Drug Safety最新文献

{"title":"VigiBase: Resource Profile Update with a Summary of Global Patterns and Trends in Adverse Event Reports for Medicines and Vaccines.","authors":"Judith S Brand, Oskar Gauffin, Daniele Sartori, Michele Fusaroli, Helena Sköld, Tomas Bergvall, Lovisa Sandberg, Magnus Wallberg, Peter Hjelmström, G Niklas Norén","doi":"10.1007/s40264-025-01642-6","DOIUrl":"10.1007/s40264-025-01642-6","url":null,"abstract":"<p><p>VigiBase, the WHO global database of adverse event reports for medicines and vaccines, receives information on suspected adverse effects of medicinal products from countries, regions and territories that are members of the WHO Programme for International Drug Monitoring. The database serves as a global resource for pharmacovigilance signal management and scientific development. Its initial establishment through the programme in 1968 has also contributed to the international harmonisation of adverse event report data. As of 31 December 2024, the database includes over 40 million individual case reports coded in standard terminologies (WHODrug and MedDRA^®). These reports, of which ~ 80% relate to medicines and ~ 20% to vaccines, come from over 160 countries. This profile paper aims to provide an update on the database infrastructure including data capture, management and analysis tools. It also presents a summary of global patterns and trends of key report characteristics, as well as strengths and limitations of the data to offer context to users and the global pharmacovigilance community.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"613-629"},"PeriodicalIF":3.8,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146092370","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":"Hepatic Effects, Potential Drug-Induced Liver Injury, and Other Liver Safety Considerations of Chimeric Antigen Receptor T-Cell (CAR-T) Therapy in the New Era of Expanding Non-oncology Indications: Literature Review and Expert Consensus.","authors":"Anna Fettiplace, Arie Regev, Alexandre Kiazand, Ulrike Heinzel-Pleines, Mahnoush Bahjat, Anju Garg, Luciana Kikuchi, Hewei Li, Ali Hamidi, David H Alpers, Hans Tillmann, Dominique Larrey, Adrian M Di Bisceglie, James H Lewis","doi":"10.1007/s40264-025-01635-5","DOIUrl":"10.1007/s40264-025-01635-5","url":null,"abstract":"<p><p>Chimeric antigen receptor T-cell (CAR-T) therapy is a rapidly expanding key therapeutic category, originally pioneered for haematological malignancies, now being developed into treatments for solid tumours and non-malignant immune-mediated conditions. Chimeric antigen receptor T-cell therapies have some relatively unique toxicities which can affect the liver, in addition to potential drug-induced liver injury and hepatitis B virus reactivation. This manuscript was developed by the IQ Consortium (International Consortium for Innovation and Quality in Pharmaceutical Development) Drug-induced Liver Injury (DILI) Initiative that consists of members from 17 pharmaceutical companies, in collaboration with academic and regulatory DILI experts. The aim was to produce a comprehensive guide to summarise the hepatic effects of CAR-T, and to propose an approach to the investigation of liver test changes. The clinical characteristics of liver test changes in association with cytokine release syndrome and immune-effector cell haemophagocytic lymphohistiocytosis are described, to enable these anticipated hepatic effects to be distinguished from other causes of abnormal liver tests. The frequency and timing of many primary and secondary liver conditions that may present after CAR-T therapy are described. This review provides the first detailed description of both anticipated and unpredictable hepatic effects of CAR-T cell therapies and is intended to assist in the future characterisation of hepatic effects of CAR-T therapies as programmes move into areas with a different benefit/risk profile, such as autoimmune or other non-oncology indications.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"631-654"},"PeriodicalIF":3.8,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145676687","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":"NSAIDs Use During Herpes Zoster Infection and Stroke Risk: A Nationwide Case-Crossover Study.","authors":"Lin-Chieh Meng, Hsi-Yu Lai, Hui-Min Chuang, Ho-Min Chen, Liang-Kung Chen, Fei-Yuan Hsiao","doi":"10.1007/s40264-026-01652-y","DOIUrl":"10.1007/s40264-026-01652-y","url":null,"abstract":"<p><strong>Background and aims: </strong>Herpes zoster (HZ) infection and long-term non-steroidal anti-inflammatory drugs (NSAIDs) use are established risk factors for stroke and other cardiovascular diseases. Given the paucity of evidence regarding an association between NSAIDs use and HZ on stroke risk, this case-crossover study, utilizing a nationwide, population-based cohort, aimed to investigate the effect of HZ infection and concurrent NSAIDs use on the incidence of stroke.