Current drug safety最新文献

{"title":"Optimizing Management of Newly Diagnosed T2DM Mellitus Through Combination Therapy: Efficacy, Safety, and Individualized Care Approaches.","authors":"Ahmad Alam, Sulthan Al Rashid, Rajkapoor Balasubramanian, Naina Mohamed Pakkir Maideen, Palanisamy Amirthalingam","doi":"10.2174/0115748863463809260715073035","DOIUrl":"https://doi.org/10.2174/0115748863463809260715073035","url":null,"abstract":"<p><strong>Background: </strong>Prolonged hyperglycemia, increasing beta-cell loss, and therapeutic inertia are common outcomes of the conventional stepwise approach to treating newly diagnosed type 2 diabetes mellitus (T2DM). In order to quickly achieve glycemic objectives and alter the course of the disease, recent guidelines recommend early combination therapy. However, putting this paradigm into practice necessitates careful assessment of diverse pharmacological profiles. The goal of this review is to assess the available data on early combination therapy for newly diagnosed T2DM, with an emphasis on safety profiles, clinical efficacy, and patient care strategies.</p><p><strong>Methods: </strong>Recent clinical trials (RCTs), meta-analyses, and significant international guidelines evaluating initial triple therapy against sequential monotherapy were identified by searching online databases such as Web of Science, PubMed, and Scopus. Medical Subject Headings (MeSH) terms such as \"triple combination therapy,\" \"newly diagnosed diabetes mellitus,\" \"T2DM,\" and \"cost-effectiveness\" were included in the search strategy. RCTs, real-world observational studies, and health-economic evaluations were all included in the review.</p><p><strong>Results: </strong>In terms of achieving and sustaining HbA1c objectives, promoting weight loss, and preserving beta-cell activity, early combination therapy shows higher efficacy. Additionally, compared with earlier secretagogue-based regimens, contemporary combinations have superior safety profiles, reducing the incidence of hypoglycemia and adverse effects. Importantly, the choice of agents needs to be customized. The optimal therapy combination is determined by patient- specific factors, such as the presence of atherosclerotic cardiovascular disease (ASCVD), heart failure, chronic kidney disease (CKD), baseline HbA1c, weight management objectives, and socioeconomic factors.</p><p><strong>Conclusion: </strong>A proactive transition from sequential add-on therapy to initial combination regimens is necessary to optimize the management of newly diagnosed T2DM. Clinicians can optimize cardiometabolic benefits, guarantee long-term safety, and enhance overall quality of life by using a patient-centered, customized approach.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.2,"publicationDate":"2026-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148599872","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pharmacists' Role in Ensuring Safe Handling and Administration of Anticancer Medications in India.","authors":"M V Neethu, Vikas Pandey, Mohana Lakshmi, C K Ashok Kumar, Palakurthi Yanadaiah, Hemraj Singh Rajput, K Anjali, Sagar Pamu","doi":"10.2174/0115748863433931260707115559","DOIUrl":"https://doi.org/10.2174/0115748863433931260707115559","url":null,"abstract":"<p><p>Pharmacists play a significant role in oncology with respect to the safe handling and administration of anti-cancer drugs. This comprehensive review analyses pharmacists' roles, emphasising adherence to national and international safety standards and the implementation of institutional programs for protocols, training, and certification. Pharmacists will aid in the formulation and adjustment of chemotherapy medications through Personal Protective Equipment kits and working practices. Among administration methods, intravenous chemotherapy, oral anticancer agents, and special routes, such as intrathecal, can be used. Other notable responsibilities of pharmacists' work are medication safety, occupational exposure risk, and pharmacovigilance. Pharmacists can gain practical insights through case studies and possibly help prevent and control errors by implementing systemic strategies. Pharmacists are also involved in counselling and teaching patients for treatment, managing side effects, and other policies that enhance compliance. This review provides valuable insights into interprofessional collaboration to improve patient safety and achieve optimal outcomes. Emerging technologies and innovations are having a growing impact on medication management, and pharmacists have been recognised as playing a vital role in ensuring safe adoption in oncology practice. Continuous education and professional development enable pharmacists to stay up to date on the latest advancements, providing the best possible care. This review discusses the essential contributions pharmacists make to the oncology department by improving the care, safety, and efficacy of anticancer treatment, demonstrating their commitment to excellence and adaptability in healthcare settings.