Expert Opinion on Drug Safety最新文献_第8页

Dupilumab induced ocular surface diseases: an analysis of FAERS database, literature review and disease-gene interaction networks. Dupilumab诱导眼表疾病：FAERS数据库、文献综述和疾病-基因相互作用网络分析

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-01-03 DOI: 10.1080/14740338.2024.2448825

Jiaojiao Chen, Huixiang Li, Huiyuan Zhang, Qiaoqiao ShenTu, Shaoxia Wang, Quan Zhao, Yinglin Wang, Fei Wang

{"title":"Dupilumab induced ocular surface diseases: an analysis of FAERS database, literature review and disease-gene interaction networks.","authors":"Jiaojiao Chen, Huixiang Li, Huiyuan Zhang, Qiaoqiao ShenTu, Shaoxia Wang, Quan Zhao, Yinglin Wang, Fei Wang","doi":"10.1080/14740338.2024.2448825","DOIUrl":"10.1080/14740338.2024.2448825","url":null,"abstract":"Background: Adverse events (AE) in dupilumab-induced ocular surface diseases (DIOSD) have raised concerns regarding its safety. The objective of this study was to evaluate DIOSD by employing database analysis and clinical case review, along with mechanism analysis.Research design and methods: Database AE data were extracted from FAERS from 2017 Quarter 1 (Q1) to 2023 Q1. Disproportionality analyses were performed to identify the risk signals associated with DIOSD. Case reports/case series reported on DIOSD from March 2017 to June 2023 were collected for a literature review. The mechanisms of DIOSD were investigated through disease-gene interaction network analysis.Results: A total of 85 signals related to DIOSD were detected from FAERS. The most reported AE was 'dry eye' (n = 3503, ROR 20.32, 95% CI: 19.53-21.14). There were 36 articles, including 201 cases showing the evidence of DIOSD, with an average age of 43 years. About 64.18% patients suffered from severe atopic dermatitis, and 48.26% were reported with a previous ocular history. The mechanisms study suggested that tumor necrosis factor plays an important role in DIOSD.Conclusions: Our findings support that dupilumab use is associated with exacerbation or new-onset OSD. Particular attention should be focused on eye symptoms during dupilumab use.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-12"},"PeriodicalIF":3.0,"publicationDate":"2025-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142914070","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

Gabapentinoids related psychiatric disorders: an analysis based on the FAERS database from 2004 to 2023. 加巴喷丁类药物相关精神疾病：基于2004 - 2023年FAERS数据库的分析

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-01-03 DOI: 10.1080/14740338.2024.2448833

Jingjing Li, Zhicheng Dai, Zhengwei Zhang, Chen Chen, Xuehui Xiong, Falin Xu

{"title":"Gabapentinoids related psychiatric disorders: an analysis based on the FAERS database from 2004 to 2023.","authors":"Jingjing Li, Zhicheng Dai, Zhengwei Zhang, Chen Chen, Xuehui Xiong, Falin Xu","doi":"10.1080/14740338.2024.2448833","DOIUrl":"10.1080/14740338.2024.2448833","url":null,"abstract":"Background: Gabapentinoids, including gabapentin and pregabalin, are commonly used for neuropathic pain but have safety concerns. This study analyzed U.S. Food and Drug Administration's (FDA) Adverse Event Reporting System (FAERS) data to assess risks of psychiatric disorders as adverse effects.Research design and methods: Data from 2004 to 2023 were extracted for disproportionality analysis using reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and the Multi-Item Gamma Poisson Shrinker (MGPS) to evaluate the association between gabapentinoids and psychiatric AEs. Kaplan-Meier and log-rank tests assessed the incidence and onset profiles, while chi-square examined mortality and hospitalization rates differences.Results: Of 174,321 AE reports, 22.67% involved psychiatric disorders. Gabapentinoids increased psychiatric disorder incidence at SOC level, with events like anxiety and suicidal ideation. Differences in incidence and health outcomes between gabapentin and pregabalin were significant (p < 0.05).Conclusion: There is a correlation between the use of gabapentinoids and psychiatric disorders. Further research is needed into the mechanisms and prevention strategies for these adverse effects.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-9"},"PeriodicalIF":3.0,"publicationDate":"2025-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142921465","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

