Giuseppe Lauletta, Luca Potestio, Cataldo Patruno, Mariateresa Cantelli, Maddalena Napolitano
{"title":"The emerging role of Bruton's tyrosine kinase inhibition in urticaria management.","authors":"Giuseppe Lauletta, Luca Potestio, Cataldo Patruno, Mariateresa Cantelli, Maddalena Napolitano","doi":"10.1080/14740338.2025.2460453","DOIUrl":"10.1080/14740338.2025.2460453","url":null,"abstract":"<p><strong>Introduction: </strong>Bruton's tyrosine kinase (BTK) is a cytoplasmic signaling protein expressed across a variety of immune cells, terminally differentiated plasma cells, and natural killer cells. Due to the signal potential and targetable nature of BTK, the use of BTK inhibitors (BTKis) has been proposed for the management of several diseases. Currently, the use of BTKis is under investigations for several dermatological conditions such as pemphigus, systemic lupus erythematosus, hidradenitis suppurativa, atopic dermatitis, and chronic spontaneous urticaria (CSU).</p><p><strong>Areas covered: </strong>The aim of this review is to delve into the use of BTKis in the management of CSU, in order to explore the potential of therapeutic inhibition of BTK in patients with CSU. A thorough analysis of the existing medical literature was conducted across the PubMed, Ovid, Scopus, Embase, and Cochrane Library databases up to 17 August 2024.</p><p><strong>Expert opinion: </strong>BTK use may represent a breakthrough in the management of CSU. Indeed, their use is characterized by oral administration and a favorable mechanism of action that acts on a significant pathogenic pathway rather than a single molecule. However, long-term studies are needed to further investigate safety data, although data from registered trials appear to be reassuring.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"507-512"},"PeriodicalIF":3.0,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143052126","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}
Endong Chen, Yaowei Gan, Yingying Chen, Chen Chen, Yujing Weng, Bowen Zhang, Yefeng Cai, Qingxuan Wang, Quan Li
{"title":"Post-marketing safety surveillance of ado-trastuzumab emtansine: a real-world data retrospective cohort study using disproportionality analysis.","authors":"Endong Chen, Yaowei Gan, Yingying Chen, Chen Chen, Yujing Weng, Bowen Zhang, Yefeng Cai, Qingxuan Wang, Quan Li","doi":"10.1080/14740338.2024.2438748","DOIUrl":"10.1080/14740338.2024.2438748","url":null,"abstract":"<p><strong>Background: </strong>Ado-trastuzumab emtansine (T-DM1) is prescribed for HER2-positive, metastatic breast cancer or early breast cancer after neoadjuvant therapy. Although several adverse events (AEs) have been reported, there remains a need for a comprehensive evaluation of its safety profile.</p><p><strong>Research design and methods: </strong>To quantify the signals of ado-trastuzumab emtansine associated AEs, we employed 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) algorithms.</p><p><strong>Results: </strong>Between Q1 2013 and Q4 2022, 3699 patient reports of AEs associated with ado-trastuzumab emtansine were received, including 440 cases of ado-trastuzumab emtansine-induced bleeding events. Of the 3699 patient reports, 142 significant disproportionality preferred terms (PTs) were identified. New AEs have been identified with ado-trastuzumab emtansine administration, including telangiectasia, spider nevus, pericardial effusion, pleural effusion, radiation necrosis, and corneal disorders. The most common bleeding events were observed in the digestive system (27.05%), respiratory system (35.00%), and nervous system (14.55%). Hemorrhagic adverse events exhibited early failure-type characteristics.</p><p><strong>Conclusion: </strong>This analysis offers the most comprehensive overview of ado-trastuzumab emtansine induced hemorrhage to date, shedding new light on this severe complication. Understanding the underlying mechanisms of these positive PTs can provide useful insights for further research.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"565-576"},"PeriodicalIF":3.0,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142785076","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":"Anti-seizure medications-associated bladder and urethral symptoms: a pharmacovigilance analysis based on the FAERS database.","authors":"Yanyan Li, Zhanshen Wu, Yang Zhao, Lei Shi","doi":"10.1080/14740338.2024.2368820","DOIUrl":"10.1080/14740338.2024.2368820","url":null,"abstract":"<p><strong>Background: </strong>In clinical practice, observations have been made regarding bladder and urethral symptoms (BUS), notably urinary frequency and urgency, among patients prescribed the anti-seizure medication (ASM) lacosamide. However, the precise association between ASMs and BUS events in real-world settings remains elusive.</p><p><strong>Research design and methods: </strong>Data from the FDA Adverse Event Reporting System (FAERS) database were employed and the analysis focused on ASMs-associated BUS events utilizing disproportionality analysis methods, including the reporting odds ratio (ROR) and the proportional reporting ratio (PRR). Furthermore, co-administration, time to onset of ASMs-associated BUS events, and severity assessments were conducted.