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.2,"publicationDate":"2026-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148599953","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Fluoroquinolone-induced liver injury and pharmacists' interventions in pneumonia: a case report and clinical pharmacist intervention.","authors":"Man Lv, Junmin Zheng, Youping Zhang, Xiaoshuang Wang, Jinmin Shi, Ping Long","doi":"10.2174/0115748863428609251111141726","DOIUrl":"https://doi.org/10.2174/0115748863428609251111141726","url":null,"abstract":"<p><p>Background The diagnosis of drug-induced liver injury (DILI) is difficult due to insufficient awareness of DILI and the lack of specific objective diagnostic tests. The importance of pharmacists' care during hospitalization is underestimated. Our aim is to review the clinical features of fluoroquinolone-induced liver injury and to highlight the importance of pharmacists' intervention in fluoroquinolone-induced liver injury. . Case presentation: An 81-year-old Chinese man was admitted to hospital for the treatment of community-acquired pneumonia. After admission, he developed chronic subdural hematoma as his condition deteriorated, followed by intracranial infection after the cranial trepanation. On day 15, the patient still presented with fever and altered consciousness. Moxifloxacin (IV, 400 mg QD) was administered as the pulmonary infection became worse. Elevated liver enzymes were then observed with alanine aminotransferase (ALT) rising from 27 U/L to 387 U/L after the three-day use of moxifloxacin. With the help of pharmacists' interventions, drug-induced liver injury was identified. Moxifloxacin was discontinued immediately and replaced with meropenem (IV, 1g, Q8h). Within another 7 days, the patient's fever subsided, liver function normalized, and consciousness improved. He was successfully discharged from the hospital 30 days after admission. Written informed consent was obtained from the patient. Ethics approval was waived by the Institutional Review Board of Taikang Tongji (Wuhan) Hospital. Conclusions: Fluoroquinolone-induced liver injury are rare but can be lethal. Pharmacists' interventions enable collaborative decision-making and can help improve the management in fluoroquinolone-induced liver injury.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.2,"publicationDate":"2026-07-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148520196","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Recognizing Subtle Neurological Adverse Effects of Fluoroquinolones: A Case Report of Isolated Dysarthria.","authors":"Benedetto Caroleo, Gianmarco Marcianò, Giuseppe Bertucci, Marica Caruso, Caterina Di Masi, Giovanni Antonio Fiorino, Remigio Iacopino, Francesco Marra, Marilena Mitra, Elisabetta Pedace, Vincenzo Rania, Domenica Scumaci, Luca Gallelli","doi":"10.2174/0115748863481172260619073442","DOIUrl":"https://doi.org/10.2174/0115748863481172260619073442","url":null,"abstract":"<p><strong>Background: </strong>Fluoroquinolones may have negative effects on the central nervous system; isolated dysarthria has not been thoroughly described.</p><p><strong>Case: </strong>Piperacillin/tazobactam and high-dose levofloxacin were used to treat a severe case of Legionella pneumophila pneumonia in a 55-year-old man with diabetes and temporary renal failure who was admitted to the hospital. On the eighth day of treatment, he experienced sudden dysarthria without any additional neurological impairment. Magnetic resonance angiography and brain magnetic resonance imaging results were negative. After levofloxacin was stopped two days later and replaced with azithromycin, the patient's dysarthria completely disappeared, and he was discharged on azithromycin (500 mg for 11 days). The Naranjo score (likely adverse reaction) was 6.</p><p><strong>Conclusion: </strong>This case report highlights the importance of quickly identifying even mild neurological problems in fluoroquinolone-treated patients, especially when risk factors are present. In a broader sense, it upholds the concepts of patient safety and therapeutic appropriateness, which state that drugs should only be used when necessary and should be stopped immediately if they have negative side effects. In this regard, strict adherence to the current regulatory cautions about fluoroquinolones is necessary.