Expert Opinion on Drug Safety最新文献_第6页

Use of signal detection methods to identify associations between prenatal medication exposure and subsequent childhood cancers: a Nordic hypothesis-generating registry-based study. 使用信号检测方法来确定产前药物暴露与随后的儿童癌症之间的关联：北欧一项基于登记的假设生成研究。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-08-01 Epub Date: 2025-02-12 DOI: 10.1080/14740338.2025.2461204

Hannah Johnson, Sarah Hjorth, Joan Morris, Anton Pottegård, Maarit Leinonen, Ulrika Norby, Hedvig Nordeng

{"title":"Use of signal detection methods to identify associations between prenatal medication exposure and subsequent childhood cancers: a Nordic hypothesis-generating registry-based study.","authors":"Hannah Johnson, Sarah Hjorth, Joan Morris, Anton Pottegård, Maarit Leinonen, Ulrika Norby, Hedvig Nordeng","doi":"10.1080/14740338.2025.2461204","DOIUrl":"10.1080/14740338.2025.2461204","url":null,"abstract":"Background: Childhood cancer is an important contributor to childhood mortality in high-income countries. Information on associations between childhood cancer and in-utero exposure is absent or limited for most medications. Signal detection methods identify medications where research should be focused but have not been applied to datasets containing prenatal medication exposures and childhood cancers.Research design and methods: The aim of this study was to apply and evaluate four signal detection methods - odds ratios (OR), the information component (IC), sequential probability ratio testing (SPRT), and Bayesian hierarchical models (BHM) - for identification of associations between medications dispensed during pregnancy and subsequent, incident diagnosis of childhood cancer <10 years, using linked Nordic registry data. Signal detection results were compared to propensity score adjusted odds ratios from generalized linear models.Results: Analysis was performed for 117 medication-cancer pairs with 5 or more observations. The OR had the greatest sensitivity (0.75). The IC had a greater specificity (0.98) than the OR (0.95).Conclusions: The IC may be the most appropriate method for identifying signals within this type of data. Reported signals should not be considered sufficient evidence of causal association and must be followed-up by tailored investigations that consider confounding by indication.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1477-1488"},"PeriodicalIF":3.0,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143382033","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 issues of Donepezil combined with Memantine in Alzheimer's disease population: real-world pharmacovigilance. 多奈哌齐联合美金刚治疗阿尔茨海默病患者的安全性问题：现实世界的药物警戒。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-08-01 Epub Date: 2025-02-23 DOI: 10.1080/14740338.2025.2467180

Yi Zeng, Bingshuo Liu, Lisi Zhou, Wenling Zeng, Xiaona Tian, Jiazhen Jiang, Dandan Dai

{"title":"Safety issues of Donepezil combined with Memantine in Alzheimer's disease population: real-world pharmacovigilance.","authors":"Yi Zeng, Bingshuo Liu, Lisi Zhou, Wenling Zeng, Xiaona Tian, Jiazhen Jiang, Dandan Dai","doi":"10.1080/14740338.2025.2467180","DOIUrl":"10.1080/14740338.2025.2467180","url":null,"abstract":"Background: Alzheimer's disease (AD) is the most common form of dementia. The combination of Donepezil and Memantine is the only FDA-approved therapy for AD, but its adverse drug reactions (ADRs) lack systematic analysis. This study carried out drug combination analysis for AD population to provide evidence support for clinical safety of drug use.Research design and methods: Using FAERS database reports (January 2004-January 2024) with Donepezil and Memantine as primary suspected drugs, four disproportionality analysis methods - ROR, PRR, BCPNN, and EBGM - were applied to identify positive ADR signals. Subgroup analyses were conducted by age and gender.Results: A total of 712 reports were analyzed (54.6% female, 55.1% aged 65-85). Across the AD population, 42 ADRs were identified, including hypertensive crisis, hyperglycemia, hyperosmolar nonketotic syndrome, proteinuria, and hydronephrosis, many of which were newly reported. Subgroup analysis revealed prostate hypertrophy, acute kidney injury, and cerebral infarction in males, while females experienced more severe cardiovascular events, such as complete AV block and ventricular extrasystole. Additional ADRs included hyperkalemia, sinus bradycardia, and extrapyramidal disorders.Conclusions: Despite partial consistency of combined ADRs for Donepezil and Memantine with instructions, new ADR signals emerged, with significant differences in AD subgroups.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1583-1593"},"PeriodicalIF":3.0,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143413810","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

