Expert Opinion on Drug Safety最新文献_第3页

Identification of drug combinations to reduce the risk of pioglitazone-related bladder cancer using the FDA adverse event reporting system database. 使用FDA不良事件报告系统数据库识别药物组合以降低吡格列酮相关膀胱癌的风险。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-05-06 DOI: 10.1080/14740338.2025.2492744

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

{"title":"Identification of drug combinations to reduce the risk of pioglitazone-related bladder cancer using the FDA adverse event reporting system database.","authors":"Jun-Jie Yang, Hui Zhao, Ming-Ming Yan, Xiang Zheng, Qian Zhang, Hai-Yan Chen, Xiao-Yan Qiu","doi":"10.1080/14740338.2025.2492744","DOIUrl":"https://doi.org/10.1080/14740338.2025.2492744","url":null,"abstract":"Background: Emerging studies have uncovered the innovative pharmacological characteristics of pioglitazone (PLZ). However, concerns regarding the potential link to an increased risk of bladder cancer (BC) had constrained its clinical application.Research design and methods: BC reports associated with PLZ and drug combinations containing PLZ from 1 January 2004 to 30 September 2024 were identified from the Food and Drug Administration Adverse Event Reporting System (FAERS) database. Reporting odds ratio (ROR) and Bayesian confidence propagation neural network (BCPNN) method was applied to mine adverse drug event signals.Results: Of 144 combinations, 15 showed an IC025 greater than 3, denoting a strong signal; 44 had an IC025 between 1.5 and 3, indicating moderate signal intensity; 36 had an IC025 between 0 and 1.5, pointing to a weak signal; and 49 had an IC025 less than 0, suggesting no apparent related signal. Importantly, the IC025 values for all drug combinations did not surpass the value observed when PLZ was used as monotherapy.Conclusions: Through comprehensive data mining, 14 PTs associated with BC were identified, indicating that specific medication combinations might mitigate the risk of PLZ-related BC. Our findings offer valuable insights for guiding decisions on PLZ combination therapies.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-10"},"PeriodicalIF":3.0,"publicationDate":"2025-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143964951","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 and pharmacological analysis of sulfasalazine based on the FDA adverse event reporting system (FAERS) database. 基于FDA不良事件报告系统（FAERS）数据库的磺胺氮嗪药物警戒研究和药理学分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-05-05 DOI: 10.1080/14740338.2025.2488241

Dandan Guo, Bufu Tang, Peng Luo, Jian Zhang, Lvdan Deng, Sentao Fu, Zhijun Shen, Qing Li, Zhao Xie, Na Hang, Hongjie Fan, Ling Wang

{"title":"A real-world pharmacovigilance study and pharmacological analysis of sulfasalazine based on the FDA adverse event reporting system (FAERS) database.","authors":"Dandan Guo, Bufu Tang, Peng Luo, Jian Zhang, Lvdan Deng, Sentao Fu, Zhijun Shen, Qing Li, Zhao Xie, Na Hang, Hongjie Fan, Ling Wang","doi":"10.1080/14740338.2025.2488241","DOIUrl":"https://doi.org/10.1080/14740338.2025.2488241","url":null,"abstract":"Objective: The purpose of this study was to use the FDA Adverse Event Reporting System (FAERS) to detect and identify adverse events (AEs) related to sulfasalazine to provide a reference for clinical use.Methods: Four algorithms (ROR, PRR, BCPNN and EBGM) were used to detect sulfasalazine-correlated AE signals in real data to calculate the signals associated with sulfasalazine-related AEs.Results: During the study period, FAERS was used to extract a total of 91,509 sulfasalazine-related (SASP-related) adverse event reports. In total, 6830 sulfasalazine adverse event signals were found, involving 23 organ systems. The analysis revealed several common adverse reactions; the most common were dizziness, malaise, asthenia, decreased appetite, rash, and anemia, and these adverse reactions are listed on the warning label for sulfasalazine. It is worth noting that in our study, in the preferred term (PT), we also found some reactions that were not mentioned on the warning label, such as blurred vision and cardiac failure.Conclusion: This study revealed potential new AEs resulting from sulfasalazine, and further studies are needed to confirm these new AEs.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-9"},"PeriodicalIF":3.0,"publicationDate":"2025-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144062437","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

