Expert Opinion on Drug Safety最新文献_第8页

Adverse event profile of setmelanotide in obesity: an integrated assessment and systematic review using disproportionality analysis, case reports and meta-analysis.

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-02-12 DOI: 10.1080/14740338.2025.2465880

Kannan Sridharan, Gowri Sivaramakrishnan

{"title":"Adverse event profile of setmelanotide in obesity: an integrated assessment and systematic review using disproportionality analysis, case reports and meta-analysis.","authors":"Kannan Sridharan, Gowri Sivaramakrishnan","doi":"10.1080/14740338.2025.2465880","DOIUrl":"10.1080/14740338.2025.2465880","url":null,"abstract":"Background: Setmelanotide is approved for genetically determined obesity. While clinical trials and clinical evidence and practice provide some insights, a comprehensive assessment of its adverse event profile is needed that led to carrying out an assessment of reported adverse events in the USFDA Adverse Event Reporting System database, case reports and clinical trials.Research design and methods: Multi-faceted analyses were carried out as follows: disproportionality measures employing frequentist and Bayesian methods; systematic review and meta-analysis (Medline, Cochrane CENTRAL and Google Scholar) generated-pooled estimates [proportion with 95% confidence intervals (CI)]; and published reports with adverse events to setmelanotide.Results: The disproportionality analysis (n = 228) identified skin hyperpigmentation, injection-site reactions, nausea, melanocytic nevus and ephelides as key safety signals. Meta-analysis (seven trials; n = 185) confirmed high rates of injection-site reactions (96%; 95% CI: 89, 100), skin hyperpigmentation (62%; 95% CI: 43, 78), nausea (36%; 95% CI: 24, 49), vomiting (26%; 95% CI: 18, 34), and diarrhea (21%; 95% CI: 14, 29). Individual case reports corroborated these findings.Conclusion: This study provides a detailed overview of setmelanotide's adverse event profile, highlighting the need for careful patient monitoring, emphasizing the importance of ongoing safety surveillance for at least 1.5 years, and further research to refine patient management strategies.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-10"},"PeriodicalIF":3.0,"publicationDate":"2025-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143382082","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 drug event profile of pharmacotherapies for alcohol use disorder: a retrospective pharmacovigilance disproportionality analysis study.

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-02-12 DOI: 10.1080/14740338.2025.2464896

Kannan Sridharan

{"title":"Adverse drug event profile of pharmacotherapies for alcohol use disorder: a retrospective pharmacovigilance disproportionality analysis study.","authors":"Kannan Sridharan","doi":"10.1080/14740338.2025.2464896","DOIUrl":"10.1080/14740338.2025.2464896","url":null,"abstract":"Background: Alcohol Use Disorder (AUD) significantly affects global health, leading to physical deterioration and impacting personal and social relationships. This study aims to evaluate the adverse event profiles (AEP) of three USFDA-approved medications for AUD, acamprosate, disulfiram, and naltrexone, using data from the USFDA Adverse Event Reporting System (AERS).Research designs and methods: Reports related to acamprosate, disulfiram, and naltrexone from March 2004 to March 2024 were extracted from the USFDA AERS database. Data were verified, and disproportionality analysis was conducted using frequentist and Bayesian methods. Adverse events were assessed based on reporting odds ratio, proportional reporting ratio, and Bayesian measures. Outcomes such as death, life-threatening events, and hospitalization were also analyzed.Results: A total of 19,177 unique reports were analyzed (naltrexone: n = 18,544; acamprosate: n = 249; disulfiram: n = 384). Common adverse events included hepatobiliary, nervous system, and psychiatric disorders. Disulfiram was associated with coagulopathy and drug interactions, while naltrexone was linked to injection site reactions and hypersensitivity. Naltrexone had higher mortality reports, and disulfiram had more hospitalizations.Conclusion: The study underscores the diverse AEPs of these medications, highlighting the need for careful monitoring and individualized treatment to ensure safety and efficacy in managing AUD.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-16"},"PeriodicalIF":3.0,"publicationDate":"2025-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143370727","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

A real-world pharmacovigilance study of sacubitrilvalsartan in older people: data mining of the FDA adverse event reporting system.