The efficacy and safety of omadacycline in treating acute bacterial infections: a meta-analysis of randomized controlled trials. 奥马达环素治疗急性细菌感染的有效性和安全性：随机对照试验的荟萃分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-08-01 Epub Date: 2025-02-16 DOI: 10.1080/14740338.2025.2467815

Yao-Jie Chen, Si-Yuan Gao, Jing Fu, Sun-Ting Qin, Meng-Yu Kong, Xiu-Hua Zhang, Guan-Yang Lin, Xu-Ben Yu

{"title":"The efficacy and safety of omadacycline in treating acute bacterial infections: a meta-analysis of randomized controlled trials.","authors":"Yao-Jie Chen, Si-Yuan Gao, Jing Fu, Sun-Ting Qin, Meng-Yu Kong, Xiu-Hua Zhang, Guan-Yang Lin, Xu-Ben Yu","doi":"10.1080/14740338.2025.2467815","DOIUrl":"10.1080/14740338.2025.2467815","url":null,"abstract":"Introduction: This study aimed to reevaluate the clinical efficacy and safety of omadacycline in treating acute bacterial infections.Methods: We searched PubMed, Embase, Cochrane Library, Web of Science, and Clinical Trials up to 1 January 2024, including only randomized controlled trials comparing OMC with other antibiotics in adults. Primary outcomes were clinical and microbiological responses; secondary outcomes included adverse events.Results: Seven RCTs with 2957 patients met the inclusion criteria. OMC showed a slightly better clinical response at the post-therapy evaluation phase in the clinically evaluable population (RR = 1.03, 95% CI = 1.01-1.05, I2 = 0%). Microbial eradication rates for Gram-positive and Gram-negative infections showed no significant differences between OMC and comparators. Safety analysis revealed no significant differences in overall AEs, treatment-related AEs, serious AEs, or drug discontinuation due to AEs. However, OMC had a lower risk of diarrhea (RR: 0.48, 95% CI = 0.23-1.00, I2 = 65%). All-cause mortality did not differ significantly between OMC and comparators.Conclusions: OMC is a safe and effective treatment for acute bacterial infections, comparable to other antibiotics.Registration: This study has been registered in the online systematic review database (Prospective Register of Systematic Reviews [PROSPERO]), and the registration number is CRD42024575416.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1465-1475"},"PeriodicalIF":3.0,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143413814","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 evaluation of ILaris: a real-world analysis of adverse events based on the FAERS database. ILaris的安全性评价：基于FAERS数据库的实际不良事件分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-08-01 Epub Date: 2025-03-02 DOI: 10.1080/14740338.2025.2465864

Xueliang Yi, Shujie Wu, He He, Yingjie Li

{"title":"Safety evaluation of ILaris: a real-world analysis of adverse events based on the FAERS database.","authors":"Xueliang Yi, Shujie Wu, He He, Yingjie Li","doi":"10.1080/14740338.2025.2465864","DOIUrl":"10.1080/14740338.2025.2465864","url":null,"abstract":"Background: There is a lack of real-world studies on the safety of Ilaris in large populations. The purpose of this study was to investigate adverse events (AEs) associated with Ilaris using data from the FDA Adverse Event Reporting System (FAERS) database to guide clinical use.Methods: We evaluated retrospectively extracted reports of AEs from the FAERS database between the first quarter of 2009 and the second quarter of 2024. The presence of a significant association between Ilaris and AEs was assessed by using disproportionality analyses including ROR,PRR,BCPNN,MGPS.Results: After evaluating 14,691,170 data, 7968 ILaris-associated AEs were obtained after removing duplicates and unspecified sex items. A number of AEs were finalized through the study, including Common Pyrexia, Condition Aggravated, Influenza, and unexpected signals not listed in the drug insert, such as Pulmonary Thrombosis, Hepatomegaly, Blood Lactate Dehydrogenase Increased, Splenomegaly, Appendicitis. Ilaris induced AEs involving 27 system organ classes (SOCs). There were gender differences in AEs signaling associated with Ilaris.Conclusions: It is critical for healthcare professionals to closely monitor patients for symptoms (such as pulmonary thrombosis, Hepatomegaly, Blood Lactate Dehydrogenase Increased, Splenomegaly, Appendicitis) and other adverse events during treatment.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1517-1529"},"PeriodicalIF":3.0,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143476140","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 disproportionality analysis of adverse events signals for naltrexone based on real-world data from the FAERS database. 基于FAERS数据库中真实数据的纳曲酮不良事件信号的挖掘和歧化分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-08-01 Epub Date: 2025-02-02 DOI: 10.1080/14740338.2025.2461200

