Drug Safety最新文献

{"title":"Safety and Effectiveness of COVID-19 Vaccines During Pregnancy: A Living Systematic Review and Meta-analysis.","authors":"Agustín Ciapponi, Mabel Berrueta, Fernando J Argento, Jamile Ballivian, Ariel Bardach, Martin E Brizuela, Noelia Castellana, Daniel Comandé, Sami Gottlieb, Beate Kampmann, Agustina Mazzoni, Edward P K Parker, Juan M Sambade, Katharina Stegelmann, Xu Xiong, Andy Stergachis, Pierre Buekens","doi":"10.1007/s40264-024-01458-w","DOIUrl":"10.1007/s40264-024-01458-w","url":null,"abstract":"<p><strong>Background: </strong>Pregnant persons are susceptible to significant complications following COVID-19, even death. However, worldwide COVID-19 vaccination coverage during pregnancy remains suboptimal.</p><p><strong>Objective: </strong>This study assessed the safety and effectiveness of COVID-19 vaccines administered to pregnant persons and shared this evidence via an interactive online website.</p><p><strong>Methods: </strong>We followed Cochrane methods to conduct this living systematic review. We included studies assessing the effects of COVID-19 vaccines in pregnant persons. We conducted searches every other week for studies until October 2023, without restrictions on language or publication status, in ten databases, guidelines, preprint servers, and COVID-19 websites. The reference lists of eligible studies were hand searched to identify additional relevant studies. Pairs of review authors independently selected eligible studies using the web-based software COVIDENCE. Data extraction and risk of bias assessment were performed independently by pairs of authors. Disagreements were resolved by consensus. We performed random-effects meta-analyses of adjusted relative effects for relevant confounders of comparative studies and proportional meta-analyses to summarize frequencies from one-sample studies using R statistical software. We present the GRADE certainty of evidence from comparative studies. Findings are available on an interactive living systematic review webpage, including an updated evidence map and real-time meta-analyses customizable by subgroups and filters.</p><p><strong>Results: </strong>We included 177 studies involving 638,791 participants from 41 countries. Among the 11 types of COVID-19 vaccines identified, the most frequently used platforms were mRNA (154 studies), viral vector (51), and inactivated virus vaccines (17). Low to very low-certainty evidence suggests that vaccination may result in minimal to no important differences compared to no vaccination in all assessed maternal and infant safety outcomes from 26 fewer to 17 more events per 1000 pregnant persons, and 13 fewer to 9 more events per 1000 neonates, respectively. We found statistically significant reductions in emergency cesarean deliveries (9%) with mRNA vaccines, and in stillbirth (75-83%) with mRNA/viral vector vaccines. Low to very low-certainty evidence suggests that vaccination during pregnancy with mRNA vaccines may reduce severe cases or hospitalizations in pregnant persons with COVID-19 (72%; 95% confidence interval [CI] 42-86), symptomatic COVID-19 (78%; 95% CI 21-94), and virologically confirmed SARS-CoV-2 infection (82%; 95% CI 39-95). Reductions were lower with other vaccine types and during Omicron variant dominance than Alpha and Delta dominance. Infants also presented with fewer severe cases or hospitalizations due to COVID-19 and laboratory-confirmed SARS-CoV-2 infection (64%; 95% CI 37-80 and 66%; 95% CI 37-81, respectively).</p><p><str","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"991-1010"},"PeriodicalIF":4.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11399161/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141619524","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"What is the Safety of COVID-19 Vaccines in Immunocompromised Patients? Results from the European \"Covid Vaccine Monitor\" Active Surveillance Study.","authors":"Chiara Bellitto, Nicoletta Luxi, Francesco Ciccimarra, Luca L'Abbate, Monika Raethke, Florence van Hunsel, Thomas Lieber, Erik Mulder, Fabio Riefolo, Felipe Villalobos, Nicolas H Thurin, Francisco B Marques, Kathryn Morton, Fergal O'Shaughnessy, Simona Sonderlichová, Andreea Farcas, Giele-Eshuis Janneke, Miriam C Sturkenboom, Gianluca Trifirò","doi":"10.1007/s40264-024-01449-x","DOIUrl":"10.1007/s40264-024-01449-x","url":null,"abstract":"<p><strong>Background: </strong>The safety profile of COVID-19 vaccines in immunocompromised patients has not been comprehensively evaluated.</p><p><strong>Aim: </strong>To measure the frequency of patient-reported adverse drug reactions (ADRs) related to the first/second/booster dose of COVID-19 vaccine in immunocompromised subject versus matched cohort. As a secondary objective, the time course, evaluated as time to onset (TTO) and time to recovery (TTR), of COVID-19 vaccine-related ADRs was explored.