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-02-11 DOI: 10.1080/14740338.2025.2464888

Zheng Kuai, Quan Li, Xiaoyi Zhang, Guowen Tang, Yangli Ye, Yu Hu

{"title":"A real-world pharmacovigilance study of sacubitrilvalsartan in older people: data mining of the FDA adverse event reporting system.","authors":"Zheng Kuai, Quan Li, Xiaoyi Zhang, Guowen Tang, Yangli Ye, Yu Hu","doi":"10.1080/14740338.2025.2464888","DOIUrl":"10.1080/14740338.2025.2464888","url":null,"abstract":"Background: Sacubitrilvalsartan is widely used in the clinical management of heart failure with reduced ejection fraction and hypertension. This study aims to systematically investigate and quantify the safety signals and potential risks associated with sacubitrilvalsartan in individuals aged 65 and older, leveraging data from the FAERS database to provide insights into its real-world safety profile.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 Sacubitrilvalsartan-associated AEs in elderly.Results: The search retrieved 94,210 sacubitrilvalsartan-associated cases within the reporting period; 86 PTs with significant disproportionality were retained in 65 + . Reports emerged for several cognitive-related AEs and several fragility acceleration AEs, which were rare. Unexpected safety signals such as 'Injury, poisoning, and procedural complications' were only detected in 65 + . Most of the cases occurred within the first month after sacubitrilvalsartan initiation, and this was consistent across age groups.Conclusions: Our study found potential new AEs signals and might provide important support for clinical monitoring and risk identification of Sacubitrilvalsartan in elderly.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-9"},"PeriodicalIF":3.0,"publicationDate":"2025-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143363814","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 luspatercept: a disproportionality analysis of the FDA adverse event reporting system.

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-02-10 DOI: 10.1080/14740338.2025.2464071

Jin-Feng Liu, Ying-Tao Bai, Yan-En Leng, En Chang, Yu-Xun Wei, Wei Wei

{"title":"Post-marketing safety concerns with luspatercept: a disproportionality analysis of the FDA adverse event reporting system.","authors":"Jin-Feng Liu, Ying-Tao Bai, Yan-En Leng, En Chang, Yu-Xun Wei, Wei Wei","doi":"10.1080/14740338.2025.2464071","DOIUrl":"10.1080/14740338.2025.2464071","url":null,"abstract":"Background: Luspatercept, approved for treating beta thalassemia, myelodysplastic syndromes (MDS) associated anemia, and MDS with ring sideroblasts or myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis associated anemia, has uncertain long-term safety in large populations. This study analyzed adverse events (AEs) linked to luspatercept using data from the FDA Adverse Event Reporting System (FAERS) with data mining techniques.Research design and methods: We collected and analyzed luspatercept-related reports from the FAERS database from the first quarter of 2022 through the first quarter of 2024. Disproportionality analysis was used in data mining to quantify luspatercept-related AE signals.Results: A total of 46 AE signals were detected in 13 SOCs (system organ classes). In addition to the AEs identified during the clinical trial stage, this study also identified some unexpected and important AEs, such as product preparation error, prescribed overdose, product preparation issue, prescribed underdose, and acute hepatitis.Conclusions: Our study provides a comprehensive description of the post-marketing safety of luspatercept and identifies new potential AEs. Healthcare workers must be vigilant in avoiding product preparation errors, an adverse event that highlights the need for enhanced training and the participation of pharmacists in assessing medication utilization scenarios.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-8"},"PeriodicalIF":3.0,"publicationDate":"2025-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143255078","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

Assessment of adverse events of tasimelteon: a real-world pharmacovigilance study based on FAERS.

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-02-10 DOI: 10.1080/14740338.2025.2464068

Tianqi Zuo, Shengzhu Sun, Jingya Yang, Hongyun Wu, Wei Peng

{"title":"Assessment of adverse events of tasimelteon: a real-world pharmacovigilance study based on FAERS.","authors":"Tianqi Zuo, Shengzhu Sun, Jingya Yang, Hongyun Wu, Wei Peng","doi":"10.1080/14740338.2025.2464068","DOIUrl":"https://doi.org/10.1080/14740338.2025.2464068","url":null,"abstract":"Background: Tasimelteon is a novel dual melatonin receptor agonist approved for the treatment of non-24-hour sleep-wake disorder (N24HSWD). The purpose of this study was to provide a comprehensive analysis of post-marketing adverse events (AEs) for tasimelteon by analyzing the U.S. FDA Adverse Event Reporting System (FAERS) database.Methods: Four algorithms are employed in this study to mine the significant signals: multi-item gamma poisson shrinker (MGPS), Bayesian confidence propagation neural network (BCPNN), reporting odds ratio (ROR), and proportional reporting ratio (PRR).Results: Tasimelteon was the primary suspected drug in 5,125 adverse event reports that were identified between the first quarter of 2014 and the first quarter of 2024. Significant system organ categories (SOC) included psychiatric disorders, general disorders and administration site conditions, and nervous system disorders. We not only confirmed the adverse reactions outlined in the prescribing information such as somnolence, nightmare or abnormal dreams, and inhibitory drug interaction, but also revealed new potential risks that were not documented, such as insomnia and sleep disorder.Conclusions: This study revealed the characteristics of tasimelteon-associated adverse drug reactions, improved understanding of drug safety, and provided valuable signals for optimizing drug use regimens. Additional large-scale prospective studies remain necessary in the future.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-8"},"PeriodicalIF":3.0,"publicationDate":"2025-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143382085","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