New strategies to manage the safety of cladribine in patients with multiple sclerosis. 多发性硬化症患者克拉德滨安全性管理的新策略。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-01-03 DOI: 10.1080/14740338.2024.2448826

Paola Reitano, Clara G Chisari, Francesco Patti

引用次数: 0

Safety and efficacy of pharmacotherapies for pelvic inflammatory disease and endometriosis. 盆腔炎和子宫内膜异位症药物治疗的安全性和有效性。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-01-02 DOI: 10.1080/14740338.2024.2446424

Simone Ferrero, Umberto Leone Roberti Maggiore, Michele Paudice, Valerio Gaetano Vellone, Umberto Perrone, Fabio Barra

{"title":"Safety and efficacy of pharmacotherapies for pelvic inflammatory disease and endometriosis.","authors":"Simone Ferrero, Umberto Leone Roberti Maggiore, Michele Paudice, Valerio Gaetano Vellone, Umberto Perrone, Fabio Barra","doi":"10.1080/14740338.2024.2446424","DOIUrl":"10.1080/14740338.2024.2446424","url":null,"abstract":"Introduction: Endometriosis and pelvic inflammatory disease (PID) are gynecological conditions affecting women of reproductive age and causing pain symptoms. The symptoms caused by these conditions are similar; thus, the differential diagnosis may be challenging. The treatment of these conditions is very different because PID is treated with antibiotic therapy, while endometriosis is treated with hormonal therapies suppressing estrogen levels.Areas covered: A narrative review was conducted through a comprehensive literature search on endometriosis and PID. The search strategy incorporated relevant keywords and MeSH terms related to these topics.Expert opinion: The antibiotics used to manage PID have high efficacy and safety profiles. Commonly prescribed regimens include a combination of ceftriaxone, doxycycline, and metronidazole. These antibiotics are generally well-tolerated, with most adverse effects being mild and manageable (gastrointestinal disturbances or hypersensitivity reactions). Hormonal therapies are a cornerstone in the management of endometriosis; they include combined oral contraceptives (COCs), progestins, gonadotropin-releasing hormone (GnRH) agonists, and antagonists. COCs and progestins are generally well-tolerated with a favorable safety profile, though they may cause side effects (breakthrough bleeding and mood changes). Oral GnRH antagonists have emerged as a noteworthy option, offering partial estrogen suppression and thereby overcoming the limitations associated with previously used GnRH agonists.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-14"},"PeriodicalIF":3.0,"publicationDate":"2025-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142881684","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

Severe cutaneous adverse reactions associated with antifungal agents: a pharmacovigilance analysis based on the FDA Adverse Event Reporting System (FAERS) database. 与抗真菌药物相关的严重皮肤不良反应：基于FDA不良事件报告系统（faers）数据库的药物警戒分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-01-02 DOI: 10.1080/14740338.2024.2438744

