Expert Opinion on Drug Safety最新文献_第8页

Safety of Janus kinase inhibitors in patients with moderate-to-severe atopic dermatitis: a systematic review and meta-analysis of observational studies. janus激酶抑制剂治疗中重度特应性皮炎的安全性：观察性研究的系统回顾和荟萃分析

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-07-16 DOI: 10.1080/14740338.2026.2701664

Mei Li, Jianing Ni, Lian Zhang, Can Chen, Jingjing Ye, Ninggang Chen

{"title":"Safety of Janus kinase inhibitors in patients with moderate-to-severe atopic dermatitis: a systematic review and meta-analysis of observational studies.","authors":"Mei Li, Jianing Ni, Lian Zhang, Can Chen, Jingjing Ye, Ninggang Chen","doi":"10.1080/14740338.2026.2701664","DOIUrl":"10.1080/14740338.2026.2701664","url":null,"abstract":"Introduction: We conducted a systematic review and meta-analysis to evaluate real-world safety outcomes associated with Janus kinase (JAK) inhibitors in patients with moderate-to-severe atopic dermatitis (AD).Methods: PubMed, Embase, Cochrane Library, and CINAHL were searched through April 2025. Two independent reviewers screened studies and extracted data according to predefined criteria. Risk of bias was assessed using Agency for Healthcare Research and Quality tools.Results: The pooled incidence rates of adverse events (AEs) and serious adverse events (SAEs) with JAK inhibitors were 0.42 (95% CI: 0.35-0.50) and 0.03 (95% CI: 0.01-0.05), respectively. The most common AEs included acne (effect size [ES] = 0.14, 95% CI: 0.12-0.16), skin and subcutaneous tissue infections (ES = 0.17, 95% CI: 0.09-0.26), and herpes virus infections (ES = 0.07, 95% CI: 0.06-0.09). Compared with anti - interleukin-4/interleukin-13 inhibitors, JAK inhibitors were associated with higher risks of acne, anemia, and creatine kinase elevations.Conclusions: AEs were common but predominantly mild to moderate. Infections, particularly skin and subcutaneous tissue and herpes virus infections, were among the most frequently reported events. The pooled incidence of SAEs, including cardiovascular events, was low within reported follow-up periods. However, heterogeneity and relatively short follow-up limit conclusions regarding long-term risk.Protocol registration: CRD42025634423.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-16"},"PeriodicalIF":3.0,"publicationDate":"2026-07-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148445297","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 and efficacy of DOACs in clinically complex phenotypes of patients with atrial fibrillation: focus on frailty, multimorbidity and polypharmacy. 探讨DOACs在临床复杂表型房颤患者中的安全性和有效性：重点关注虚弱、多病和多药。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-07-14 DOI: 10.1080/14740338.2026.2701663

Panteleimon E Papakonstantinou, Gregory Y H Lip

{"title":"Safety and efficacy of DOACs in clinically complex phenotypes of patients with atrial fibrillation: focus on frailty, multimorbidity and polypharmacy.","authors":"Panteleimon E Papakonstantinou, Gregory Y H Lip","doi":"10.1080/14740338.2026.2701663","DOIUrl":"10.1080/14740338.2026.2701663","url":null,"abstract":"Introduction: Direct oral anticoagulants (DOACs) are widely used for stroke prevention in atrial fibrillation (AF); however, patients encountered in real-world practice frequently exhibit frailty, multimorbidity, and polypharmacy, phenotypes underrepresented in randomized clinical trials.Areas covered: This narrative review addresses the safety and efficacy of DOACs in clinically complex AF populations. Targeted searches of PubMed/MEDLINE, Embase, and major cardiology society documents (ESC/EHRA) were performed from inception to May 2025, prioritizing randomized trials and complemented by large observational studies and registries. Available evidence indicates that DOACs demonstrate similar or superior efficacy and safety compared with vitamin K antagonists in frail and multimorbid patients. Although polypharmacy increases the risk of drug-drug interactions, DOACs are associated with fewer interactions and simplified dosing strategies. Observational data support the real-world effectiveness of DOACs when treatment is individualized according to frailty status, comorbidity burden, renal function, and medication review.Expert opinion: DOACs can be used safely and effectively in complex AF patients when care is individualized. Integration of frailty screening, structured polypharmacy review, and holistic management approaches, such as the ABC pathway, may improve outcomes. Future research should focus on prospective studies and implementation strategies in underrepresented high-risk populations.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-13"},"PeriodicalIF":3.0,"publicationDate":"2026-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148419861","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

