Expert Opinion on Drug Safety最新文献

Neural dysfunction, inflammatory disorder, and metabolic interference feature in amantadine-related adverse drug events: a perspective from FAERS and network toxicology. 金刚烷胺相关药物不良事件的神经功能障碍、炎症障碍和代谢干扰特征：来自FAERS和网络毒理学的视角

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-06-23 DOI: 10.1080/14740338.2025.2524400

Jing Yang, Yang Tian, Yue Luo, Hong-Wei Luo, Yi-Ling Wang, Bin Chen, Xing Jiang, Gu-Yu Liu, Ying-Qiu Wu, Zhi Liu, Rui-Ling Ye, Chao Wang, Xin-Lan Guan

{"title":"Neural dysfunction, inflammatory disorder, and metabolic interference feature in amantadine-related adverse drug events: a perspective from FAERS and network toxicology.","authors":"Jing Yang, Yang Tian, Yue Luo, Hong-Wei Luo, Yi-Ling Wang, Bin Chen, Xing Jiang, Gu-Yu Liu, Ying-Qiu Wu, Zhi Liu, Rui-Ling Ye, Chao Wang, Xin-Lan Guan","doi":"10.1080/14740338.2025.2524400","DOIUrl":"https://doi.org/10.1080/14740338.2025.2524400","url":null,"abstract":"Background: Adverse drug events (ADEs) related to amantadine gradually increase as the drug is broadly acknowledged for remission of Parkinson's disease or Parkinsonism. The ADEs vary according to the affected organs and the potential mechanisms remain elusive.Methods: We mined data from the FAERS Database and employed network toxicology to appraise amantadine-related ADEs and dissect the toxicological mechanisms.Results: We found 1,917 ADE reports relevant to amantadine that embodied 1,871 intense-signal ADEs (implicating 134 preferred terms (PTs)). Of those PTs, 69 were undeclared in current amantadine insert. System organ class (SOC) term-based analysis showed that PDGFRB, STAT3, and PRKCD, as well as the enriched pathways such as Neuroactive ligand - receptor interaction and Toll-like receptor signaling pathway were instrumental in amantadine-related Death outcome. Toxicological analysis for the representative undeclared ADEs showed that the toxic targets like STAT3, MAPK1, and CYP3A4 played central roles in amantadine toxicity and adverse events. Molecular docking revealed high-affinity binding of amantadine to MAPK1, MAPK3, HSP90AA1, CYP3A4, and CYP2C19 which were involved in neural function, inflammation, and metabolism.Conclusion: The mechanisms underlying amantadine-related ADEs allow new insights into pharmacovigilance for amantadine use.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-06-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144368741","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 of musculoskeletal disorders associated with Bruton's tyrosine kinase inhibitors: a disproportionality analysis of FAERS database and meta-analysis. 与布鲁顿酪氨酸激酶抑制剂相关的肌肉骨骼疾病风险：FAERS数据库的歧化分析和荟萃分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-06-18 DOI: 10.1080/14740338.2025.2521358

Mohammed Zuber, Christy Thomas, Shifa Taj, Muhammed Rashid, Krishna Undela, Jeyanthi Ramanarayanan, Francisco J Hernandez-Ilizaliturri, Lorenzo Villa Zapata

