Expert Opinion on Drug Safety最新文献_第7页

Efficacy and safety of omitting 5-fluorouracil bolus in combination chemotherapy regimens for gastrointestinal cancers: a systematic review and meta-analysis. 胃肠道肿瘤联合化疗方案中不使用5-氟尿嘧啶丸的疗效和安全性：一项系统综述和荟萃分析

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-07-02 DOI: 10.1080/14740338.2025.2527962

Yusuf Ilhan, Onur Yazdan Balcık, Elif Sahın, Aysegul Merc Cetınkaya, Elvina Almuradova, Murat Bardakcı, Cigdem Dınckal, Murat Karateke, Kadriye Bır Yucel, Arif Hakan Onder, Yakup Ergun

{"title":"Efficacy and safety of omitting 5-fluorouracil bolus in combination chemotherapy regimens for gastrointestinal cancers: a systematic review and meta-analysis.","authors":"Yusuf Ilhan, Onur Yazdan Balcık, Elif Sahın, Aysegul Merc Cetınkaya, Elvina Almuradova, Murat Bardakcı, Cigdem Dınckal, Murat Karateke, Kadriye Bır Yucel, Arif Hakan Onder, Yakup Ergun","doi":"10.1080/14740338.2025.2527962","DOIUrl":"https://doi.org/10.1080/14740338.2025.2527962","url":null,"abstract":"Introduction: This meta-analysis aimed to evaluate the impact of omitting the 5-FU bolus in chemotherapy regimens for gastrointestinal cancers on treatment efficacy and toxicity.Methods: We searched major databases and congress proceedings until 25 October 2024 to identify studies comparing 5-FU bolus and non-5-FU bolus regimens in patients with gastrointestinal cancers. The studies included those reporting on progression-free survival (PFS), overall survival (OS), and adverse events in metastatic gastrointestinal cancer patients.Results: The analysis included 7 studies with 12,698 patients. No significant differences in PFS (HR: 0.94, 95% CI: 0.83-1.07) or OS (HR: 0.96, 95% CI: 0.89-1.03) were found between the 5-FU bolus and non-bolus groups. However, significantly higher rates of grade 3-4 neutropenia (OR: 0.46, 95% CI: 0.37-0.57) and any grade thrombocytopenia (OR: 0.53, 95% CI: 0.35-0.80) were observed in the 5-FU bolus group. No significant differences were found for other toxicities like febrile neutropenia, diarrhea, or nausea.Conclusions: This meta-analysis demonstrates that the omission of 5-FU bolus from the commonly used 5-FU-based chemotherapy regimens in gastrointestinal cancers, with the use of only 5-FU infusion, may reduce the risk of hematologic toxicities such as neutropenia and thrombocytopenia without affecting survival outcomes in metastatic gastrointestinal cancers.Protocol registration: www.crd.york.ac.uk/prospero identifier is CRD42024602968.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-10"},"PeriodicalIF":3.0,"publicationDate":"2025-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144539750","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 limb amputation and bone fractures with sodium glucose cotransporter-2 inhibitors: a network meta-analysis and meta-regression. 使用钠葡萄糖共转运体-2 抑制剂导致截肢和骨折的风险：网络 Meta 分析和 Meta 回归。

IF 3.1 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-07-01 Epub Date: 2024-07-08 DOI: 10.1080/14740338.2024.2377755

Kannan Sridharan, Gowri Sivaramakrishnan

{"title":"Risk of limb amputation and bone fractures with sodium glucose cotransporter-2 inhibitors: a network meta-analysis and meta-regression.","authors":"Kannan Sridharan, Gowri Sivaramakrishnan","doi":"10.1080/14740338.2024.2377755","DOIUrl":"10.1080/14740338.2024.2377755","url":null,"abstract":"Background: Sodium glucose cotransporter-2 inhibitors (SGLT2is) have gained immense attention for a variety of indications. Limb amputations (LA) and fractures were reported in clinical trials. This network meta-analysis and meta-regression were carried out to quantify the risks of these events.Research design and methods: Randomized clinical trials evaluating SGLT2is and reporting patients developing LA/fracture were included. Odds ratios (OR) with 95% confidence intervals (95% CI) were the effect estimates. Sub-group analyses and meta-regression analysis were carried out.Results: Ninety articles were included (LA: 36 studies; 96522 participants and fracture: 66 studies; 102,862 participants). An increased risk of LA (OR: 1.2; 95% CI: 1.1, 1.3) was observed. Amongst SGLT2is, canagliflozin was associated with increased risk of LA (OR: 1.6, 95% CI: 1.1, 2.4) while dapagliflozin with fracture (OR: 1.1, 95% CI: 1, 1.2). Sub-group analysis revealed increased risk of LA with an OR of 1.3 among those in the age group of > 40 to < 65, body-mass index of > 30 kg/m2, HbA1c category of > 7%, duration of diabetes of > 10 years, type 2 diabetes, and an OR of 1.2 for SGLT2is administration of > 6 months.Conclusions: SGLT2is were observed with an increased risk of LA. High- risk categories were identified for which precautions should be recommended in the standard treatment guidelines.Protocol registration: Open Science Framework (https://osf.io/5fwyk).","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"797-804"},"PeriodicalIF":3.1,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141533978","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 effectiveness and safety of aripiprazole, bromocriptine, and cabergoline in the treatment of hyperprolactinemia: a systematic review and network meta-analysis. 阿立哌唑、溴隐亭和卡麦角林治疗高催乳素血症的有效性和安全性：系统综述和网络荟萃分析。