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.2,"publicationDate":"2026-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148395897","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Explainable Artificial Intelligence in Pharmacovigilance and Drug Safety: A Systematic Review of Enhancing Transparency and Regulatory Acceptance.","authors":"Virendra S Gomase, Shenbagavel Vairachilai, Rupali Sharma, Suchita P Dhamane, Satish Sardana, Bijith Marakarkandy, Sandeep Kelkar","doi":"10.2174/0115748863467208260529094811","DOIUrl":"https://doi.org/10.2174/0115748863467208260529094811","url":null,"abstract":"<p><strong>Introduction: </strong>Explainable Artificial Intelligence (XAI) is rapidly transforming drug safety assessment by making complex AI models interpretable, transparent, and trustworthy for clinicians, healthcare regulators, and patients. This study emphasizes recent advances in the methodologies of XAI, including rule-based, post hoc, and hybrid models, and assesses the effectiveness of these approaches in pharmacovigilance and drug discovery.</p><p><strong>Method: </strong>This paper evaluates the state-of-the-art techniques in XAI methods, such as methodbased or rule-based approaches, post-hoc explanation methods, and hybrid methods in general, used in drug safety and pharmaceutical-related research and applications. The role and treatment of explainability in AI in the EU AI Act and EU MDR regulations will also be discussed in this paper.</p><p><strong>Results: </strong>Integration of XAI into clinical prediction systems (CPS) evaluation will increase the level and quality of transparency and error identification, and clinician trust, although with a trade-off between interpretation and accuracy within prediction tasks. There is a shift towards greater focus on transparency and human evaluation mentioned within regulatory frameworks, although there is no standardization with respect to clinical prediction systems (CPS) evaluation and validation of XAI.</p><p><strong>Discussion: </strong>Emerging technologies emphasize the importance of clinician-centric design, personalized and causal inference-based explanations, and the integration of technical aspects and clinician feedback. Large research gaps are present in the standardization of evaluation criteria, ethical integration, and real-world clinically valid XAI systems.</p><p><strong>Conclusion: </strong>In clinical applications associated with drug safety, emerging areas of research should be targeted towards collaborations, evaluations, and XAI design adaptable to meeting growing demands for operation, acceptability, and patient safety.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.2,"publicationDate":"2026-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148344097","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Intravenous Methylcobalamin-Induced Anaphylactic Shock: A Case Report.","authors":"Alaimagal Ravi, Lalitha R, Sam Johnson Udaya Chander J","doi":"10.2174/0115748863468407260605062252","DOIUrl":"https://doi.org/10.2174/0115748863468407260605062252","url":null,"abstract":"<p><strong>Background: </strong>Methylcobalamin is a naturally occurring, active form of Vitamin B12. Vitamin B12 is essential for the growth and development of healthy nerves and red blood cell production. Usually, the requirement of vitamin B12 is increased in thyrotoxicosis due to increased utilization and accelerated turnover imposed by increased metabolism. Vitamin B12 is generally well-tolerated and widely used in clinical settings. Parenteral vitamin B12 treatment in hospitalized patients is considered an effective therapy regardless of its etiology.</p><p><strong>Case presentation: </strong>Herein, we report the case of a 26-year-old female patient admitted to the Obstetrics and Gynaecology department. She received a slow intravenous methylcobalamin injection on the 4th day of admission for his complaints. Then, she was administered with 2nd dose of intravenous methylcobalamin, after which she developed anaphylactic shock immediately. To address these serious adverse effects, the patient was administered Critical care with cardiopulmonary resuscitation without further delay. The patient had a spontaneous return of circulation within a few minutes of high-quality cardiopulmonary resuscitation. After treatment, the patient recovered and was discharged from the hospital.</p><p><strong>Conclusion: </strong>Anaphylactic shock, after slow intravenous methylcobalamin injection, is an uncommon but potentially serious adverse effect. The purpose of this case report is to highlight the importance of this rare but serious life-threatening adverse effect. To our knowledge, this is the first reported case of intravenous methylcobalamin-induced anaphylactic shock. Physicians and healthcare teams should be cautious while administering methylcobalamin to patients, especially via the intravenous route.