Expert Opinion on Drug Safety最新文献_第3页

Post-marketing safety associated with sodium zirconium cyclosilicate: a pharmacovigilance study based on the FDA reporting system. 与环硅酸锆钠相关的上市后安全性：基于FDA报告系统的药物警戒研究。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-09-01 Epub Date: 2025-03-29 DOI: 10.1080/14740338.2025.2486310

Jiankang Chen, Zuzhuang Lu, Honghong Luo, Tiaomin Wang, Xiaoying Qin

{"title":"Post-marketing safety associated with sodium zirconium cyclosilicate: a pharmacovigilance study based on the FDA reporting system.","authors":"Jiankang Chen, Zuzhuang Lu, Honghong Luo, Tiaomin Wang, Xiaoying Qin","doi":"10.1080/14740338.2025.2486310","DOIUrl":"10.1080/14740338.2025.2486310","url":null,"abstract":"Background: Sodium zirconium cyclosilicate (SZC) is a novel oral therapy for hyperkalemia with limited adverse reactions documented on its label. Accordingly, the objective of this study was to investigate real-world adverse events (AEs) associated with SZC using the FDA Adverse Event Reporting System (FAERS).Research design and methods: Relevant data regarding SZC were extracted from FAERS, and signal detection was conducted using four distinct algorithms. The Weibull shape parameter characterized the AE onset time. Kaplan-Meier analysis was used to evaluate the cumulative incidence of AEs associated with SZC.Results: Among 8,846,085 case reports recorded in the FAERS database, 1,160 SZC-related AEs were identified. Beyond AEs, such as hypokalemia, edema, constipation, and ileus, listed on the SZC label, 26 additional positive risk signals were not stated, including X-ray gastrointestinal tract abnormal, cardiac failure, and aspiration pneumonia. The median onset time of SZC-related AEs was 42 days. Furthermore, AEs differed between male and female patients.Conclusions: This study confirmed SZC label safety warnings and identified new AEs, offering insights for clinical monitoring of SZC.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1703-1710"},"PeriodicalIF":3.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143729531","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 of treatments for children with functional constipation. 儿童功能性便秘治疗的安全性。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-08-24 DOI: 10.1080/14740338.2026.2721396

Tirza M van Os, Megan A Read, Richard J Wood, Carlo Di Lorenzo, Marc A Benninga, Peter L Lu

{"title":"Safety of treatments for children with functional constipation.","authors":"Tirza M van Os, Megan A Read, Richard J Wood, Carlo Di Lorenzo, Marc A Benninga, Peter L Lu","doi":"10.1080/14740338.2026.2721396","DOIUrl":"https://doi.org/10.1080/14740338.2026.2721396","url":null,"abstract":"Introduction: Functional constipation (FC) in children is a common diagnosis that can be challenging to treat effectively. Internet and social media are shaping parental knowledge and beliefs has become of great importance.Areas covered: A literature review was conducted by searching electronic databases (inception-April 2026) for studies on safety of current management options for FC in children. Our main goal was to describe safety and patients' and parents' satisfaction regarding pharmacological, neuromodulation and surgical therapies. We also addressed myths commonly shared by the lay public. Current evidence supports osmotic and stimulant laxatives as safe first-line treatments for pediatric FC. More novel therapies such as secretagogues and noninvasive neuromodulation may shift management in the future, but long-term safety data regarding these treatments need to be collected. Surgical options are reserved for refractory cases due to complication risks.Expert opinion: Emphasizing safety and addressing misconceptions are essential in order to improve treatment adherence. The availability of more therapeutic options highlights the need for patient stratification to maximize benefit and minimize adverse effects. The growing influence of social media on caregivers underscores the importance of evidence-based communication and shared decision-making in clinical practice.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-9"},"PeriodicalIF":3.0,"publicationDate":"2026-08-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148808508","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

Early recognition, prevention, and management of glucocorticoid toxicity in patients with rheumatic diseases. 风湿病患者糖皮质激素毒性的早期识别、预防和管理。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-08-19 DOI: 10.1080/14740338.2026.2718746