{"title":"Risk of musculoskeletal disorders associated with Bruton's tyrosine kinase inhibitors: a disproportionality analysis of FAERS database and meta-analysis.","authors":"Mohammed Zuber, Christy Thomas, Shifa Taj, Muhammed Rashid, Krishna Undela, Jeyanthi Ramanarayanan, Francisco J Hernandez-Ilizaliturri, Lorenzo Villa Zapata","doi":"10.1080/14740338.2025.2521358","DOIUrl":"10.1080/14740338.2025.2521358","url":null,"abstract":"Background: Randomized controlled trials (RCTs) have reported an increased risk of musculoskeletal disorders with BTK inhibitors (BTKis). We conducted a disproportionality analysis using the FDA Adverse Event Reporting System (FAERS) and a meta-analysis of RCTs to further investigate.Research design and methods: A retrospective case/non-case study was performed using FAERS reports through Q2 2024. Disproportionality analysis calculated Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), and Information Component (IC) to identify signals (PRR ≥2, lower bound ROR > 1, IC025 > 0). A meta-analysis calculated risk ratios (RR) for musculoskeletal outcomes.Results: In FAERS, ibrutinib was associated with increased reports of muscle spasms [PRR: 2.2 (χ2 : 521.9), LB ROR: 2.1, IC025 = 1.0]. Acalabrutinib showed higher risks for myalgia [PRR: 2.4, LB ROR: 2.0, IC025 = 0.9] and bone pain [PRR: 2.2, LB ROR: 1.6, IC025 = 0.6]. In the meta-analysis, ibrutinib was associated with higher risks of arthralgia (RR: 1.46, 95% CI 1.21-1.76), muscle spasm (RR: 2.32, 95% CI 1.72-3.12), and back pain (RR: 1.22, 95% CI 0.75-1.96).Conclusions: Findings from FAERS and meta-analysis suggest a stronger association between BTKis, particularly ibrutinib, and musculoskeletal adverse events.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-8"},"PeriodicalIF":3.0,"publicationDate":"2025-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144301476","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 effectiveness of empagliflozin in Japanese patients with heart failure: a 1-year post-marketing surveillance study stratified by age. 恩格列净在日本心力衰竭患者中的安全性和有效性：一项按年龄分层的1年上市后监测研究

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-06-18 DOI: 10.1080/14740338.2025.2519835

Kazuhiro Yamamoto, Yusuke Naito, Sakurako Watanabe

{"title":"Safety and effectiveness of empagliflozin in Japanese patients with heart failure: a 1-year post-marketing surveillance study stratified by age.","authors":"Kazuhiro Yamamoto, Yusuke Naito, Sakurako Watanabe","doi":"10.1080/14740338.2025.2519835","DOIUrl":"10.1080/14740338.2025.2519835","url":null,"abstract":"Background: The sodium-glucose cotransporter-2 (SGLT2) inhibitor empagliflozin is approved in Japan for the treatment of heart failure (HF) with reduced left ventricular ejection fraction (HFrEF) and HF with preserved left ventricular ejection fraction (HFpEF). We conducted a post-marketing surveillance study of empagliflozin for HF in Japan.Research design & methods: This was a 1-year prospective, multicenter, observational study of patients with chronic HF who had not previously received empagliflozin. The primary endpoint was incidence of adverse drug reactions (ADRs). Prespecified effectiveness endpoints were all-cause death, cardiovascular (CV) death, and hospitalization for HF (HHF).Results: 1,166 patients were included (61.0% male, mean age 74.9 years). At baseline, mean left ventricular ejection fraction was 49.0%, mean body mass index was 24.2 ± 4.6 kg/m2, and 34.2% had type 2 diabetes. ADRs occurred in 61 (5.2%) patients overall, 5.8% of those aged ≥ 75 years, 6.2% of those aged 65 to < 75 years, and 2.2% of those aged < 65 years. Incidences of all-cause death, CV death, and HHF were 3.0, 0.9, and 2.5 per 100 PY, respectively.Conclusions: In this 1-year post-marketing surveillance study, empagliflozin was generally well-tolerated in patients with HF in Japan.Trial registration: ClinicalTrials.gov identifier is NCT05262764.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-9"},"PeriodicalIF":3.0,"publicationDate":"2025-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144283151","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

Comprehensive post-marketing safety analysis of tildrakizumab: insights from the FDA adverse event reporting system. 全面的Tildrakizumab上市后安全性分析：来自FDA不良事件报告系统的见解

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-06-17 DOI: 10.1080/14740338.2025.2520422