Trigger tool methodologies in hospital settings: reappraising their role in pharmacovigilance and digital safety surveillance. 医院环境中的触发工具方法：重新评估其在药物警戒和数字安全监测中的作用。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-07-10 DOI: 10.1080/14740338.2026.2701660

Marija Ilic, Dejana Krajacic, Marina Blagojevic, Milica Paut Kusturica, Jovanka Kolarovic, Djendji Siladji, Nebojsa Stilinovic, Aleksandar Raskovic

{"title":"Trigger tool methodologies in hospital settings: reappraising their role in pharmacovigilance and digital safety surveillance.","authors":"Marija Ilic, Dejana Krajacic, Marina Blagojevic, Milica Paut Kusturica, Jovanka Kolarovic, Djendji Siladji, Nebojsa Stilinovic, Aleksandar Raskovic","doi":"10.1080/14740338.2026.2701660","DOIUrl":"10.1080/14740338.2026.2701660","url":null,"abstract":"Introduction: Trigger tool methodologies have become important approaches for detecting adverse events in hospital care because they identify more harm than conventional incident reporting systems. Their role is particularly relevant for medication-related harm, which is often under-recognized or insufficiently documented in routine clinical practice.Areas covered: This structured narrative review examines the development, methodological foundations, performance, and clinical applications of trigger tools in hospital settings, with emphasis on their use in detecting adverse drug events. It also discusses population-specific adaptations, methodological variability, and recent advances in electronic health record-based, automated, and artificial intelligence-assisted trigger approaches. The literature search was conducted using PubMed and Google Scholar, with additional studies identified through manual screening of reference lists.Expert opinion: Trigger tools should be viewed not only as methods for retrospective harm detection, but also as potential links between hospital patient safety monitoring and pharmacovigilance. Their future value will likely depend on greater standardization and on the development of hybrid, clinically validated systems that combine relevant triggers, electronic health record data, and clinician review. Importantly, trigger tool findings should be incorporated into closed-loop workflows that support pharmacovigilance reporting, clinician feedback, quality improvement, and measurable reduction of preventable medication-related harm.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-15"},"PeriodicalIF":3.0,"publicationDate":"2026-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148404142","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

Incidence and risk of treatment-related fatal adverse events in cancer patients treated with antibody conjugated drugs: a systematic review and meta-analysis of randomized controlled trials. 在接受抗体偶联药物治疗的癌症患者中，与治疗相关的致命不良事件的发生率和风险：随机对照试验的系统回顾和荟萃分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-07-01 Epub Date: 2025-02-21 DOI: 10.1080/14740338.2025.2460452

Zhaohui Huang, Xinyu Li, Xin Zhou, Ziwen Yang, Xiaotong Huo, Jianhong Zhu, Sha Li, Jie Jiang

{"title":"Incidence and risk of treatment-related fatal adverse events in cancer patients treated with antibody conjugated drugs: a systematic review and meta-analysis of randomized controlled trials.","authors":"Zhaohui Huang, Xinyu Li, Xin Zhou, Ziwen Yang, Xiaotong Huo, Jianhong Zhu, Sha Li, Jie Jiang","doi":"10.1080/14740338.2025.2460452","DOIUrl":"10.1080/14740338.2025.2460452","url":null,"abstract":"Introduction: Antibody-drug conjugates (ADCs) have radically transformed the therapeutic landscape for cancer treatment, but little is known about the treatment-related fatal adverse events (FAEs). We aimed to comprehensively investigate the safety of ADCs regarding treatment-related FAEs.Methods: We conducted a systematic search of PubMed, Embase, and the Cochrane database for randomized controlled trials (RCTs) of ADCs. The meta-analysis assessed the incidence of treatment-related FAEs and the odds ratio (OR) in the ADCs group compared with the control group.Results: A total of 49 RCTs involving 13,052 patients treated with ADCs were included. The incidence of treatment-related FAEs in the ADCs group was 0.62% (95% CI = 0.36-1.08), while the control group was 0.52% (95% CI = 0.29-0.95), with an OR of 1.41 (95% CI = 1.12-1.79; p < 0.05). In the subgroup analysis by drug and cancer type, gemtuzumab ozogamicin, which for acute myeloid leukemia were associated with a higher risk of treatment-related FAEs compared to controls (OR = 1.63; 95% CI = 1.12-2.36; p < 0.05). There was no evidence of publication bias observed.Conclusions: The meta-analysis of RCTs found that ADCs were associated with an increased risk of treatment-related FAEs compared with the control group. Moreover, the occurrence of treatment-related FAEs was associated with specific types of ADCs.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1245-1251"},"PeriodicalIF":3.0,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143457364","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 does real-world data reveal about cangrelor's safety? An analysis of FDA adverse event reporting system (FAERS) database. 真实世界的数据揭示了canrelor的哪些安全性？FDA不良事件报告系统（FAERS）数据库分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-07-01 Epub Date: 2025-02-20 DOI: 10.1080/14740338.2025.2467812

