Expert Opinion on Drug Safety最新文献_第5页

Incidence and risk of drug-induced interstitial lung disease associated with anti-neoplastic drugs. 与抗肿瘤药物相关的药物性间质性肺疾病的发病率和风险

IF 3.1 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-08-01 Epub Date: 2025-03-03 DOI: 10.1080/14740338.2025.2472918

Il-Hyung Hwang, Seung Hyeun Lee, Hankil Lee

{"title":"Incidence and risk of drug-induced interstitial lung disease associated with anti-neoplastic drugs.","authors":"Il-Hyung Hwang, Seung Hyeun Lee, Hankil Lee","doi":"10.1080/14740338.2025.2472918","DOIUrl":"10.1080/14740338.2025.2472918","url":null,"abstract":"Background: To evaluate the incidence and risk of drug-induced interstitial lung disease (DIILD) associated with anti-neoplastic drugs among patients with cancer in Korea.Research design and methods: This nested case-control study included 457,685 patients diagnosed with cancer and treated with anti-neoplastic drugs from a retrospective nationwide population-based cohort between 2017 and 2021. The incidence rate of DIILD and the risks of DIILD by anti-neoplastic drug categories were analyzed.Results: Among 270,595 patients, 2,634 developed ILD, resulting in an incidence rate of 4.12 per 1,000 person-years (95% confidence interval (CI): 3.97-4.28). DIILD was more prevalent in men, older patients, and those with a history of pulmonary disease or lung cancer. In a multivariable conditional logistic regression analysis, immune checkpoint inhibitors (odds ratio (OR): 2.37; 95%CI: 1.48-3.78), mammalian target of rapamycin inhibitors (OR: 9.79; 95%CI: 5.20-18.45), antibody-drug conjugates (OR: 7.99; 95%CI: 3.24-19.74), cyclin-dependent kinase 4/6 inhibitors (OR: 2.28; 95%CI: 1.26-4.12), and any combination of different drug categories (OR: 1.93; 95%CI: 1.21-3.09) were associated with an increased risk of DIILD.Conclusion: Our findings suggest that the risk of incident DIILD depends on the category of anti-neoplastic drugs. Patients with identified risk factors and treated with these drugs should be monitored closely.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"899-907"},"PeriodicalIF":3.1,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143500117","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 role of artificial intelligence in pharmacovigilance for rare diseases. 人工智能在罕见病药物警戒中的作用。

IF 3.1 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-08-01 Epub Date: 2025-03-03 DOI: 10.1080/14740338.2025.2474645

Ashish Jain, Zahabia Adenwala

{"title":"The role of artificial intelligence in pharmacovigilance for rare diseases.","authors":"Ashish Jain, Zahabia Adenwala","doi":"10.1080/14740338.2025.2474645","DOIUrl":"10.1080/14740338.2025.2474645","url":null,"abstract":"Introduction: There are considerable gaps in the conventional pharmacovigilance (PV) measures which might result in significant safety issues, especially in monitoring the effectiveness of orphan drugs that are used to treat rare diseases. In this paper, we evaluate if and how Artificial Intelligence (AI) and Machine Learning (ML) can be used to mitigate these problems.Areas covered: The article identifies ineffective adverse events (AE) reporting systems, low patient enrollment, and weak signal monitoring as barriers to the effective safety evaluation of rare diseases. It also addresses the possibility of employing AI and ML technologies to automate the reporting of AEs by integrating data from multiple sources and increasing the sensitivity of risk detection. The method to conduct the literature search consisted of searching PubMed and Google Scholar for relevant AI and ML studies and publications about PV.Expert opinion: We identified technical and regulatory concerns such as privacy and model explainability as hurdles to the adoption of AI in PV. However, the same technology, if properly integrated into the system, has the potential to enhance treatment monitoring for rare diseases and to increase the rate of new therapies being developed.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"893-898"},"PeriodicalIF":3.1,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143531579","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

Long-term safety profile and secondary effectiveness of canakinumab in pediatric rheumatic diseases: a single-center experience. 卡纳金单抗治疗小儿风湿病的长期安全性和辅助疗效：单中心经验。

IF 3.1 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-08-01 Epub Date: 2024-08-01 DOI: 10.1080/14740338.2024.2386370

Elif Kilic Konte, Nergis Akay, Umit Gul, Kubra Ucak, Ecenur Izzete Derelioglu, Damla Gurleyik, Esma Aslan, Aybuke Gunalp, Fatih Haslak, Mehmet Yildiz, Amra Adrovic, Sezgin Sahin, Kenan Barut, Ozgur Kasapcopur