Kaidi Zhao, Shengxiang Xiao, Yang Zhao, Chen Tu

{"title":"Comprehensive post-marketing safety analysis of tildrakizumab: insights from the FDA adverse event reporting system.","authors":"Kaidi Zhao, Shengxiang Xiao, Yang Zhao, Chen Tu","doi":"10.1080/14740338.2025.2520422","DOIUrl":"10.1080/14740338.2025.2520422","url":null,"abstract":"Background: Tildrakizumab is a biologic agent approved for the treatment of moderate to severe psoriasis. Although its safety has been established in clinical trials, its real-world safety profile remains to be further investigated.Research design and methods: This study analyzed adverse events (AEs) from the FDA Adverse Event Reporting System (FAERS) database between the first quarter of 2018 and the first quarter of 2024. Four disproportionality analysis methods were applied: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS). Subgroup analyses, sensitivity analyses, and Weibull distribution modeling were conducted.Results: A total of 1,263 reports involving 2,344 AEs were included. Several known AEs were confirmed, and unexpected AEs such as urinary tract infections, herpes zoster, atrial fibrillation, and basal cell carcinoma were identified. Sensitivity analysis further confirmed the reliability of the overall findings.Conclusions: This study confirmed some known AEs and identified several unexpected AEs, highlighting the importance of early-stage monitoring. These findings may provide preliminary insights into the safe use of tildrakizumab. However, the FAERS database has limitations, including reporting bias, incomplete clinical information, and the inability to establish causality. These findings warrant further validation through prospective studies.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-8"},"PeriodicalIF":3.0,"publicationDate":"2025-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144283150","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 antibody-drug conjugates: a multi-database analysis of adverse events in leukemia treatment. 抗体-药物偶联物的药物警戒洞察：白血病治疗不良事件的多数据库分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-06-16 DOI: 10.1080/14740338.2025.2521365

Honglong Wu, Xuchen Fan, Sheng Wu, Yiming Sun, Meiling Yu, Zhe Liu

{"title":"Pharmacovigilance insights into antibody-drug conjugates: a multi-database analysis of adverse events in leukemia treatment.","authors":"Honglong Wu, Xuchen Fan, Sheng Wu, Yiming Sun, Meiling Yu, Zhe Liu","doi":"10.1080/14740338.2025.2521365","DOIUrl":"https://doi.org/10.1080/14740338.2025.2521365","url":null,"abstract":"Background: Gemtuzumab ozogamicin and inotuzumab ozogamicin play a crucial role in leukemia treatment. This study aims to explore multiple databases to identify adverse event (AE) signals that could enhance the safe use of these drugs.Methods design and methods: The FDA Adverse Event Reporting System (FAERS) database ASCII packages, covering 83 quarters from Q1 2004 to Q3 2024, were imported into SAS software (version 9.4) for data cleaning and analysis. Signal detection methods included the ROR, PRR, BCPNN and MGPS. The Japanese Adverse Drug Event Report database (JADER) and WHO Adverse Drug Event Report database (VigiAccess) were used to validate the results.Results: In FAERS and VigiAccess, the most frequent positive PT signal for gemtuzumab ozogamicin was 'febrile neutropenia.' In FAERS, the most frequent positive PT signal for inotuzumab ozogamicin was 'death.' The top five PTs with the highest signal intensity for both drugs across the three databases consistently included 'fibrin degradation products increased' and 'veno-occlusive liver disease.'Conclusion: Mining multiple databases enabled the identification of SOCs and AEs strongly associated with frequent adverse reactions to gemtuzumab ozogamicin and inotuzumab ozogamicin, offering valuable insights for clinical dosing guidance.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-06-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144301475","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

Clozapine-treated patients and myocardial infarction in adults: a pharmacovigilance study in VigiBase interpreted in the context of the literature. 氯氮平治疗的患者和成人心肌梗死：在文献背景下解释的VigiBase药物警戒研究。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-06-13 DOI: 10.1080/14740338.2025.2518234

