Expert Opinion on Drug Safety最新文献

IF 3.1 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-10-01 Epub Date: 2024-08-19 DOI: 10.1080/14740338.2024.2393278

Xin Wang, Hui Yang, Zhuoling An

{"title":"Tacrolimus related diabetic ketoacidosis and hyperglycaemic hyperosmolar nonketotic syndrome: an observational, retrospective, pharmacovigilance study.","authors":"Xin Wang, Hui Yang, Zhuoling An","doi":"10.1080/14740338.2024.2393278","DOIUrl":"10.1080/14740338.2024.2393278","url":null,"abstract":"Background: Information on the incidence and risk factors for diabetic ketoacidosis (DKA) and hyperglycemic hyperosmolar nonketotic syndrome (HHNS) caused by tacrolimus has rarely been reported. This study aims to assess the spectrum of DKA/HHNS associated with tacrolimus.Methods: We conducted an observational, retrospective pharmacovigilance study using the Food and Drug Administration adverse event reporting system (FAERS) database. We employed the information component (IC) and reporting odds ratio (ROR) to evaluate the association between tacrolimus and DKA/HHNS.Results: A total of 232 events were identified as tacrolimus-related DKA/HHNS, 186 cases from DKA and 54 cases from HHNS. The frequency of tacrolimus-associated DKA and HHNS was found to be significantly higher compared to all other drugs. Specifically, HHNS was significantly associated with tacrolimus based on its ROR and IC. There were no significant differences in death and non-death cases in gender, age group, year of reporting and region of reporting.Conclusion: Our study showed that DKA and HHNS were associated with tacrolimus use. Healthcare professionals should be aware of the possibility of DKA/HHNS following tacrolimus administration, as they were associated with an increased risk of mortality in transplant recipients.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1179-1184"},"PeriodicalIF":3.1,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141987751","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

An updated safety review of Hidradenitis Suppurativa treatment options. 化脓性汗腺炎治疗方案的最新安全性综述。

IF 3.1 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-10-01 Epub Date: 2025-04-17 DOI: 10.1080/14740338.2025.2484022

Ruggero Cascio Ingurgio, Luciano Ibba, Angela Alfano, Alessandra Narcisi, Antonio Costanzo, Mario Valenti

{"title":"An updated safety review of Hidradenitis Suppurativa treatment options.","authors":"Ruggero Cascio Ingurgio, Luciano Ibba, Angela Alfano, Alessandra Narcisi, Antonio Costanzo, Mario Valenti","doi":"10.1080/14740338.2025.2484022","DOIUrl":"10.1080/14740338.2025.2484022","url":null,"abstract":"Introduction: Moderate-to-severe hidradenitis suppurativa (HS) is a chronic inflammatory condition with a significant impact on patients' quality of life. Recent advancements in biologics and small-molecule therapies offer new treatment options by targeting diverse inflammatory pathways.Areas covered: This review evaluates the safety profiles of key biologics and small molecules based on Phase 2 and 3 clinical trials. Infection-related adverse events (AEs) were the most common, particularly with IL-17 inhibitors. Mild gastrointestinal and neurological AEs occurred frequently, while serious AEs were rare, indicating an overall acceptable safety profile.Expert opinion: Emerging therapies such as IL-17 inhibitors (bimekizumab), IL-36 inhibitors (spesolimab), and small molecules like the JAK inhibitor povorcitinib provide promising alternatives for patients unresponsive to conventional treatments. Personalized treatment plans integrating biologics, small molecules, and adjunctive therapies are crucial for optimal outcomes. Challenges remain, including diagnostic delays, economic barriers, and the need for real-world evidence to validate long-term safety and efficacy. Advancing precision medicine, improving early diagnosis, and adopting comprehensive care models will enhance HS management and patients' quality of life.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1121-1129"},"PeriodicalIF":3.1,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143691520","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

Signal mining and gender differences analysis of adverse events in NMIBC treatment with gemcitabine and BCG bladder instillation based on the FAERS database. 基于 FAERS 数据库的吉西他滨和卡介苗膀胱灌注治疗 NMIBC 不良事件的信号挖掘和性别差异分析。

IF 3.1 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-10-01 Epub Date: 2024-08-08 DOI: 10.1080/14740338.2024.2388212