A real-world pharmacovigilance study of blinatumomab based on the FDA adverse event reporting system.

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-02-10 DOI: 10.1080/14740338.2025.2464070

Zheng Zhang, Wenhao Guo, Minghao Chen, Qianzhi Yang, Xia Song, Yuping Wang

{"title":"A real-world pharmacovigilance study of blinatumomab based on the FDA adverse event reporting system.","authors":"Zheng Zhang, Wenhao Guo, Minghao Chen, Qianzhi Yang, Xia Song, Yuping Wang","doi":"10.1080/14740338.2025.2464070","DOIUrl":"10.1080/14740338.2025.2464070","url":null,"abstract":"Background: Blinatumomab, the first CD3/CD19 bispecific antibody, is FDA-approved for relapsed or refractory precursor B-cell acute lymphoblastic leukemia in adults and children. This study evaluates its safety profile through pharmacovigilance analysis of adverse events (AEs) reported in the FDA Adverse Event Reporting System (FAERS).Method: We conducted a disproportionality analysis using four algorithms: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-Item Gamma Poisson Shrinker (MGPS). Data from 2014Q1 to 2023Q4 were analyzed to identify safety signals related to blinatumomab, along with a stratification analysis to examine AE onset timing.Result: A total of 17,131 AE reports were retrieved from the FAERS database, with 6,266 indicating blinatumomab as the primary suspect. We identified 277 preferred terms (PTs) demonstrating significant disproportionality across all algorithms. Notably, unexpected AEs included Graft Versus Host Disease, myelosuppression, and hypokalaemia. Common AEs were consistent across gender and age groups, predominantly occurring within one month of treatment.Conclusion: This pharmacovigilance study utilizing the FAERS database identified potential AE signals associated with blinatumomab, providing essential insights for its safe clinical use.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-8"},"PeriodicalIF":3.0,"publicationDate":"2025-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143255075","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 profile of ocular injury associated with JAK inhibitors in patients with rheumatoid arthritis: a disproportionality analysis.

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-02-10 DOI: 10.1080/14740338.2025.2465862

Dan Li, Xiongwen Yang, Yueyan Li, Hongying Kuang, Qin Tong, Bo Yang, Danjun Chen, Chengxiao Fu

{"title":"Adverse event profile of ocular injury associated with JAK inhibitors in patients with rheumatoid arthritis: a disproportionality analysis.","authors":"Dan Li, Xiongwen Yang, Yueyan Li, Hongying Kuang, Qin Tong, Bo Yang, Danjun Chen, Chengxiao Fu","doi":"10.1080/14740338.2025.2465862","DOIUrl":"10.1080/14740338.2025.2465862","url":null,"abstract":"Background: Janus kinase inhibitors (JAKIs) have been approved for the treatment of rheumatoid arthritis (RA) for several years. A recent real-world study has shown the possibility of a relationship between the occurrence of ocular adverse events (OEs) and the use of JAKIs but failed to rule out whether those OEs are related to RA.Research design and methods: A retrospective, pharmacovigilance study using the FDA Adverse Event Reporting System to evaluate OE reports following treatment with JAK inhibitors in patients with RA from Q1 2004 to Q1 2024.Results: We identified 3226 cases associated with JAKIs and 24,158 cases associated with TNFIs. Most of the OEs are serious cases, the age distribution was similar but the sex distribution was not balanced. The OEs with top 10 ROR values in TNFIs had no detectable signal in JAKIs, and the time of onset of OEs also shows difference. Besides, far fewer OE were reported for baricitinib than for the other JAKIs.Conclusions: Different types of JAKIs are associated with special types of OEs and differ in time of onset compared with TNF inhibitors. More rigorous trials should be conducted to better understand the risk factors in JAKIs-related OEs.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-8"},"PeriodicalIF":3.0,"publicationDate":"2025-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143374038","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Association of ocular adverse events with varenicline solution use: a population-based study.

