Expert Opinion on Drug Safety最新文献

{"title":"Investigating drug-induced urinary retention: a pharmacovigilance analysis of FDA adverse event reports from 2004 to 2024","authors":"Fuchun Zheng, Fei Wang, Yuyang Yuan, Zhipeng Wang, Sheng Li, Bin Fu, Wei Liu","doi":"10.1080/14740338.2024.2405126","DOIUrl":"https://doi.org/10.1080/14740338.2024.2405126","url":null,"abstract":"Drug-induced urinary retention (DIUR) can severely impact patient quality of life and complicate treatment. This study investigates the incidence and characteristics of DIUR using data from the FDA...","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":"38 1","pages":""},"PeriodicalIF":3.1,"publicationDate":"2024-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142248909","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}

{"title":"Adverse events associated with Atogepant: a FAERS-based pharmacovigilance analysis.","authors":"Ying Zhang, Shengzhu Sun, Yuming Wang","doi":"10.1080/14740338.2024.2393268","DOIUrl":"10.1080/14740338.2024.2393268","url":null,"abstract":"<p><strong>Background: </strong>Migraine, a prevalent neurovascular disorder, can significantly disrupt an individual's daily life. Atogepant (AGN-241689), an orally administered small-molecule drug classified as a calcitonin gene-related peptide receptor antagonist, is utilized for prophylactic migraine treatment. The objective of this study was to investigate adverse events (AEs) associated with atogepant through data mining in the FDA Adverse Event Reporting System (FAERS) to enhance clinical safety.</p><p><strong>Methods: </strong>Data for atogepant were obtained from the FAERS database covering Q3 2021 through Q4 2023. Disproportionality analysis was employed to quantify relevant AEs associated with atogepant. Reported Ratio of Ratios (ROR) was utilized for identifying risk signals within the FAERS data. This methodology relies on the System Organ Class (SOC) and Preferred Terminology (PT) of the Medical Dictionary for Regulatory Activities (MedDRA).</p><p><strong>Results: </strong>From the FAERS database, a collection of 7,991,243 reports was obtained. Among these reports, a subset of 3015 was identified as 'primary suspected (PS)' AEs specifically related to atogepant. AEs induced by atogepant were observed across 27 organ systems. A total of 48 significantly disproportionate Preferred Terminologies (PTs) meeting all four algorithms were identified.</p><p><strong>Conclusion: </strong>Our study has identified adverse events (AEs) associated with atogepant, potentially providing crucial support for the clinical monitoring and risk identification of atogepant.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-7"},"PeriodicalIF":3.0,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142145489","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}

{"title":"Antibody-drug conjugates-related interstitial lung diseases: data mining of the FAERS database.","authors":"Zicheng Yu, Haibin Zhu, Xiaolan Liao","doi":"10.1080/14740338.2024.2401025","DOIUrl":"10.1080/14740338.2024.2401025","url":null,"abstract":"<p><strong>Background: </strong>Interstitial lung diseases (ILD) is a serious adverse event (AE) associated with antibody-drug conjugates (ADCs). This study aims to delve deeply into the signals of AE associated with ILD linked to ADCs.</p><p><strong>Research design and methods: </strong>The AE reports were extracted from the first quarter of 2004 to the fourth quarter of 2023 based on the FDA Adverse Event Reporting System (FAERS) database. Signal mining was performed using the reporting odds ratio (ROR) method and the multi-item gamma Poisson shrinker (MGPS) method. Data management, analysis, and visualization were carried out using Python, R software, and MySQL.</p><p><strong>Results: </strong>A total of 1389 AE reports related to ILD with 11 types of ADCs as the primary suspected drugs were obtained. The age groups most represented were 61-80 age group. ILD-related AE signals were detected for 11 ADCs in the study. Trastuzumab deruxtecan showed the strongest signals in both for ROR and MGPS methods. The median onset time vary from 8 days to 207 days.</p><p><strong>Conclusions: </strong>The signals of ILD AE associated with ADCs are notably strong. ILD should be closely monitored and assessed in the clinical use of ADCs taking full account of the efficacy and risks of these drugs.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-7"},"PeriodicalIF":3.0,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142125243","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}