Risk factors for drug-related non-infectious pneumonia: insights from the FDA adverse event reporting system (FAERS). 药物相关非感染性肺炎的危险因素：来自FDA不良事件报告系统（FAERS）的见解

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-05-05 DOI: 10.1080/14740338.2025.2500716

Peize Meng, Yi Zhang, Qingnan Zhao, Hang Zhang, Zheng Ruan

{"title":"Risk factors for drug-related non-infectious pneumonia: insights from the FDA adverse event reporting system (FAERS).","authors":"Peize Meng, Yi Zhang, Qingnan Zhao, Hang Zhang, Zheng Ruan","doi":"10.1080/14740338.2025.2500716","DOIUrl":"https://doi.org/10.1080/14740338.2025.2500716","url":null,"abstract":"Background: Non-infectious pneumonitis (NIP) is a severe adverse drug reaction. To better understand drug-induced NIP, improve patient safety, and inform clinical decision-making, this study aims to utilize the FDA Adverse Event Reporting System (FAERS) database to evaluate the association between medications and NIP, identify potential risk factors, and offer clinical alerts.Research design and methods: We reviewed the FAERS database from the 2004 through the second quarter of 2024. Using 'NIP' as the search term, we sorted, counted, and analyzed cases by generic drug name and trends of reports related to NIP submitted to FAERS database. We employed four statistical methods to identify drugs associated with the NIP.Results: From 21,433,114 reported drug adverse events (AEs), 9,224 cases were classified as NIP. Our analysis identified 20 drugs associated with NIP, with the main categories being antineoplastic agents, antibiotics and immunosuppressants. Daptomycin, methotrexate, and tacrolimus had the highest NIP-related deaths. Trends in AEs reporting indicate that the drugs showing the fastest increase in NIP reports are daptomycin, methotrexate, sertraline, and amiodarone.Conclusion: These findings could assist clinicians in the early identification of drug-related NIP and provide valuable insights for future research into the mechanisms underlying drug-related NIP.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-12"},"PeriodicalIF":3.0,"publicationDate":"2025-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143994604","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, clinical characteristics and related drugs analyzing of drug-induced movement disorders in 102914 inpatients: a retrospective real-world study. 102914例住院患者药物性运动障碍发生率、临床特点及相关药物分析

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-05-05 DOI: 10.1080/14740338.2025.2499673

Liqiang Cui, Daihong Guo, Man Zhu, Tianlin Wang, Ao Gao, Jing Xiao

{"title":"Incidence, clinical characteristics and related drugs analyzing of drug-induced movement disorders in 102914 inpatients: a retrospective real-world study.","authors":"Liqiang Cui, Daihong Guo, Man Zhu, Tianlin Wang, Ao Gao, Jing Xiao","doi":"10.1080/14740338.2025.2499673","DOIUrl":"https://doi.org/10.1080/14740338.2025.2499673","url":null,"abstract":"Background: To investigate the incidence and clinical characteristics of drug-induced movement disorders(DIMDs)in a large group of hospitalized patients.Research design and methods: A retrospective study was conducted among hospitalized patients in 2022, utilizing the Adverse Drug Event Active Surveillance and Assessment System-II (ADE-ASAS-II). After the operation and manual selection, DIMDs cases were identified for analysis of incidence, associated drugs, and clinical characteristics.Results: Among 102,914 hospitalized patients, 504 cases were identified as DIMDs, with an incidence of 0.49%. There were more males than females.Most patients were over 65 years old.A total of 158 associated drugs across 15 classes were identified, with the top three classes being antibiotics(12.10%), antiepileptics(8.13%), and calcium channel blockers (7.14%).The top three drugs were sodium valproate(1.67%),meropenem(0.58%)and pregabalin (0.55%).The clinical manifestations were primarily shakiness, tremor and tic. Different manifestations are difficult to distinguish.It's necessary to make a thorough record and consult specialists.Conclusion: For the first time, this study found that the incidence of DIMDs in hospitalized patients in general hospitals was 0.49%, occurs occasionally. Clinicians should pay close attention to the manifestations and identification of involuntary movements. Enhanced monitoring is recommended when using valproate, meropenem and pregabalin.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-9"},"PeriodicalIF":3.0,"publicationDate":"2025-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143984529","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