Carlos De Las Cuevas, Emilio J Sanz, Jose de Leon

{"title":"Clozapine-treated patients and myocardial infarction in adults: a pharmacovigilance study in VigiBase interpreted in the context of the literature.","authors":"Carlos De Las Cuevas, Emilio J Sanz, Jose de Leon","doi":"10.1080/14740338.2025.2518234","DOIUrl":"10.1080/14740338.2025.2518234","url":null,"abstract":"Background: Clozapine is the best treatment for treatment-resistant schizophrenia (TRS) but is associated with metabolic adverse drug reactions (ADRs).Research dosing/methods: The international pharmacovigilance database (VigiBase) uses the information component (IC) as a disproportionality analysis. On 1 July 2024, we studied in VigiBase: 1) the myocardial infarction (MI) ICs for antipsychotics and 2) clozapine reports for MI since clozapine's introduction. After excluding 298 patients with incomplete data, 1490 adults were studied for fatal outcomes using logistic regression with adjusted odds ratios (aOR) and survival analysis.Results: Clozapine was associated with the highest IC (IC = 0.903; IC025 = 0.835). Olanzapine (IC = 0.524; IC025 = 0.398) showed a lower but significant association. The ICs for quetiapine, risperidone and haloperidol were non-significant or negative. Mortality in 1490 adult clozapine-treated patients with MI was 68%. Using a baseline age 18-44 years, age 45-64 years had a significant (p < 0.001) aOR = 1.87 with CI 1.43-2.44, while age ≥65 years had a significant (p < 0.001) aOR = 4.07 with CI 2.77-5.97. High clozapine doses (>600 mg/day) displayed an aOR = 2.18 for fatal outcomes.Conclusion: A MI IC around 0.9 is higher than that of other antipsychotics, but we cannot rule out that it is explained by TRS present in clozapine-treated patients.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-11"},"PeriodicalIF":3.0,"publicationDate":"2025-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144247207","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

Analysis of the relationship between histamine H1 receptor antagonists and broad dementia events using the FAERS, JADER, and CVAR databases. 使用FAERS、JADER和CVAR数据库分析组胺H1受体拮抗剂与广泛痴呆事件之间的关系。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-06-12 DOI: 10.1080/14740338.2025.2517232

Jingjing Kan, Yechao Chen, Qiaoling Gu, Na Hu, Yanli Qiao, Yawen Chen, Dayu Chen, Haixia Zhang

{"title":"Analysis of the relationship between histamine H1 receptor antagonists and broad dementia events using the FAERS, JADER, and CVAR databases.","authors":"Jingjing Kan, Yechao Chen, Qiaoling Gu, Na Hu, Yanli Qiao, Yawen Chen, Dayu Chen, Haixia Zhang","doi":"10.1080/14740338.2025.2517232","DOIUrl":"10.1080/14740338.2025.2517232","url":null,"abstract":"Background: Recent studies suggest histamine H1 receptor antagonists (H1RAs) may elevate broad dementia events risk, though real-world data remain scarce.Methods: This pharmacovigilance study analyzed FDA Adverse Event Reporting System (FAERS), Japanese Adverse Drug Event Report (JADER), and Canada Vigilance Adverse Reaction (CVAR) databases from January 2004 to June 2024. Using disproportionality analyses such as the reporting odds ratio (ROR) and proportion reporting ratio (PRR), time-to-onset analysis, propensity score matching, and multivariate regression, we compared broad dementia event signals among first-generation H1RAs (FG-H1RAs), second-generation H1RAs (SG-H1RAs), and benzodiazepines (BDs).Results: According to the FAERS database, FG-H1RAs (ROR = 3.33, 95%CI 3.22-3.44; PRR = 3.11, χ2 = 5426.01), SG-H1RAs (ROR = 2.03, 95%CI 1.98-2.07; PRR = 1.97, χ2 = 3706.58), and BDs (ROR = 2.74, 95%CI 2.68-2.80; PRR = 2.6, χ2 = 8338.34) were significantly associated with broad dementia events, with FG-H1RAs having a stronger association with broad dementia events compared to SG-H1RAs (aROR = 0.60, 95%CI 0.54-0.67, p < 0.001). Analysis of the JADER and CVAR databases yielded similar results. FG-H1RAs exhibited immediate broad dementia events reporting (median = 0 days), while SG-H1RAs showed delayed onset (median = 1 day), both with early risk decay.Conclusion: This study provides evidence for the association between H1RAs treatment and broad dementia events, highlighting signaling differences among H1RAs. However, large-scale, high-quality epidemiological studies are still needed for validation.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-12"},"PeriodicalIF":3.0,"publicationDate":"2025-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144274551","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

