Expert Opinion on Drug Safety最新文献_第2页

Association between dual orexin receptor antagonists (DORAs) and suicidality: reports to the United States Food and Drug Administration Adverse Event Reporting System (FAERS). 双奥曲肽受体拮抗剂（DORAs）与自杀之间的关系：向美国食品药品监督管理局不良事件报告系统（FAERS）提交的报告。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-06-01 Epub Date: 2024-06-03 DOI: 10.1080/14740338.2024.2361300

Roger S McIntyre, Sabrina Wong, Angela T H Kwan, Taeho Greg Rhee, Kayla M Teopiz, Roger Ho, Bing Cao, Rodrigo B Mansur, Joshua D Rosenblat, Gia Han Le

{"title":"Association between dual orexin receptor antagonists (DORAs) and suicidality: reports to the United States Food and Drug Administration Adverse Event Reporting System (FAERS).","authors":"Roger S McIntyre, Sabrina Wong, Angela T H Kwan, Taeho Greg Rhee, Kayla M Teopiz, Roger Ho, Bing Cao, Rodrigo B Mansur, Joshua D Rosenblat, Gia Han Le","doi":"10.1080/14740338.2024.2361300","DOIUrl":"10.1080/14740338.2024.2361300","url":null,"abstract":"Background: Package inserts for the FDA-approved dual orexin receptor antagonists (DORAs) suvorexant, lemborexant and daridorexant state that suicide risk should be monitored. It remains unknown whether suicidality is attributed to DORAs. We aim to evaluate suicidality associated with DORAs reported to the FDA Adverse Event Reporting System (FAERS).Methods: The reporting odds ratio (ROR) was determined with trazodone as the control. Significant disproportionate reporting was determined when 95% confidence intervals (CIs) did not encompass 1.0. We used information components (ICs) to calculate the lower limit of the 95% CI (IC025). IC was significantly increased when the IC025 ≥0.Results: Suvorexant (0.025 ROR), lemborexant (0.019 ROR) and daridorexant (0.002 ROR) were significantly associated with lower odds of reported completed suicides compared to trazodone (p < 0.05). There was no significantly increased RORs for the DORAs regarding suicidal ideation, depression suicidal, suicidal behavior and suicide attempts. Nonsignificant associations between all parameters of suicidality were observed for each DORA using IC025.Conclusion: We did not find a significant association between any parameter of suicidality captured in the FAERS for each DORA. All persons treated for insomnia pharmacologically/non-pharmacologically should be evaluated for emergence/worsening of any suicidality aspect.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"753-757"},"PeriodicalIF":3.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141156790","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

Data mining study on adverse events of tirzepatide based on FAERS database. 基于 FAERS 数据库的特西帕肽不良事件数据挖掘研究。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-06-01 Epub Date: 2024-07-15 DOI: 10.1080/14740338.2024.2376686

Yan Huo, Minghua Ma, Xiaolan Liao

{"title":"Data mining study on adverse events of tirzepatide based on FAERS database.","authors":"Yan Huo, Minghua Ma, Xiaolan Liao","doi":"10.1080/14740338.2024.2376686","DOIUrl":"10.1080/14740338.2024.2376686","url":null,"abstract":"Background: Tirzepatide is a novel dual gastric inhibitory polypeptide (GIP) and glucagon-like peptide-1 receptor agonist (GLP-1 RA) for type 2 diabetes or obesity. To explore the safety profile of tirzepatide in real-world clinical applications.Research design and methods: A retrospective analysis of adverse events (AEs) reports associated with tirzepatide was conducted from the second quarter of 2022 through the fourth quarter of 2023, utilizing the FDA Adverse Event Reporting System (FAERS) database. Signal mining utilized the reporting odds ratio (ROR) method, and onset time was analyzed utilizing the Weibull Shape Parameter (WSP).Results: We identified 25,215 AE reports related to tirzepatide, predominantly in the 65 to 85 age group. Four positive signals were found at the system organ classes level. Additionally,109 AEs at the preferred terms level with positive signals were indicated. Included among these are novel signals, such as the presence of thyroid mass, medullary thyroid carcinoma, and conditions affecting the reproductive system and breast. Most AEs occurred within the first 30 days. The WSP was 0.66, indicating a propensity for early failure type.Conclusions: This study identified several novel AE signals for tirzepatide, highlighting the need for careful monitoring, especially in the early stages of treatment.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"675-683"},"PeriodicalIF":3.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141616139","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 and effectiveness of intravenous fomepizole in patients with ethylene glycol and methanol poisoning in Japan: results of a 7-year post-marketing surveillance study. 日本乙二醇和甲醇中毒患者静脉注射福美匹唑的实际安全性和有效性：上市后 7 年监测研究的结果。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-06-01 Epub Date: 2024-07-22 DOI: 10.1080/14740338.2024.2372410

