Therapeutic Advances in Drug Safety最新文献

{"title":"Assessing potential risk factors for metamizole-induced leukopenia","authors":"Birgit Brüne, Sarah Sonderer, Maria Bösing, Simona Hübner, Kanchan Dongre, Selina Späni, Andreas Holboro, Jörg D. Leuppi, Anne B. Leuppi-Taegtmeyer","doi":"10.1177/20420986241275255","DOIUrl":"https://doi.org/10.1177/20420986241275255","url":null,"abstract":"Background:Metamizole is a non-opioid analgesic agent that can rarely cause agranulocytosis, a severe form of leukopenia.Objectives:The aim of this study was to assess previously identified potential risk factors for the development of metamizole-induced leukopenia.Design:A retrospective, observational, matched case-control study was performed in a single-center setting.Methods:Patients who developed leukopenia in the setting of metamizole therapy were included as cases and matched 1:3 on the basis of age and sex to control patients who did not develop leukopenia when treated with metamizole. The data were obtained from the medical records of patients hospitalized at Cantonal Hospital Baselland between 2015 and 2020. Univariate and multivariate analyses were performed.Results:Eighty-six cases and 258 matched controls aged between 18 and 102 years were included. Fifty-seven percent were female. Previous leukopenic episodes (odds ratio (OR): 4.02, 95% CI: 1.95–8.28, p < 0.001) and a history of penicillin allergy (OR: 2.49, 95% CI: 1.03–6.03, p = 0.044) were found to be independent risk factors for metamizole-induced leukopenia.Conclusion:A history of previous leukopenic episodes and a history of penicillin allergy were confirmed as risk factors for metamizole-induced leukopenia. In our opinion, metamizole should be avoided in patients with these risk factors.","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"214 1","pages":""},"PeriodicalIF":4.4,"publicationDate":"2024-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142259643","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":"Fetal exposure to isotretinoin in Saudi Arabia: a multicenter real-world data analysis from 2015 to 2020","authors":"Yasser Albogami, Ohoud Almadani, Sumaya N. Almohareb, Sultan Alshehri, Abdullah Alkhaibari, Mona Anzan, Alaa Alsharif, Abdulaziz Alhossan, Adel Alrwisan","doi":"10.1177/20420986241272822","DOIUrl":"https://doi.org/10.1177/20420986241272822","url":null,"abstract":"Background:Despite its high efficacy in treating severe acne, isotretinoin is associated with serious side effects, including teratogenicity. However, the extent of isotretinoin exposure during pregnancy in Saudi Arabia remains unknown.Objectives:This study aims to quantify the extent of fetal exposure to isotretinoin in Saudi Arabia and to evaluate adherence to risk minimization measures approved by the Saudi Food and Drug Authority.Design:Retrospective cohort study.Methods:This multicenter retrospective study included a cohort of 6233 women of childbearing ages (WCBAs) who had received isotretinoin therapy between 2015 and 2020. Exposure to isotretinoin use was ascertained from patients’ electronic health records and was defined as any positive pregnancy test (urine or serum) or any diagnosis or procedure related to pregnancy occurring during the risk period. We defined the risk period starting from isotretinoin initiation until up to 30 days after the last prescription. We quantified the overall incidence proportion of fetal exposure to isotretinoin by dividing the number of pregnancy cases during the risk period by the total study sample of WCBAs.Results:The cohort predominantly included young females (20–29 years), with a mean age of 24 years. Only 5% of the WCBAs used contraceptives, and 10% have a record of pregnancy testing. During the risk period, 34 pregnancies were identified, yielding a cumulative pregnancy incidence of 5.6 per 1000 WCBAs. Pregnancy outcomes for exposed women were about 5% of births had defects, while abortions accounted for 14.3% of pregnancies.Conclusion:Our investigation shows an alarming incidence of fetal exposure to isotretinoin in Saudi Arabia, substantially surpassing global estimates. These results underscore a critical need for enhanced interventions and robust risk minimization strategies tailored to the distinct challenges faced by the Saudi Arabian population.","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"84 1","pages":""},"PeriodicalIF":4.4,"publicationDate":"2024-09-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142259644","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":"Pirfenidone-induced liver injury, a case report of a rare idiosyncratic reaction","authors":"Florent Fortunati, Antoine Froidure, Pamela Baldin, Yves Horsmans, Nicolas Lanthier, Géraldine Dahlqvist, Bénédicte Delire","doi":"10.1177/20420986241270866","DOIUrl":"https://doi.org/10.1177/20420986241270866","url":null,"abstract":"Nearly all medications carry the risk of drug-induced liver injury (DILI). Idiosyncratic reactions are rare and poorly predictable, and the mechanisms are not always well understood. Pirfenidone is an oral antifibrotic drug used to treat idiopathic pulmonary fibrosis. While elevation of liver enzymes is a common adverse