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":1.2,"publicationDate":"2026-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148263707","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pharmacovigilance Analysis of Azelastine-Related Adverse Events: Insights from the FDA FAERS Database (2006-2024).","authors":"Feihong Liang, Lulu Chen, Caixi Hu, Renbin Lu, Caihui He, Guodong Yu","doi":"10.2174/0115748863416393260406204526","DOIUrl":"https://doi.org/10.2174/0115748863416393260406204526","url":null,"abstract":"<p><strong>Background: </strong>Azelastine is widely used in the treatment of allergic rhinitis, and it is necessary to gain insight into the true extent of adverse events (AEs) associated with it.</p><p><strong>Methods: </strong>This pharmacovigilance study was based on an analysis of reports from the FDA Adverse Event Reporting System (FAERS) for the period January 1, 2006, to December 31, 2024. AEs of drugs were compared using the Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), Bayesian Confidence Propagation Neural Network (BCPN), and Multi-item Gamma Poisson Shrinkage (MGPS).</p><p><strong>Results: </strong>The number of AE occurrences in Respiratory, thoracic, and mediastinal disorders and Product issues was high. There is a significant difference in the proportion of occurrence between men and women. All AEs listed in the drug insert were validated through this analysis. In addition to the improvement of the drug process, the focus should still be on the adverse reactions such as Dysgeusia, Nasal discomfort, and Somnolence.</p><p><strong>Conclusion: </strong>This study systematically depicts the safety profile of azelastine by analysing large-scale adverse reaction data and provides empirical evidence for the improvement of clinical dosing guidelines and risk communication strategies. Pharmacovigilance departments should maintain vigilance for rare but serious adverse reactions to azelastine to optimize its risk-benefit profile.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":0.7,"publicationDate":"2026-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148197585","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessing the Risk of Drug-Induced Influenza-Like Illness: A Disproportionality Analysis of Two Decades of FAERS Data (2004-2025).","authors":"Xing Gao, Xhuang Chen, Jie Zu, Tianya Liu","doi":"10.2174/0115748863440350260326055214","DOIUrl":"https://doi.org/10.2174/0115748863440350260326055214","url":null,"abstract":"<p><strong>Introduction: </strong>With the rising incidence of Influenza-like Illness (ILI), comprehensive studies on causative drugs remain lacking. This study aimed to detect drugs associated with ILI through disproportionality analysis of the FDA Adverse Event Reporting System (FAERS) database.</p><p><strong>Methods: </strong>Adverse Event (AE) reports were extracted from the FAERS database for the period spanning 2004 Q1 through 2025 Q1. The Medical Dictionary for Regulatory Activities (MedDRA) was used to identify ILI cases. Four statistical methods were employed to identify drugs with positive signals: the Reporting Odds Ratio (ROR), the Proportional Reporting Ratio (PRR), the Bayesian Confidence Propagation Neural Network (BCPNN), and the Empirical Bayes Geometric Mean (EBGM).</p><p><strong>Results: </strong>Our analysis identified 77,060 ILI-associated reports. A total of 60 drugs exhibited positive signals. The 5 most frequently reported drugs were interferon β-1a, evolocumab, ofatumumab, interferon β-1b, and zoledronic acid. Under the ATC1 classification, antineoplastic and immunomodulating agents accounted for the majority of reported cases (n=43,436), followed by nervous system agents (n=8,941), cardiovascular system agents (n=6,871), and musculoskeletal system agents (n=5,577). Weibull shape parameter analyses revealed β<1 for most drugs, indicating that drug-induced ILI predominantly manifested early failure types.</p><p><strong>Discussion: </strong>This study confirms known ILI risks (e.g., interferons) and reveals new signals for immunotherapies and lipid-lowering agents, providing evidence for prescribing updates. Timeto- onset analysis shows declining risk over time, highlighting the need for early symptom monitoring.</p><p><strong>Conclusion: </strong>This first comprehensive FAERS study identifies key drugs associated with ILI, including interferon β-1a, evolocumab, ofatumumab, interferon β-1b, and zoledronic acid. Clinical monitoring for drug-induced ILI is essential to enhance medication safety.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":0.7,"publicationDate":"2026-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148143001","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Possible Protective Effect of Cerium Oxide Nanoparticles on Colistin-Induced Injury in Renal Cortex of Adult Male Albino Rats: Light and Electron Microscopic Study.","authors":"Azza I Helal, Aml Younis Marei, Maha Mohamed Abo Gazia, Sherif Abdelbaky, Marwa M Abd-Elsalam","doi":"10.2174/0115748863457976260326200744","DOIUrl":"https://doi.org/10.2174/0115748863457976260326200744","url":null,"abstract":"<p><strong>Introduction: </strong>Acute Kidney Injury (AKI) is a rapid decline in renal function. Colistin, a last resort antibiotic for multidrug-resistant infections, is associated with significant nephrotoxicity. Cerium oxide nanoparticles (CeONPs) are potent scavengers of reactive oxygen species (ROS), exhibiting antioxidant and anti-inflammatory properties. This study aimed to investigate the protective effects of CeONPs against colistin-induced renal damage in adult male albino rats.