Constipation-predominant irritable bowel syndrome treatment options Linaclotide, Lubiprostone, plecanatide, and Tenapanor: analysis of the FDA adverse event reporting system (FAERS) database. 便秘为主的肠易激综合征治疗方案利那洛肽、鲁比前列酮、普莱那肽和泰那诺：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 : 2025-06-12 DOI: 10.1080/14740338.2025.2519833

Michael B Andrews, Douglas G Adler

{"title":"Constipation-predominant irritable bowel syndrome treatment options Linaclotide, Lubiprostone, plecanatide, and Tenapanor: analysis of the FDA adverse event reporting system (FAERS) database.","authors":"Michael B Andrews, Douglas G Adler","doi":"10.1080/14740338.2025.2519833","DOIUrl":"https://doi.org/10.1080/14740338.2025.2519833","url":null,"abstract":"Background: FDA approved treatments for constipation-predominant irritable bowel syndrome (IBS-C) include secretagogues (Linaclotide, Lubiprostone, and Plecanatide) and a retainagogue (Tenapanor). The FDA Adverse Event Reporting System (FAERS) database collects suspected medication-related adverse events (AEs).Research design and methods: Reports in FAERS from the date of each medication's FDA approval until 30 June 2024 were analyzed. Reports containing other suspected medications or a reason for use outside of IBS and/or constipation were excluded.Results: Linaclotide was most associated with diarrhea (n = 2,082, 24.1%), abdominal pain (n = 815, 9.4%), abdominal bloating (n = 795, 9.2%), and nausea/vomiting (n = 266, 3.1%). Plecanatide was most associated with diarrhea (n = 137, 20.4%), abdominal pain (n = 76, 11.3%), abdominal bloating (n = 62, 9.2%), and nausea/vomiting (n = 34, 5.1%). Tenapanor was most associated with diarrhea (n = 51, 32.9%), abdominal pain (n = 13, 8.4%), and abdominal bloating and nausea/vomiting (n = 11 each, 7.1%). Lubiprostone was most associated with dyspnea (n = 221, 13.0%), nausea/vomiting (n = 161, 9.5%), chest pain (n = 157, 9.3%), abdominal pain (n = 85, 5.0%), and diarrhea (n = 79, 4.7%).Conclusions: This post-marketing analysis of the FAERS database revealed diarrhea, abdominal pain, bloating, and nausea/vomiting were the most frequently reported AEs across all medications. Novel findings include the potential for clinically significant dehydration from Linaclotide-induced diarrhea and Lubiprostone-associated dyspnea and chest pain.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144274552","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

Comparative disproportionality analysis of adverse events associated with combined therapy versus monotherapy of abiraterone and olaparib for prostate cancer: a pharmacovigilance study using the FAERS database. 阿比特龙和奥拉帕尼联合治疗与单药治疗前列腺癌相关不良事件的比较歧化分析：使用FAERS数据库的药物警戒研究。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-06-05 DOI: 10.1080/14740338.2025.2496434