{"title":"Long-term safety profile and secondary effectiveness of canakinumab in pediatric rheumatic diseases: a single-center experience.","authors":"Elif Kilic Konte, Nergis Akay, Umit Gul, Kubra Ucak, Ecenur Izzete Derelioglu, Damla Gurleyik, Esma Aslan, Aybuke Gunalp, Fatih Haslak, Mehmet Yildiz, Amra Adrovic, Sezgin Sahin, Kenan Barut, Ozgur Kasapcopur","doi":"10.1080/14740338.2024.2386370","DOIUrl":"10.1080/14740338.2024.2386370","url":null,"abstract":"Background: To demonstrate the long-term safety profile of canakinumab over a nine-year period by documenting adverse events in patients with various pediatric rheumatic diseases.Research design and methods: This retrospective observational study was conducted at the Pediatric Rheumatology Department of Istanbul University Cerrahpasa between 2015 and 2023. The analysis concerned individuals who had been administered canakinumab treatment for at least six months. The exposure-adjusted event rates were calculated as adverse events per 100 patient days and were compared among three groups based on the cumulative canakinumab dose of <35 mg/kg, 35-70 mg/kg, and >70 mg/kg.Results: Among 189 patients, the median exposure time to canakinumab was 2.9 (1.5-4.1) years, corresponding to 573.4 patient years. The median cumulative dose of canakinumab was 2205 (1312-3600) mg. The most common adverse event was upper respiratory tract infection (0.76), followed by urinary tract infection (0.02), pneumonia (0.009), latent tuberculosis (0.009) and lymphadenitis (0.004). A total of 55 serious adverse events (0.025) were reported, 12 (0.006) of which led to drug discontinuation. The event rate of macrophage activation syndrome and disease exacerbation was statistically higher in patients receiving <35 mg/kg cumulative canakinumab dose (p < 0.05).Conclusions: An increase in side effect was not observed with the increasing cumulative doses of canakinumab. Canakinumab demonstrated long-term safety with appropriate indication and monitoring.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"915-923"},"PeriodicalIF":3.1,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141787739","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Post-marketing safety surveillance of fostamatinib: an observational, pharmacovigilance study leveraging FAERS database. 福斯塔替尼上市后安全性监测：一项利用 FAERS 数据库进行的观察性药物警戒研究。

IF 3.1 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-08-01 Epub Date: 2024-08-01 DOI: 10.1080/14740338.2024.2387315

Wei Wei, Ying-Tao Bai, En Chang, Jin-Feng Liu

{"title":"Post-marketing safety surveillance of fostamatinib: an observational, pharmacovigilance study leveraging FAERS database.","authors":"Wei Wei, Ying-Tao Bai, En Chang, Jin-Feng Liu","doi":"10.1080/14740338.2024.2387315","DOIUrl":"10.1080/14740338.2024.2387315","url":null,"abstract":"Objective: Fostamatinib, an FDA-approved oral small-molecule spleen tyrosine kinase (SYK) inhibitor, is used to treat thrombocytopenia in adults with chronic immune thrombocytopenia (ITP) who have not responded to previous treatments. However, comprehensive safety data is lacking. This study uses the FDA Adverse Event Reporting System (FAERS) database to explore real-world adverse events (AEs) related to fostamatinib, aiming to inform its clinical use.Methods: The FAERS database was retrospectively queried to extract reports associated with fostamatinib from 2019 to 2023. To identify and evaluate potential AEs in patients receiving fostamatinib, various disproportionality analyses such as the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN), and the multi-item gamma Poisson shrinker (MGPS) were employed.Results: A total of 23 AE signals were included in our analysis. Among them, hypertension, blood pressure increase, blood pressure abnormality, hepatic enzyme increase, and diarrhea were consistent with the common AEs described for fostamatinib in clinical trials. In addition, unexpected serious AEs were detected including cerebral thrombosis and necrotizing soft tissue infection. The median time to onset of fostamatinib-related AEs was 86 days.Conclusion: Our investigation revealed several possibly emergent safety concerns associated with fostamatinib in real-world clinical practice, which might provide essential vigilance evidence for clinicians and pharmacists to manage the safety issues of fostamatinib.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"991-999"},"PeriodicalIF":3.1,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141792319","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