reaction during therapy, it rarely leads to discontinuation or reduction of the drug. Although isolated cases of liver damage or liver failure have been reported, they are infrequent. This report presents the case of a 70-year-old woman with known idiopathic pulmonary fibrosis, depression, hypothyroidism, and hypercholesterolemia who presented at our emergency department with jaundice, anorexia, and asthenia. The patient’s medication regimen included lamotrigine, simvastatin, levothyroxine, and pirfenidone, which had been introduced 6 months prior. Laboratory testing revealed elevated liver enzyme levels consistent with acute hepatocellular hepatitis. Following a medical workup, which included anamnesis, laboratory testing, iconographic investigations, and liver biopsy, we concluded that the patient had suffered from pirfenidone-induced liver injury. Pirfenidone was withdrawn, and liver tests gradually improved. The purpose of this clinical case report is to highlight this rare adverse reaction and to make clinicians aware of its assessment and management. In 2018, only one other case of severe liver failure leading to the death of the patient was reported. Early detection of potential DILI during the workup is crucial to discontinue the suspected medication promptly. Any drug-induced hepatitis must be reported for registration.","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"39 1","pages":""},"PeriodicalIF":4.4,"publicationDate":"2024-09-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142259642","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":"Characterizing medication safety incidents in surgical patients: a retrospective cross-sectional analysis of incident reports","authors":"Noah Sagua, Andrew Carson-Stevens, Kathryn Lynette James","doi":"10.1177/20420986241271881","DOIUrl":"https://doi.org/10.1177/20420986241271881","url":null,"abstract":"Background:Medication-related safety incidents (MSIs) are among the most frequent contributors to preventable harm in hospital patients. There is a paucity of research that explores the factors that contribute to MSIs across the departments of high-risk specialties such as surgery.Objectives:To characterize MSIs involving surgical patients across two secondary care sites at a University Health Board.Design:Retrospective cross-sectional convergent analysis of anonymous MSI reports extracted from the risk management system between 1st January 2017 and 31st October 2020 was undertaken.Methods:Incident reports contained categorical data pertaining to the type and nature of the incident as well as free-text reporter accounts. Categorical data were analyzed quantitatively, undergoing descriptive analysis using IBM SPSS Statistics © software (Version 26.0.01; 2019). Content analysis of free-text responses was undertaken using the Organizational Accident Causation model as the underpinning theoretical framework.Results:Of a total of 670 incidents, most MSIs did not result in harm ( n = 495, 73.9%). Most MSIs occurred during administration ( n = 439, 65.5%). Half of the incidents ( n = 335, 50%) were related to one of three medication types: opioids, antimicrobials, and antithrombotic agents. Communication failures were the most frequent error-producing condition ( n = 39, 5.8%) and drug omission was the most frequent active failure ( n = 156, 23.3%).Conclusion:To the knowledge of the authors, this is the first study in the United Kingdom that reports the medications most frequently involved in MSI reports for surgical patients. Staff in the surgical setting should be informed of the high frequency of incidents involving opioids, antimicrobials, heparin, and other antithrombotic agents as they appear in half of MSI reports in the surgical setting. Further research should explore administration error reduction strategies as well as tools to improve communication between staff to mitigate the risk of medicines-related harm associated with key medications.","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"17 1","pages":""},"PeriodicalIF":4.4,"publicationDate":"2024-09-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142259645","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":"Assessing the risk of tumor lysis syndrome associated with the use of antineoplastic agents: a real-world pharmacovigilance study based on the FDA Adverse Event Reporting System database.","authors":"Dongxuan Li, Chunmeng Qin, Hongli Wang, Dan Du, Yalan Wang, Qian Du, Songqing Liu","doi":"10.1177/20420986241274909","DOIUrl":"10.1177/20420986241274909","url":null,"abstract":"<p><strong>Background: </strong>The use of antineoplastic agents is one of the important triggers of tumor lysis syndrome (TLS), but there is still a lack of comprehensive understanding of antineoplastic agents that may trigger TLS and the TLS risk differences between different antineoplastic agents.</p><p><strong>Objectives: </strong>This study aims to investigate the TLS risk of different antineoplastic agents and provide reference information for clinical practice.</p><p><strong>Design: </strong>Real-world adverse events data in the FDA Adverse Event Reporting System (FAERS) database were used as the basis for the disproportionality analysis.