Ben Wang, Er-Hao Bao, Bing-Lei Jiang, Lin Yang, Ying Liu, Long Xia, Jia-Hao Wang, Li Wang, Ping-Yu Zhu

{"title":"Signal mining and gender differences analysis of adverse events in NMIBC treatment with gemcitabine and BCG bladder instillation based on the FAERS database.","authors":"Ben Wang, Er-Hao Bao, Bing-Lei Jiang, Lin Yang, Ying Liu, Long Xia, Jia-Hao Wang, Li Wang, Ping-Yu Zhu","doi":"10.1080/14740338.2024.2388212","DOIUrl":"10.1080/14740338.2024.2388212","url":null,"abstract":"Objective: To explore safety differences and perform a gender-based analysis of adverse events related to gemcitabine and Bacillus Calmette-Guérin (BCG) vaccine using the U.S. FDA Adverse Event Reporting System (FAERS) database.Methods: Using the Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR) methods, adverse events associated with gemcitabine and BCG were mined from FAERS database reports spanning from Q1 2004 to Q3 2023.Results: The study extracted 37,855 reports with gemcitabine and 5,455 reports with BCG as the primary suspected drugs. Adverse events were more prevalent in males (male-to-female ratio: gemcitabine 1.10, BCG 4.25). Differences in high-frequency adverse events among the top 20 signals were detected for both drugs. Both drugs affected similar organ systems, including potential pulmonary, ocular, and renal toxicity, with gemcitabine showing a broader range of adverse events. Gender analysis revealed fewer adverse reactions to gemcitabine in females, while males had fewer adverse reactions to BCG.Conclusion: Differences in high-frequency adverse events between gemcitabine and BCG, including some not listed on drug labels, were observed. Both drugs affect similar organ systems, with gemcitabine showing a broader range of adverse events. Gender differences in adverse events were notable.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1241-1248"},"PeriodicalIF":3.1,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141878553","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 disproportionality analysis of baloxavir marboxil: post-marketing pharmacovigilance data. 巴洛沙韦 Marboxil 真实世界比例失调分析：上市后药物警戒数据。

IF 3.1 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-10-01 Epub Date: 2024-09-16 DOI: 10.1080/14740338.2024.2393269

Jie Zhou, Junchang Ye, Maohua Chen, Xinlei Zheng

{"title":"A real-world disproportionality analysis of baloxavir marboxil: post-marketing pharmacovigilance data.","authors":"Jie Zhou, Junchang Ye, Maohua Chen, Xinlei Zheng","doi":"10.1080/14740338.2024.2393269","DOIUrl":"10.1080/14740338.2024.2393269","url":null,"abstract":"Objective: Baloxavir marboxil (hereafter referred to as baloxavir) is the only cap-dependent endonuclease inhiabitor approved for the treatment and prevention of influenza. However, as a new drug marketed in 2018, the long-term safety of baloxavir in large sample population was unclear. This study aims to evaluate baloxavir-associated adverse events (AEs) through data mining of the international pharmacovigilance database of US FDA Adverse Event Reporting System (FAERS).Methods: Disproportionality analysis was conducted to assess the association between baloxavir and its AEs. Data were collected from FAERS from March 2018 to June 2023. After standardizing the data, signal quantification techniques including ROR, PRR, BCPNN and MGPS were used for analysis.Results: A total of 49 significant baloxavir-related preferred terms (PTs) in 20 system organ classes (SOCs) were identified in our data analysis. Compared to baloxavir's FDA label, some new PTs emerged, with the top 10 being pneumonia, loss of consciousness, rhabdomyolysis, seizure, altered state of consciousness, hepatic function abnormal, delirium, depressed level of consciousness, encephalopathy and cardio-respiratory arrest.Conclusion: In clinical application of baloxavir, attention should be paid to the new AE signals in addition to the those recorded in the labels, so as to ensure the safety of the patients.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1231-1239"},"PeriodicalIF":3.1,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142132264","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 events associated with Atogepant: a FAERS-based pharmacovigilance analysis. 与阿托格潘相关的不良事件：基于法尔斯的药物警戒分析。

IF 3.1 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-10-01 Epub Date: 2024-09-12 DOI: 10.1080/14740338.2024.2393268