Analyzing the patterns of adverse drug reactions due to anti-infectives from large-scale nationwide database in Thailand. 泰国大型全国性数据库抗感染药物不良反应模式分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-05-02 DOI: 10.1080/14740338.2025.2500064

Sopit Sittiphan, Apiradee Lim, Nurin Dureh, Shahid Shah, Anan Tanchanarat, Haris Khurram

{"title":"Analyzing the patterns of adverse drug reactions due to anti-infectives from large-scale nationwide database in Thailand.","authors":"Sopit Sittiphan, Apiradee Lim, Nurin Dureh, Shahid Shah, Anan Tanchanarat, Haris Khurram","doi":"10.1080/14740338.2025.2500064","DOIUrl":"https://doi.org/10.1080/14740338.2025.2500064","url":null,"abstract":"Background: Adverse drug reactions (ADRs), which can occur in any drug class and are one of the leading causes of morbidity and hospitalization around the world, remain a public health concern. This study aimed to explore the distribution and patterns of anti-infective-induced ADRs in Thailand.Research design and methods: The national database of anti-infective-induced ADRs from January 2012 to December 2021 in the 77 provinces of Thailand. After the pre-processing, frequencies and percentages were used to examine the distribution of the ADRs. The chi-square test was used for measuring association for anti-infective-induced ADRs.Results: A total of 82,333 anti-infective-induced ADR reports were recorded from 2012-2021 in the 77 provinces of Thailand. The most commonly reported ADRs were in Central Thailand (29.0%), followed by the Northeast (25.9%). Most of the patients were females aged 20-39. Antibiotics categorized by chemical structure, cephalosporin (28.0%) and penicillin (23.4%), were the most common anti-infective drug-induced ADRs. Dose frequency and ADR onset were statistically associated with therapeutic drug class, anti-infective group, and disease (p-value < 0.05).Conclusions: The results of this study will enable healthcare professionals to prioritize groups and policymakers to make effective ADR prevention policies to reduce the risk and improve patient safety.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-12"},"PeriodicalIF":3.0,"publicationDate":"2025-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144001230","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

Pharmacovigilance insights into drug-induced cystitis: analysis of FDA data from 2004 to 2024. 药物警戒对药物性膀胱炎的启示：2004 年至 2024 年 FDA 数据分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-05-01 Epub Date: 2024-11-19 DOI: 10.1080/14740338.2024.2431587

Fuchun Zheng, Xin Yang, Sheng Li, Yuyang Yuan, Zhipeng Wang, Situ Xiong, Bin Fu, Wei Liu, Qi Lu

{"title":"Pharmacovigilance insights into drug-induced cystitis: analysis of FDA data from 2004 to 2024.","authors":"Fuchun Zheng, Xin Yang, Sheng Li, Yuyang Yuan, Zhipeng Wang, Situ Xiong, Bin Fu, Wei Liu, Qi Lu","doi":"10.1080/14740338.2024.2431587","DOIUrl":"10.1080/14740338.2024.2431587","url":null,"abstract":"Background: Drug-induced cystitis (DIC) significantly impacts patient quality of life and treatment outcomes. This study investigates the incidence and characteristics of DIC using data from the FDA Adverse Event Reporting System (FAERS).Methods: We reviewed FAERS reports related to cystitis from Q1 2004 to Q1 2024, compiling a list of potential causative drugs. The top 50 drugs with the highest number of cystitis reports were ranked. Statistical disproportionality analyses, including Proportional Reporting Ratio (PRR) and Reporting Odds Ratio (ROR), were used to detect unusually high reporting frequencies of cystitis associated with specific drugs.Results: From 17,703,515 FAERS reports spanning 2004-2024, 36399 involved cystitis. The majority of implicated drugs were antineoplastics. Busulfan, BCG, and mitomycin had the highest ROR and PRR values. Additionally, drugs such as defibrotide sodium, milrinone, and dyazide, which do not have cystitis listed on their labels, were identified, highlighting the need for increased clinical vigilance and awareness.Conclusion: The findings underscore the importance of ongoing pharmacovigilance in identifying and characterizing DIC. Further clinical studies are warranted to validate these associations and to develop strategies for mitigating the risk of DIC, thereby improving patient safety and treatment outcomes.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"557-564"},"PeriodicalIF":3.0,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142643403","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

Pharmacologic features, clinical applications, and drug safety evaluation of futibatinib in the treatment of biliary tract cancer (BTC). 福替替尼治疗胆道癌的药理特点、临床应用及药物安全性评价