</p><p><strong>Methods: </strong>We reviewed the TLS reports in the FAERS database from 2004 to 2022 to summarize an antineoplastic agent list that was reported to trigger TLS, based on which we conducted disproportionality analysis to assess the TLS risk of each antineoplastic agent.</p><p><strong>Results: </strong>In all, 164 antineoplastic agents were reported to trigger TLS. On the whole, rituximab was the most reported antineoplastic agent in TLS reports, followed by cyclophosphamide, venetoclax, doxorubicin, and etoposide, while tagraxofusp was the antineoplastic agent with the highest adverse drug reaction (ADR) signal strength in signal detection, followed by floxuridine, pentostatin, tebentafusp, and venetoclax. Integrating ADR signal detection results, 129 of 164 antineoplastic agents showed at least one positive ADR signal, and six antineoplastic agents (bevacizumab, carboplatin, cisplatin, fluorouracil, lenvatinib, and paclitaxel) have the highest total number of positive signals. Further classifying the 164 antineoplastic agents into 46 chemical subgroups to conduct ADR signal detection, nitrogen mustard analogs were the most reported antineoplastic agent subclasses, followed by clusters of differentiation 20 inhibitors, and pyrimidine analogs, while clusters of differentiation 22 inhibitors were the antineoplastic agent subclass with the highest ADR signal strength, followed by podophyllotoxin derivatives and actinomycines.</p><p><strong>Conclusion: </strong>Our study showed the TLS risk characteristics of 164 antineoplastic agents by detecting and integrating ADR signals, which may help to optimize clinical practice.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"15 ","pages":"20420986241274909"},"PeriodicalIF":3.4,"publicationDate":"2024-09-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11380128/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142154984","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Interventions and impact of pharmacist-delivered services in perioperative setting on clinically important outcomes: a systematic review and meta-analysis","authors":"Lina Naseralallah, Somaya Koraysh, Bodoor Aboujabal, May Alasmar","doi":"10.1177/20420986241260169","DOIUrl":"https://doi.org/10.1177/20420986241260169","url":null,"abstract":"Background:The perioperative arena is a unique and challenging environment that requires coordination of the complex processes and involvement of the entire care team. Pharmacists’ scope of practice has been evolving to be patient-centered and to expand to variety of settings including perioperative settings.Objectives:To critically appraise, synthesize, and present the available evidence of the characteristics and impact of pharmacist-led interventions on clinically important outcomes in the perioperative settings.Design:A systematic review and meta-analysis.Methods:We searched PubMed, Embase, and CINAHL from index inception to September 2023. Included studies compared the effectiveness of pharmacist-led interventions on clinically important outcomes (e.g. length of stay, readmission) compared to usual care in perioperative settings. Two independent reviewers extracted the data using the DEPICT-2 (Descriptive Elements of Pharmacist Intervention Characterization Tool) and undertook quality assessment using the Crowe Critical Appraisal (CCAT). A random-effect model was used to estimate the overall effect [odds ratio (OR) for dichotomous and standard mean difference (SMD) for continuous data] with 95% confidence intervals (CIs).Results:Twenty-five studies were eligible, 20 (80%) had uncontrolled study design. Most interventions were multicomponent and continuous over the perioperative period. The intervention components included clinical pharmacy services (e.g. medication management/optimization, medication reconciliation, discharge counseling) and education of healthcare professionals. While some studies provided a minor description in regards to the intervention development and processes, only one study reported a theoretical underpinning to intervention development. Pooled analyses showed a significant impact of pharmacist care compared to usual care on length of stay (11 studies; SMD −0.09; 95% CI −0.49 to −0.15) and all-cause readmissions (8 studies; OR 0.60; 95% CI 0.39–0.91). The majority of included studies ( n = 21; 84%) were of moderate quality.Conclusion:Pharmacist-led interventions are effective at improving clinically important outcomes in the perioperative setting; however, most studies were of moderate quality. Studies lacked the utilization of theory to develop interventions; therefore, it is not clear whether theory-derived interventions are more effective than those without a theoretical element. Future research should prioritize the development and evaluation of multifaceted theory-informed pharmacist interventions that target the whole surgical care pathway.","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"87 1","pages":""},"PeriodicalIF":4.4,"publicationDate":"2024-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141868244","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":"Vonoprazan-associated