</p><p><strong>Methods: </strong>Forty-eight adult male albino rats were equally divided into four groups: Group I (Control), Group II (CeONPs), Group III (Colistin), and Group IV (CeONPs + Colistin). At the end of the experiment, blood samples were collected to assess renal function by measuring serum urea and creatinine. Kidney tissue was processed for histological examination and immunohistochemical staining to evaluate the expression of the inflammatory marker for nuclear factor Kappa B (NF-κB).</p><p><strong>Results: </strong>Colistin administration in Group III resulted in significant renal impairment, characterized by elevated serum urea and creatinine, severe histopathological damage (including tubular necrosis), and a marked increase in NF-κB expression. In contrast, rats pre-treated with CeONPs (Group IV) demonstrated significantly improved kidney function tests, a substantial reduction in histopathological lesions, and a notable decrease in NF-κB expression compared to the colistin group.</p><p><strong>Discussion: </strong>Colistin induces AKI through increased membrane permeability, oxidative damage, and acute tubular necrosis. This oxidative stress upregulates inflammatory mediators like NF- κB, exacerbating tissue injury. The renoprotective effect of CeONPs is attributed to their unique ability to switch between Ce³⁷ and Ce³⁷ oxidation states, allowing continuous ROS scavenging. By reducing oxidative stress, CeONPs also suppress the NF-κB-mediated inflammatory pathway.</p><p><strong>Conclusion: </strong>CeONPs exhibit notable nephroprotective effects against colistin-induced AKI through their antioxidant and anti-inflammatory characteristics. These findings propose CeONPs as a potential therapeutic adjunct to reduce nephrotoxicity in patients requiring colistin treatment.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":0.7,"publicationDate":"2026-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148143006","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pharmacovigilance Assessment of Thrombotic Adverse Events Linked to GLP-1 Receptor Agonists: Analysis of FAERS Reports from 2020-2025.","authors":"Eman M Mansory, Osman O Radhwi","doi":"10.2174/0115748863468899260323094036","DOIUrl":"https://doi.org/10.2174/0115748863468899260323094036","url":null,"abstract":"<p><strong>Introduction: </strong>Glucagon-like peptide-1 receptor agonists are widely prescribed for diabetes and obesity. The association between GLP-1 RAs and thrombotic events remains unclear, with conflicting evidence from clinical and experimental studies. This study aims to assess the reporting of thrombotic adverse events with GLP-1 RAs in the FDA Adverse Event Reporting System (FAERS).</p><p><strong>Methods: </strong>A retrospective pharmacovigilance analysis of FAERS reports was performed. Thrombotic adverse events were identified using Standardized MedDRA Queries. Disproportionality was assessed via Reporting Odds Ratios. Time-to-onset was analyzed, and comparative analyses were conducted with Orlistat and SGLT2i.</p><p><strong>Results: </strong>1,618 unique thrombotic AE reports involving GLP-1 RAs were identified. Arterial events predominated (55.3%), followed by venous (23.2%) and mixed events (21.5%). Compared with all other drugs, GLP-1 RAs were not disproportionately associated with thrombotic AEs (overall ROR = 0.67, 95% CI: 0.64-0.71). Venous events showed the lowest disproportionality (ROR = 0.53, 95% CI: 0.48-0.59). Liraglutide displayed higher RORs than other GLP-1 RAs, while tirzepatide showed the lowest. Compared with Orlistat, GLP-1 RAs had markedly lower odds of venous events (OR 0.27), and, versus SGLT2i, lower odds across all event types.</p><p><strong>Discussion: </strong>In this large FAERS analysis, GLP-1 RAs did not show a disproportionate reporting signal for thrombotic events and, in several comparisons, appeared to have lower thrombotic reporting than alternative agents. While limitations of spontaneous reporting preclude causal inference, these findings provide reassuring real-world safety data.</p><p><strong>Conclusion: </strong>GLP-1 RAs were not associated with thrombotic AEs in FAERS and may confer a protective profile. Continued post-marketing surveillance is warranted.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":" ","pages":""},"PeriodicalIF":0.7,"publicationDate":"2026-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148143043","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}