</p><p><strong>Results: </strong>Several ASMs demonstrated statistically meaningful associations with BUS signals, notably ezogabine, valproic acid/valproate sodium, and clorazepate (<i>p</i> < 0.05). And ASMs-associated BUS events predominantly occurred within the first week and persisted for more than 180 days afterward. Diazepam, gabapentin, and brivaracetam exhibited distinct risk profiles for severe BUS events compared to valproic acid/sodium valproate (<i>p</i> < 0.05). And the nomogram constructed in this study exhibited robust predictive performance.</p><p><strong>Conclusion: </strong>This study yields valuable insights into the association between ASMs and BUS events, but several limitations warrant consideration. Nonetheless, these findings emphasize the significance of vigilance and proactive management of ASMs-associated BUS events.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"585-594"},"PeriodicalIF":3.0,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141316924","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}
Mufei Tang, Peiyan Liu, Linzhe Du, Yuanyuan Li, Jinjin Chen, Yang Li
{"title":"Detection and analysis of the safety profile of talazoparib based on FAERS database.","authors":"Mufei Tang, Peiyan Liu, Linzhe Du, Yuanyuan Li, Jinjin Chen, Yang Li","doi":"10.1080/14740338.2024.2392011","DOIUrl":"10.1080/14740338.2024.2392011","url":null,"abstract":"<p><strong>Background: </strong>Talazoparib was approved for the treatment of breast cancer. However, the safety of talazoparib in a large population sample over an extended period remained uncertain. The objective of this study is to offer guidance for the secure utilization of talazoparib in clinical settings.</p><p><strong>Methods: </strong>Four algorithms were used to quantify the signals of talazoparib associated adverse events(AEs), using data from the food and drug administration adverse event reporting system(FAERS) between fourth quater of 2018 and second quater of 2023.</p><p><strong>Results: </strong>A total of 7,186,517 records were reported, with 737 indicating talazoparib as the primary suspected (PS) AEs. A total of 40 significant preferred terms (PTs) that adhere to the four algorithms were simultaneously retained. There is a possibility of experiencing unforeseen and noteworthy AEs, including embolism(0.46%), pulmonary embolism(1.06%), hyponatremia(0.46%), hypokalemia(0.40%), hematuria(0.33%), and pericardial effusion(0.26%). Most of the AEs related to talazoparib occurred within the initial month of starting the medication, with a median onset time of 79 days (IQR: 22-207 days).</p><p><strong>Conclusion: </strong>Results of our study were consistent with clinical observations, and we also found potential new and unexpected AEs signals for talazoparib, suggesting prospective clinical studies were needed to confirm these results and illustrate their relationship. Our results may provide valuable evidence for further safety studies of talazoparib.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"577-584"},"PeriodicalIF":3.0,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141916497","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":"Treating psychosis in people with Parkinson's disease.","authors":"Leora L Borek, Joseph H Friedman","doi":"10.1080/14740338.2025.2467813","DOIUrl":"10.1080/14740338.2025.2467813","url":null,"abstract":"<p><strong>Introduction: </strong>Psychotic symptoms in Parkinson's disease are common and are comprised of hallucinations and delusions. Psychosis is a major cause of disability in PD and is primarily due to an interaction with PD medication. The decision to treat psychosis is determined by the severity of the symptoms, impact on quality of life and tolerance for the treatment. Initial management involves a reduction in non-PD psychoactive medications and/or modification of PD medications. Pharmacotherapy is primarily limited to atypical antipsychotics and pimavanserin.</p><p><strong>Areas covered: </strong>This review will focus on the phenomenology of Parkinson's disease psychosis and its management.</p><p><strong>Expert opinion: </strong>Pimavanserin is the only Food and Drug Administration medication approved for the treatment of PDP. Among the antipsychotics, only clozapine and pimavanserin demonstrated efficacy in the treatment of PDP. Despite lack of evidence for efficacy in PDP, quetiapine is commonly used because it does not worsen motor function and lacks the blood monitoring requirement of clozapine. Pimavanserin is the first-line treatment for mild psychotic symptoms that do not require a rapid response and quetiapine and clozapine for psychosis that requires improvement in a short period of time. Antipsychotics used to treat PDP should demonstrate safety, motor tolerability and efficacy over time.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"513-518"},"PeriodicalIF":3.0,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143406510","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}