Ying Zhang, Shengzhu Sun, Yuming Wang

{"title":"Adverse events associated with Atogepant: a FAERS-based pharmacovigilance analysis.","authors":"Ying Zhang, Shengzhu Sun, Yuming Wang","doi":"10.1080/14740338.2024.2393268","DOIUrl":"10.1080/14740338.2024.2393268","url":null,"abstract":"Background: Migraine, a prevalent neurovascular disorder, can significantly disrupt an individual's daily life. Atogepant (AGN-241689), an orally administered small-molecule drug classified as a calcitonin gene-related peptide receptor antagonist, is utilized for prophylactic migraine treatment. The objective of this study was to investigate adverse events (AEs) associated with atogepant through data mining in the FDA Adverse Event Reporting System (FAERS) to enhance clinical safety.Methods: Data for atogepant were obtained from the FAERS database covering Q3 2021 through Q4 2023. Disproportionality analysis was employed to quantify relevant AEs associated with atogepant. Reported Ratio of Ratios (ROR) was utilized for identifying risk signals within the FAERS data. This methodology relies on the System Organ Class (SOC) and Preferred Terminology (PT) of the Medical Dictionary for Regulatory Activities (MedDRA).Results: From the FAERS database, a collection of 7,991,243 reports was obtained. Among these reports, a subset of 3015 was identified as 'primary suspected (PS)' AEs specifically related to atogepant. AEs induced by atogepant were observed across 27 organ systems. A total of 48 significantly disproportionate Preferred Terminologies (PTs) meeting all four algorithms were identified.Conclusion: Our study has identified adverse events (AEs) associated with atogepant, potentially providing crucial support for the clinical monitoring and risk identification of atogepant.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1185-1191"},"PeriodicalIF":3.1,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142145489","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 profile of eculizumab: an analysis of FDA adverse event reporting system and systematic review of case reports. 依库珠单抗的实际安全性概况：美国食品药品管理局不良事件报告系统分析和病例报告系统回顾。

IF 3.1 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-10-01 Epub Date: 2024-08-26 DOI: 10.1080/14740338.2024.2392885

Zhihui Zhang, Xin Liu, Jinlan Zhang, Bo Zhang

{"title":"Real-world safety profile of eculizumab: an analysis of FDA adverse event reporting system and systematic review of case reports.","authors":"Zhihui Zhang, Xin Liu, Jinlan Zhang, Bo Zhang","doi":"10.1080/14740338.2024.2392885","DOIUrl":"10.1080/14740338.2024.2392885","url":null,"abstract":"Background: Most of the safety data regarding eculizumab came from clinical trials, while its safety information in the real world is still limited.Research design and methods: The data of eculizumab in the FDA Adverse Event Reporting System (FAERS) database (from the first quarter of 2007 to the first quarter of 2023) was collected and analyzed. The case reports of adverse drug reactions (ADRs) related to eculizumab in PubMed, Embase and Web of Science before May 2023 were systematically reviewed.Results: A total of 464 ADRs of eculizumab were identified in the FAERS database. The top five ADRs with the highest proportional reporting ratio (PRR) are total complement activity decreased, extravascular hemolysis, hemoglobinuria, total complement activity increased and breakthrough hemolysis. Fifty-one cases of ADR related to eculizumab were identified from 44 publications. The number of reported cases of eculizumab associated Neisseria gonorrhoeae infection in case reports was observed to be comparable to the number of cases of Neisseria meningitidis infection.Conclusions: Clinicians must pay close attention to the risk of infections in patients receiving eculizumab, including severe N. meningitidis infection and other potentially fatal infections such as N. gonorrhoeae infection. In addition, The possible emergence of new ADRs should be vigilant during clinical medication.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1157-1163"},"PeriodicalIF":3.1,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141975482","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

Ocular adverse events associated with platins: a disproportionality analysis of pharmacovigilance data and extensive systematic review of case reports. 与普拉廷斯相关的眼部不良事件：药物警戒数据的比例失调分析和病例报告的广泛系统回顾。

IF 3.1 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-10-01 Epub Date: 2024-08-19 DOI: 10.1080/14740338.2024.2392860