{"title":"ORENITRAM's decadal journey: unveiling safety profiles and adverse event through a real-world pharmacovigilance study of FAERS events.","authors":"Shengjun Chai,Haiming Xu,Guocai Xu,Chunmei Cai","doi":"10.1080/14740338.2024.2396410","DOIUrl":"https://doi.org/10.1080/14740338.2024.2396410","url":null,"abstract":"BACKGROUNDORENITRAM, an oral treprostinil formulation, was approved in 2013 for pulmonary arterial hypertension (PAH) treatment, necessitating ongoing safety monitoring.RESEARCH DESIGN AND METHODSThis retrospective analysis used FDA Adverse Event Reporting System data from Q4 2013 to Q4 2023, employing disproportionality analysis and the reporting odds ratio (ROR) to identify adverse events (AEs) linked with ORENITRAM.RESULTSOut of 15,660,695 reports, ORENITRAM was the primary suspect in 10,125 cases. We identified 174 significant adverse events across 27 organ systems, with notable issues like pulmonary edema, ascites, and ventricular fibrillation. Females reported more AEs (75.6%) than males (24.0%), suggesting potential metabolic differences. AEs were most common within 30 days of starting treatment or after one year.CONCLUSIONSThe study indicates significant safety issues with ORENITRAM, including serious unexpected events such as pulmonary edema, ascites, and ventricular fibrillation. These findings highlight the necessity for careful clinical monitoring and effective risk management, particularly with observed gender differences in AE profiles. The study's retrospective nature and reliance on spontaneous reports may affect result generalizability.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":"9 1","pages":"1-16"},"PeriodicalIF":3.1,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142191198","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}

{"title":"Toxicity profiles associated with EGFR-TKIs combined with angiogenesis inhibitors in non-small cell lung cancer: an epidemiological surveillance analysis of the FDA adverse event reporting system.","authors":"Wenjie Li,Ruxue Lv,Wei Wang","doi":"10.1080/14740338.2024.2399082","DOIUrl":"https://doi.org/10.1080/14740338.2024.2399082","url":null,"abstract":"BACKGROUNDOngoing studies are evaluating the efficacy and toxicity profiles of combining epidermal growth factor receptor inhibitors (EGFR-TKIs) with antiangiogenic agents in non-small cell lung cancer (NSCLC). However, the complete toxicity profiles remain elusive.RESEARCH DESIGN AND METHODSThis study conducted an extensive pharmacovigilance analysis utilizing the FDA Adverse Event Reporting System database. The analysis focused on identifying and characterizing adverse events (AEs) associated with the concurrent use of EGFR-TKIs and antiangiogenic inhibitors in patients with NSCLC.RESULTSThe study identified significant occurrences of AEs linked to the combination therapy, particularly impacting general disorders, skin and subcutaneous tissue conditions, and vascular disorders. Frequently reported AEs included rash, diarrhea, fatigue, nausea, decreased appetite, and anemia. Notably, the combination of EGFR-TKIs with antiangiogenic inhibitors resulted in an increased incidence of AEs across multiple organ systems compared to EGFR-TKIs alone, with some adverse effects, such as anemia, arrhythmia, and ulcerative keratitis, persisting beyond one year in a subset of patients.CONCLUSIONSThe combination of EGFR-TKIs and antiangiogenic inhibitors in NSCLC treatment presents a distinct and substantial AE profile, often with delayed onset. This finding underscores the necessity for rigorous and ongoing monitoring protocols to mitigate potential long-term adverse effects.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":"10 1","pages":"1-10"},"PeriodicalIF":3.1,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142191200","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}