</p><p><strong>Methods: </strong>A prospective cohort study, based on electronic questionnaires filled by vaccinees from 11 European countries in the period February 2021 to February 2023 was conducted. All immunocompromised vaccinees who provided informed consent and registered to the project's web-app within 48 h after first/booster vaccine dose administration of any EMA-authorised COVID-19 vaccine were recruited. Participants filled baseline and up to six follow-up questionnaires (FU-Qs) over 6 months from vaccination, collecting information on suspected COVID-19 vaccine-related ADRs. As a control group, non-immunocompromised vaccinees from the same source population were 1:4 matched by sex, age, vaccine dose, and brand. A descriptive analysis of demographic/clinical characteristics of vaccinees was conducted. Heatmaps of the frequency of solicited ADRs, stratified by gender and vaccine brand, were generated. Median TTO/TTR of reported ADRs were visualised using violin/box-plots.</p><p><strong>Results: </strong>A total of 773 immunocompromised vaccines were included in the analyses. Most participants were females (F/M ratio: 2.1 and 1.6) with a median age of 56 (43-74) and 51 (41-60) years, at the first vaccination cycle and booster dose, respectively. Injection-site pain and fatigue were the most frequently reported ADRs in immunocompromised vaccinees with higher frequency than matched control, especially after the first dose (41.2% vs 37.8% and 38.2% vs 32.9%, respectively). For both cohorts, all solicited ADRs were more frequently reported in females than males, and in those who had received a first dose of the Vaxzevria vaccine. Dizziness was the most frequently reported unsolicited ADR after the first dose in both groups (immunocompromised subjects: 2.5% and matched controls: 2.1%). At the booster dose, lymphadenopathy (3.9%) and lymphadenitis (1.8%) were the most reported unsolicited ADRs for immunocompromised subjects and matched controls, respectively. A very low number of subjects reported adverse event of special interest (AESI) (2 immunocompromised, 3 matched controls) and serious ADRs (5 immunocompromised, 5 matched controls). A statistically significant difference among study cohorts was observed for median TTO after the booster dose, and for median TTR after the first vaccination cycle and booster dose (p < 0.001).</p><p><strong>Conclusion: </strong>The overall safety profile of COVID-19 vaccines in immunocompromised people was fav","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"1011-1023"},"PeriodicalIF":4.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11399172/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141440296","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pregnancy Outcomes in Patients Treated with Upadacitinib: Analysis of Data from Clinical Trials and Postmarketing Reports.","authors":"Uma Mahadevan, Gweneth Levy, Lianne Gensler, Mira Ali, Ana P Lacerda, Lani Wegrzyn, Hannah Palac, Tina Bhutani-Jacques, Millie Long, Megan E B Clowse, Alexa B Kimball, Christina Chambers, Anthony R Scialli","doi":"10.1007/s40264-024-01454-0","DOIUrl":"10.1007/s40264-024-01454-0","url":null,"abstract":"<p><strong>Background and objective: </strong>Upadacitinib is indicated for diseases affecting persons of childbearing potential including rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, atopic dermatitis, Crohn's disease, and ulcerative colitis; however, teratogenicity was observed in animal studies. Given the potential for human fetal risk, pregnancy avoidance measures were required during clinical trials. This analysis describes pregnancy outcomes in patients exposed to upadacitinib during pregnancy.</p><p><strong>Methods: </strong>Clinical trial and postmarketing cases of in utero exposure to upadacitinib were identified in AbbVie's safety database through 25 April, 2023. Analysis of clinical trial cases and postmarketing reports are presented separately; prospective and retrospectively reported pregnancy outcomes are integrated for each. Descriptive rates are presented to summarize outcomes.</p><p><strong>Results: </strong>There were 128 maternal upadacitinib-exposed pregnancies with known outcomes identified; 80 and 48 pregnancies were reported in clinical trials and the postmarketing setting, respectively. In clinical trials (mean in utero exposure of 5 weeks, 3 days), live births (54%), spontaneous abortions (24%), elective terminations (21%), and ectopic pregnancy (1%) were reported. There was one report of a congenital malformation: a 35-week infant with an atrial septal defect. In postmarketing cases, live births (46%), spontaneous abortions (38%), elective terminations (15%), and ectopic pregnancy (2%) were reported.</p><p><strong>Conclusions: </strong>As the data are limited for in utero exposure to upadacitinib, definitive conclusions cannot be drawn regarding the effect of upadacitinib on pregnancy outcomes. Rates of adverse pregnancy outcomes with upadacitinib exposure were comparable to rates observed in the general population or patients with autoimmune inflammatory diseases. To date, no apparent evidence of teratogenicity exists in the analyses of human pregnancies exposed to upadacitinib during the first trimester.