</p><p><strong>Methods: </strong>Using Taiwan's National Health Insurance database (2014-2020), we identified 336,075 patients with incident stroke. A case-crossover design comparing exposure to HZ and NSAIDs between the focal period (1-30 days before stroke) and referent period (366-395 days before stroke) was employed. Conditional logistic regression estimated adjusted odds ratios (aORs) for stroke risk associated with NSAIDs use during HZ episodes. Pre-planned subgroup analyses further examined such effects on stroke subtypes (ischemic stroke, hemorrhagic stroke, and transient ischemic attack [TIA]), across age groups (< 50, 50-64, ≥ 65 years) and in patients with various comorbidities, including immunocompromised and autoimmune diseases, cardiometabolic risk factors, and renal and liver diseases.</p><p><strong>Results: </strong>Combined HZ infection and NSAIDs use was associated with doubled stroke risk (aOR 2.05, 95% confidence interval [CI] 1.80-2.33) compared with periods without either exposure. For specific stroke types, the aORs were 1.94 (95% CI 1.65-2.29) for ischemic stroke, 1.81 (95% CI 1.34-2.43) for hemorrhagic stroke, and 2.81 (95% CI 2.06-3.85) for TIA. HZ episodes without NSAIDs (aOR 1.70, 95% CI 1.45-2.00) and NSAIDs use alone (aOR 1.42, 95% CI 1.40-1.44) showed lower but significant risk increment. In age-stratified analyses, individuals aged 65 years and older exhibited a significantly elevated stroke risk while concurrently utilizing NSAIDs during HZ episodes (aOR 2.19, 95% CI 1.92-2.62). Subgroup analyses demonstrated consistent elevated risks in patients with pre-existing comorbidities, particularly immunocompromised conditions (aOR 3.07, 95% CI 1.95-4.81) and renal disease (aOR 4.30, 95% CI 2.20-8.41).</p><p><strong>Conclusions: </strong>Our findings demonstrate a significant association between HZ infection and NSAIDs use on stroke risk, particularly among individuals aged 65 years and older or those with pre-existing immunocompromised, cardiometabolic, and chronic conditions. The optimization of pain management strategies during HZ episodes is paramount to mitigate the risk of stroke while ensuring effective management of HZ-associated pain.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"717-727"},"PeriodicalIF":3.8,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146178525","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":"Risk of Cancer Comparing Warfarin and Direct Oral Anticoagulants: Population-Based Cohort Studies in England and Hong Kong.","authors":"Zixuan Wang, Qiuyan Yu, Julian Matthewman, John Tazare, Sara Benitez Majano, Jeremy Brown, Ka Shing Cheung, Celine S L Chui, Esther W Y Chan, Krishnan Bhaskaran, Ian C K Wong, Ian J Douglas, Angel Y S Wong","doi":"10.1007/s40264-025-01645-3","DOIUrl":"10.1007/s40264-025-01645-3","url":null,"abstract":"<p><strong>Background: </strong>Previous evidence suggests a potential protective effect of warfarin against cancer, compared to non-users. However, it may be prone to immortal time bias and residual confounding.</p><p><strong>Objective: </strong>We aimed to examine the association between cancer and warfarin, compared with active comparator (direct oral anticoagulants).</p><p><strong>Methods: </strong>We conducted studies using population-based databases from England and Hong Kong to investigate the association between warfarin and hazard of cancer using a new-user active-comparator cohort design. People with atrial fibrillation aged ≥ 18 years who had first received anticoagulant treatment during 01/01/2011-31/12/2019 were involved.</p><p><strong>Results: </strong>No evidence supported the association between warfarin and hazard of overall cancer, compared with direct oral anticoagulants in both settings (England: hazard ratio [HR] = 1.03, 95% confidence interval [CI] 0.94-1.13; Hong Kong: HR = 0.89, 95% CI 0.79-1.01). A lower hazard of female breast (HR = 0.49, 95% CI 0.30-0.79), ovarian (HR = 0.07, 95% CI 0.01-0.58), and pancreatic (HR = 0.46, 95% CI 0.22-0.96) cancers and a higher hazard of kidney cancer (HR = 3.57, 95% CI 1.64-7.76) were found in Hong Kong, comparing warfarin with direct oral anticoagulants, but these were not replicated in England.</p><p><strong>Conclusions: </strong>This study does not find a protective effect of warfarin against cancer versus direct oral anticoagulants. The risks of site-specific cancers including pancreatic, kidney, and sex-specific cancers between oral anticoagulants shown in the Hong Kong setting only may require further investigation in other independent datasets.