Toshiharu Yoshioka, Momoha Koyanagi, Naoki Yoshida

{"title":"Real-world safety and effectiveness of intravenous fomepizole in patients with ethylene glycol and methanol poisoning in Japan: results of a 7-year post-marketing surveillance study.","authors":"Toshiharu Yoshioka, Momoha Koyanagi, Naoki Yoshida","doi":"10.1080/14740338.2024.2372410","DOIUrl":"10.1080/14740338.2024.2372410","url":null,"abstract":"Background: Fomepizole is a competitive alcohol dehydrogenase inhibitor used for the treatment of ethylene glycol and methanol poisoning. We evaluated the safety and effectiveness of fomepizole in patients with ethylene glycol or methanol poisoning in Japan.Research design and methods: This retrospective post-marketing surveillance study conducted in Japan registered patients who received fomepizole intravenous infusion per the package insert (January 2015-June 2022). Endpoints included adverse drug reactions/infections (ADRs), arterial blood pH, and treatment outcomes.Results: Of 147 patients registered (91 institutions), 131 and 126 were included in the safety and effectiveness analysis sets, respectively. Mean age was 43.6 years, and 66.4% were male. Mean time from poison ingestion to treatment was 15.1 hours; 66.4% received concomitant hemodialysis. No serious ADRs were reported. ADRs were reported in seven patients; the most-reported ADR was vomiting (2.3%). Seven patients died, 105 survived without sequelae, and 19 survived with sequelae. Most common sequelae were renal failure or renal dysfunction. Mean arterial blood pH increased to 7.4 by 4 hours of treatment, remaining stable for 24 hours post-treatment.Conclusions: Fomepizole is well tolerated and helps improve clinical outcomes in patients with ethylene glycol or methanol poisoning in Japan.Trial registration: Japanese Pharmaceutical Information Center (JapicCTI-152817).","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"685-693"},"PeriodicalIF":3.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141456123","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 Thrombocytopenia Severity and Toxicity (DITPst): binary classification of drugs by human thrombocytopenia toxicity. 药物性血小板减少的严重程度和毒性（ditpst）：根据人血小板减少毒性对药物进行二元分类。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-06-01 Epub Date: 2025-02-02 DOI: 10.1080/14740338.2025.2460439

Xiaolu Nie, Fang Hu, Xiaoling Cheng, Jingyao Ma, Xiaoxia Peng, Feng Sun, Xin Ni, Siyan Zhan

{"title":"Drug-Induced Thrombocytopenia Severity and Toxicity (DITPst): binary classification of drugs by human thrombocytopenia toxicity.","authors":"Xiaolu Nie, Fang Hu, Xiaoling Cheng, Jingyao Ma, Xiaoxia Peng, Feng Sun, Xin Ni, Siyan Zhan","doi":"10.1080/14740338.2025.2460439","DOIUrl":"10.1080/14740338.2025.2460439","url":null,"abstract":"Background: Drug-induced thrombocytopenia (DITP) often occurs in patients during clinical treatment. However, clinicians usually fail to distinguish which drugs can be plausible culprits accurately. We aimed to develop a large comprehensive drug benchmark database with DITP toxicity using the recommended method by FDA.Research design and methods: We collected information from six databases that involved drug labeling information, literature, safety signal mining and laboratory testing to generate the annotated drug list with DITP toxicity. Then, we descripted the DITP positive-negative distribution based on the Anatomical Therapeutic Chemical (ATC) coding system; hotspot analysis was conducted to identify therapeutic categories of drugs within each organ system that warrant attention regarding DITP.Results: The DITPst database comprised 1,765 drugs, of which 858 were DITP-positives, whereas 907 were negatives. The investigation of distribution across various therapeutic categories revealed the most frequent DITP-positive categories were immunostimulants (10/11), anti-inflammatory, and antirheumatic products (28/32), and antibacterials for systemic use (102/121). On the contrary, the least frequent DITP-positive therapeutic categories were diagnostic radiopharmaceuticals (12/12), pituitary and hypothalamic hormones and analogues (17/18), and drugs for constipation (16/17).Conclusions: We consider the DITPst benchmark database to be an invaluable resource for the community to improve DITP safety research and drug development.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"731-743"},"PeriodicalIF":3.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143058462","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Assessing adverse event burden in chronic lymphocytic leukemia treatment regimens: what's best for patient quality of life? 评估慢性淋巴细胞白血病治疗方案的不良事件负担：什么对患者生活质量最好？