Huifang Shan, Chunyan Wei, Jingyi Zhang, Bin Wu

{"title":"Severe cutaneous adverse reactions associated with antifungal agents: a pharmacovigilance analysis based on the FDA Adverse Event Reporting System (FAERS) database.","authors":"Huifang Shan, Chunyan Wei, Jingyi Zhang, Bin Wu","doi":"10.1080/14740338.2024.2438744","DOIUrl":"10.1080/14740338.2024.2438744","url":null,"abstract":"Background: The aim of this study was to explore the risk of severe cutaneous adverse reactions (SCARs) caused by different antifungal drugs in the real world.Methods: We extracted the data from the FDA Adverse Event Reporting System (FAERS) from January 2004 to December 2022 and performed disproportionality analyses to characterize the signal differences of antifungal agents-related SCARs.Results: A total of 952 antifungals-related SCARs were identified. Antifungal drugs-related SCARs were more common in the 18-64 age group than other groups, and five agents were detected significant SCAR signals in this age group. Among these antifungals, fluconazole had the strongest associations with the SCARs, and showed significant SCAR signals at all age stages. Six antifungals showed a significant association with SCARs under disproportionality. The reporting odds ratios (RORs) and the 95% confidence intervals (95% CI) for six antifungals were as follows: fluconazole (9.50, 8.62-10.47), caspofungin (8.92, 7.29-10.91), itraconazole (3.48, 2.78-4.35), amphotericin B (2.73, 2.20-3.39), micafungin (2.62, 1.85-3.71) and voriconazole (2.50, 2.12-2.94).Conclusions: The data mining of FAERS demonstrated that antifungal drugs were significantly associated with SCARs, which reminded clinicians to continue monitoring patients who are at risk of developing SCARs with the use of these drugs.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-8"},"PeriodicalIF":3.0,"publicationDate":"2025-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142893403","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

Mining and analysis of adverse events associated with aducanumab: a real-world study using FDA Adverse Event Reporting System database. 挖掘和分析与aducanumab相关的不良事件：使用FDA不良事件报告系统数据库的真实世界研究。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-01-02 DOI: 10.1080/14740338.2024.2448205

Shuangshuang Wu, Yiming Qi, Cheng Jiang, Junxian Zheng

{"title":"Mining and analysis of adverse events associated with aducanumab: a real-world study using FDA Adverse Event Reporting System database.","authors":"Shuangshuang Wu, Yiming Qi, Cheng Jiang, Junxian Zheng","doi":"10.1080/14740338.2024.2448205","DOIUrl":"10.1080/14740338.2024.2448205","url":null,"abstract":"Background: Aducanumab, a monoclonal antibody, received approval for the treatment of Alzheimer's disease in 2021. However, it remains controversial over the security of this drug. In this study, aducanumab-related adverse events (AEs) were evaluated through data mining based on the FDA Adverse Event Reporting System (FAERS) database.Research design and methods: The AE reports induced by aducanumab as the primary suspected drug were extracted from the FAERS database. The clinical characteristics of aducanumab-associated reports were analyzed. The potential new AE signals of aducanumab were explored using four disproportionality analysis methods. Furthermore, the difference in aducanumab-associated AE signals was investigated concerning sex, age, weight, dose, onset time, and continent.Results: In total, 328 reports and 793 AEs associated with aducanumab were identified. Six new AEs were identified. No significant sex and weight difference in aducanumab-related signals was found. Notably, nervous system disorders, especially 'amyloid related imaging abnormality-edema/effusion' and 'amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits,' were more frequently to be reported within 121-240 days, particularly in Europe.Conclusions: This study contributes real-world evidence regarding the safety of aducanumab.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-10"},"PeriodicalIF":3.0,"publicationDate":"2025-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142893401","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 analysis of the FDA adverse event reporting system events for polatuzumab vedotin. 美国食品药物管理局不良事件报告系统对波拉珠单抗维多汀事件的真实世界药物警戒分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-01-01 Epub Date: 2024-05-02 DOI: 10.1080/14740338.2024.2348572

Zhongliang Xu, Dan Huang, Qiusha Liu, Sha Liu, Jiating Liu, Hongli Wang, Zhengze Shen