Clostridioides difficile infection: an analysis of the Japanese Adverse Drug Event Report and the FDA Adverse Event Reporting System","authors":"Mengling Ouyang, Shupeng Zou, Qian Cheng, Xuan Shi, Yazheng Zhao, Minghui Sun","doi":"10.1177/20420986241260211","DOIUrl":"https://doi.org/10.1177/20420986241260211","url":null,"abstract":"Background:Prolonged or excessive use of acid suppressants may increase the risk of Clostridioides difficile infection (CDI) by altering the intestinal microecosystem. Vonoprazan, a novel potassium-competitive acid blocker, exhibits a faster and more sustained acid-suppressive effect than proton pump inhibitors (PPIs). Therefore, vonoprazan may have a greater impact on the gut microbiota, potentially resulting in CDI.Objectives:This study aimed to explore the potential relationship between acid suppressants and CDI by the Japan Adverse Drug Event Report (JADER) and the FDA Adverse Event Reporting System (FAERS) databases.Design:A retrospective analysis of the JADER and FAERS databases was examined by disproportionality analysis.Methods:We performed signal detection analyses of CDI induced by vonoprazan and PPIs using the JADER and FAERS databases. The association between acid suppressants and CDI was calculated using the reporting odds ratio (ROR) and corresponding 95% confidence interval (95% CI). When the lower limit of the 95% CI is exceeded by 1, the association is considered statistically significant.Results:In the JADER database, the ROR (95% CI) for vonoprazan and PPIs based on suspect drug reports was 15.84 (12.23–20.50) and 2.51 (1.92–3.28), respectively. In the FAERS database, the ROR (95% CI) for vonoprazan and PPIs based on primary and secondary suspect drug reports was 11.50 (6.36–20.82) and 1.42 (1.34–1.51), respectively. Subgroup analysis showed that elderly patients aged 60 years and older were more strongly associated with CDI. The ROR (95% CI) for vonoprazan and PPIs in patients aged 60 years and older in the JADER database was 15.35 (11.59–20.33) and 1.65 (1.14–2.39), respectively. Similarly, the ROR (95% CI) for vonoprazan and PPIs in the FAERS database was 12.56 (6.26–25.20) and 1.43 (1.31–1.57), respectively. Excluding the effect of Helicobacter pylori ( H. pylori) infection, the use of acid suppressants was still associated with CDI.Conclusion:While signal detection analysis based on the JADER and FAERS databases could not establish causality, our study demonstrated that both vonoprazan and PPIs were significantly associated with CDI. Vonoprazan showed a stronger association with CDI in both databases.","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"56 1","pages":""},"PeriodicalIF":4.4,"publicationDate":"2024-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141868161","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":"Oxaliplatin-associated shock in stage III colorectal cancer patients: real-world evidence in Taiwan.","authors":"Ling-Yi Wang, Hui-Hsia Hsieh, Sung-Chao Chu, Wei-Chuan Chang, Yi-Ting Kuo, Tien-Yuan Wu","doi":"10.1177/20420986241266439","DOIUrl":"10.1177/20420986241266439","url":null,"abstract":"<p><strong>Background: </strong>Oxaliplatin-associated shock (referred to as shock) is a rare but life-threatening adverse event.</p><p><strong>Objectives: </strong>This pioneering cohort study aimed to quantitatively investigate the association between oxaliplatin use and shock in patients with stage III colorectal cancer (CRC), identify potential independent risk factors for shock, and assess the cycle-to-shock during oxaliplatin treatment.</p><p><strong>Design: </strong>The study utilized a nested case-control (NCC) design to assess the association between oxaliplatin and shock and employed a case-crossover approach to address unmeasured confounders.</p><p><strong>Methods: </strong>All newly diagnosed stage III CRC patients were identified from the CRC Health Database (2012-2016). Conditional logistic regression was used to calculate odds ratios (OR) and 95% confidence intervals (CIs) for oxaliplatin's link to shock incidence.</p><p><strong>Results: </strong>Among 6932 oxaliplatin recipients, 331 suffered shock. In all, 3309 controls were selected <i>via</i> risk-set sampling for the shock cases. Oxaliplatin use is associated with a doubled risk of shock (adjusted OR: 2.08, 95% CI: 1.23-3.52). Two independent risk factors were male sex (adjusted OR: 1.33, 95% CI: 1.05-1.69) and heart diseases (adjusted OR: 1.65, 95% CI: 1.17-2.32). The case-crossover analysis revealed a more than fourfold risk (OR: 4.4, 95% CI: 1.67-11.62). In total, 22 of 331 shock cases were exposed to oxaliplatin within 2 days of shock onset, with a median cycle-to-shock time at the seventh cycle.</p><p><strong>Conclusion: </strong>Oxaliplatin use significantly increased shock risk in stage III CRC patients. Male sex and heart disease are two independent risk factors.