safety of pimavanserin: a real-world pharmacovigilance study based on the FDA adverse event reporting system (FAERS).","authors":"Dong Liu, Xueni Zhang, Haiyan Xu","doi":"10.1080/14740338.2025.2460444","DOIUrl":"10.1080/14740338.2025.2460444","url":null,"abstract":"Background: Pimavanserin is a new non-dopamine neurotransmitter antipsychotic drug. This study aimed to conduct a post-marketing pharmacovigilance study of pimavanserin, through data mining technology using the FDA Adverse Event Reporting System (FAERS) database.Research design and methods: We analyzed adverse event reports for patients using pimavanserin. Data were classified using systematic organ classification (SOC) and preferred term (PT) of the Medical Dictionary for Regular Activities (MedDRA). Four signal algorithms [reporting odds ratio (ROR), proportional reporting ratio (PRR), multi-item gamma poisson shrinker (MGPS), and bayesian confidence propagation neural network (BCPNN)] were used to detect positive signals, and the median time-to-onset was determined.Results: Adverse drug events (ADEs) related to pimavanserin (n = 31,852) were analyzed, exhibiting an annual linear upward trend (p = 0.027). The ADEs involved 27 SOCs, but only 'Psychiatric disorders' simultaneously satisfied four algorithms. Overall, 153 PTs simultaneously satisfied four algorithms. Subgroup analysis of differences in the top 30 signal intensity PTs according to sex yielded significant results for seven PTs (p < 0.05). The median time-to-onset was 97 days, the highest proportion occurred within the first 30 days (31.79%).Conclusions: Some new PT signals not listed in the label were identified, and some PT signals showed differences according to sex.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1371-1379"},"PeriodicalIF":3.0,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143052123","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 nasal septum perforation: a disproportionality analysis of the FDA adverse event reporting system database. 药物性鼻中隔穿孔：FDA不良事件报告系统数据库的歧化分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-07-01 Epub Date: 2025-02-02 DOI: 10.1080/14740338.2025.2460448

Chubo Xie, Yi Cui, Suizi Zhou, Fang Sun, Zhilin Jiang, Keshuang Wang, Yitong Liu, Yuewu Wang, Qianhui Qiu

{"title":"Drug-induced nasal septum perforation: a disproportionality analysis of the FDA adverse event reporting system database.","authors":"Chubo Xie, Yi Cui, Suizi Zhou, Fang Sun, Zhilin Jiang, Keshuang Wang, Yitong Liu, Yuewu Wang, Qianhui Qiu","doi":"10.1080/14740338.2025.2460448","DOIUrl":"10.1080/14740338.2025.2460448","url":null,"abstract":"Background: Nasal septum perforation represents a significant clinical concern, with limited investigations into the role of medications in its etiology. This study utilizes the FDA Adverse Event Reporting System (FAERS) database to identify the drugs associated with nasal septum perforation and assess their risk.Research design and methods: This retrospective pharmacovigilance study analyzed drug-induced nasal septum perforation data from January 2004 to December 2023. Disproportionality analysis using reporting odds ratio (ROR) assessed drug associations with nasal septum perforation.Results: For 552 identified cases, the most commonly reported drugs were bevacizumab (n = 56), fluticasone propionate (n = 50), methotrexate (n = 34), hydrocodone and acetaminophen (n = 22), and paclitaxel (n = 17). Twenty-six drugs showed positive risk signals, with the top five being azelastine hydrochloride and fluticasone propionate (ROR = 173.82), beclomethasone dipropionate (ROR = 90.91), oxymetazoline (ROR = 53.77), desmopressin (ROR = 51.43), and leucovorin (ROR = 42.83). Intriguingly, 18 of these drugs did not list nasal septum perforation as a known side effect.Conclusion: This study provides a comprehensive overview of drug-induced nasal septum perforation from a pharmacovigilance perspective, highlighting the need for further research to clarify these associations and update drug safety information to reduce patient risk.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1389-1397"},"PeriodicalIF":3.0,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143074391","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