Disproportionality analysis of data from VigiBase and other global product safety databases on toxicity of iron chelating agents. 对 VigiBase 和其他全球产品安全数据库中有关铁螯合剂毒性的数据进行比例失调分析。

IF 3.1 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-08-01 Epub Date: 2024-08-01 DOI: 10.1080/14740338.2024.2386371

Burcu Eda Arda, Hande Sipahi

{"title":"Disproportionality analysis of data from VigiBase and other global product safety databases on toxicity of iron chelating agents.","authors":"Burcu Eda Arda, Hande Sipahi","doi":"10.1080/14740338.2024.2386371","DOIUrl":"10.1080/14740338.2024.2386371","url":null,"abstract":"Background: Iron chelators; deferasirox, deferiprone, and deferoxamine; used to treat iron toxicities due to excessive ingestions or blood transfusions, may cause serious adverse reactions.Research design and methods: This study investigates pharmacovigilance data to uncover unknown safety information. Disproportionality analysis was conducted using VigiBase, the WHO global database of individual case safety reports, to known safety profile of products and the FDA Adverse Event Reporting System, reviewing over 117.000 iron chelator cases between 2010 and 2020.Results: Commonly reported adverse events for iron chelators are general disorders and administration site conditions and GI-related disorders. Reporting Odds Ratio was calculated for iron chelator associations to headache (common), blurred vision (rare) and sepsis (serious). Strong association between deferoxamine and blurred vision (ROR: 2.47 in VigiBase and 3.04 in FAERS), deferiprone and sepsis (ROR; 5.95 in VigiBase and 1.24 in FAERS) were identified. However, results showed some inconsistent associations, such as headache and deferiprone, blurred vision and deferasirox association as per FAERS data; sepsis and deferasirox and deferoxamine association as per VigiBase data. Forty-five new potential signals with different associative values were suggested.Conclusion: The study identified strong associations between specific iron chelators and adverse events, though some inconsistencies were observed in the data. These findings, including the 45 new potential signals, suggest areas for further review and validation with additional data.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"937-948"},"PeriodicalIF":3.1,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141787738","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

Comparing musculoskeletal and connective tissue disorder risks of teriparatide and abaloparatide in osteoporosis: an analysis based on FDA adverse event reporting system (FAERS). 比较特立帕肽和阿巴帕肽治疗骨质疏松症的肌肉骨骼和结缔组织疾病风险：基于 FDA 不良事件报告系统 (FAERS) 的分析。

IF 3.1 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-08-01 Epub Date: 2024-07-18 DOI: 10.1080/14740338.2024.2382228

Ming-Tao Wen, Di Luo, Jia-Cheng Li, Bo-Wen Lu, Pei-Xue Ling, Fei Liu, Gang Li

{"title":"Comparing musculoskeletal and connective tissue disorder risks of teriparatide and abaloparatide in osteoporosis: an analysis based on FDA adverse event reporting system (FAERS).","authors":"Ming-Tao Wen, Di Luo, Jia-Cheng Li, Bo-Wen Lu, Pei-Xue Ling, Fei Liu, Gang Li","doi":"10.1080/14740338.2024.2382228","DOIUrl":"10.1080/14740338.2024.2382228","url":null,"abstract":"Background: Osteoporosis (OP), characterized by low bone mass and increased fracture risk, is a prevalent skeletal disorder. Teriparatide (TP) and abaloparatide (ABL) are anabolic agents that may reduce fracture incidence, but their impact on musculoskeletal and connective tissue disorders (MCTD) risk is uncertain.Research design and methods: A retrospective, observational disproportionality analysis was conducted utilizing FAERS data from Q1 2004 to Q3 2023, where TP or ABL was identified as the primary suspect drug. Multiple data mining algorithms, including reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS), were employed to detect MCTD safety signals.Results: A total of 366,747 TP-related and 422,377 ABL-related cases were identified, predominantly among female patients aged ≥45 years. The top specific AEs involved musculoskeletal, connective tissue, and administration site disorders. Comparative analysis revealed a higher frequency of AEs related to the nervous, cardiovascular, and gastrointestinal systems for ABL compared to TP. Both drugs exhibited strong signals for arthralgia, limb pain, back pain, muscle spasms, bone pain, muscle pain, and muscle weakness.Conclusion: The analysis suggests a potential MCTD risk with TP and ABL treatment in OP patients, highlighting the need for AE monitoring and management in clinical practice. This contributes to a better understanding of the safety profiles of these anabolic medications.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1001-1010"},"PeriodicalIF":3.1,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141626516","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Post-marketing safety concern of PI3K inhibitors in the cancer therapies: an 8-year disproportionality analysis from the FDA Adverse Event Reporting System. 癌症疗法中 PI3K 抑制剂上市后的安全性问题：美国食品及药物管理局不良事件报告系统的 8 年比例失调分析。