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"15 ","pages":"20420986241266439"},"PeriodicalIF":3.4,"publicationDate":"2024-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11289823/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141861032","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Anticholinergic burden among in-patients: a cross-sectional study on prevalence, determinants, and impact on mortality in Ethiopia.","authors":"Eyob Alemayehu Gebreyohannes, Wagaye Atalay Taye, Biniam Siyum Shibe, Emneteab Mesfin Ayele, Kenneth Lee, Segenet Bizuneh Mengistu, Roy Louis Soiza, Phyo Kyaw Myint, Ousman Abubeker Abdela","doi":"10.1177/20420986241259624","DOIUrl":"10.1177/20420986241259624","url":null,"abstract":"<p><strong>Background: </strong>Numerous studies report that anticholinergic burden (ACB) has been linked with several health consequences, including increased hospital admissions, prolonged hospitalization, and physical and cognitive impairment. However, low- and middle-income settings, as well as younger individuals, are underrepresented.</p><p><strong>Objectives: </strong>To assess the prevalence and determinants of ACB, and to assess the impact of ACB on in-hospital mortality among adult in-patients at University of Gondar Comprehensive Specialized Hospital (UOGCSH).</p><p><strong>Design: </strong>A cross-sectional study was conducted from June to August 2022 at UOGCSH among adult in-patients.</p><p><strong>Methods: </strong>A pre-tested questionnaire was utilized to collect data from patients and their corresponding medical charts. A consecutive sampling technique was used to select the participants. Descriptive statistics were used to summarize socio-demographic and clinical characteristics. Chi-squared, Fisher's exact, and Wilcoxon rank sum tests, as appropriate, were used to determine associations between independent variables and ACB. Kaplan-Meier survival curve and Cox proportional hazards regression test were used to assess the impact of ACB on in-hospital mortality.</p><p><strong>Results: </strong>A total of 420 adult in-patients, median (interquartile range) age of 38 (26, 55) years, participated in this study. Over half (58.3%) were exposed to anticholinergic medicines, with a high ACB (⩾3) seen in 11.2% of participants. High ACB was associated with higher median number of medicines per patient (<i>p</i> = 0.003) higher median hospital length of stay (<i>p</i> = 0.033), and having mental and behavioral disorders (<i>p</i> < 0.001). No significant association was found between ACB and in-hospital mortality (log-rank test <i>p</i> = 0.26, Cox regression adjusted hazard ratio: 1.47, 95% CI: 0.335-6.453, <i>p</i> = 0.61).</p><p><strong>Conclusion: </strong>Among adult in-patients, a significant majority (58.3%) were subjected to medications possessing anticholinergic properties, with a noteworthy 11.2% of the study subjects exhibiting a high ACB. Participants with higher median length of hospital stay were more likely to have high ACB even in this relatively younger adult patient population.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"15 ","pages":"20420986241259624"},"PeriodicalIF":4.4,"publicationDate":"2024-06-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11179449/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141331741","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A retrospective pharmacovigilance study of post-marketing safety concerns with cefuroxime.","authors":"Cheng Jiang, Xiaoxiao Zheng, Ping Li, Jiancheng Qian, Qin Li","doi":"10.1177/20420986241258049","DOIUrl":"10.1177/20420986241258049","url":null,"abstract":"<p><strong>Background: </strong>Cefuroxime has played a crucial role in the prevention and treatment of bacterial infections. However, the differences in adverse events across formulations and routes remain unclear.</p><p><strong>Objectives: </strong>This study aimed to investigate the post-marketing safety of cefuroxime, particularly concerning formulations and routes.</p><p><strong>Design: </strong>A retrospective pharmacovigilance study of cefuroxime was conducted using the data from Food and Drug Administration Adverse Event Reporting System database.</p><p><strong>Methods: </strong>The clinical characteristics and concomitant drugs reported with cefuroxime were investigated. Adverse event signals of cefuroxime were identified based on four disproportionality algorithms. The signal differences of cefuroxime across formulations and routes were further examined.</p><p><strong>Results: </strong>A total of 1810 adverse event reports associated with cefuroxime were identified, and 181 cefuroxime-associated signals were detected. Compared with tablets, injections were more likely to cause preferred terms 'blood pressure decreased' and 'anaphylactic shock'. In addition, system organ class 'eye disorders' significantly increased when cefuroxime was administered intraocularly, underscoring the importance of exercising caution regarding ocular toxicity.</p><p><strong>Conclusion: </strong>The adverse events associated with cefuroxime were significantly different across formulations and routes, which deserve special attention in clinical use.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"15 ","pages":"20420986241258049"},"PeriodicalIF":4.4,"publicationDate":"2024-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11177735/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141331740","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}