IF 3.1 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-07-01 Epub Date: 2024-10-16 DOI: 10.1080/14740338.2024.2416918

Kun Ma, Linna Ma, Tianjiao Huang, Yue Wang, Guanlan Zhong, Cong Gao, Zhiyu Zhou, Jie Luo

{"title":"The effectiveness and safety of aripiprazole, bromocriptine, and cabergoline in the treatment of hyperprolactinemia: a systematic review and network meta-analysis.","authors":"Kun Ma, Linna Ma, Tianjiao Huang, Yue Wang, Guanlan Zhong, Cong Gao, Zhiyu Zhou, Jie Luo","doi":"10.1080/14740338.2024.2416918","DOIUrl":"10.1080/14740338.2024.2416918","url":null,"abstract":"Objective: To assess the efficacy and safety of aripiprazole, bromocriptine, and cabergoline in the treatment of hyperprolactinemia (HPRL) using network meta-analysis.Method: We searched PubMed, Cochrane Library, Embase, Web of Science, China National Knowledge Infrastructure (CNKI), Wanfang, VIP, and China Biology Medicine disc (CBMdisc) for randomized controlled trials (RCTs). The quality of the included studies was assessed using the Cochrane risk-of-bias tool, and data were analyzed using RevMan 5.4, R 4.3.3, and Stata 17.Results: 44 RCTs involving a total of 3886 patients were finally included. The results showed that at 12 week of treatment, cabergoline plus conventional therapy had optimal efficacy in reducing prolactin (PRL) levels. Cabergoline plus conventional therapy was most effective in reducing PRL levels in patients with non-drug-induced HPRL. Aripiprazole plus conventional therapy had optimal efficacy in reducing PRL levels in patients with antipsychotics-induced or antidepressant-induced HPRL. Bromocriptine was the most efficacious intervention in improving estrogen (E2) levels.Conclusion: Three dopamine receptor agonists (DAs) have different advantages in improving serum PRL and E2 levels in HPRL patients.Prospero id: CRD42024510695.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"773-786"},"PeriodicalIF":3.1,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142461475","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

Evaluating potential unexpected adverse events and mortality after oral analgesics administration in fracture care-a cohort study. 评估骨折护理中口服镇痛药后可能出现的意外不良事件和死亡率--一项队列研究。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-07-01 Epub Date: 2024-08-19 DOI: 10.1080/14740338.2024.2392863

Zehra Abdul Muhammad, Tashfeen Ahmad, Haroon Rashid

{"title":"Evaluating potential unexpected adverse events and mortality after oral analgesics administration in fracture care-a cohort study.","authors":"Zehra Abdul Muhammad, Tashfeen Ahmad, Haroon Rashid","doi":"10.1080/14740338.2024.2392863","DOIUrl":"10.1080/14740338.2024.2392863","url":null,"abstract":"Introduction: Analgesic selection per individual's tolerance is essential to avoid risks. The study evaluated current oral analgesic prescription practice, analgesic adverse effects-related factors, unexpected events, and mortality post-fracture surgery.Research design and methods: The present prospective cohort study from June 2022 to July 2023 enrolled a total of 198 proximal femoral, ankle, and hindfoot trauma fracture patients. Stratification was done for oral analgesics prescribed at hospital discharge and 1 week with their accompanying toxicity assessed for 2 weeks. Analyzed Kaplan-Meier curve and the absolute risk for possible analgesics-related deaths.Results: Following oral analgesic administration, 122 (62%) patients experienced adverse events. In seven expiries, five were possibly due to acetaminophen added tramadol combined with any of pregabalin, diclofenac, etoricoxib, or gabapentin (absolute risk 2.5%, 97.5% proportion 2 weeks survival). Three (2% of 122) patients taking acetaminophen added tramadol or diclofenac experienced unexpected serious adverse events. Elderly diabetic and hypertensive hip fracture patients expired or experienced unexpected events.Conclusion: Data suggest that oral acetaminophen added tramadol combined with any of pregabalin, diclofenac, etoricoxib, or gabapentin might increase the death risk or unexpected serious adverse events in elderly diabetic and hypertensives suffering from intertrochanteric/femoral neck fracture. Safe analgesic selection is necessitated for at-risk patients.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"865-872"},"PeriodicalIF":3.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141975480","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