IF 3.1 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-08-01 Epub Date: 2024-09-18 DOI: 10.1080/14740338.2024.2387317

Xiaorong Lin, Yimin Zhang, Hongyan Huang, Wei Zhuang, Lisha Wu

{"title":"Post-marketing safety concern of PI3K inhibitors in the cancer therapies: an 8-year disproportionality analysis from the FDA Adverse Event Reporting System.","authors":"Xiaorong Lin, Yimin Zhang, Hongyan Huang, Wei Zhuang, Lisha Wu","doi":"10.1080/14740338.2024.2387317","DOIUrl":"10.1080/14740338.2024.2387317","url":null,"abstract":"Background: The Phosphoinositide 3-kinases (PI3Ks) family plays a crucial role in tumorigenesis. Alpelisib (inhibiting PI3Kα), copanlisib (inhibiting PI3Kα andPI3Kδ), duvelisib (inhibiting PI3Kδ and PI3Kγ), and idelalisib (inhibiting PI3Kδ) were developed to target the PI3K pathway. However, the toxicity limits their application to some extent. It's necessary to investigate the adverse effects (AEs) of these inhibitors.Research design and methods: We conducted a comparative analysis of the safety signals of AEs in PI3K inhibitors using disproportionality analysis in the FDA Adverse Event Reporting System database(FAERS).Results: Our study identified significant safety signals for metabolic disorders with all PI3K inhibitors. Notable safety signals for gastrointestinal disorders were observed with most PI3K inhibitors, with the exception of copanlisib. Common AEs shared among all PI3K inhibitors included colitis and dehydration. Alpelisib displayed unique AEs associated with metabolic disorders, whereas copanlisib exhibited idiosyncratic AEs linked to cardiac and vascular disorders. Stevens-Johnson syndrome emerged as a common severe adverse event (SAE) among alpelisib, copanlisib, and idelalisib, while febrile neutropenia was prevalent among copanlisib, duvelisib, and idelalisib. Intestinal perforation was solely associated with alpelisib.Conclusions: The safety profiles of the five PI3K inhibitors vary concerning adverse events. These findings could guide drug selection and inform future prospective research.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"925-936"},"PeriodicalIF":3.1,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141859475","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Post-marketing safety monitoring of tirzepatide: a pharmacovigilance study based on the FAERS database. 替西帕肽上市后安全性监测：基于FAERS数据库的药物警戒研究

IF 3.1 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-08-01 Epub Date: 2025-03-08 DOI: 10.1080/14740338.2025.2468860

Han Chen, Yuhang Ding, Yongqi Shan

{"title":"Post-marketing safety monitoring of tirzepatide: a pharmacovigilance study based on the FAERS database.","authors":"Han Chen, Yuhang Ding, Yongqi Shan","doi":"10.1080/14740338.2025.2468860","DOIUrl":"10.1080/14740338.2025.2468860","url":null,"abstract":"Objective: To explore adverse drug events (ADEs) associated with tirzepatide using real-world data from the U.S. Food and Drug Administration's Adverse Event Reporting System (FAERS) database to guide its safe management.Methods: ADE reports from the second quarter of 2022 to the fourth quarter of 2023 were analyzed using the Reporting Odds Ratio (ROR) and Bayesian Confidence Propagation Neural Network (BCPNN) methods. Gender-specific differences and reporting biases were also assessed.Results: Among 25,212 tirzepatide-related ADE reports, 101 significant ADE signals across 15 system organ classifications were identified. Common ADEs included nausea (n = 3030, ROR 5.38) and vomiting (n = 1147, ROR 3.44). Previously unreported ADEs included eructation (n = 500, ROR 46.56), gastroesophageal reflux disease (n = 191, ROR 3.24), injection site hemorrhage (n = 1610, ROR 27.8), and increased blood glucose (n = 641, ROR 6.22). Women reported more injection-site reactions, while men experienced more gastrointestinal issues. Weibull analysis indicated a median ADE onset time of 23 days (IQR: 6-90 days).Conclusion: This pharmacovigilance study identified both known and novel ADEs of tirzepatide, highlighting gender differences and reporting biases. Close monitoring and further research are needed to ensure its safe use.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"959-967"},"PeriodicalIF":3.1,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143556224","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