Zhaojun Wang, Junhang Zhang, Donglei Shi, Li Wei

{"title":"What does real-world data reveal about cangrelor's safety? An analysis of FDA adverse event reporting system (FAERS) database.","authors":"Zhaojun Wang, Junhang Zhang, Donglei Shi, Li Wei","doi":"10.1080/14740338.2025.2467812","DOIUrl":"10.1080/14740338.2025.2467812","url":null,"abstract":"Background: Cangrelor is used to reduce thrombotic events in adults undergoing percutaneous coronary intervention, but real-world safety data is limited. This study analyzes adverse events (AEs) related to cangrelor using the FDA adverse event reporting system (FAERS) database.Methods: We employed statistical techniques such as the reporting odds ratio, proportional reporting ratio, bayesian confidence propagation neural network, and multi-item gamma poisson shrinker to analyze the data from the FAERS database.Results: Out of a total of 15,011,506 case reports, 209 events were related to cangrelor. Thirty-one preferred term (PT) describing AEs were identified, affecting eight organ systems. The most reported PT was off-label use (n = 163). Several unexpected AEs not listed in the drug labeling emerged, including cardiac arrest, and cardiac failure. Although percutaneous coronary intervention was the most common indication (35.4%), numerous events were associated with off-label use, particularly for conditions such as acute myocardial infarction, antiplatelet therapy, and anticoagulant therapy.Conclusion: Our research reveals both anticipated and unexpected AEs, providing important new information on the safety profile of cangrelor. Furthermore, we have discovered certain problems pertaining to product applications. It is recommended that manufacturers clearly highlight indications and usage instructions, and medical personnel closely follow drug administration protocols.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1271-1278"},"PeriodicalIF":3.0,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143457366","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

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-07-01 Epub Date: 2025-02-04 DOI: 10.1080/14740338.2025.2460449

Xiang Wang, Rujie Chen, Jialin Liu, E Wang, Hui Luo

{"title":"Liver injury related to vascular endothelial growth factor tyrosine kinase inhibitors: a pharmacovigilance analysis of the USA FDA adverse event reporting system (FAERS) database.","authors":"Xiang Wang, Rujie Chen, Jialin Liu, E Wang, Hui Luo","doi":"10.1080/14740338.2025.2460449","DOIUrl":"10.1080/14740338.2025.2460449","url":null,"abstract":"Background: While vascular endothelial growth factor tyrosine kinase inhibitors (VEGFR-TKIs) are known to cause adverse events like cardiotoxicity and haematotoxicity, their impact on liver injury remains understudied. This study evaluates the association between VEGFR-TKIs and liver injury using data from the FDA Adverse Event Reporting System (FAERS) database from 2006 to 2024.Research design and methods: Nine VEGFR-TKIs (Axitinib, Vandetanib, Cabozantinib, Lenvatinib, Pazopanib, Ponatinib, Regorafenib, Sunitinib, Sorafenib) were analyzed. Disproportionality and Bayesian analyses identified cases of VEGFR-TKI-induced liver injury, assessing onset time, mortality, and hospitalization rates.Results: 8,619 cases of liver injury were identified. Pazopanib had the highest association with liver injury (reporting odds ratio 3.9). The median onset of liver injury was 21 days. Mortality was 28.5%, with Sorafenib linked to the highest mortality (48.6%). Lenvatinib had the highest hospitalization rate (56%).Conclusion: VEGFR-TKIs are associated with liver injury. Close monitoring is required to mitigate the risks of hospitalization and early mortality during treatment.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1351-1359"},"PeriodicalIF":3.0,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143064452","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 esomeprazole: real-world adverse event signal mining and analysis based on FAERS database. 埃索美拉唑的安全性评估：基于 FAERS 数据库的真实世界不良事件信号挖掘与分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-07-01 Epub Date: 2025-03-08 DOI: 10.1080/14740338.2025.2473636