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"677-687"},"PeriodicalIF":3.8,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145997597","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":"Disseminated Intravascular Coagulation Following Idarucizumab and Andexanet Alfa: Assessment of a Signal of Disproportionate Reporting From the Food and Drugs Administration Adverse Event Reporting System (FAERS) Database.","authors":"Giuseppe Roberto, Lorenzo Parmeggiani, Alessandra Flaccavento, Alfredo Vannacci, Guido Mannaioni, Rosa Gini, Gianni Virgili, Marco Tuccori","doi":"10.1007/s40264-026-01648-8","DOIUrl":"10.1007/s40264-026-01648-8","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Idarucizumab and andexanet alfa are licensed for the emergency reversal of the antithrombotic effect of direct oral anticoagulants (DOAC). Given their recent commercialization and rare use in clinical practice, current evidence on rare thromboembolic adverse events following idarucizumab or andexanet alfa administration is insufficient to draw definitive conclusions.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;The aim of this study was to perform a signal detection analysis based on data from a large spontaneous reporting database to identify possible safety signals concerning rare, serious and unexpected thromboembolic events reported following the administration of idarucizumab and andexanet alfa, respectively.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;A disproportionality analysis was performed based on Individual Case Safety Reports (ICSRs) submitted from any US or non-US country between 2004 and 2022 to the FDA Adverse Event Reporting System (FAERS). A case/non-case approach was applied: cases were ICSRs containing the event of interest, non-cases were the remaining reports. The odds of exposure to idarucizumab and andexanet alfa, respectively, in cases versus non-cases was measured. Reporting odds ratio (ROR) and 95% confidence intervals (95% CI) were calculated for 434 Preferred Terms from three relevant sub-standardized MedDRA&lt;sup&gt;®&lt;/sup&gt; queries. Signals of disproportionate reporting (SDR) were drug-event pairs reported in three or more ICSRs, with the lower 95% CI of RORs &gt; 1. SDRs corresponding to unexpected and biologically plausible drug-event pairs were selected for further evaluation through a case-by-case assessment. Original ICSRs, including case narratives, were obtained from the FDA. The WHO-UMC system for standardized case causality assessment was used to guide and classify the expert-based judgement of individual cases.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;A total of 11,561,146 ICSRs submitted to FAERS between 2004 and 2022 were analysed. Idarucizumab and andexanet alfa were listed as suspected drugs in 1463 and 399 reports, respectively. A total of 21 SDRs for idarucizumab and 19 for andexanet alfa were obtained. Eleven ICSRs containing the drug-event pair idarucizumab-disseminated intravascular coagulation (DIC) (ROR 14.5; 95% CI 8.0-26.3) and four containing andexanet-alfa-DIC (ROR 19.4; 95% CI 7.2-51.9) were selected for case-by-case assessment. Two additional andexanet-alfa-DIC ICSRs submitted in 2023 were identified using the FAERS Public Dashboard, although one was a duplicate. Nine of the 11 for idarucizumab and four of the five for andexanet alfa were original ICSRs with a case narrative available. Age was reported in ten idarucizumab cases (mean 79 years) and four andexanet alfa cases (mean 71 years). Nine idarucizumab cases and four andexanet alfa cases were fatal. Causality was judged 'possible' for five idarucizumab cases and three andexanet alfa cases which occurred within 1 day from administration. The r","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"689-704"},"PeriodicalIF":3.8,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147497937","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":"Prescription Drugs Subject to a Risk Evaluation and Mitigation Strategy: Patient Perspectives on Risk Communication and the Value of Educational Materials.","authors":"Susan Chimonas, Carol Cosenza, Aaron S Kesselheim, Gita A Toyserkani, Kate Heinrich Oswell, Cynthia LaCivita, Gerald J Dal Pan, Ameet Sarpatwari","doi":"10.1007/s40264-025-01636-4","DOIUrl":"10.1007/s40264-025-01636-4","url":null,"abstract":"<p><strong>Background: </strong>The US Food and Drug Administration (FDA)-mandates Risk Evaluation and Mitigation Strategy (REMS) programs for certain drugs with serious side effects help ensure that the benefits of use outweigh the risks. REMS materials-including enrollment forms, fact sheets, and medication guides-inform patients and caregivers about drug risks and program requirements.</p><p><strong>Objective: </strong>To explore how effectively REMS materials communicate drug risk information and program requirements to patients and caregivers and to identify patients' and caregivers' preferences for risk communication.</p><p><strong>Methods: </strong>Interviews with patients and caregivers of patients prescribed REMS-covered drugs focused on REMS materials. Transcripts were coded manually, with answers to closed-ended questions tabulated in Excel.