P N Hasik, Christy Thomas, Munlima Hazarika, Krishna Undela

{"title":"Ocular adverse events associated with platins: a disproportionality analysis of pharmacovigilance data and extensive systematic review of case reports.","authors":"P N Hasik, Christy Thomas, Munlima Hazarika, Krishna Undela","doi":"10.1080/14740338.2024.2392860","DOIUrl":"10.1080/14740338.2024.2392860","url":null,"abstract":"Background: Anti-cancer drugs, particularly platinum-based chemotherapy drugs, have been showing ocular adverse events (OAEs) in patients undergoing chemotherapy, which is concerning due to the potential impact on patient's quality of life and the ability to continue effective cancer treatment.Research design and methods: A retrospective case/non-case study was conducted using spontaneous reports on OAEs by platins from the FDA Adverse Event Reporting System (FAERS) database. A disproportionality analysis was performed by calculating the Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), and the Information Component (IC) to identify OAE signals for platinum-based chemotherapy drugs. In parallel, a review of case reports for OAEs from platins was conducted by a systematic literature search in PubMed and Google Scholar.Results: Using disproportionality analysis, 69 signals were identified for platinum-based chemotherapy drugs and OAEs (carboplatin: 42, oxaliplatin: 16, cisplatin: 11). Choroidal infarction [PRR = 215.1; χ2 = 4527.1; lower bound (LB) ROR = 140.7; IC025 = 5.1] and orbital hemorrhage [PRR = 120.0; χ2 = 300.5; LB ROR = 35.1; IC025 = 1.3] were the strong signals identified for carboplatin. Optic disc hyperemia [PRR = 208.2; χ2 = 742.5; LB ROR = 74.1; IC025 = 2.2] and blindness cortical [PRR = 23.7; χ2 = 382.5; LB ROR = 14.8; IC025 = 3.1] were the signals identified for oxaliplatin and cisplatin, respectively. A total of 32 case reports of OAEs from platinum-based chemotherapy drugs were identified through a systematic search in PubMed and Google Scholar, strengthening the association.Conclusion: The study revealed a potential risk of OAEs when using platinum-based chemotherapy drugs as an anticancer medication.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1143-1156"},"PeriodicalIF":3.1,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141975481","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 drug safety surveillance study of lenvatinib from the FAERS database. 来自FAERS数据库的一项关于来伐替尼的真实世界药物安全性监测研究。

IF 3.1 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-10-01 Epub Date: 2024-08-21 DOI: 10.1080/14740338.2024.2393284

Yipin Yang, Yafen Wang, Bangjie Chen, Yuchen Liu, Kangsheng Gu

{"title":"A real-world drug safety surveillance study of lenvatinib from the FAERS database.","authors":"Yipin Yang, Yafen Wang, Bangjie Chen, Yuchen Liu, Kangsheng Gu","doi":"10.1080/14740338.2024.2393284","DOIUrl":"10.1080/14740338.2024.2393284","url":null,"abstract":"Background: There is a need to determine lenvatinib-associated real-world adverse events (AEs) as its adverse effects may result in its discontinuation.Research design and methods: Lenvatinib-associated AEs were analyzed and quantified and risk signals from the first quarter of 2015 to the fourth quarter of 2023 were detected through data mining. Potential targets for lenvatinib-associated cholecystitis, cholangitis, and hepatic encephalopathy were identified by data mining.Result: 68 Preferred Terms (PTs) with an important imbalance were kept. Unexpected AEs, such as immune-mediated hepatitis, portal vein thrombosis and adrenal insufficiency were associated with the use of lenvatinib use. Lenvatinib alone was more strongly associated with adrenal insufficiency than lenvatinib and pembrolizumab combination. Hepatic encephalopathy was more strongly correlated with drug use when Lenvatinib was administered to male patients with hepatocellular carcinoma. Most AEs occurred during the first month after treatment, with a median onset time of 41 days. FGFR4, PDGFRA, and KIT (Lenvatinib targets) are potentially linked to cholecystitis, cholangitis, and hepatic encephalopathy.Conclusions: We identified Lenvatinib-associated AEs and discovered new AEs that will be useful for clinical monitoring and risk assessment.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1207-1219"},"PeriodicalIF":3.1,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141982012","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

Considerations for practical use of tree-based scan statistics for signal detection using electronic healthcare data: a case study with insulin glargine. 使用电子医疗数据进行信号检测时基于树状扫描统计的实际应用考虑因素：胰岛素格列卫案例研究。

IF 3.1 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-10-01 Epub Date: 2024-08-23 DOI: 10.1080/14740338.2024.2393274

Lockwood G Taylor, Marie-Laure Kürzinger, Ruben Hermans, Shirin Enshaeifar, Bernadette Dwan, Priyanka Chhikara, Xinyu Li, Sreenivas Thummisetti, Sandrine Colas, Marielle Duverne, Juhaeri Juhaeri