Louis Cohen, Vivekanand Tiwari, John Tesser, Martin Bergman

{"title":"Early recognition, prevention, and management of glucocorticoid toxicity in patients with rheumatic diseases.","authors":"Louis Cohen, Vivekanand Tiwari, John Tesser, Martin Bergman","doi":"10.1080/14740338.2026.2718746","DOIUrl":"https://doi.org/10.1080/14740338.2026.2718746","url":null,"abstract":"Introduction: Glucocorticoids (GCs) are the mainstay treatment for acute and chronic rheumatic diseases. However, several treatment guidelines recommend limited use of GCs due to their associated toxicity. Rheumatic diseases, including rheumatoid arthritis, vasculitis, and polymyalgia rheumatica, often entail prolonged GC treatment, which may lead to major GC-related adverse events (AEs), such as osteoporosis, fracture, hyperglycemia, infection, and weight gain, along with cardiovascular, ophthalmic, and psychiatric-related AEs.Areas covered: This review elaborates on common GC-associated toxicities, the requirement of baseline assessment of patients before GC initiation, and the use of steroid-sparing agents. It also indicates differences in GC-prescribing patterns between primary care physicians (PCPs) and specialists, highlighting referral delay challenges for suspected rheumatic disease cases.Expert opinion: Treatment guidelines recommend baseline assessment and continuous monitoring of patients prescribed long-term GC treatment. In patients with rheumatic diseases, different risk contributing factors are responsible for GC-related AEs and are found to be dependent on dose and duration. GC therapies are an integral part of managing rheumatic diseases; however, inclusion of steroid-sparing alternative therapies could help reduce the long-term GC toxicity burden. Early referral and good communication between PCPs and specialists play an important role in reducing the long-term GC treatment burden.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-12"},"PeriodicalIF":3.0,"publicationDate":"2026-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148790137","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

Lesser-known medication safety considerations in sickle cell disease. 镰状细胞病中鲜为人知的药物安全注意事项。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-08-19 DOI: 10.1080/14740338.2026.2719768

Najbah Galadanci, Julie Kanter

{"title":"Lesser-known medication safety considerations in sickle cell disease.","authors":"Najbah Galadanci, Julie Kanter","doi":"10.1080/14740338.2026.2719768","DOIUrl":"10.1080/14740338.2026.2719768","url":null,"abstract":"Introduction: Sickle cell disease (SCD) is a clinically heterogeneous condition in which individuals experience markedly different disease trajectories. As more people with SCD now survive to adulthood, their disease becomes more complicated due to comorbidities, both related and unrelated to SCD. Thus, a precision-oriented approach is essential when initiating new treatments to ensure the delivery of meaningful and sustained benefits for people with SCD.Areas covered: This expert review examines selected, underrecognized safety concerns related to disease-modifying therapies for SCD as well as for other medications often used in this population. We discuss examples of safety issues involving SCD-modifying therapies, cardiovascular and renal medications, antibiotics, and corticosteroids, highlighting how the unique pathophysiology of SCD may influence drug safety, tolerability, and organ injury. The review is based on a narrative assessment of published clinical trials, observational studies, post-marketing safety reports, registry data, and expert clinical experience.Expert opinion: Although SCD is recognized as a highly heterogeneous condition, this issue is not consistently considered in clinical trial design or when using non-SCD therapies in this population. The recent emergence of new drugs emphasizes the importance of longitudinal monitoring, real-world safety assessment, and multidisciplinary specialist care.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-10"},"PeriodicalIF":3.0,"publicationDate":"2026-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148762999","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

Myositis in cancer patients receiving immune checkpoint inhibitors: the ARON-MOUSEION-017 systematic review and meta-analysis. 接受免疫检查点抑制剂的癌症患者的肌炎：ARON-MOUSEION-017系统评价和荟萃分析

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-08-14 DOI: 10.1080/14740338.2026.2719047

Elsa Vitale, Gerardo Cazzato, Lorenza Maistrello, Mario Della Mura, Mauro Francesco Pio Maiorano, Francesco Ciccimarra, Oronzo Brunetti, Concetta Calabrò, Brigida Anna Maiorano, Fernando Sabino Marques Monteiro, Enes Erul, Francesco Massari, Alessandro Rizzo, Matteo Santoni