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-05-01 DOI: 10.1080/14740338.2025.2495178

Angelo Pirozzi, Celine Hoyek, Naohiro Okano, Oluseyi Abidoye, Lorenza Rimassa, Mohamad Bassam Sonbol, Pedro Luiz Serrano Uson Junior, Tanios Bekaii-Saab, Mitesh J Borad

{"title":"Pharmacologic features, clinical applications, and drug safety evaluation of futibatinib in the treatment of biliary tract cancer (BTC).","authors":"Angelo Pirozzi, Celine Hoyek, Naohiro Okano, Oluseyi Abidoye, Lorenza Rimassa, Mohamad Bassam Sonbol, Pedro Luiz Serrano Uson Junior, Tanios Bekaii-Saab, Mitesh J Borad","doi":"10.1080/14740338.2025.2495178","DOIUrl":"https://doi.org/10.1080/14740338.2025.2495178","url":null,"abstract":"Introduction: Futibatinib is a small, potent, covalent, irreversible fibroblast growth factor receptor (FGFR) 1-4 inhibitor that has been added as a new standard of care for previously treated unresectable and/or advanced FGFR2 fusion/rearrangement-positive BTC. FGFR2 fusions/rearrangements play a key role in BTC survival, proliferation, invasion, and development of distant metastasis. The inhibition of this pathway is an important target in the treatment of BTC.Areas covered: The article covers the development of futibatinib for the treatment of refractory unresectable/advanced BTC, its mechanism of action, and key pharmacodynamic/pharmacokinetic data with a focus on the safety profile. Data are based on published clinical trials, pooled analysis, and retrospective studies indexed in PubMed (2010-2024).Expert opinion: Futibatinib is an FDA and EMA approved FGFR2 inhibitor for the treatment of patients with refractory BTC with FGFR2 fusions/rearrangements. Ongoing drug development strategies are centered on designing new FGFR2 fusion inhibitors able to overcome on-target and off-target resistances coupled with a high target selectivity to spare the most common treatment-related adverse events (hyperphosphatemia, stomatitis, alopecia, nail toxicity, skin reactions, eye toxicity).","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-8"},"PeriodicalIF":3.0,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143986479","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 the risk of acute kidney injury associated with a four-drug regimen for heart failure: a ten-year real-world pharmacovigilance analysis based on FAERS events. 评估与四种药物治疗心衰相关的急性肾损伤风险：基于FAERS事件的十年现实世界药物警戒分析

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-05-01 Epub Date: 2025-02-17 DOI: 10.1080/14740338.2025.2467822

Sen Lin, Ruiqi Zhao, Huimin Zhang, Yanwen Liang, Jiansuo Lin, Mengjiao Yu, Danfei Li, Bei Zhang, Lanyue Ma, Lisheng Peng

{"title":"Assessing the risk of acute kidney injury associated with a four-drug regimen for heart failure: a ten-year real-world pharmacovigilance analysis based on FAERS events.","authors":"Sen Lin, Ruiqi Zhao, Huimin Zhang, Yanwen Liang, Jiansuo Lin, Mengjiao Yu, Danfei Li, Bei Zhang, Lanyue Ma, Lisheng Peng","doi":"10.1080/14740338.2025.2467822","DOIUrl":"10.1080/14740338.2025.2467822","url":null,"abstract":"Background: The four-drug regimen for heart failure with reduced ejection fraction (HFrEF) significantly reduces the risks of hospitalization and mortality. To identify key adverse drug events (ADEs) warranting attention with this regimen, we conducted a real-world pharmacovigilance analysis based on the FDA Adverse Event Reporting System (FAERS) events.Research design and methods: We collected ADE reports of the four-drug regimen from FAERS that matched this regimen over a 10-year period. Disproportionality analysis and subgroup analysis were performed using four algorithms. Time-to-onset (TTO) analysis was used to assess the temporal risk patterns of ADE occurrence. Lastly, logistic regression was applied to investigate the relationship-value between patient characteristics and ADEs.Results: A total of 1,237 cases with 6,580 ADE reports were collected. Disproportionality analysis identified the most frequent ADEs as hypotension, acute kidney injury (AKI), and hyperkalemia. TTO analysis revealed a median TTO of 39 days for all important medical events, and the median TTO for AKI was 28 days, both fitting an early failure curve.Conclusion: In the comprehensive management of HFrEF with the four-drug regimen, in addition to routine monitoring of ADEs such as hypotension and hyperalemia, early-onset AKI should be a particular focus.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"547-556"},"PeriodicalIF":3.0,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143413746","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