Lingqing Ding, Congqin Chen, Yongkuan Yang, Jie Xiao
{"title":"Risk of thromboembolic events in patients co-treated with factor Xa-inhibiting direct oral anticoagulants and anti-seizure medications: insights from pharmacovigilance data.","authors":"Lingqing Ding, Congqin Chen, Yongkuan Yang, Jie Xiao","doi":"10.1080/14740338.2025.2500722","DOIUrl":"https://doi.org/10.1080/14740338.2025.2500722","url":null,"abstract":"<p><strong>Background: </strong>Limited data have raised concerns about an increased risk of thromboembolic adverse events in atrial fibrillation (AF) patients co-treated with factor Xa-inhibiting direct oral anticoagulants (FXa-DOACs) and anti-seizure medications (ASMs). However, evidence regarding this association remains controversial.</p><p><strong>Objectives: </strong>This study aims to investigate the impact of ASMs on the reporting of thromboembolic events in FXa-DOAC-treated patients.</p><p><strong>Methods: </strong>This study analyzed data from the FDA Adverse Event Reporting System (FAERS) between 2011Q3 and 2024Q1 using the weighted composite score integrated by four pharmacovigilance signals [reporting odds ratio (ROR), Empirical Bayes Geometric Mean (EBGM), additive model and multiplicative model].</p><p><strong>Results: </strong>A total of 177 cases of thromboembolic events were identified in patients using combined FXa-DOACs and ASMs. Levetiracetam together with FXa-DOACs was associated with an increased risk of thromboembolic events, particularly apixaban (ROR: 2.29, 95%CI 1.56-3.38; EBGM05:1.32; additive model:0.14 > 0; multiplicative mode: 2.47 > 1;composite score:1) and rivaroxaban (ROR:3.81, 95% CI 2.77-5.26; EBGM05:1.99; additive model:0.13; multiplicative model:1.71; composite score:1). Valproic acid was associated with thromboembolic risk when with rivaroxaban (ROR:4.80, 95%CI 2.50-9.19; EBGM05:1.64; additive model:0.29; multiplicative model:8.48; composite score:1).</p><p><strong>Conclusion: </strong>This study suggests that the concomitant use of levetiracetam and valproic acid with FXa-DOACs is associated with an increased risk of thromboembolic events.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-11"},"PeriodicalIF":3.0,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143999249","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":"Safety profile of lasmiditan: a retrospective post-marketing pharmacovigilance study based on the real-world data of FAERS database.","authors":"Xiaochen Wan, Shuohan Zhang, Cheng Jiang, Hongrui Zhang","doi":"10.1080/14740338.2024.2371382","DOIUrl":"10.1080/14740338.2024.2371382","url":null,"abstract":"<p><strong>Background: </strong>Lasmiditan offers a promising option for the treatment of migraines, particularly for individuals with cardiovascular concerns. It is crucial to gather comprehensive safety information of lasmiditan through large-scale post market monitoring.</p><p><strong>Research design and methods: </strong>This study assessed the safety profile of lasmiditan based on real-world data of FDA Adverse Event Reporting System (FAERS) database. Four disproportionality analysis methods were applied to mining the significant signals. The differences in adverse event signals among different subgroups were investigated concerning race, sex, age, weight, dose, and concomitant drug.</p><p><strong>Results: </strong>A total of 820 reports and 1,661 adverse events with lasmiditan as the primary suspected drug were identified. Two new adverse event signals related to nervous system disorders emerged. Females and males were more likely to develop paresthesia and dizziness, respectively. Most common adverse events were more likely to occur in the elderly patients and at high doses.</p><p><strong>Conclusions: </strong>It is essential to be vigilant about the relation of potential nervous system disorders with lasmiditan. The importance of heightened clinical vigilance regarding paresthesia in females and dizziness in males was underscored. Additionally, it is advised to administer a lower initial dose for elderly patients.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"607-617"},"PeriodicalIF":3.0,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141426624","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":"Catatonia related to tacrolimus: a real world pharmacovigilance study of FDA adverse event reporting system (FAERS) database.","authors":"Jing Yang, Hui Yang, Zhuoling An","doi":"10.1080/14740338.2024.2393757","DOIUrl":"10.1080/14740338.2024.2393757","url":null,"abstract":"<p><strong>Background: </strong>Emerging case reports have highlighted that catatonia may be a complication that is easily misdiagnosed. Our study aimed to summarize the clinical characteristics of patients with tacrolimus-induced catatonia and assess the association between tacrolimus and catatonia through disproportionality analysis.