{"title":"A real-world pharmacovigilance analysis of the FDA adverse event reporting system events for polatuzumab vedotin.","authors":"Zhongliang Xu, Dan Huang, Qiusha Liu, Sha Liu, Jiating Liu, Hongli Wang, Zhengze Shen","doi":"10.1080/14740338.2024.2348572","DOIUrl":"10.1080/14740338.2024.2348572","url":null,"abstract":"Background: Polatuzumab vedotin is the first antibody-drug conjugate approved by the US Food and Drug Administration (FDA) for patients with diffuse large B-cell lymphoma. This study evaluated adverse events (AEs) associated with polatuzumab vedotin by data mining of the FDA Adverse Event Reporting System (FAERS).Methods: This study included AEs registered in FAERS between 2019 Q2 and 2023 Q2. Four algorithms were used to quantify the signals of polatuzumab vedotin-associated AEs, including reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker.Results: A total of 7,609,450 reports were collected from the FAERS database, and 1,388 reports of polatuzumab vedotin were identified as primary suspected AEs. Polatuzumab vedotin-associated AEs involved 26 organ systems. According to the four algorithms, 108 significant disproportionality AEs were retained simultaneously. Unexpected significant AEs included gastrointestinal hemorrhage, ileus, gastrointestinal perforation, cholecystitis, hypogammaglobulinemia, hepatitis B reactivation, hypercalcemia, hydronephrosis, cystitis hemorrhagic, interstitial lung disease, and thrombophlebitis. The median time to onset of polatuzumab vedotin-associated AEs was 20 (interquartile range 4-56) days.Conclusions: Our study identified significant new AE signals for polatuzumab vedotin through real-world disproportionality analysis data and may provide additional evidence for risk identification of polatuzumab vedotin.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"49-57"},"PeriodicalIF":3.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140852570","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 pharmacovigilance study of adverse events associated with polymyxins based on the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database. 基于美国食品和药物管理局不良事件报告系统（FAERS）数据库的多粘菌素相关不良事件药物警戒研究。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-01-01 Epub Date: 2024-05-01 DOI: 10.1080/14740338.2024.2348610

Tingxi Wu, Yanfeng Shi, Chang Xu, Bin Zhu, Dandan Li, Zhe Li, Zhigang Zhao, Yang Zhang

{"title":"A pharmacovigilance study of adverse events associated with polymyxins based on the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database.","authors":"Tingxi Wu, Yanfeng Shi, Chang Xu, Bin Zhu, Dandan Li, Zhe Li, Zhigang Zhao, Yang Zhang","doi":"10.1080/14740338.2024.2348610","DOIUrl":"10.1080/14740338.2024.2348610","url":null,"abstract":"Background: Polymyxins have been regarded as last-line treatment for multidrug-resistant gram-negative bacterial infections. Nonetheless, concerns regarding toxicity persist. This study aimed to explore and compare potential adverse events (AEs) between colistin and polymyxin B (PMB).Methods: Polymyxins-related AEs were retrieved from the U.S. Food and Drug Administration Adverse Event Reporting System between 2004 and 2022. Potential signals were estimated by the reporting odds ratio (ROR), and subgroup analyses were preformed to adjust for potential factors in AEs with significant disproportionality.Results: Analysis of 3,915 records involving 718 patients revealed a higher disproportionality of renal and urinary disorders (ROR 1.62, 95% CI 1.01-2.59) and acute kidney injury (ROR 1.75, 95% CI 1.07-2.87) with colistin treatment. Conversely, colistin exhibited a lower risk for neurotoxicity (ROR 0.47, 95% CI 0.30-0.73). Seven cases of skin hyperpigmentation were reported with PMB, whereas none were reported with colistin. Over 80% of cases involving polymyxin-related AEs occurred during the first two weeks of therapies, with a median onset time of 4.5 days.Conclusions: Patients received colistin displayed a higher potential risk of nephrotoxicity but a lower risk of neurotoxicity. Clinicians should be vigilant in monitoring the AEs of hyperpigmentation disorders induced by PMB.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"69-77"},"PeriodicalIF":3.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140853589","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

Development and validation of a machine learning model to improve precision prediction for irrational prescriptions in orthopedic perioperative patients. 开发和验证机器学习模型，提高骨科围手术期患者不合理处方的精准预测。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-01-01 Epub Date: 2024-05-02 DOI: 10.1080/14740338.2024.2348569