Yaqi Zeng, Zhe Chen, Yaan Luo, Jing Luo, Li Shi, Xuhui Zhou

{"title":"Mining and disproportionality analysis of adverse events signals for naltrexone based on real-world data from the FAERS database.","authors":"Yaqi Zeng, Zhe Chen, Yaan Luo, Jing Luo, Li Shi, Xuhui Zhou","doi":"10.1080/14740338.2025.2461200","DOIUrl":"10.1080/14740338.2025.2461200","url":null,"abstract":"Background: This study aims to analyze adverse events (AEs) associated with naltrexone based on the FAERS database, providing a foundation for its safety monitoring.Research design and methods: Disproportionality analysis methods, including Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-Item Gamma Poisson Shrinker (MGPS) algorithms, were employed to quantify signals of naltrexone-related AEs.Results: AEs related to naltrexone from the first quarter of 2013 to the fourth quarter of 2023 were extracted from the FAERS database for detailed analysis. Among a total of 41,757,311 reports 28,745 were directly associated with naltrexone, involving 27 organ systems. We identified 110 positive signals for AEs at the preferred term (PT) level using disproportionality analysis, which included known AEs such as agitation, depressed mood, sleep disorder, tremor, delirium, and decreased libido. Additionally, our findings suggested potential risks of restless legs syndrome, eosinophilic pneumonia, and otolithiasis, which were not mentioned in the drug's label, thereby supplementing the existing safety information.Conclusions: The analysis of the FAERS database identified AEs associated with naltrexone, contributing to the awareness of clinical practitioners and pharmacists regarding the drug-related risk signals. This awareness facilitates timely preventive and therapeutic measures, ensuring patient safety.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1489-1496"},"PeriodicalIF":3.0,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143074395","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 amphotericin B adverse reaction signals: a real-world study based on the FAERS database. 两性霉素B不良反应信号的挖掘和分析：基于FAERS数据库的现实世界研究。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-08-01 Epub Date: 2025-03-12 DOI: 10.1080/14740338.2025.2468856

Siqi Wang, Yimei Cheng, Xing Wang, Qian Wang

{"title":"Mining and analysis of amphotericin B adverse reaction signals: a real-world study based on the FAERS database.","authors":"Siqi Wang, Yimei Cheng, Xing Wang, Qian Wang","doi":"10.1080/14740338.2025.2468856","DOIUrl":"10.1080/14740338.2025.2468856","url":null,"abstract":"Background: Invasive fungal infections (IFIs) have become an increasingly serious public health problem. Amphotericin B (AmB) remains the important component in the treatment of IFIs. But its clinical application is limited due to its adverse reactions.Research design and methods: In this study we mined the adverse drug event signals of AmB based on the Food and Drug Administration Adverse Event Reporting System (FAERS) from the first quarter of 2004 to the third quarter of 2023, using the Reported Odds Ratio, Proportional Reporting Ratio, Bayesian Confidence Propagation Neural Network and Multi-item Gamma Poisson Shrinker methods to provide a reference for the safe clinical use.Results: A total of 3597 adverse event (AE) reports for the primary suspect drug AmB were obtained, involving 22 system organ classes (SOCs), 1355 AEs. Patients aged 18-60 (47.93%) and female patients (53.82%) were at a higher risk of AEs with AmB. High risk signals in the report include hypokalemia, pyrexia, chill, renal failure. Additional high risk signals not mentioned in the instructions conclude respiratory failure, tachycardia, deafness.Conclusions: Mining the adverse reaction signal study of AmB based on the FAERS database provides support for the clinical monitoring and risk identification of this drug.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1607-1614"},"PeriodicalIF":3.0,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143604445","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 active tuberculosis and herpes zoster with tumor necrosis factor inhibitor treatment in adults with autoimmune disease conditions: a systematic trial sequential analysis of randomized placebo-controlled clinical trials. 在患有自身免疫性疾病的成年人中，肿瘤坏死因子抑制剂治疗活动性肺结核和带状疱疹的风险：随机安慰剂对照临床试验的系统试验顺序分析