Potentially inappropriate anticholinergic drug use among older adults in primary healthcare: prevalence and determinants. 基层医疗机构中老年人潜在的抗胆碱能药物不当使用：发生率和决定因素。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-07-01 Epub Date: 2024-08-06 DOI: 10.1080/14740338.2024.2385479

Daniela A Rodrigues, Maria Teresa Herdeiro, Ramona Mateos-Campos, Adolfo Figueiras, Fátima Roque

{"title":"Potentially inappropriate anticholinergic drug use among older adults in primary healthcare: prevalence and determinants.","authors":"Daniela A Rodrigues, Maria Teresa Herdeiro, Ramona Mateos-Campos, Adolfo Figueiras, Fátima Roque","doi":"10.1080/14740338.2024.2385479","DOIUrl":"10.1080/14740338.2024.2385479","url":null,"abstract":"Background: Considering the vulnerability of older adults to adverse drug reactions, medications with strong anticholinergic properties are considered potentially inappropriate for this population. This study aims to characterize older adults' profile of anticholinergics use and to identify the factors associated with their potentially inappropriate use.Research design and methods: A retrospective study was conducted on 1200 older adults in primary health care centers of Portugal between April 2021 and August 2022. Potentially inappropriate use was assessed according to the 2023 Beers criteria. Logistic regression analyses were performed to determine associations between independent variables and potentially inappropriate use.Results: A 8.9% (95% CI 0.074-0.107) of the older adults were exposed to one or more potentially inappropriate anticholinergics, and amitriptyline was the most used (2.0%). Multivariate analysis revealed that use was associated with a higher mean number of medications (OR 1.173, 95% CI 1.115-1.234), diagnoses of depression (OR 2.889, 95% CI 1.785-4.674) and psychiatric disorders (OR 1.654, 95% CI 1.003-2.729).Conclusions: This study underscores the importance of vigilance in prescribing anticholinergic medications to older adults, particularly those with higher medication burdens and mental health diagnoses. By identifying factors associated with potentially inappropriate use, healthcare providers can better tailor medication regimens to mitigate risks and optimize the well-being of older adults.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"831-837"},"PeriodicalIF":3.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141893289","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

Cardiovascular toxicities of selective ret-specific tyrosine kinase inhibitors: a pharmacovigilance study based on the United States Food and Drug Administration Adverse Event Reporting System database. 选择性网状特异性酪氨酸激酶抑制剂的心血管毒性：基于美国食品药品监督管理局不良事件报告系统数据库的药物警戒研究。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-07-01 Epub Date: 2024-08-19 DOI: 10.1080/14740338.2024.2392003

Yinjing Hou, Xiayang Ren, Ying Chen, Yanfeng Wang

{"title":"Cardiovascular toxicities of selective ret-specific tyrosine kinase inhibitors: a pharmacovigilance study based on the United States Food and Drug Administration Adverse Event Reporting System database.","authors":"Yinjing Hou, Xiayang Ren, Ying Chen, Yanfeng Wang","doi":"10.1080/14740338.2024.2392003","DOIUrl":"10.1080/14740338.2024.2392003","url":null,"abstract":"Background: Selective RET-specific tyrosine kinase inhibitors (RET-TKIs) treat RET fusion-positive non-small cell lung cancer (NSCLC), but studies on their cardiovascular toxicities are limited. This study aimed to characterize the cardiovascular toxicities associated with selective RET-TKI in real-world settings.Research design and methods: Data from the United States Food and Drug Administration Adverse Event Reporting System database from 1 January 2020 to 30 June 2023, were analyzed. Two disproportionality methods, information component and reporting odds ratio (ROR) were used.Results: Both pralsetinib and selpercatinib showed positive signals for hypertension (pralsetinib: ROR: 5.25, 95% CI: 4.40-6.26; selpercatinib: ROR: 2.68, 95% CI: 1.87-3.82). Additionally, pralsetinib showed a positive signal for ischemic heart disease (ROR: 3.92, 95% CI: 2.94-5.23), and selpercatinib for torsade de pointes/QT prolongation (ROR: 2.65, 95% CI: 1.74-4.04). The median time to onset(TTO) of cardiovascular toxicities was 33 days (IQR: 9-73 days) for pralsetinib and 15 days (IQR: 10-50 days) for selpercatinib. The proportion of deaths, life-threatening events, and hospitalizations due to cardiovascular toxicities were 8.57%, 1.19%, and 31.43%, respectively, for total selective RET-TKI.Conclusions: Selective RET-TKIs are related to multiple cardiovascular toxicities. Pralsetinib was linked to ischemic heart disease, and selpercatinib to torsade de pointes/QT prolongation and thrombotic events.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"883-891"},"PeriodicalIF":3.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141975479","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