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-06-01 Epub Date: 2025-03-14 DOI: 10.1080/14740338.2025.2471508

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

{"title":"Assessing adverse event burden in chronic lymphocytic leukemia treatment regimens: what's best for patient quality of life?","authors":"Anna Korycka-Wołowiec, Dariusz Wołowiec, Hanna Ławnicka, Tadeusz Robak","doi":"10.1080/14740338.2025.2471508","DOIUrl":"10.1080/14740338.2025.2471508","url":null,"abstract":"Introduction: In recent years, chronic lymphocytic leukemia (CLL) treatment has changed dramatically. Chemoimmunotherapy with fludarabine/cladribine, cyclophosphamide, and rituximab have been almost completely replaced by targeted therapies with small molecules, such as Bruton's tyrosine kinase inhibitors or B-cell lymphoma 2 (BCL-2) antagonists. However, few studies have assessed the impact of novel therapies on patient quality of life (QoL).Areas covered: This article reviews the safety profile of new therapeutic options and their impact on the QoL of CLL patients. The MEDLINE database was searched for English language publications from 2010 through June 2024, including the Proceedings of the American Society of Hematology from over the past 5 years.Expert opinion: CLL is a clinically heterogenous disease predominantly affecting elderly patients. The variable clinical course of disease requires personalization and individualized treatment to achieve the optimal survival outcome and acceptable safety profile, especially in the case of poor prognosis. Clinical trials performed in the past decade indicate that novel drugs, used as a single agent or as part of a conventional chemotherapy, offer promise in minimalizing relapse rates, and may allow more effective and safer treatment options by reducing the risk of adverse events, especially cytopenias and infections.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"643-655"},"PeriodicalIF":3.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143482572","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Association of ocular adverse events with varenicline solution use: a population-based study. 使用伐尼克兰溶液与眼部不良事件的关联：一项基于人群的研究。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-06-01 Epub Date: 2025-02-08 DOI: 10.1080/14740338.2025.2460454

Moiz Lakhani, Angela T H Kwan, Anne Xuan-Lan Nguyen, Marko M Popovic, Roger S McIntyre, Albert Y Wu

{"title":"Association of ocular adverse events with varenicline solution use: a population-based study.","authors":"Moiz Lakhani, Angela T H Kwan, Anne Xuan-Lan Nguyen, Marko M Popovic, Roger S McIntyre, Albert Y Wu","doi":"10.1080/14740338.2025.2460454","DOIUrl":"10.1080/14740338.2025.2460454","url":null,"abstract":"Background: Approved by the FDA in 2021, varenicline solution is the first nasal spray specifically designed to enhance basal tear film production for treating dry eye disease (DED). However, there is a lack of data comprehensively comparing its safety profile to conventional DED therapies. Herein, we assess whether ocular adverse events (AEs) are disproportionately reported with the real-world use of varenicline solution.Research design and methods: This observational, population-based pharmacovigilance study analyzed the Food and Drug Administration Adverse Event Reporting System (FAERS) data (inception-April 2024) using reporting odds ratio (ROR), with significance defined as a 95% CI lower bound > 1.0. Nasal saline and systane were the controls.Results: A total of 1,125 AE reports were associated with varenicline solution. No disproportionate reporting of specific ocular AEs was observed when comparing varenicline solution with nasal saline. However, when compared with systane, varenicline solution showed higher odds of lacrimation (ROR = 2.18, 95%CI = 1.46-3.26, p < 0.0001), visual impairment (ROR = 2.27, 95%CI = 1.24-4.16, p = 0.0085), and photophobia (ROR = 7.50, 95%CI = 3.68-15.27, p < 0.0001).Conclusions: Although a direct causal relationship for higher RORs cannot be established for varenicline solution compared to systane, our findings provide evidence for potential risk signals and highlight the crucial role of post-marketing pharmacovigilance in monitoring long-term safety.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"665-673"},"PeriodicalIF":3.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143374039","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 FDA adverse event reporting system events for atogepant. 美国食品药物管理局不良事件报告系统对阿托格潘事件的真实世界药物警戒研究。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-06-01 Epub Date: 2024-07-08 DOI: 10.1080/14740338.2024.2377347

