Therapeutic Advances in Drug Safety最新文献

{"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":null,"pages":null},"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}

{"title":"Effect of heparin for the prevention of venous thromboembolism in patients with spontaneous intracranial cerebral hemorrhage: a meta-analysis.","authors":"Yifu Zhou, Gang Wang, Chunxiao Xue, Guojun He, Yan Zhang, Feilong He, Chenjun He, Xiaosong Liang","doi":"10.1177/20420986241253469","DOIUrl":"10.1177/20420986241253469","url":null,"abstract":"<p><strong>Background: </strong>Venous thromboembolism (VTE) has a serious impact on the prognosis of patients with spontaneous intracranial hemorrhage (sICH). However, the use of prophylactic heparin remains controversial.</p><p><strong>Objectives: </strong>This study investigated the safety and timing of prophylactic heparin for VTE in patients with sICH.</p><p><strong>Design: </strong>This study followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting guidelines.</p><p><strong>Methods: </strong>Two authors systematically searched Web of Science, Cochrane Library, Embase, and PubMed to find all published research before June 2023. The incidence of deep venous thrombosis (DVT) and mortality were set as primary endpoints.</p><p><strong>Results: </strong>This meta-analysis included seven randomized controlled trials (RCTs) and five observational studies involving a total of 4419 sICH patients in the heparin (<i>n</i> = 2808) and control (<i>n</i> = 1183) groups. Among these patients, 205 received early heparin administration, while 223 received late heparin administration. The results suggested that, compared to the control group, patients in the heparin group had a lower incidence of VTE [odds ratio (OR), 0.47; 95% CI, 0.31-0.71; <i>p</i> < 0.001], DVT (OR, 0.53; 95% CI, 0.33-0.85; <i>p</i> = 0.009), pulmonary embolism (OR, 0.31 95% CI, 0.15-0.65; <i>p</i> = 0.002), and mortality (OR, 0.70; 95% CI, 0.54-0.90; <i>p</i> = 0.006), but there were no statistical differences in hematoma enlargement, extracranial hematoma, and major disability (<i>p</i> > 0.05). There was no statistically significant difference in DVT, mortality, hematoma enlargement, and extracranial hemorrhage between the early heparin group (<24-48 h) and the late heparin group (<i>p</i> > 0.05).</p><p><strong>Conclusion: </strong>In patients with sICH, prophylactic use of heparin may be beneficial because it reduces the incidence of VTE and mortality without increasing the risk of additional bleeding. In addition, early prophylactic use of heparin appears to be safe. However, large-scale RCTs are lacking to support this evidence.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.4,"publicationDate":"2024-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11113067/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141087792","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":"The crucial role of pharmacovigilance in managing infectious diseases in lower and middle-income countries.","authors":"Zakir Khan, Ali Ahmed, Umair Ilyas","doi":"10.1177/20420986241251593","DOIUrl":"10.1177/20420986241251593","url":null,"abstract":"","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.4,"publicationDate":"2024-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11092529/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140923246","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":"The American Program in Pharmacovigilance (Am2P): a new accredited online training program in pharmacovigilance and pharmacoepidemiology.","authors":"Veronique Kugener, Karine Palin, Maribel Salas, Peggy Webster, Abimbola Cole, John Price, Sepideh Habibi, Christa Naboulet, Dona Ely, Pinak Joshi, Marina A Malikova","doi":"10.1177/20420986241249905","DOIUrl":"10.1177/20420986241249905","url":null,"abstract":"","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.4,"publicationDate":"2024-05-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11088298/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140913668","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":"Adverse event profiles of drug-induced liver injury caused by antidepressant drugs: a disproportionality analysis.","authors":"Aidou Jiang, Chunyan Wei, Weiwei Zhu, Fengbo Wu, Bin Wu","doi":"10.1177/20420986241244585","DOIUrl":"10.1177/20420986241244585","url":null,"abstract":"<p><strong>Background: </strong>Antidepressants are widely used to manage depression and other psychiatric diseases. A previous study revealed that hepatotoxicity was the main adverse event related to antidepressants. Therefore, drug-induced liver injury (DILI) caused by antidepressants deserves more attention.</p><p><strong>Objectives: </strong>To investigate DILI adverse events reported due to antidepressant use in the United States Food and Drug Administration Adverse Events Reporting System (FAERS) database.</p><p><strong>Research design: </strong>A disproportionality analysis of spontaneously reported adverse events was conducted to assess the association between antidepressant drugs and DILI.</p><p><strong>Methods: </strong>FAERS data from 1 January 2004 to 31 December 2021 were compiled and analyzed using the reporting odds ratio (ROR) and information component (IC).