Cardiovascular toxicities of hypoxia-inducible factor prolyl hydroxylase inhibitors: a disproportionality analysis based on JADER database. 缺氧诱导因子脯氨酸羟化酶抑制剂的心血管毒性：基于JADER数据库的歧化分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-07-01 Epub Date: 2025-02-13 DOI: 10.1080/14740338.2025.2465873

Danna Wu, Ting Xie, Shuxin Jiao, Peitao Xie, Hongru Lin, Guo Yu

{"title":"Cardiovascular toxicities of hypoxia-inducible factor prolyl hydroxylase inhibitors: a disproportionality analysis based on JADER database.","authors":"Danna Wu, Ting Xie, Shuxin Jiao, Peitao Xie, Hongru Lin, Guo Yu","doi":"10.1080/14740338.2025.2465873","DOIUrl":"10.1080/14740338.2025.2465873","url":null,"abstract":"Background: Hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs) have shown promising prospects as novel therapeutic agents in renal anemia, but their potential cardiovascular toxicities have raised widespread concern. This study aim to explore the cardiovascular toxicities associated with HIF-PHIs through real-world long-term safety data.Research design and methods: A disproportionality analysis was employed by calculating the reporting odds ratios (ROR), information component (IC), and their 95% credibility intervals (CrI) in Japan Adverse Drug Event Report (JADER) database from 1 January 2020, to 30 September 2023.Results: From Q1 2020 to Q3 2023, 253,599 adverse events (AEs) cases were extracted from the JADER database, including 4,015 cases related to HIF-PHIs and 1,537 (38.28%) cases of cardiovascular toxicities. Embolic and thrombotic events (ROR = 6.66, IC = 2.74), cardiac failure (ROR = 3.86, IC = 1.95), and ischemic heart disease (ROR = 3.37, IC = 1.75) indicated positive signals in HIF-PHIs. The median time to onset (TTO) of hypertension for HIF-PHIs was noted to be the earliest at 15.50 days.Conclusion: HIF-PHIs are related to multiple cardiovascular toxicities. Although disproportionality analysis is a hypothesis-driven method, improving the surveillance of these toxicities related to HIF-PHIs used in managing renal anemia is still crucial.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"873-882"},"PeriodicalIF":3.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143382089","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

Cytokine release syndrome associated with immune checkpoint inhibitors: a pharmacovigilance study based on spontaneous reports in FAERS. 与免疫检查点抑制剂相关的细胞因子释放综合征：基于 FAERS 自发报告的药物警戒研究。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-07-01 Epub Date: 2024-07-29 DOI: 10.1080/14740338.2024.2385489

Xin Xi, Xida Yan, Ying Chen, Wenjun Li, Jie Dong, Xuan Ou, Haowen Tan

{"title":"Cytokine release syndrome associated with immune checkpoint inhibitors: a pharmacovigilance study based on spontaneous reports in FAERS.","authors":"Xin Xi, Xida Yan, Ying Chen, Wenjun Li, Jie Dong, Xuan Ou, Haowen Tan","doi":"10.1080/14740338.2024.2385489","DOIUrl":"10.1080/14740338.2024.2385489","url":null,"abstract":"Objective: To describe cytokine release syndrome (CRS) associated with immune checkpoint inhibitors (ICIs) reported in the FDA Adverse Event Reporting System (FAERS).Methods: We obtained ICIs adverse event (AE) reports from January 2011 to September 2023 from the FAERS database. The preferred term (PT) 'cytokine release syndrome' from the Medical Dictionary for Regulatory Activities (MedDRA) 26.1 was used to identify cases with ICIs-related CRS. The reporting odds ratio (ROR) of the disproportionality method was performed to quantify the association between CRS and ICIs treatment strategy.Results: Three hundred and ninety-five cases were gathered. 42.03% of the patients were aged 18 to 65. Male patients outnumbered female patients (53.67% vs. 34.94%). The prevalent potential cancer types were lung cancer (33.42%) and skin cancer (20.51%). Japanese were responsible for the majority of ICIs-related CRS cases (176 cases). The combination of nivolumab and ipilimumab resulted in the most CRS cases (138 cases), and the ICIs combination therapy had the highest ROR signal value (ROR = 11.95 [10.14-14.06]). ICIs-related CRS had a median time to onset of 14 days (interquartile range [IQR] 7-43.25).Conclusions: ICIs-related CRS is an increasingly important immune-related AE. Our study provided helpful information to help medical professionals learn more about ICIs-related CRS.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"839-846"},"PeriodicalIF":3.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141758086","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