IF 3 3区医学

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

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

{"title":"Association of ocular adverse events with varenicline solution use: a population-based study.","authors":"Moiz Lakhani, Angela T H Kwan, Anne Xuan-Lan Nguyen, Marko M Popovic, Roger S McIntyre, Albert Y Wu","doi":"10.1080/14740338.2025.2460454","DOIUrl":"https://doi.org/10.1080/14740338.2025.2460454","url":null,"abstract":"Background: Approved by the FDA in 2021, varenicline solution is the first nasal spray specifically designed to enhance basal tear film production for treating dry eye disease (DED). However, there is a lack of data comprehensively comparing its safety profile to conventional DED therapies. Herein, we assess whether ocular adverse events (AEs) are disproportionately reported with the real-world use of varenicline solution.Research design and methods: This observational, population-based pharmacovigilance study analyzed the Food and Drug Administration Adverse Event Reporting System (FAERS) data (inception-April 2024) using reporting odds ratio (ROR), with significance defined as a 95% CI lower bound > 1.0. Nasal saline and systane were the controls.Results: A total of 1,125 AE reports were associated with varenicline solution. No disproportionate reporting of specific ocular AEs was observed when comparing varenicline solution with nasal saline. However, when compared with systane, varenicline solution showed higher odds of lacrimation (ROR = 2.18, 95%CI = 1.46-3.26, p < 0.0001), visual impairment (ROR = 2.27, 95%CI = 1.24-4.16, p = 0.0085), and photophobia (ROR = 7.50, 95%CI = 3.68-15.27, p < 0.0001).Conclusions: Although a direct causal relationship for higher RORs cannot be established for varenicline solution compared to systane, our findings provide evidence for potential risk signals and highlight the crucial role of post-marketing pharmacovigilance in monitoring long-term safety.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-9"},"PeriodicalIF":3.0,"publicationDate":"2025-02-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143374039","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

IF 3 3区医学

Expert Opinion on Drug Safety Pub 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":"1-9"},"PeriodicalIF":3.0,"publicationDate":"2025-02-04","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

Cyclin-dependent kinase 4/6 inhibitor-associated pulmonary toxicity: a disproportionality analysis from 2015 to 2023 based on the FAERS database.

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-02-04 DOI: 10.1080/14740338.2025.2461197

Qian Cheng, JunSheng Qi, Shupeng Zou, Xuan Shi, Yazheng Zhao, Mengling Ouyang, Minghui Sun

{"title":"Cyclin-dependent kinase 4/6 inhibitor-associated pulmonary toxicity: a disproportionality analysis from 2015 to 2023 based on the FAERS database.","authors":"Qian Cheng, JunSheng Qi, Shupeng Zou, Xuan Shi, Yazheng Zhao, Mengling Ouyang, Minghui Sun","doi":"10.1080/14740338.2025.2461197","DOIUrl":"10.1080/14740338.2025.2461197","url":null,"abstract":"Objectives: This study aimed to describe the pulmonary toxicity of cyclin-dependent kinase 4/6 inhibitors (CDK 4/6 inhibitors) (palbociclib, ribociclib, and abemaciclib) in patients being treated for breast cancer using the Food and Drug Administration Adverse Event Reporting System (FAERS) database.Research design and methods: Disproportionality analysis was performed to assess pulmonary toxicity associated with CDK 4/6 inhibitors. Clinical characteristics, onset time, sensitivity analysis, subgroup analyses, drug combinations, comorbidities, and co-reported events were performed.Results: Out of 83,505 CDK 4/6 inhibitor-related adverse events (AEs) documented in the FAERS database during the study period, 437 cases of pneumonitis, 555 cases of pulmonary edema, and 181 cases of pulmonary thrombosis related to CDK 4/6 inhibitors were analyzed. Pneumonitis and pulmonary thrombosis had the strongest signal strength in abemaciclib; pulmonary edema had the strongest signal strength in ribociclib. The median latency for pneumonitis, pulmonary edema, and pulmonary thrombosis was 66-173.5 days, 27-131 days, and 68-279 days, respectively. Pulmonary toxicity is statistically significant disproportionality in females as well as in patients over 60 years old.Conclusion: Abemaciclib was most strongly associated with pneumonitis and pulmonary thrombosis. Ribociclib was most strongly associated with pulmonary edema. The correlation with pulmonary toxicity was, in descending order, abemaciclib, ribociclib, and palbociclib.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-10"},"PeriodicalIF":3.0,"publicationDate":"2025-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143079147","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