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"1039-1049"},"PeriodicalIF":4.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11399166/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141616088","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-World Effectiveness and Safety of Tixagevimab-Cilgavimab: A Target Trial Emulation Study.","authors":"Vincent Ka Chun Yan, Yu Yang, Eric Yuk Fai Wan, Francisco Tsz Tsun Lai, Celine Sze Ling Chui, Xue Li, Carlos King Ho Wong, Ivan Fan Ngai Hung, Chak Sing Lau, Ian Chi Kei Wong, Esther Wai Yin Chan","doi":"10.1007/s40264-024-01450-4","DOIUrl":"10.1007/s40264-024-01450-4","url":null,"abstract":"<p><strong>Background: </strong>Immunocompromised individuals are at high risk of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and subsequent severe or fatal coronavirus disease 2019 (COVID-19), yet they have suboptimal responses to mRNA and inactivated COVID-19 vaccines. The efficacy of tixagevimab-cilgavimab in reducing symptomatic SARS-CoV-2 infection was demonstrated in phase III clinical trials. Nevertheless, real-world data on the effectiveness and safety of tixagevimab-cilgavimab remain limited.</p><p><strong>Objective: </strong>The aim was to evaluate the effectiveness and safety of tixagevimab-cilgavimab among immunocompromised individuals.</p><p><strong>Methods: </strong>Adults who were immunocompromised or receiving immunosuppressive therapies were included in this target trial emulation using territory-wide electronic health records in Hong Kong. A sequential trial emulation approach was adopted to compare effectiveness and safety outcomes between individuals who received tixagevimab-cilgavimab and individuals who did not.</p><p><strong>Results: </strong>A total of 746 tixagevimab-cilgavimab recipients and 2980 controls were included from 1 May 2022 to 30 November 2022. Tixagevimab-cilgavimab significantly reduced the risk of COVID-19 infection (hazard ratio [HR] 0.708, 95% confidence interval [CI] 0.527-0.951) during a median follow-up of 60 days. No significant difference was observed in the risk of COVID-19-related hospitalisation. Zero versus eight COVID-19 mortality cases and zero versus two severe COVID-19 cases were observed in tixagevimab-cilgavimab recipients and controls, respectively. Notably, significant risk reduction in COVID-19 infection was also observed among immunocompromised individuals who had been previously vaccinated with three or more doses of COVID-19 vaccine, or had no prior COVID-19 infection history.</p><p><strong>Conclusions: </strong>Tixagevimab-cilgavimab was effective in reducing COVID-19 infection among immunocompromised patients during the Omicron wave. Findings were consistent among individuals who previously received three or more doses of COVID-19 vaccine, or had no previous history of COVID-19 infection.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"1025-1037"},"PeriodicalIF":4.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11399184/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141445885","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The PrescIT platform: An interoperable Clinical Decision Support System for ePrescription to Prevent Adverse Drug Reactions and Drug-Drug Interactions.","authors":"Pantelis Natsiavas, George Nikolaidis, Jenny Pliatsika, Achilles Chytas, George Giannios, Haralampos Karanikas, Margarita Grammatikopoulou, Martha Zachariadou, Vlasios Dimitriadis, Spiros Nikolopoulos, Ioannis Kompatsiaris","doi":"10.1007/s40264-024-01455-z","DOIUrl":"10.1007/s40264-024-01455-z","url":null,"abstract":"<p><strong>Introduction: </strong>Preventable medication errors have been proven to cause significant public health burden, and ePrescription is a key part of the process where medication errors and adverse effects could be prevented. Information systems and \"intelligent\" computational approaches could provide a valuable tool to prevent such errors with profound impact in clinical practice.</p><p><strong>Objectives: </strong>The PrescIT platform is a Clinical Decision Support System (CDSS) that aims to facilitate the prevention of adverse drug reactions (ADRs) and drug-drug interactions (DDIs) in the phase of ePrescription in Greece. The proposed platform could be relatively easily localized for use in other contexts too.</p><p><strong>Methods: </strong>The PrescIT platform is based on the use of Knowledge Engineering (ΚΕ) approaches, i.e., the use of Ontologies and Knowledge Graphs (KGs) developed upon openly available data sources. Open standards (i.e., RDF, OWL, SPARQL) are used for the development of the platform enabling the integration with already existing IT systems or for standalone use. The main KG is based on the use of DrugBank, MedDRA, SemMedDB and OpenPVSignal. In addition, the Business Process Management Notation (BPMN) has been used to model long-term therapeutic protocols used during the ePrescription process. Finally, the produced software has been pilot tested in three hospitals by 18 clinical professionals via in-person think-aloud sessions.