</p><p><strong>Results: </strong>As per the FAERS database, of the 324,588 cases that were administered antidepressants, 10,355 were identified as cases with DILI. Among the identified 42 antidepressants, nefazodone (<i>n</i> = 47, ROR = 7.79, IC = 2.91), fluvoxamine (<i>n</i> = 29, ROR = 4.69, IC = 2.20), and clomipramine (<i>n</i> = 24, ROR = 3.97, IC = 1.96) had the highest ROR for cholestatic injury; mianserin (<i>n</i> = 3, ROR = 21.46, IC = 3.99), nefazodone (<i>n</i> = 264, ROR = 18.67, IC = 3.84), and maprotiline (<i>n</i> = 15, ROR = 5.65, IC = 2.39) for hepatocellular injury; and nefazodone (<i>n</i> = 187, ROR = 12.71, IC = 0.48), clomipramine (<i>n</i> = 35, ROR = 2.07, IC = 0.26), and mirtazapine (<i>n</i> = 483, ROR = 1.96, IC = 0.94) for severe drug-related hepatic disorders. Only nefazodone elicited hepatic failure signals (<i>n</i> = 48, ROR = 18.64, IC = 4.16). There are limited reports on the adverse reactions of relatively new antidepressant drugs, such as milnacipran, viloxazine, esketamine, and tianeptine, and those not approved by the Food and Drugs Administration, such as reboxetine and agomelatine.</p><p><strong>Conclusion: </strong>A significant association was observed between DILI and nefazodone. Duloxetine and clomipramine were associated with three DILI categories, except hepatic failure. The disproportionality analysis cannot conclude on a definite causal link between antidepressants and DILI. Additional research is required to assess new-generation antidepressants for their propensity to cause DILI.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.4,"publicationDate":"2024-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11075604/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140877425","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":"Structured medication reviews in Parkinson’s disease: pharmacists’ views, experiences and needs – a qualitative study","authors":"Nicol G. M. Oonk, Lucille D. A. Dorresteijn, Eline te Braake, Kris L. L. Movig, Job van der Palen, Henk-Willem Nijmeijer, Mirjam E. van Kesteren, Christina Bode","doi":"10.1177/20420986241237071","DOIUrl":"https://doi.org/10.1177/20420986241237071","url":null,"abstract":"Background:Executing structured medication reviews (SMRs) in primary care to optimize drug treatment is considered standard care of community pharmacists in the Netherlands. Patients with Parkinson’s disease (PD) often face complex drug regimens for their symptomatic treatment and might, therefore, benefit from an SMR. However, previously, no effect of an SMR on quality of life in PD was found. In trying to improve the case management of PD, it is interesting to understand if and to what extent SMRs in PD patients are of added value in the pharmacist’s opinion and what are assumed facilitating and hindering factors.Objectives:To analyse the process of executing SMRs in PD patients from a community pharmacist’s point of view.Design:A cross-sectional, qualitative study was performed, consisting of face-to-face semi-structured in-depth interviews.Methods:The interviews were conducted with community pharmacists who executed at least one SMR in PD, till data saturation was reached. Interviews were transcribed verbatim, coded and analysed thematically using an iterative approach.Results:Thirteen pharmacists were interviewed. SMRs in PD were considered of added value, especially regarding patient contact and bonding, individualized care and its possible effect in the future, although PD treatment is found already well monitored in secondary care. Major constraints were time, logistics and collaboration with medical specialists.Conclusion:Although community pharmacist-led SMRs are time-consuming and sometimes logistically challenging, they are of added value in primary care in general, and also in PD, of which treatment occurs mainly in secondary care. It emphasizes the pharmacist’s role in PD treatment and might tackle future drug-related issues. Improvements concern multidisciplinary collaboration for optimized SMR execution and results.","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.4,"publicationDate":"2024-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140832756","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":"Abemaciclib pharmacology and interactions in the treatment of HR+/HER2− breast cancer: a critical review","authors":"Federica Martorana, Maria Vita Sanò, Maria Rosaria Valerio, Stefano Fogli, Paolo Vigneri, Romano Danesi, Vittorio Gebbia","doi":"10.1177/20420986231224214","DOIUrl":"https://doi.org/10.1177/20420986231224214","url":null,"abstract":"Abemaciclib (ABE) in combination with endocrine therapy represents the mainstay treatment for either endocrine-resistant metastatic or high-risk early-stage HR+/HER2− breast cancer patients. Hence, an adequate knowledge of this agent pharmacodynamic, pharmacokinetic, and of its drug–drug interactions (DDIs) is crucial for an optimal patients management. Additionally, ABE interference with food and complementary/alternative medicines should be taken into account in the clinical practice. Several online tools allow to freely check DDIs and can be easily consulted before prescribing ABE. According to one of this instruments, ABE display the lowest number of interactions among the available cyclin-dependent kinase 4/6 inhibitors. Still, clinicians should be aware that online tools cannot replace the technical datasheet of the drug as well as a comprehensive clinical assessment for each patient. Here we critically review the main pharmacological features of ABE, then focusing on its potential interactions with drugs, food, and alternative medicine, in order to provide a guide for its optimal use in the treatment of HR+/HER2− breast cancer patients.","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.4,"publicationDate":"2024-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140798088","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":"Drug–drug interaction between tacrolimus and caspofungin