Infectious complications associated with immune and targeted anti-cancer therapies: a retrospective study of the FDA adverse events reporting system (FAERS). 与免疫和靶向抗癌治疗相关的感染性并发症：FDA不良事件报告系统（FAERS）的回顾性研究

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-07-01 Epub Date: 2025-02-01 DOI: 10.1080/14740338.2025.2461199

Yazed S Alsowaida, Ahmed Alsolami, Thamer A Almangour, Ivo Abraham

{"title":"Infectious complications associated with immune and targeted anti-cancer therapies: a retrospective study of the FDA adverse events reporting system (FAERS).","authors":"Yazed S Alsowaida, Ahmed Alsolami, Thamer A Almangour, Ivo Abraham","doi":"10.1080/14740338.2025.2461199","DOIUrl":"10.1080/14740338.2025.2461199","url":null,"abstract":"Background: Immune and targeted anti-cancer therapies are associated with an increased risk of infectious complications. The objectives of the present study were to evaluate the infectious complications associated with immune and targeted anti-cancer drugs.Research design and methods: This was a retrospective study for immune and targeted anti-cancer drugs submitted to the FDA Adverse Event Reporting System (FAERS) from 1996 to 20 March 2024. The primary outcome was the rate of infectious disease events, and the secondary outcomes were the incidence of febrile neutropenia (FN), all-cause mortality, and the top 10 infections in each class.Results: Our study included 14 drug classes comprising 44 drugs. The incidence of infectious complications was 14.31% (110,671/773,130). The highest incidence rate was reported with IL-6 inhibitors (30.89%), the highest incidence of FN was reported with Histone deacetylase inhibitors (8.43%), and the highest all-cause mortality was reported with BCR-ABL tyrosine kinase inhibitors (17.17%).Conclusion: Immune and targeted anti-cancer therapies vary in the incidence of infectious complications. Pirtobrutinib, copanlisib, sirolimus, vorinostat, and tocilizumab were associated with high infectious complications (>30%) that warrant emphasis in the clinical guidelines. Thus, clinicians should vigilantly monitor patients undergoing immune and targeted therapies for infectious complications and use antimicrobial prophylaxes when indicated.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1399-1406"},"PeriodicalIF":3.0,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143064447","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 evaluation of zanubrutinib: a real-world pharmacovigilance analysis based on the FAERS database. zanubrutinib上市后安全性评价：基于FAERS数据库的真实世界药物警戒分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-07-01 Epub Date: 2025-02-12 DOI: 10.1080/14740338.2025.2465872

Xiaolu Chen, Biao Zhang, Yajiao Huang, Yan Chen, Yuanrong Yang

{"title":"Post-marketing safety evaluation of zanubrutinib: a real-world pharmacovigilance analysis based on the FAERS database.","authors":"Xiaolu Chen, Biao Zhang, Yajiao Huang, Yan Chen, Yuanrong Yang","doi":"10.1080/14740338.2025.2465872","DOIUrl":"10.1080/14740338.2025.2465872","url":null,"abstract":"Background: Zanubrutinib has been demonstrated to have significant response rates and promising survival data in clinical trials. However, real-world adverse events still need to be ameliorated to facilitate rational clinical drug use.Research design and methods: Adverse incident reports from October 2019 to March 2024 were extracted from the FDA's Adverse Event Reporting System (FAERS) database. Zanubrutinib-related adverse events were obtained after data cleaning and analysis with SAS 9.4. Four methods were utilized to calculate disproportionality and evaluate AE signals of zanubrutinib.Result: At the system organ class (SOC) level, one SOC met the criteria of the four algorithms. At the preferred term (PT) level, most AEs are those already included in the product monograph, and no unexpected safety signals have been identified. Furthermore, the average time to onset of adverse events was 134.8 days, with a median time of 16.5 days. Adverse events occurred in 57.96% of cases within 1 month.Conclusion: Compared to the adverse events reported in clinical trials and drug labels, no unreported signals were identified. This finding will provide clinicians with a more comprehensive understanding of the clinical application of zanubrutinib and provide valuable insights for future investigations.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1319-1328"},"PeriodicalIF":3.0,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143382027","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