Eye disorders associated with selective serotonin reuptake inhibitors: a real-world disproportionality analysis of FDA adverse event reporting system. 与选择性 5-羟色胺再摄取抑制剂相关的眼部疾病：美国食品药物管理局不良事件报告系统的真实世界比例失调分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-07-01 Epub Date: 2024-07-29 DOI: 10.1080/14740338.2024.2385497

Jiahao Li, Rujia Zhong, Yi Guo, Feng Zhang

{"title":"Eye disorders associated with selective serotonin reuptake inhibitors: a real-world disproportionality analysis of FDA adverse event reporting system.","authors":"Jiahao Li, Rujia Zhong, Yi Guo, Feng Zhang","doi":"10.1080/14740338.2024.2385497","DOIUrl":"10.1080/14740338.2024.2385497","url":null,"abstract":"Background: Selective serotonin reuptake inhibitors (SSRIs) are widely used in depression and other psychiatric disorders. Despite their efficacy, there is a growing concern about the risk of eye disorders. This study aims to explore the potential correlation between eye disorders and SSRIs utilizing real-world data.Research design and methods: The data were extracted from the US FDA Adverse Event Reporting System database from 2004Q1 to 2023Q3. The analysis focused on the clinical characteristics, the ranking of adverse reactions, the time-to-onset, and the severity proportion of SSRI-related eye disorders.Results: Our analysis revealed that SSRIs were significantly associated with eye disorders, with a higher risk of vision blurred with escitalopram, angle closure glaucoma with citalopram, and photopsia with paroxetine. The most common eye disorders were vision blurred, visual impairment, mydriasis, etc. Most of these adverse events occurred within the first 30 days of treatment. The reported incidence of severe eye disorders was 38.6% for SSRIs, with fluoxetine exhibiting the highest rate at 45.9%.Conclusion: Our study demonstrates a significant association between SSRIs and the risk of eye disorders. These findings provide crucial insights for clinicians when prescribing SSRIs and underscore the need to monitor eye health in patients receiving these medications.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"853-863"},"PeriodicalIF":3.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141758087","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 the novel antiepileptic drug lamotrigine: a real-world pharmacovigilance study based on FAERS. 新型抗癫痫药物拉莫三嗪不良事件的评估：基于FAERS的真实世界药物警戒研究。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-07-01 Epub Date: 2025-02-25 DOI: 10.1080/14740338.2025.2465867

Lidan Tu, Jingyang Xiao, Qingxia Hong, Aijun Ouyang, Ying Tu, Shuping Wang

{"title":"Assessment of adverse events of the novel antiepileptic drug lamotrigine: a real-world pharmacovigilance study based on FAERS.","authors":"Lidan Tu, Jingyang Xiao, Qingxia Hong, Aijun Ouyang, Ying Tu, Shuping Wang","doi":"10.1080/14740338.2025.2465867","DOIUrl":"10.1080/14740338.2025.2465867","url":null,"abstract":"Background: Lamotrigine (LTG), a medication frequently prescribed for epilepsy. Despite its widespread use, there remains a lack of clarity regarding the drug's safety profile when used over extended periods in large patient populations. This study evaluated the safety profile of LTG using the FDA Adverse Event Reporting System (FAERS), aiming to enhance clinical decision-making.Research design and methods: We used disproportionate analyses, including the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and empirical Bayes geometric mean (EBGM), to identify signals of adverse reactions associated with LTG.Results: A total of 187,024 records were reported, involving 905 adverse drug event (ADE) signals across 27 system organs classes (SOCs). We detected several known adverse event (AE) signals from the clinical trial phase, including seizures, rash, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). Additionally, we uncovered several unforeseen and significant adverse effects that were not documented in the medication's prescribing information, encompassing suicides, atrial septal defects, Brugada syndrome, and signals associated with aortic stenosis.Conclusions: Our analysis in the post-marketing setting reveals new AE signals associated with LTG, highlighting the need for ongoing risk surveillance.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"805-814"},"PeriodicalIF":3.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143440352","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