Heli Wen, Yitian Ding, Feichi Chen

{"title":"A real-world pharmacovigilance study of FDA adverse event reporting system events for atogepant.","authors":"Heli Wen, Yitian Ding, Feichi Chen","doi":"10.1080/14740338.2024.2377347","DOIUrl":"10.1080/14740338.2024.2377347","url":null,"abstract":"Background: Atogepant, an orally administered, small-molecule, calcitonin gene-related peptide (CGRP) receptor antagonist, is being investigated for the treatment of migraine.Methods: We collected data from the US Food and Drug Administration Adverse Event Reporting System (FAERS) database. Four algorithms (ROR, PRR, BCPNN, and EBGM) were used as measures to detect signals of atogepant-associated adverse events (AEs) in real-world data.Result: Of the 3,552,072 reports, 2876 expressly stated the use of atogepant. Women accounted for the majority of adverse events (AEs), with a notable age concentration of 45-65 years. The percentage of reported adverse events was the highest in the United States. Significant system organ categories (SOC) included nervous system disorders, gastrointestinal disorders, nervous system disorders, surgical and medical procedures, ear and labyrinth disorders. Notably, preferred terms (PTs) related to atogepant include migraine, constipation, nausea, vertigo, somnolence, decreased appetite, dizziness and fatigue. Unexpected adverse events such as abnormal dreams, self-injurious ideation, brain fog, tension headache, nightmare, brain neoplasm, feeling abnormal, euphoric mood, hyperacusis and post concussion syndrome were also identified.Conclusions: The present investigation has detected new and unexpected signals of atogepant-related adverse drug reactions (ADRs). In order to confirm these solve safety issues that were previously overlooked, more research is necessary.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"745-752"},"PeriodicalIF":3.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141544673","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

Hypercalcemia in children induced by denosumab: a case report and an analysis of the FDA adverse event reporting system database. 地诺单抗诱发的儿童高钙血症：病例报告和美国食品药物管理局不良事件报告系统数据库分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-06-01 Epub Date: 2024-07-15 DOI: 10.1080/14740338.2024.2379446

Yiyu Chen, Chuxuan Fang, Zhiyong Yang, Guosheng Qiu, Shuangyi Tang

{"title":"Hypercalcemia in children induced by denosumab: a case report and an analysis of the FDA adverse event reporting system database.","authors":"Yiyu Chen, Chuxuan Fang, Zhiyong Yang, Guosheng Qiu, Shuangyi Tang","doi":"10.1080/14740338.2024.2379446","DOIUrl":"10.1080/14740338.2024.2379446","url":null,"abstract":"Background: The potential risks of denosumab on pediatric patients have raised concerns about its safety. This article aims to analyze the adverse effects of denosumab in minors, with a specific focus on hypercalcemia.Research design and methods: A case study involving a child was analyzed. The OpenVigil 2.1 was utilized to extract adverse event data from the FAERS database, focusing on denosumab as the primary suspect drug in pediatric patients. The study also reviewed published cases of children developing hypercalcemia after discontinuing denosumab.Results: The incidence of denosumab induced hypercalcemia in individuals under 18 years old is significantly higher than the overall incidence. The signal value for hypercalcemia was higher in the male group and was highest in the adolescent group. Hypercalcemia usually appeared approximately 4 months after denosumab discontinuation. Males had a higher peak blood calcium level. Patients aged 0-11 years had a higher average peak serum calcium compared to aged 12-17 years.Conclusions: This study highlights the risk of hypercalcemia after discontinuation of denosumab in minors, with young age and male gender identified as potential high-risk factors. These findings offer valuable safety warnings and preventative measures for the secure administration of this drug in pediatric populations.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"719-730"},"PeriodicalIF":3.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141616140","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