</p><p><strong>Research design and methods: </strong>We conducted a retrospective pharmacovigilance study using the FAERS database, analyzing data up to the third quarter of 2023. The clinical characteristics of the reported cases were summarized using descriptive statistics. Information component (IC) and reporting odds ratio (ROR) were used to evaluate the association between tacrolimus and catatonia.</p><p><strong>Results: </strong>There were 66 reports of tacrolimus-related catatonia, with the majority of cases occurring in the United States (78.79%). The risk signal for tacrolimus-related catatonia was significantly higher compared to all other drugs (ROR 3.222 [2.524, 4.111], IC 1.632 [1.273, 1.991]). A significant association was detected in both male and female, while the risk signal of tacrolimus-associated catatonia was only found in the subgroups aged over 40 years.</p><p><strong>Conclusions: </strong>Our study identified a safety signal for the association between tacrolimus and catatonia compared to all other drugs in FAERS database, particularly in patients aged 40 and above.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"595-598"},"PeriodicalIF":3.0,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141995621","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}
Wenqiang Kong, Yunfeng Shu, Juan Tang, Jie Wan, Xueting Yang
{"title":"Compartment syndrome associations with drugs: a pharmacovigilance study of the FDA adverse event reporting system (FAERS).","authors":"Wenqiang Kong, Yunfeng Shu, Juan Tang, Jie Wan, Xueting Yang","doi":"10.1080/14740338.2024.2376687","DOIUrl":"10.1080/14740338.2024.2376687","url":null,"abstract":"<p><strong>Background: </strong>Compartment syndrome is an uncommon but life-threatening condition. No study has comprehensively compared compartment syndrome (CS) association with available drugs. The objective of this study was to estimate the association between CS and drugs using the FDA Adverse Event Report System (FAERS).</p><p><strong>Research design and methods: </strong>FAERS reports from the first quarter of 2004 to the third quarter of 2023 were analyzed. The Medical Dictionary for Regulatory Activities (MedDRA) was used to identify CS cases. Reporting odds ratio (ROR), corresponding to 95% confidence intervals (95% CI) were calculated to detect a positive signal.</p><p><strong>Results: </strong>A total of 2197 reports were considered in the study after the inclusion criteria were applied. Totally 100 drugs were found to be associated with CS. The median time for drug-associated CS was 45 days.</p><p><strong>Conclusions: </strong>By analyzing the FAERS database, the study revealed that certain drugs are significantly associated with compartment syndrome. Further studies are needed to verify whether these drugs are associated with such a risk.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"619-625"},"PeriodicalIF":3.0,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141533976","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}
Rashudy Fatiha Mahomedradja, Steven Wang, Kim Catherina Eve Sigaloff, Jelle Tichelaar, Michiel Adriaan van Agtmael
{"title":"Hospital-wide interventions for reducing or preventing in-hospital prescribing errors: a scoping review.","authors":"Rashudy Fatiha Mahomedradja, Steven Wang, Kim Catherina Eve Sigaloff, Jelle Tichelaar, Michiel Adriaan van Agtmael","doi":"10.1080/14740338.2025.2467831","DOIUrl":"10.1080/14740338.2025.2467831","url":null,"abstract":"<p><strong>Introduction: </strong>Prescribing errors (PEs) in hospital care lead to patient harm, prolonged hospital stays, readmissions, and mortality. Despite interventions that successfully target 'high risk' populations in trials, PE rates remain largely unchanged in real-world settings. Existing studies often focus narrowly on specific populations, overlooking the wider complexities of hospital-wide prescribing. This scoping review evaluates interventions for adult inpatients to identify knowledge gaps in how to reduce in-hospital PEs.</p><p><strong>Methods: </strong>A systematic search of PubMed, EMBASE.com, and the Cochrane Library (inception to 13 December 2024) was conducted following PRISMA-ScR guidelines. Studies prospectively evaluating interventions reducing in-hospital PEs were eligible for inclusion; those focusing on specific drugs, wards or populations or lacking original data were excluded.</p><p><strong>Results: </strong>Fourteen studies met the inclusion criteria. Technological interventions, such as computerized order entry systems, accounted for 35.7% of the studies. Half addressed prescriber-related factors, such as inadequate drug knowledge and prescribing skills, while organizational factors were underexplored.</p><p><strong>Conclusion: </strong>Current interventions fail to address the underlying complexities, leaving critical gaps to decrease in-hospital PEs. To achieve sustainable PE reductions and improve patient safety, a multidisciplinary approach, standardized reporting, organizational reform, and a Safety-II perspective are essential.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"529-546"},"PeriodicalIF":3.0,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143457363","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}