Biosimilars and immunogenicity: a matter of concern? 生物仿制药和免疫原性：值得关注的问题？

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-05-01 Epub Date: 2025-02-16 DOI: 10.1080/14740338.2025.2467817

Anan S Jarab, Shrouq R Abu Heshmeh, Ahmad Z Al Meslamani

{"title":"Biosimilars and immunogenicity: a matter of concern?","authors":"Anan S Jarab, Shrouq R Abu Heshmeh, Ahmad Z Al Meslamani","doi":"10.1080/14740338.2025.2467817","DOIUrl":"10.1080/14740338.2025.2467817","url":null,"abstract":"Introduction: Biosimilars have transformed treatment modalities across various medical fields such as oncology, rheumatology, and immunology. Despite their potential for reducing healthcare costs, concerns persist regarding their ability to induce an immune response, which could affect efficacy and safety. This review critically evaluates the current evidence on the immunogenicity of biosimilars and discusses the regulatory frameworks guiding their approval and monitoring.Areas covered: This review includes studies from databases like Scopus, PubMed, Web of Science, and ScienceDirect, published up to April 2024. It explores the 'totality of the evidence' approach used by regulatory bodies like the FDA and EMA, detailing analytical, preclinical, and clinical assessments that ensure biosimilars' similarity to their reference products in terms of structure, function, and clinical outcomes. The review also addresses the challenges and limitations in current research methodologies and the implications of immunogenicity on therapeutic efficacy and patient safety.Expert opinion: While substantial evidence confirms the safety and efficacy of biosimilars, the review emphasizes the need for continuous regulatory vigilance and advanced methodologies in post-marketing surveillance to capture long-term immunogenicity data effectively. It advocates for integrating cutting-edge analytical techniques and personalized medicine to better manage immunogenic risks associated with biological therapies.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"519-527"},"PeriodicalIF":3.0,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143425409","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 concerns with abrocitinib: a real-world pharmacovigilance analysis of the FDA adverse event reporting system. 阿罗西替尼上市后的安全性问题：美国食品药品管理局不良事件报告系统的真实世界药物警戒分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-05-01 Epub Date: 2024-05-17 DOI: 10.1080/14740338.2024.2356020

Zhou Zhu, Mingjuan Liu, Hanlin Zhang, Heyi Zheng, Jun Li

{"title":"Post-marketing safety concerns with abrocitinib: a real-world pharmacovigilance analysis of the FDA adverse event reporting system.","authors":"Zhou Zhu, Mingjuan Liu, Hanlin Zhang, Heyi Zheng, Jun Li","doi":"10.1080/14740338.2024.2356020","DOIUrl":"10.1080/14740338.2024.2356020","url":null,"abstract":"Background: Abrocitinib was newly approved for treatment of moderate-to-severe atopic dermatitis. The present study was to assess abrocitinib-related adverse events (AEs) using the Food and Drug Administration Adverse Event Reporting System (FAERS).Methods: Disproportionality analyses, including the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN), and the multi-item gamma Poisson shrinker (MGPS) algorithms, were employed to quantify the signals of abrocitinib-related AEs.Results: A total of 3,177,744 reports of AEs were collected from the FAERS database, of which 1370 reports were identified with abrocitinib as the primary suspect drug. Abrocitinib-induced adverse events (AEs) occurred across 27 system organ classes (SOCs). A total of 68 preferred terms (PTs) with significant disproportionality, meeting the criteria of all four algorithms simultaneously, were identified. Unexpected significant AEs, such as increased blood cholesterol, venous embolism, hypoacusis, cellulitis, and tuberculosis, might also occur. The median onset time for abrocitinib-associated AEs was 182 days (interquartile range [IQR] 47-527 days).Conclusions: The results of this study were consistent with clinical observations. Additionally, unexpected safety signals for abrocitinib were identified, which provided supportive information for the safety profile of abrocitinib. Prospective clinical studies are warranted to validate these findings.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"599-606"},"PeriodicalIF":3.0,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140921819","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