Recommendations for the selection of nucleoside analogues as antihuman herpesvirus drugs: a real-world analysis of reported cases from the FDA adverse event reporting system. 选择核苷类似物作为抗人类疱疹病毒药物的建议：对美国食品药物管理局不良事件报告系统所报告病例的实际分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-06-01 Epub Date: 2024-07-04 DOI: 10.1080/14740338.2024.2374919

Caixia Gao, Xiaomei Dong, Jun Zhang, Lejiao Mao, Changxin Guo, Xia Qin, Zhen Zou

{"title":"Recommendations for the selection of nucleoside analogues as antihuman herpesvirus drugs: a real-world analysis of reported cases from the FDA adverse event reporting system.","authors":"Caixia Gao, Xiaomei Dong, Jun Zhang, Lejiao Mao, Changxin Guo, Xia Qin, Zhen Zou","doi":"10.1080/14740338.2024.2374919","DOIUrl":"10.1080/14740338.2024.2374919","url":null,"abstract":"Objective: The aim of this study is to provide guidance for refining medication protocols, developing alternative strategies, and enhancing protection against herpesvirus infections in personalized clinical settings.Methods: Adverse drug events (ADEs) data for anti-herpesvirus from the first quarter of 2004 to the fourth quarter of 2022 were collected from the FDA Adverse Event Reporting System (FAERS). Disproportionality analysis was performed using Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), and Bayesian Confidence Propagation Neural Network (BCPNN) methods for data mining.Results: A total of 18,591, 24,206, 6,150, and 419 reports of ADEs associated with acyclovir (ACV), valacyclovir (VACV), ganciclovir (GCV), and famciclovir (FCV) were screened and extracted from the FAERS. In this study, the report summarized the high frequency and strong correlation of ADEs for the four drugs at the Preferred Term (PT) level. Additionally, the analysis also identified the relationship between ADEs and factors such as age, gender, and severity of outcome at the System Organ Class (SOC) level.Conclusion: The safety reports for the four-nucleoside analogue anti-herpesvirus drugs are diverse and interconnected. Dosing for patients with herpesvirus infections should be tailored to their specific conditions and the potential risk of disease.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"695-709"},"PeriodicalIF":3.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141467299","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 pharmacovigilance study on the safety of faricimab in real-world scenario using FDA adverse event reporting system database. 利用FDA不良事件报告系统数据库对法利昔单抗在现实情况下的安全性进行药物警戒研究。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-06-01 Epub Date: 2025-01-21 DOI: 10.1080/14740338.2025.2456173

Furong Han, Xiang Li, Tao Tao, Jiawei Wang

{"title":"A pharmacovigilance study on the safety of faricimab in real-world scenario using FDA adverse event reporting system database.","authors":"Furong Han, Xiang Li, Tao Tao, Jiawei Wang","doi":"10.1080/14740338.2025.2456173","DOIUrl":"10.1080/14740338.2025.2456173","url":null,"abstract":"Background: Faricimab is predominantly prescribed for conditions such as age-related macular degeneration (AMD), diabetic macular edema (DME), and macular edema related to retinal vein occlusion (RVO-ME). Currently, a notable absence of large-scale, real-world studies focusing on the adverse reactions of faricimab exists.Methods: This study assesses the side effects of faricimab by analyzing reports of adverse events (AEs) from the FDA's AE Reporting System (FAERS) database. Through disproportionality analysis, this study substantiates the drug's safety oversight.Results: Our study revealed 2,746 instances of adverse events linked to faricimab, spanning 21 system organ classes (SOCs). The study retained 121 significant disproportionality preferred terms (PTs) that met criteria across all four analytical methods. Faricimab-associated AEs not documented in the drug instructions included visual impairment, blindness, retinal hemorrhage, anterior chamber inflammation, keratic precipitates, dry eye, chorioretinitis, diabetic retinopathy, and others.Conclusion: The majority of our results align with earlier clinical studies and the details outlined in the product's manual. Additionally, we identified several unforeseen and potential AE signals related to faricimab use. These insights are instrumental for ongoing clinical surveillance and risk assessment associated with the drug.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"657-664"},"PeriodicalIF":3.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143002908","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