{"title":"Myositis in cancer patients receiving immune checkpoint inhibitors: the ARON-MOUSEION-017 systematic review and meta-analysis.","authors":"Elsa Vitale, Gerardo Cazzato, Lorenza Maistrello, Mario Della Mura, Mauro Francesco Pio Maiorano, Francesco Ciccimarra, Oronzo Brunetti, Concetta Calabrò, Brigida Anna Maiorano, Fernando Sabino Marques Monteiro, Enes Erul, Francesco Massari, Alessandro Rizzo, Matteo Santoni","doi":"10.1080/14740338.2026.2719047","DOIUrl":"https://doi.org/10.1080/14740338.2026.2719047","url":null,"abstract":"Background: Myositis may present as a treatment-related adverse event (TRAE) during immune checkpoint inhibitor (ICI) therapy. In the ARON-MOUSEION-017 meta-analysis, we aimed to assess the frequency of myositis among cancer patients treated with ICIs.Research design and methods: The present systematic review and meta-analysis was registered in PROSPERO with ID no. CRD420261278193. Embase, PubMed, Scopus and Web of Science databases were consulted, using Boolean terms and keywords 'Immunotherapy,' 'Myositis' and 'Neoplasms.'Results: For myositis of any grade, 13 studies were included, suggesting that heterogeneity across studies was high and statistically significant (p < 0.001; τ2 = 3.78; I2 = 95.3%, 95% CI [93.1%; 96.7%]), and the pooled proportion of patients affected by any-grade myositis treatment-related adverse events (TRAEs) was 4.2% (95% CI = [1.1%; 14.6%]).Conclusions: ICI-myositis often appears in concomitance with other immune-mediated conditions, such as myocarditis and myasthenia gravis. These events are clinically relevant, since they are often associated with more severe disease courses and unfavorable outcomes, increasing morbidity and mortality.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-9"},"PeriodicalIF":3.0,"publicationDate":"2026-08-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148758081","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 profile of dual TIGIT and PD-L1 blockade with tiragolumab plus atezolizumab in solid tumors: a systematic review and meta-analysis of randomized controlled trials. tiragolumab + atezolizumab双重TIGIT和PD-L1阻断治疗实体瘤的安全性：随机对照试验的系统评价和荟萃分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-08-12 DOI: 10.1080/14740338.2026.2704844

Zaher Mutaz Ashour, Mus'ab Theeb Mustafa, Osama Wadah Rammaha, Abdallah Moh'd Said Hamdan, Yihea Mohammad Al-Mashaqbah, Abdallah Yaser Alasmar, Lou'y Ahmed Al-Rabaeh, Mohammad AlElaimat, Ayham Omar Khalifah, Omar Jamal Ramadan, Aws Khalid Abushanab, Abdulqadir J Nashwan

{"title":"Safety profile of dual TIGIT and PD-L1 blockade with tiragolumab plus atezolizumab in solid tumors: a systematic review and meta-analysis of randomized controlled trials.","authors":"Zaher Mutaz Ashour, Mus'ab Theeb Mustafa, Osama Wadah Rammaha, Abdallah Moh'd Said Hamdan, Yihea Mohammad Al-Mashaqbah, Abdallah Yaser Alasmar, Lou'y Ahmed Al-Rabaeh, Mohammad AlElaimat, Ayham Omar Khalifah, Omar Jamal Ramadan, Aws Khalid Abushanab, Abdulqadir J Nashwan","doi":"10.1080/14740338.2026.2704844","DOIUrl":"10.1080/14740338.2026.2704844","url":null,"abstract":"Introduction: Dual immune-checkpoint blockade targeting T-cell immunoreceptor with Ig and ITIM domains (TIGIT) and programmed death-ligand 1 (PD-L1) shows synergistic antitumor activity. However, its safety profile remains incompletely defined. Our systematic review and meta-analysis aim to evaluate the safety of tiragolumab in combination with atezolizumab (TA) for the treatment of solid tumors.Methods: We conducted a comprehensive literature search up to March 2026. Eligible studies were Phase II or III randomized controlled trials (RCTs) comparing TA with atezolizumab-based regimens and reporting adverse events (AEs); pooled risk ratios (RRs) with 95% confidence intervals (CIs) were calculated.Results: Five RCTs involving 1001 patients were included. TA was associated with significantly higher risks of rash (RR 1.66, 95% CI 1.16-2.37), pruritus (RR 2.28, 95% CI 1.65-3.16), and infusion-related reactions (RR 1.80, 95% CI 1.23-2.62). No significant differences were observed for gastrointestinal, hematologic, endocrine, laboratory, or high-grade AEs. Subgroup analyses of TA alone versus atezolizumab alone showed only a significantly higher rash risk (RR 3.85, 95% CI 1.40-10.53).Conclusions: TA increases rash, pruritus, and infusion-related reactions without a significant rise in severe toxicities. Limited trial numbers and clinical heterogeneity require cautious interpretation and further long-term safety evaluation.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-8"},"PeriodicalIF":3.0,"publicationDate":"2026-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148435877","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

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