</p><p><strong>Results: </strong>The PrescIT platform has been successfully integrated in a transparent fashion in a proprietary Hospital Information System (HIS), and it has also been used as a standalone application. Furthermore, it has been successfully integrated with the Greek National ePrescription system. During the pilot phase, one psychiatric therapeutic protocol was used as a testbed to collect end-users' feedback. Summarizing the feedback from the end-users, they have generally acknowledged the usefulness of such a system while also identifying some challenges in terms of usability and the overall user experience.</p><p><strong>Conclusions: </strong>The PrescIT platform has been successfully deployed and piloted in real-world environments to evaluate its ability to support safer medication prescriptions.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"1051-1059"},"PeriodicalIF":4.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141727025","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The STAR Compass to Guide Future Pharmacovigilance Based on a 10-Year Review of the Strengthened EU System.","authors":"Priya Bahri, Georgy Genov, Peter Arlett, Viola Macolić Šarinić, Evdokia Korakianiti, Alexis Nolte, Martin Huber, Sabine M J M Straus","doi":"10.1007/s40264-024-01451-3","DOIUrl":"10.1007/s40264-024-01451-3","url":null,"abstract":"<p><p>This article reflects on the 2010 pharmacovigilance legislation of the European Union (EU). Its legislative aim of better patient and public health protection through new responsibilities for pharmaceutical companies and regulatory bodies is considered to have been achieved and is well supported by the good pharmacovigilance practices 'EU-GVP'. For future progress, we set out a vision for high-quality pharmacovigilance in a world of ongoing medical, technological and social changes. To deliver this vision, four principles are proposed to guide actions for further progressing the EU pharmacovigilance system: synergistic interactions with healthcare systems; trustworthy evidence for regulatory decisions; adaptive process efficiency; and readiness for emergency situations (the 'STAR principles'). Like a compass, these principles should guide actions for building capacity, technology and methods; improving regulatory processes; and expanding policies, frameworks and research agendas. Fit for the future, the EU system should achieve further improved outputs in terms of safe, effective and trusted use of medicines and positive health outcomes within patient-centred healthcare.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"941-956"},"PeriodicalIF":4.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11399220/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141579246","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pharmacovigilance in the Age of Legalized Cannabis: Using Social Media to Monitor Drug–Drug Interactions Between Immunosuppressants and Cannabis-Derived Products","authors":"Matthew R. Allen, Gwenyth Portillo Wightman, Zechariah Zhu, Adam Poliak, Davey M. Smith, Mark Dredze, John W. Ayers","doi":"10.1007/s40264-024-01481-x","DOIUrl":"https://doi.org/10.1007/s40264-024-01481-x","url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Introduction</h3><p>A clinical trial of Epidiolex^®, the only US FDA-approved cannabis-derived consumer product (CDP), discovered an interaction with an immunosuppressant (tacrolimus) that led to drug toxicity, highlighting the unique intersection of prescription and commonly unregulated consumer products.</p><h3 data-test=\"abstract-sub-heading\">Objective</h3><p>We aimed to identify if similar drug–drug interactions (DDIs) are occurring among the consumer CDP market, even though they cannot be identified through trials.</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>We searched Reddit for subreddits related to CDPs or health, resulting in 63,561,233 posts. From these, we identified 190 posts discussing both immunosuppressants and CDPs. Two blinded investigators evaluated the following. (1) Was there a concern about a potential DDI between consumer CDPs and immunosuppressants? (2) Was there a unique adverse event attributed to a DDI between consumer CDPs and immunosuppressants?</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>Of these, 66 posts (35%) expressed concern about a potential DDI, such as <i>“Hey, my partner wants to try my edibles … she’s on Prograf [tacrolimus] and wants to talk to a stoner who’s had a heart transplant.”</i> Four posts (2%) reported a unique DDI, such as <i>“I have clinical results that are semi-anecdotal, showing the coordination to my halting substance use … It's the CBD. Shot my prograf to 30 at like 4 mg.”</i> Two of the four reported DDIs are similar to those first reported for Epidiolex. The remaining two reported DDIs include a potential cannabidiol (CBD)/sirolimus or delta-9-tetrahydrocannabinol (THC)/sirolimus interaction and a THC/tacrolimus interaction, both resulting in drug toxicity.