Si-Han Zhang, Jin-Zhou Xu, Na Zeng, Zhi-Yu Xia, Lin-Tao Miao, Ci Zhang, Shao-Gang Wang, Qi-Dong Xia

{"title":"Comparative disproportionality analysis of adverse events associated with combined therapy versus monotherapy of abiraterone and olaparib for prostate cancer: a pharmacovigilance study using the FAERS database.","authors":"Si-Han Zhang, Jin-Zhou Xu, Na Zeng, Zhi-Yu Xia, Lin-Tao Miao, Ci Zhang, Shao-Gang Wang, Qi-Dong Xia","doi":"10.1080/14740338.2025.2496434","DOIUrl":"10.1080/14740338.2025.2496434","url":null,"abstract":"Objectives: This study compares adverse events (AEs) of combined abiraterone acetate and olaparib treatment with their individual treatments for prostate cancer, focusing on safety profile differences and their clinical implications.Methods: Data on AEs for abiraterone acetate and olaparib were extracted from the FDA Adverse Event Reporting System (FAERS) database between April 2011 and April 2024. The reporting odds ratio (ROR) was mainly utilized to analyze AEs and their preferred terms (PTs).Results: A total of 32,745 AE reports for abiraterone acetate, 2493 for olaparib and 113 for combination therapy in males were identified. The combination therapy was associated with a higher risk of hematologic and lymphatic disorders and cardiovascular events compared to monotherapy. Notably, venous embolism and acute myocardial infarction showed significant ROR values in the combination therapy group.Conclusions: Combining abiraterone and olaparib increases risks of acute myocardial infarction, embolism, and pneumonitis over monotherapy. Though this combination improves survival, it demands vigilant patient monitoring and risk assessment. We recommend patients undergo serum lipid measurement, electrocardiograms, and cardiac and vascular ultrasounds to facilitate early detection and management of potential adverse effects. Additional research is needed to confirm these results and ensure the safe application of this drug combination.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-11"},"PeriodicalIF":3.0,"publicationDate":"2025-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144215315","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

Hemorrhagic events associated with tacrolimus: a real-world pharmacovigilance study. 与他克莫司相关的出血事件：一项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: 2024-07-15 DOI: 10.1080/14740338.2024.2380792

Haolin Teng, Honglan Zhou, Faping Li

{"title":"Hemorrhagic events associated with tacrolimus: a real-world pharmacovigilance study.","authors":"Haolin Teng, Honglan Zhou, Faping Li","doi":"10.1080/14740338.2024.2380792","DOIUrl":"10.1080/14740338.2024.2380792","url":null,"abstract":"Background: Tacrolimus is a potent macrolide immunosuppressant frequently used to prevent graft rejection in organ transplantation. Despite the known side effect of hemorrhage, there are no extensive descriptive series of patients who experience hemorrhage events associated with tacrolimus. We sought to review and describe tacrolimus-related hemorrhage events reported by healthcare professionals to the United States Food and Drug Association Adverse Event Reporting System (FAERS) database.Methods: The FAERS database (2004q1-2022q4) was retrospectively analyzed to characterize reporting of hemorrhage adverse events (AEs) with tacrolimus. Subgroup analysis was completed on the hemorrhage.Results: A total of 75,310 tacrolimus-associated AEs were identified, of which 1,511 cases met specific inclusion/exclusion criteria with most occurring in the gastrointestinal tract (422 cases, 27.93% of all included cases). Death was reported in 558 patients (36.93% of hemorrhage cases), the most of which occurred in cases of brain hemorrhage (219 cases, 39.25% of death cases). Among definitive organ transplants, renal transplant was the most common indication for tacrolimus (62 cases, 4.10%) followed by bone marrow transplant (44 cases, 2.91%) and liver transplant (30 cases, 1.99%).Conclusions: This study presents the largest collective description of tacrolimus-related hemorrhage events. We additionally described a number of previously unreported tacrolimus-related hemorrhage events.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"711-718"},"PeriodicalIF":3.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141619779","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