Systematic analysis of the adverse effects of commonly used clinical tetracycline drugs based on the FAERS database. 基于 FAERS 数据库对临床常用四环素药物不良反应的系统分析。

IF 3.1 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-08-01 Epub Date: 2024-08-19 DOI: 10.1080/14740338.2024.2392865

Chun-Yan Xiong, Yong-Min Yang, Ying Zhou, Tian-Shu He, Xing-Wei Luo, Jiang Wang, Chen-Xue Mao

{"title":"Systematic analysis of the adverse effects of commonly used clinical tetracycline drugs based on the FAERS database.","authors":"Chun-Yan Xiong, Yong-Min Yang, Ying Zhou, Tian-Shu He, Xing-Wei Luo, Jiang Wang, Chen-Xue Mao","doi":"10.1080/14740338.2024.2392865","DOIUrl":"10.1080/14740338.2024.2392865","url":null,"abstract":"Background: Tetracyclines are a class of antibacterial drugs commonly used in clinical practice, but there is no systematic analysis of the adverse effects (AEs) of these drugs. We performed such pharmacovigilance analyses using the US Food and Drug Administration Adverse Event Reporting System (FAERS) database to explore tetracycline-related AEs.Research design and methods: We used the pharmacovigilance analysis tool Open Vigil 2.1 to access FAERS data and obtained AE reports from January 2004 to June 2023, including doxycycline, minocycline, tigecycline, omadacycline, sarecycline, and eravacycline as the top suspect drugs. The signal value of the AE of the analyzed drug was calculated by the reporting odds ratio (ROR).Results: A total of 15,020 cases were identified by analyzing drugs. In terms of adverse signals, doxycycline caused gastrointestinal mucosal necrosis (ROR = 1699.652); minocycline was reported to cause bone hyperpigmentation (ROR = 30976.223); tigecycline is responsible for blood fibrinogen decreased (ROR = 1714.078).Conclusions: AE reports of tetracycline drugs varied significantly. We found some AEs not mentioned in the instruction, such as the ototoxicity of tetracyclines. Doxycycline was associated with psychiatric side effects; minocycline presented in thyroid and skin tissue-associated tumors; abnormal signals were detected with eravacycline in the blood system.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"949-957"},"PeriodicalIF":3.1,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141975484","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

Signal of dementia with proton pump inhibitor after minimizing competition bias: an updated disproportionality analysis. 尽量减少竞争偏差后的质子泵抑制剂痴呆症信号：最新比例失调分析。

IF 3.1 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-08-01 Epub Date: 2024-08-05 DOI: 10.1080/14740338.2024.2387314

Bin Wu, Min Xiao, Fengbo Wu, Ting Xu

{"title":"Signal of dementia with proton pump inhibitor after minimizing competition bias: an updated disproportionality analysis.","authors":"Bin Wu, Min Xiao, Fengbo Wu, Ting Xu","doi":"10.1080/14740338.2024.2387314","DOIUrl":"10.1080/14740338.2024.2387314","url":null,"abstract":"Objective: The association between proton pump inhibitor (PPI) and dementia was controversial. The aim of the current study was to perform an updated pharmacovigilance analysis of the association between dementia event and PPI treatment after minimizing competition bias.Methods: We gathered cases reported with PPI treatment based on the United States Food and Drug Administration Adverse Event Reporting System database from 2004 to 2023. We employed disproportionality algorithms, including reporting odds ratio (ROR) and the information component (IC), to detect the association between dementia event and PPI. We investigated the affection of event competition bias on the current disproportionality signal detection.Results: We finally included a total of 776,191 PPI cases, and 1813 cases in the dementia group. Analyzing primary suspect PPIs, we detected a significant association between dementia and PPI (ROR = 1.38, 95%CI 1.22 to 1.56; IC = 0.46, 95%CI 0.04 to 0.86). After excluding the PPI case with renal injury events, the strength of the dementia signal increased. Omeprazole (589 cases), pantoprazole (514 cases), and esomeprazole (386 cases) were the top three PPI reported with dementia events.Conclusion: The current pharmacovigilance study identified a significant association between dementia and PPIs, except vonoprazan and tegoprazan, especially taking competition bias into account. Further high-quality prospective study still needed.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"969-976"},"PeriodicalIF":3.1,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141855343","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