Bojing Wang, Shu Huang, Shiqi Li, Yaqi Deng, Ziyan Li, Yizhou Wang, Xiaomin Shi, Wei Zhang, Lei Shi, Xiaowei Tang

{"title":"Safety assessment of esomeprazole: real-world adverse event signal mining and analysis based on FAERS database.","authors":"Bojing Wang, Shu Huang, Shiqi Li, Yaqi Deng, Ziyan Li, Yizhou Wang, Xiaomin Shi, Wei Zhang, Lei Shi, Xiaowei Tang","doi":"10.1080/14740338.2025.2473636","DOIUrl":"10.1080/14740338.2025.2473636","url":null,"abstract":"Background: Esomeprazole holds a significant position in the treatment of acid-related diseases. However, as with all drugs, it may also carry some potential risk of adverse effects. This study aims to further evaluate the safety of esomeprazole for clinical use.Research design and methods: The data of esomeprazole-related adverse events was extracted from the FAERS database from the first quarter of 2004 to the first quarter of 2024 and used Reporting Odds Ratios (ROR), Proportional Reporting Ratios (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayes Geometric Mean(EBGM) for data mining.Results: A total of 67,712 esomeprazole-related adverse events were extracted from the FAERS database, involving 27 system organ class. The frequency of renal and urinary occurrence was the highest, and the signal was the strongest. Additionally, we detected 324 preferred terms: rebound acid hypersecretion, nephrogenic anemia, and hyperparathyroidism secondary showed significant high signal strength. In the elderly, adverse events were concentrated in the gastrointestinal disorders system, and the most common adverse events were dyspepsia and hyponatremia. Unexpected adverse events, such as vomiting, acute kidney injury, and anaphylactic reaction occurred in children.Conclusions: We discovered some new and special esomeprazole-related adverse events, raising awareness of the safety of esomeprazole and further helping to mitigate associated risks.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1341-1349"},"PeriodicalIF":3.0,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143522972","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

Adverse event profiles of CDK4/6 inhibitors: a disproportionality analysis of the FDA Adverse Event Reporting System (FAERS) database. CDK4/6抑制剂的不良事件概况：FDA不良事件报告系统（FAERS）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: 2025-02-21 DOI: 10.1080/14740338.2025.2465852

Xiaojiang Tian, Lin Chen, Yonghong Chen, Ni Zhang

{"title":"Adverse event profiles of CDK4/6 inhibitors: a disproportionality analysis of the FDA Adverse Event Reporting System (FAERS) database.","authors":"Xiaojiang Tian, Lin Chen, Yonghong Chen, Ni Zhang","doi":"10.1080/14740338.2025.2465852","DOIUrl":"10.1080/14740338.2025.2465852","url":null,"abstract":"Background: The safety profile of CDK4/6 inhibitors has not yet been systemically analysed in the real world. This study aimed to provide a comprehensive understanding of AEs associated with CDK4/6 inhibitors using the FAERS database.Methods: FAERS data (2014Q1 to 2022Q4) were searched for reports of all FDA-approved CDK4/6 inhibitors across all indications. We used the SMQ generalized search AEs on the PT level. Disproportionality analysis was used to detect safety signals by calculating RORs.Results: Within the standardized MedDRA queries, significant safety signals were found, including those for palbociclib [haematopoietic leukopenia, erythropenia], ribociclib [haematopoietic leukopenia , conduction defects], and abemaciclib [eosinophilic pneumonia, dehydration]. For AEs at the PT level, we found several significant blood and lymphatic system disorders for both palbociclib and ribociclib, such as abnormal full blood count and decreased white blood cell count for palbociclib and anisocytosis, neutropenia for ribociclib. Palbociclib also had high RORs for pseudocirrhosis, stomatitis, oral pain, and alopecia, while ribociclib had high RORs for electrocardiogram PR shortened, sinus arrhythmia, and blood bilirubin abnormal. However, the RORs were significant for abemaciclib in terms of diarrhoea, vena cava thrombosis, thrombophlebitis migrans and pneumonitis.Conclusion: CDK4/6 inhibitors differed in their safety profile reports.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1329-1339"},"PeriodicalIF":3.0,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143457361","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 of Adagrasib: a disproportionality analysis based on the FAERS database. Adagrasib上市后的安全性：基于FAERS数据库的比例失调分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-07-01 Epub Date: 2025-03-02 DOI: 10.1080/14740338.2025.2468866