{"title":"Clozapine may consistently protect from suicidal behaviors while other antipsychotics may lack a specific protective effect: a comprehensive VigiBase study interpreted in the context of the prior literature.","authors":"Carlos De Las Cuevas, Victoria C de Leon, Hilario Blasco-Fontecilla, Enrique Baca-García, Marina Sagud, Emilio J Sanz, Jose de Leon","doi":"10.1080/14740338.2024.2399094","DOIUrl":"10.1080/14740338.2024.2399094","url":null,"abstract":"<p><strong>Background: </strong>In the United States, clozapine was first approved for treatment-resistant schizophrenia and then for suicidality in schizophrenia psychoses. Systematic reviews support clozapine's anti-suicidal effect, but the forensic literature stresses its lethality during overdoses.</p><p><strong>Research design and methods: </strong>Clozapine reports to the international pharmacovigilance database (VigiBase) were analyzed for suicidal ideation, suicide attempts, intentional overdose, and completed suicides from introduction to 1 January 2024. VigiBase uses the information component (IC) as a disproportionality analysis.</p><p><strong>Results: </strong>The clozapine ICs (range: other antipsychotics) were: 1) suicidal ideation IC = 0.570 with IC₀₂₅ = 0.454 to IC₉₇₅ = 0.680 (IC = 3.568 for aripiprazole and 1.729 for risperidone), 2) suicide attempt IC = 1.428 with IC₀₂₅ = 1.323 to IC₉₇₅ = 1.529 (IC = 4.150 for quetiapine and 2.968 for risperidone), 3) intentional overdose: IC = 0.995 with IC₀₂₅ = 0.864 to IC₉₇₅ = 1.120 (IC = 4.080 for quetiapine and 1.957 for aripiprazole), and 4) completed suicide IC = 1.133 with IC₀₂₅ = 1.026 to IC₉₇₅ = 1.235 (IC = 4.648 for quetiapine and 2.160 for risperidone). In summary, all clozapine ICs were significantly lower. We found 2391 clozapine-treated patients on the suicidality spectrum (627 cases with suicidal ideation, 752 with suicide attempt, 488 with intentional overdose, and 731 with completed suicide) but many were taking other antipsychotics. The most frequent reporting countries were the United States, the United Kingdom, and Croatia.</p><p><strong>Conclusion: </strong>This pharmacovigilance study, with all its inherent limitations, provides independent proof, not overlapping with prior literature, that clozapine may have specific strong anti-suicidal effects that do not appear to be present in other antipsychotics. Further VigiBase studies are needed to compare the lethality of an intentional overdose of clozapine (14.3%) with other antipsychotics.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-11"},"PeriodicalIF":3.0,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142119259","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}

{"title":"The use of denosumab in osteoporosis - an update on efficacy and drug safety.","authors":"Dima L Diab,Nelson B Watts","doi":"10.1080/14740338.2024.2386365","DOIUrl":"https://doi.org/10.1080/14740338.2024.2386365","url":null,"abstract":"INTRODUCTIONDenosumab (Prolia) is a fully human monoclonal antibody against the receptor activator of the nuclear factor kappaB ligand. It is a potent antiresorptive agent that reduces osteoclastogenesis.AREAS COVEREDDenosumab has been shown to improve bone mineral density and reduce the incidence of new fractures in postmenopausal women and men. It is also used in the treatment of glucocorticoid-induced osteoporosis, as well as for the prevention of bone loss and reduction of fracture risk in men receiving androgen deprivation therapy for non-metastatic prostate cancer and women receiving adjuvant aromatase inhibitor therapy for breast cancer. Initial safety concerns included infections, cancer, skin reactions, cardiovascular disease, hypocalcemia, osteonecrosis of the jaw, and atypical femur fractures; however, further study and experience provide reassurance on these issues. Anecdotal reports have raised concerns about an increased risk of multiple vertebral fractures following discontinuation of denosumab.EXPERT OPINIONAlthough bisphosphonates are often selected as initial therapy for osteoporosis, denosumab may be an appropriate initial therapy in patients at high risk for fracture, including older patients who have difficulty with the dosing requirements of oral bisphosphonates, as well as patients who are intolerant of, unresponsive to, or have contraindications to other therapies. Additional data is needed to address questions regarding treatment duration and discontinuation.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":"2 1","pages":"1-9"},"PeriodicalIF":3.1,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142191199","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}