</p><h3 data-test=\"abstract-sub-heading\">Conclusion</h3><p>This case study is the first to report on DDIs involving consumer CDPs, including both CBD and THC products, as well as a broader class of immunosuppressants. This demonstrates the risks associated with using consumer CDPs alongside prescription medications while highlighting the need for development of increased surveillance to monitor consumer CDPs for drug safety signals, as well as comprehensive regulations that take into account the unique characteristics of the consumer marketplace.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":"32 1","pages":""},"PeriodicalIF":4.2,"publicationDate":"2024-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142266374","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"23rd ISoP Annual Meeting \"Global Perspectives on Pharmacovigilance in the Digital Age and Advanced Therapeutics\" 1-5 October 2024 Montreal, Canada.","authors":"","doi":"10.1007/s40264-024-01477-7","DOIUrl":"https://doi.org/10.1007/s40264-024-01477-7","url":null,"abstract":"","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":"20 1","pages":""},"PeriodicalIF":4.2,"publicationDate":"2024-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142266375","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Drug-Induced Hypouricemia","authors":"Chaker Ben Salem, Myriam Agrebi, Dhouha Sahnoun, Neila Fathallah, Houssem Hmouda","doi":"10.1007/s40264-024-01485-7","DOIUrl":"https://doi.org/10.1007/s40264-024-01485-7","url":null,"abstract":"<p>Hypouricemia is defined as a serum uric acid concentration of ≤ 2.0 mg/dL or 119 μmol/L. Hypouricemia may occur secondarily to a number of underlying conditions, including severe hepatocellular disease, neoplasia, defective renal tubular reabsorption of uric acid, inherited metabolic defect in purine metabolism, and drugs. Medications are an important cause of hypouricemia. They can cause hypouricemia by a variety of mechanisms. Drug-induced hypouricemia mostly occurs as overtreatment of hyperuricemia by urate-lowering therapies including xanthine oxidase inhibitors, uricosuric agents and uricases. Drugs not used in the treatment of gout may also lead to a decrease of uric acid levels. In this literature review, medications leading to hypouricemia are summarized with regard to their mechanism of action and clinical significance.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":"54 1","pages":""},"PeriodicalIF":4.2,"publicationDate":"2024-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142266373","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Qualitative Interviews with Stakeholders in Herbal Pharmacovigilance and Recommendations for Best Practices to be Applied Worldwide","authors":"Corine Ekhart, Sjoerd H. P. Wiarda, Sonja van de Koppel, Souad Skalli, Waad Alghamdi, Francesca Menniti-Ippolito, Kunwarang Tangchitkhachon, John Samson Mponda, Herman J. Woerdenbag, Florence van Hunsel","doi":"10.1007/s40264-024-01480-y","DOIUrl":"https://doi.org/10.1007/s40264-024-01480-y","url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Background and Objective</h3><p>The use of herbal products globally is substantial, but varying definitions and regulatory frameworks have led to differences in their status as medicinal products and in approaches to monitoring their safety. This article explores the current landscape of herbal pharmacovigilance, drawing insights from interviews with global experts in the field, and offers recommendations for best practices to enhance the safety and benefit-to-harm balance of herbal products.</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>This study comprised semi-structured interviews with members of the International Society of Pharmacovigilance-Herbal and Traditional Medicines Special Interest Group and the Nutrivigilance Information Exchange Network, recruited using purposive sampling. Data were stored and coded using NVIVO^® and analysed thematically using a qualitative inductive approach.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>Sixteen participants from 11 countries were interviewed, revealing diverse regulatory approaches and challenges in herbal pharmacovigilance. Key themes included legal status, awareness, identification and coding of herbal products, pre-/post-marketing product control, reporting of adverse drug reactions, causality assessment and signals of herbal products. This study yielded five general recommendations to further improve herbal pharmacovigilance worldwide.</p><h3 data-test=\"abstract-sub-heading\">Conclusions</h3><p>This study offers an overview of the global landscape of herbal pharmacovigilance, highlighting challenges in monitoring herbal products and presenting universal recommendations. These recommendations encompass increasing awareness, enhancing education and improving legislative frameworks. Given the growing use of herbal products, the implementation of strong pharmacovigilance practices is crucial to ensure consumer safety.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":"28 1","pages":""},"PeriodicalIF":4.2,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142200715","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}