{"title":"Considerations for practical use of tree-based scan statistics for signal detection using electronic healthcare data: a case study with insulin glargine.","authors":"Lockwood G Taylor, Marie-Laure Kürzinger, Ruben Hermans, Shirin Enshaeifar, Bernadette Dwan, Priyanka Chhikara, Xinyu Li, Sreenivas Thummisetti, Sandrine Colas, Marielle Duverne, Juhaeri Juhaeri","doi":"10.1080/14740338.2024.2393274","DOIUrl":"10.1080/14740338.2024.2393274","url":null,"abstract":"Background: Hypothesis-free signal detection (HFSD) methods such as tree-based scan statistics (TBSS) applied to longitudinal electronic healthcare data (EHD) are increasingly used in safety monitoring. However, challenges may arise in interpreting HFSD results alongside results from disproportionality analysis of spontaneous reporting.Research design and methods: Using the anti-diabetes drug insulin glargine (Lantus®) we apply two different tree-based scan designs using TreeScan™ software on retrospective EHD and compare the results to one another as well as to results from a disproportionality analysis using SRD.Results: The self-controlled tree temporal scan method produced the larger number of alerts relative to propensity-score matched approach; however, far fewer alerts were observed when analyses were limited to EHD in inpatient/emergency room settings only. Very few reference adverse events were observed using TBSS methods on EHD relative to disproportionality methods in SRD.Conclusion: Differences in detected alerts between TBSS methods and between TBSS and disproportionality analysis of SRD are likely attributable to differences in data, comparator, and study design. Our results suggest that HFDS methods like TBSS applied to EHD may complement more traditional approaches such as disproportionality analysis of SRD to provide a more complete picture of product safety in the post-approval setting.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1131-1141"},"PeriodicalIF":3.1,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142003996","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

Auditory system adverse events with sacubitril/valsartan: an active-comparator restricted disproportionality analysis using the FDA adverse event reporting system database. sacubitril/缬沙坦的听觉系统不良事件：使用FDA不良事件报告系统数据库的活性比较器限制歧化分析。

IF 3.1 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-09-30 DOI: 10.1080/14740338.2025.2568242

Atefeh Jafari, Niaz Chalabianloo, Flory T Muanda

{"title":"Auditory system adverse events with sacubitril/valsartan: an active-comparator restricted disproportionality analysis using the FDA adverse event reporting system database.","authors":"Atefeh Jafari, Niaz Chalabianloo, Flory T Muanda","doi":"10.1080/14740338.2025.2568242","DOIUrl":"10.1080/14740338.2025.2568242","url":null,"abstract":"Background: Sacubitril/valsartan, an angiotensin receptor-neprilysin inhibitor, is used for heart failure with reduced ejection fraction. Emerging evidence suggests potential ototoxicity, including hearing loss and vestibular disorders, which remain underreported and poorly characterized.Research design and methods: Our objective was to compare auditory adverse event (AE) reports associated with sacubitril/valsartan versus those associated with lisinopril and losartan. A retrospective active-comparator disproportionality analysis was conducted using individual case safety reports (ICSRs) from the U.S. FDA Adverse Event Reporting System (FAERS) via OpenFDA (2015Q3-2023Q3). The Medical Dictionary for Regulatory Activities (MedDRA) terms identified AEs related to hearing impairment, vestibular disorders, and hypoacusis. Adjusted reporting odds ratios (aRORs) and 95% confidence intervals (CIs) were estimated using logistic regression, adjusting for age, sex, hypertension, and heart failure. Bayesian methods complemented the analysis.Results: Among 55,101 ICSRs, 28,091 involved sacubitril/valsartan, with 590 (1.07%) reports of hearing impairment and 4,732 (8.58%) vestibular disorders. Compared to lisinopril, sacubitril/valsartan had higher aRORs for hearing impairment (2.35), vestibular disorders (2.58), and hypoacusis (15.03). Similar elevated risks were found versus losartan. Bayesian analysis confirmed these patterns.Conclusions: Sacubitril/valsartan may be associated with a higher risk of auditory AEs than lisinopril and losartan. These findings warrant further confirmation through pharmacoepidemiologic studies.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-8"},"PeriodicalIF":3.1,"publicationDate":"2025-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145185176","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