{"title":"Comparative risk of infection of medications used for type 2 diabetes.","authors":"Estefania Zapata-Bravo,Antonios Douros,Oriana Hoi Yun Yu,Kristian B Filion","doi":"10.1080/14740338.2024.2401024","DOIUrl":"https://doi.org/10.1080/14740338.2024.2401024","url":null,"abstract":"INTRODUCTIONGlucose-lowering drugs pose a potential infection risk among individuals with type 2 diabetes. The U.S. Food and Drug Administration has issued safety warnings regarding increased risks of urinary tract infections (UTIs) and genital infections with sodium-glucose cotransporter 2 (SGLT2) inhibitors. However, the infection risk associated with other glucose-lowering drugs remains unclear. We conducted a PubMed database search to review the infection risk of glucose-lowering drugs, focusing on meta-analysis of randomized controlled trials.AREAS COVEREDWe described the infection risks associated with SGLT2 inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, glucose-like peptide-1 receptor agonists, metformin, and thiazolidinediones, covering infections of the genitourinary, respiratory, and gastrointestinal systems, including skin and soft tissue infections (SSTIs).EXPERT OPINIONSGLT2 inhibitors are associated with a higher genital infection risk, while their UTI risk remains inconclusive. DPP-4 inhibitors could be a treatment option for those intolerant to SGLT2 inhibitors, given their lower genital infection risk compared to placebo. Uncertainty persists regarding the risks of respiratory infections, gastroenteritis, and SSTIs with SGLT2 inhibitors. Limited evidence is available regarding the impact of DPP-4 inhibitors on respiratory infections. Additional research is needed to determine the comparative infection risk of other glucose-lowering drugs.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":"75 1","pages":"1-13"},"PeriodicalIF":3.1,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142191201","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}

{"title":"An update on the cognitive safety of antimuscarinics in the treatment of overactive bladder","authors":"Musab M. Alghamdi, Kwang Jin Ko, Kyu-Sung Lee","doi":"10.1080/14740338.2024.2392000","DOIUrl":"https://doi.org/10.1080/14740338.2024.2392000","url":null,"abstract":"Antimuscarinics are often the first-choice medications used to treat overactive bladder (OAB), a condition that increasingly affects the aging population. However, concerns regarding their potentia...","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":"1 1","pages":""},"PeriodicalIF":3.1,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142191197","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}

{"title":"Clinical features, treatment, and prognosis of SGLT2 inhibitors induced acute pancreatitis.","authors":"Ronghui Li, Panpan Luo, Yuge Guo, Yang He, Chunjiang Wang","doi":"10.1080/14740338.2024.2396387","DOIUrl":"10.1080/14740338.2024.2396387","url":null,"abstract":"<p><strong>Background: </strong>Sodium-glucose cotransporter-2 inhibitors (SGLT-2i) have recently been linked to be associated with acute pancreatitis (AP), but the clinical characteristics are unclear. This study investigated the clinical characteristics of SGLT-2i and AP and provided reference for the prevention and treatment of AP.</p><p><strong>Research design and methods: </strong>Case reports, case series, and clinical studies of SGLT2i induced AP were collected by retrieving Chinese and English data from the database until 31 December 2023.</p><p><strong>Results: </strong>Twenty-one patients were included, with a median age of 50.5 years (range 26,73). SGLT-2i were mainly involved in empagliflozin (13 cases, 61.9%), canagliflozin (4 cases, 19%) and dapagliflozin (4 cases, 19%). The median time from initial administration to the onset of AP was 21 days (range 1, 120). Abdominal pain (21 cases, 100%) was the most commonly complained symptom. The median lipase value was 388 U/L (range 36, 10000), and the median amylase value was 535 U/L (range 26, 3765). Twenty-one patients recovered completely after stopping the drug and receiving conservative treatment.</p><p><strong>Conclusions: </strong>SGLT-2i are associated with AP. Given the rising prescription of SGLT-2i, physicians should consider these agents as a potential cause of pancreatitis after excluding other etiologies.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-5"},"PeriodicalIF":3.0,"publicationDate":"2024-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142016833","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}