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-08-01 Epub Date: 2026-03-11 DOI: 10.1080/14740338.2026.2642872

George N Okoli, Benjamin J Cowling, Nicole Askin, Diane M Harper, Paul Van Caeseele

{"title":"Risk of active tuberculosis and herpes zoster with tumor necrosis factor inhibitor treatment in adults with autoimmune disease conditions: a systematic trial sequential analysis of randomized placebo-controlled clinical trials.","authors":"George N Okoli, Benjamin J Cowling, Nicole Askin, Diane M Harper, Paul Van Caeseele","doi":"10.1080/14740338.2026.2642872","DOIUrl":"10.1080/14740338.2026.2642872","url":null,"abstract":"Introduction: To thoroughly examine the risk of active tuberculosis and herpes zoster infections with tumor necrosis factor (TNF) inhibitor treatment in adults (≥18-year-olds) with autoimmune disease conditions.Methods: A trial sequential analysis (TSA) informed by a high-quality systematic review and meta-analysis of evidence from published randomized placebo-controlled trials. We pooled appropriate trial data using an inverse variance, random-effects model and expressed the results as relative risk and associated 95% confidence intervals. Statistical heterogeneity was calculated using the I2 statistic. Further, we assessed the strength/quality of the pooled evidence.Results: We included 49 trials. Irrespective of autoimmune disease condition type and TNF inhibitor treatment dosage, while we observed a marginally increased risk of active tuberculosis with infliximab (3.66 [1.13-11.90], I2 = 0%, 7 pooled estimates, moderate certainty), there was no increased risk of active tuberculosis or herpes zoster with other evaluated TNF inhibitors. However, TSA suggested that pooled sample sizes were not enough to support definitive conclusions on all the analyses.Conclusions: The available evidence from randomized placebo-controlled clinical trials in adults with autoimmune disease conditions does not support the risk of active tuberculosis or herpes zoster with TNF inhibitors. However, the evidence is insufficient for strong conclusions.Protocol registration: www.crd.york.ac.uk/prospero identifier is CRD42024614017.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1445-1464"},"PeriodicalIF":3.0,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147369431","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 acute renal failure associated with combined use of SGLT2 inhibitors and potentially nephrotoxic drugs: an epidemiological surveillance study based on the FDA adverse event reporting system (FAERS). 联合使用SGLT2抑制剂和潜在肾毒性药物相关的急性肾衰竭风险：基于FDA不良事件报告系统（FAERS）的流行病学监测研究

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-08-01 Epub Date: 2025-03-02 DOI: 10.1080/14740338.2025.2471529

Ting Yu, Jian Xiao, Mengyao Li, Shu Qiao Cheng, Ruwen Cai, Ling Huang, Huimin Yu, Jing Yang Li, Ying-Ying Zhang, Ying Wang