Zheng Shi, Xiayao Yu, Yifan Zhao, Keda Shao, Chunwei Xu, Zhengbo Song

{"title":"Post-marketing safety of Adagrasib: a disproportionality analysis based on the FAERS database.","authors":"Zheng Shi, Xiayao Yu, Yifan Zhao, Keda Shao, Chunwei Xu, Zhengbo Song","doi":"10.1080/14740338.2025.2468866","DOIUrl":"10.1080/14740338.2025.2468866","url":null,"abstract":"Background: Adagrasib is a novel KRAS G12C inhibitor. While its clinical efficacy has been demonstrated, comprehensive post-marketing safety data remain limited. This study aimed to analyze adverse reactions involving Adagrasib from the FAERS database to identify potential safety signals.Research design and methods: A retrospective pharmacovigilance analysis was performed using FAERS data during Q4 2022 through Q2 2024. After deduplication. disproportionality analysis was performed using four algorithms: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayes Geometric Mean (EBGM).Results: A total of 598 cases involving Adagrasib were identified, encompassing 1717 adverse events (AEs). The most common AEs were diarrhea, nausea, vomiting, asthenia, and decreased appetite. New strong significant AE signals were detected, including dissociation, status epilepticus, cerebral disorder, and photosensitivity reaction. The median time to AE onset was 34 days, and most AEs happened within the initial month of treatment.Conclusions: Our study highlights some new AE signals associated with Adagrasib, emphasizing the importance of continued pharmacovigilance. While the findings contribute to understanding Adagrasib's safety profile, further validation through large-scale prospective studies is needed.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1291-1298"},"PeriodicalIF":3.0,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143514953","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 surveillance of Amivantamab: a real world study based on the FDA adverse event reporting system. Amivantamab上市后安全监测：基于FDA不良事件报告系统的真实世界研究。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-07-01 Epub Date: 2025-02-26 DOI: 10.1080/14740338.2025.2471512

Xiang Fu, Dongqiang Zeng, Min Li, Jianhua Wu, Yufan Yang, Qianqian Mao, Wenjun Qiu, Xiatong Huang, Yiran Fang, Luyang Jiang, Panwei Hu, Jiani Wu, Wangjun Liao

{"title":"Post-marketing safety surveillance of Amivantamab: a real world study based on the FDA adverse event reporting system.","authors":"Xiang Fu, Dongqiang Zeng, Min Li, Jianhua Wu, Yufan Yang, Qianqian Mao, Wenjun Qiu, Xiatong Huang, Yiran Fang, Luyang Jiang, Panwei Hu, Jiani Wu, Wangjun Liao","doi":"10.1080/14740338.2025.2471512","DOIUrl":"10.1080/14740338.2025.2471512","url":null,"abstract":"Background: Amivantamab stands as the pioneering bispecific antibody that targets both EGFR and MET, utilized in the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR ex20ins mutations. Nevertheless, a thorough assessment of its safety characteristics in the real-world remains unknown.Research design and methods: The adverse event (AE) reports were collected through a search of the FDA Adverse Event Reporting System (FAERS) database spanning from 2019 Q1 to 2024 Q1, and then disproportionality analysis was utilized.Results: Totally, 9,252,269 AE reports were obtained from the FAERS database, with 893 reports of amivantamab classified as primary suspect AEs. Amivantamab-related AEs were distributed in 23 organ systems, and 87 significant preferred terms (PTs) met the reporting odds ratio criteria. Novel significant AEs were detected, and the median time to onset of amivantamab-associated AEs was 43 days. In subgroup analysis, a higher proportion of patients who were male, over 65 years, and with pneumonitis or pneumonia were reported in the death cases. We also found that AEs may vary between intravenous and subcutaneous administration.Conclusions: This investigation offered novel prospects for monitoring and addressing undesirable medication effects associated with amivantamab, which might improve the clinical medication safety.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1309-1317"},"PeriodicalIF":3.0,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143500119","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