Weipeng Li, Nan Shang, Zhiqi Zhang, Yun Li, Xianlin Li, Xiaojun Zheng

{"title":"Development and validation of a machine learning model to improve precision prediction for irrational prescriptions in orthopedic perioperative patients.","authors":"Weipeng Li, Nan Shang, Zhiqi Zhang, Yun Li, Xianlin Li, Xiaojun Zheng","doi":"10.1080/14740338.2024.2348569","DOIUrl":"10.1080/14740338.2024.2348569","url":null,"abstract":"Objective: Our objective was to develop a machine learning model capable of predicting irrational medical prescriptions precisely within orthopedic perioperative patients.Methods: A dataset comprising 3047 instances of suspected irrational medication prescriptions was collected from a sample of 1318 orthopedic perioperative patients from April 2019 to March 2022. Four machine learning models were employed to forecast irrational prescriptions, following which, the performance of each model was meticulously assessed. Subsequently, a thorough variable importance analysis was conducted on the model that performed the best predictive capabilities. Thereafter, the efficacy of integrating this optimal model into the existing audit prescription process was rigorously evaluated.Results: Of the models utilized in this study, the RF model yielded the highest AUC of 92%, whereas the NB model presented the lowest AUC of 68%. Also, the RF model boasted the most robust performance in terms of PPV, reaching 82.4%, and NPV, reaching 86.6%. The ANN and the XGBoost model were neck and neck, with the ANN slightly edging out with a higher PPV of 95.9%, while the XGBoost model boasted an impressive NPV of 98.2%. The RF model singled out the following five factors as the most influential in predicting irrational prescriptions: the type of drug, the type of surgery, the number of comorbidities, the date of surgery after hospitalization, as well as the associated hospital and drug costs.Conclusion: The RF model showcased significantly high level of proficiency in predicting irrational prescriptions among orthopedic perioperative patients, outperforming other models by a considerable margin. It effectively enhanced the efficiency of pharmacist interventions, displaying outstanding performance in assisting pharmacists to intervene with irrational prescriptions.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"99-109"},"PeriodicalIF":3.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140848704","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 disproportionality analysis of CDK4/6 inhibitors in the FDA Adverse Event Reporting System (FAERS). FDA 不良事件报告系统 (FAERS) 中 CDK4/6 抑制剂的比例失调分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-01-01 Epub Date: 2024-08-05 DOI: 10.1080/14740338.2024.2387323

Yuan Peng, Yuying Zhou, Xuanyi Zhou, Xu Jia, Yan Zhong

{"title":"A disproportionality analysis of CDK4/6 inhibitors in the FDA Adverse Event Reporting System (FAERS).","authors":"Yuan Peng, Yuying Zhou, Xuanyi Zhou, Xu Jia, Yan Zhong","doi":"10.1080/14740338.2024.2387323","DOIUrl":"10.1080/14740338.2024.2387323","url":null,"abstract":"Objective: The FDA Adverse Event Reporting System (FAERS) was used to mine and evaluate adverse events (AEs) associated with cyclin-dependent kinase (CDK) 4/6 inhibitors, thereby providing a reference for clinical rational drug use.Methods: AE data related to CDK4/6 inhibitors from the first quarter of 2015 to the first quarter of 2023 were acquired from FAERS, while the signal mining was processed using the reporting odds ratio (ROR) method and Bayesian confidence propagation neural network (BCPNN) method.Results: The number of AE reports for CDK4/6 inhibitors was, respectively, 132,494 for palbociclib, 56,151 for ribociclib, and 7,014 for abemaciclib. The corresponding numbers of AE signals were 322,522, and 59, with the number of involved System Organ Class (SOC) being 23, 23, and 15, mainly involving blood and lymphatic system disorders, respiratory, thoracic and mediastinal disorders, hepatobiliary disorders, skin and subcutaneous tissue disorders, etc.Conclusion: CDK4/6 inhibitors could lead to pulmonary toxicity, myelosuppression, skin reactions, etc. Special attention should be paid to abemaciclib for interstitial lung disease (ILD), erythema multiforme, and thrombosis risk; ribociclib for cardiac toxicity, hepatotoxicity, and musculoskeletal toxicity; palbociclib for neurocognitive impairment and osteonecrosis of the jaw.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"25-33"},"PeriodicalIF":3.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141859473","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