{"title":"Risk of acute renal failure associated with combined use of SGLT2 inhibitors and potentially nephrotoxic drugs: an epidemiological surveillance study based on the FDA adverse event reporting system (FAERS).","authors":"Ting Yu, Jian Xiao, Mengyao Li, Shu Qiao Cheng, Ruwen Cai, Ling Huang, Huimin Yu, Jing Yang Li, Ying-Ying Zhang, Ying Wang","doi":"10.1080/14740338.2025.2471529","DOIUrl":"10.1080/14740338.2025.2471529","url":null,"abstract":"Background: Limited knowledge exists regarding nephrotoxic risks associated with the combination of sodium-glucose co-transporter-2 inhibitors (SGLT2i) and potentially nephrotoxic drugs. This study evaluates acute renal failure (ARF) events linked to such combinations using data from the FDA Adverse Event Reporting System (FAERS).Methods: Signal mining was performed by estimating reporting odds ratios (ROR), with validation through additive, multiplicative, and proportional reporting ratio (PRR) models. Logistic regression assessed mortality risk factors.Results: Among 4,417,195 reports, 1,636 ARF cases were associated with SGLT2i combinations, primarily involving diuretics, lipid-lowering agents, and anticoagulants. The highest ARF risk was observed with dapagliflozin-cefazolin [ROR adjusted (a) 59.63, 95% CI (9.96, 356.87); ROR adjusted (b) 19.88, 95% CI (1.80, 219.21); additive model (0.53); multiplicative model (8.36); PRR (8.53)]. Consistent associations were found for empagliflozin-allopurinol and canagliflozin-vancomycin. Among single drugs, 12, including canagliflozin, met all four significance criteria for ARF signals. Logistic regression revealed male patients had higher mortality risk (OR = 0.356, p = 0.043).Conclusion: This study confirms prior evidence of ARF associated with the combined use of SGLT2i with diuretics or NSAIDs and identifies new risks with proton pump inhibitors (PPIs), antigout medications, and anticoagulants. Male gender was a significant risk factor.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1531-1542"},"PeriodicalIF":3.0,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143476052","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

Rare irAEs associated with immune checkpoint inhibitor therapy. 与免疫检查点抑制剂治疗相关的罕见irae。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-08-01 Epub Date: 2026-02-16 DOI: 10.1080/14740338.2026.2629998

Jarrett Rong, Faraz Jafri, Sean Ngo, Anirudha Chatterjee, Maria Julia Moura Nascimento Santos, Devin Garza, Hamza Salim, Raakhi Menon, Rachel Mortan, Andres Caleb Urias Rivera, Hao Chi Zhang, Anisha Patel, Cristhiam Rojas Hernandez, Yuanteng Jeff Li, Ajay Sheshadri, Ashley Aaroe, Afreen Shariff, Bryan Schneider, Anusha Thomas, Yinghong Wang

{"title":"Rare irAEs associated with immune checkpoint inhibitor therapy.","authors":"Jarrett Rong, Faraz Jafri, Sean Ngo, Anirudha Chatterjee, Maria Julia Moura Nascimento Santos, Devin Garza, Hamza Salim, Raakhi Menon, Rachel Mortan, Andres Caleb Urias Rivera, Hao Chi Zhang, Anisha Patel, Cristhiam Rojas Hernandez, Yuanteng Jeff Li, Ajay Sheshadri, Ashley Aaroe, Afreen Shariff, Bryan Schneider, Anusha Thomas, Yinghong Wang","doi":"10.1080/14740338.2026.2629998","DOIUrl":"10.1080/14740338.2026.2629998","url":null,"abstract":"Introduction: Immune checkpoint inhibitors (ICIs), although revolutionary in the field of oncology, have been associated with immune-related adverse events (irAEs) that affect nearly every organ of the body. Many common AEs are well documented, but in this review, we highlight some rare irAEs that are mostly limited to reports of observational or case studies. Although these irAEs can be difficult to associate with ICI use due to their scarcity and often delayed onset, understanding and characterizing these rare irAEs is crucial to refining treatment strategies and improving outcomes for patients with cancer receiving ICIs.Areas covered: This review covers the rare irAEs affecting various organ systems, including cardiac, dermatological, endocrine, gastrointestinal, hematological, hepatobiliary, neurological, ocular, pancreatic, renal, and rheumatological. Information regarding irAEs compiled in this review are largely derived from case reports and case series and includes discussion surrounding proposed etiology, phenotype, and treatment of AEs.Expert opinion: Rare irAEs can occur in nearly all organ systems. Although it is difficult to attribute causation of an AE to ICIs, it is important for clinicians to be aware of possible AEs to rapidly diagnose and treat potential symptoms. Further research should focus on strategies to improve recognition of rare irAEs.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1415-1429"},"PeriodicalIF":3.0,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146149583","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. 周期蛋白依赖性激酶4/6抑制剂相关肺毒性：基于FAERS数据库的2015 - 2023年歧化分析

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-08-01 Epub 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":"1497-1506"},"PeriodicalIF":3.0,"publicationDate":"2026-08-01","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