in Chinese kidney transplant patients with different CYP3A5 genotypes","authors":"Yundi Zhang, Bowen Shen, Yue Li, Huiying Zong, Xiaoming Zhang, Xiaohong Cao, Fengxi Liu, Yan Li","doi":"10.1177/20420986241243165","DOIUrl":"https://doi.org/10.1177/20420986241243165","url":null,"abstract":"Background:The effect of drug–drug interaction between tacrolimus and caspofungin on the pharmacokinetics of tacrolimus in different CYP3A5 genotypes has not been reported in previous studies.Objectives:To investigate the effect of caspofungin on the blood concentration and dose of tacrolimus under different CYP3A5 genotypes.Design:We conducted a retrospective cohort study in The First Affiliated Hospital of Shandong First Medical University and Shandong Provincial Qianfoshan Hospital from January 2015 to December 2022. All kidney transplant patients were divided into the combination or non-combination group based on whether tacrolimus was combined with caspofungin or not. Patients were subdivided into CYP3A5 expressers ( CYP3A5*1/*1 or CYP3A5*1/*3) and CYP3A5 non-expressers ( CYP3A5*3/*3).Methods:Data from the combination and the non-combination groups were matched with propensity scores to reduce confounding by SPSS 22.0. A total of 200 kidney transplant patients receiving tacrolimus combined with caspofungin or not were enrolled in this study. Statistical analysis was conducted on the dose-corrected trough concentrations ( C<jats:sub>0</jats:sub>/ D) and dose requirements ( D) of tacrolimus using independent sample two-sided t-test and nonparametric tests to investigate the impact on patients with different.Results:In this study, the C<jats:sub>0</jats:sub>/ D values of tacrolimus were not significantly different between the combination and non-combination groups ( p = 0.054). For CYP3A5 expressers, there was no significant difference in tacrolimus C<jats:sub>0</jats:sub>/ D or D values between the combination and non-combination groups ( p = 0.359; p = 0.851). In CYP3A5 nonexpressers, the C<jats:sub>0</jats:sub>/ D values of tacrolimus were significantly lower in the combination than in the non-combination groups ( p = 0.039), and the required daily dose of tacrolimus was increased by 11.11% in the combination group.Conclusion:Co-administration of caspofungin reduced tacrolimus blood levels and elevated the required daily dose of tacrolimus. In CYP3A5 non-expressers, co-administration of caspofungin had a significant effect on tacrolimus C<jats:sub>0</jats:sub>/ D values. An approximate 10% increase in the weight-adjusted daily dose of tacrolimus in CYP3A5 non-expressers is recommended to ensure the safety of tacrolimus administration.","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.4,"publicationDate":"2024-04-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140625864","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":"Olanzapine for the prevention of postoperative nausea and vomiting after gynecologic laparoscopic surgery: a randomized controlled trial","authors":"Nanjin Chen, Shuman Ji, Junfei Liu, Liping Wang, Fenglin Chen, Yanwu Zhu, Jiao Li, Minjuan Chen, Lingyang Chen, Mingcang Wang, Ruyi He, Xiaopeng Mei, Zhanqin Zhang, Shengwei Jin, Jingming Zheng, Yongpo Jiang","doi":"10.1177/20420986241244593","DOIUrl":"https://doi.org/10.1177/20420986241244593","url":null,"abstract":"Purpose:This study was designed to investigate the prophylactic effect of oral olanzapine in postoperative nausea and vomiting after gynecologic laparoscopic surgery.Methods:ASA I–II, aged 18–75 years, planned to undergo gynecologic laparoscopic surgery with general anesthesia in adult female patients. Using the randomized numbers table, the patients were placed in two groups. Oral olanzapine 5 mg or placebo was given 1 h before anesthesia. All patients received standard antiemetic prophylaxis with dexamethasone and granisetron. The primary outcome was nausea and/or vomiting in the 24 h after the postoperative.Results:A total of 250 patients were randomized, and 241 were analyzed. The primary outcome occurred in 10 of 120 patients (8.3%) in the olanzapine group and 23 of 121 patients (19.2%) in the placebo group ( p = 0.014). According to Kaplan–Meier analysis, the probabilities of nausea and/or vomiting in the 24 h after the postoperative in the olanzapine group were lower than in the placebo group (log-rank p = 0.014). In a multivariate Cox analysis, the variables of use of olanzapine [hazard ratio (HR): 0.35, 95% confidence interval (CI): 0.16–0.79; p = 0.012] and use of vasoactive drugs (HR: 2.48, 95% CI: 1.07–5.75; p = 0.034) were independently associated with nausea and/or vomiting in the 24 h after the postoperative.Conclusion:Our data suggest that olanzapine relative to placebo decreased the risk of nausea and/or vomiting in the 24 h after gynecologic laparoscopic surgery.Trial registration:The trial was registered prior to patient enrollment at The Chinese Clinical Trial Registry ( https://www.chictr.org.cn/showproj.html?proj=166900 , link to registry page, Principal investigator: Nanjin Chen, Date of registration: 25 April 2022).","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.4,"publicationDate":"2024-04-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140625813","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":"Expression of Concern","authors":"","doi":"10.1177/20420986241239903","DOIUrl":"https://doi.org/10.1177/20420986241239903","url":null,"abstract":"","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.4,"publicationDate":"2024-03-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140072448","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}