</p><p><strong>Results: </strong>The study included 43 patients and six caregivers across eight REMS-covered drugs: alemtuzumab, ambrisentan, clozapine, isotretinoin, lenalidomide, pegvaliase, pomalidomide, and sodium oxybate. Most participants were female (N = 42, 86%), white/non-Hispanic (N = 40, 82%), and college educated (N = 37, 76%). The average age was 40 years, with 27 (55%) having annual family incomes over $100,000. Most participants learned about REMS-covered drugs via printed information (N = 36, 73%), mostly REMS materials; conversations with providers about drug risks and benefits (N = 29, 59%); and websites found on their own (N = 42, 86%). Nearly all participants (N = 47, 96%) felt well-informed about drug risks and benefits, and most participants taking self-administered drugs (N = 28, 67%) reported understanding safe use \"very well.\" However, knowledge gaps emerged around REMS-related risks and reasons for safe use measures; some participants misunderstood REMS enrollment forms as legal protections, not safety measures. Patients also widely varied in their valuations of REMS materials, with some feeling informed and empowered and others confused or intimidated. Preferences for risk communication varied; most participants (N = 36, 73%) wanted to receive information verbally from providers, with several wanting visual aids, summaries, and other resources.</p><p><strong>Discussion: </strong>Gaps in patients' and caregivers' understanding of REMS programs and drug risks highlight the merits of reviewing communication materials and strategies. Clear, concise, and comprehensive educational documents could promote understanding and adherence to REMS requirements.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"667-675"},"PeriodicalIF":3.8,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12973593/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145631257","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":"A National Response to Warfarin Shortages: Evaluating Regulatory Substitution and Notified Shortages and Their Effects on Antithrombotic Dispensings, Pathology Monitoring and Adverse Event Trends in Australia.","authors":"Roua Azroun, Lisa Kalisch Ellett, Nicole Pratt, Michael Ward, Jack Janetzki","doi":"10.1007/s40264-025-01633-7","DOIUrl":"10.1007/s40264-025-01633-7","url":null,"abstract":"<p><strong>Background: </strong>Medicine shortages are an increasing threat to medicine safety and access. In Australia, a 7-month shortage of Coumadin 5-mg tablets (Dec 2022-Jul 2023) prompted Therapeutic Goods Administration (TGA) intervention via the Serious Scarcity Substitution Instrument (SSSI), allowing pharmacists to substitute 5-mg warfarin tablets with lower-strength tablets. Understanding the impact of this shortage on anticoagulant use and safety is essential for informing future regulatory responses.</p><p><strong>Aims: </strong>The aim of this study was to assess the impact of the 2023 warfarin shortage in Australia on dispensing of warfarin and direct oral anticoagulants (DOACs), International Normalised Ratio (INR) testing, and adverse event reporting.</p><p><strong>Methods: </strong>Monthly national dispensing data (January 2020-August 2024) were obtained from Pharmaceutical Benefits Scheme (PBS) Date of Supply data. INR pathology data were sourced from Services Australia. The TGA Medicines Shortages Database identified relevant shortage periods. Warfarin-related adverse events were extracted from the TGA Database of Adverse Event Notifications. Interrupted time series assessed changes in dispensing and INR testing trends over time.</p><p><strong>Results: </strong>Warfarin dispensing declined by 1094 prescriptions per month prior to March 2023 (p < 0.0001). A short-term increase occurred in March 2023 (+ 8625 prescriptions; p = 0.0017) following implementation of the SSSI, although this was not sustained. At the warfarin strength level, dispensing rose for warfarin 1 mg and 2 mg but fell for 5 mg, with subsequent compensatory increases; 3 mg remained stable. DOAC dispensing increased steadily before March 2023 (+ 3771 prescriptions per month; p < 0.0001) but declined thereafter (- 3056 per month; p < 0.0001), most notably for rivaroxaban and dabigatran, while apixaban decreased non-significantly. INR testing briefly increased during the shortage and SSSI. A modest rise in haemorrhage-related adverse events was observed.</p><p><strong>Conclusion: </strong>Warfarin supply was maintained during the 2023 shortage through strength-based substitution under the SSSI, with limited impact on DOAC dispensing.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"655-665"},"PeriodicalIF":3.8,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145437501","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":"9^th ISoP Intelligent Automation Boston Seminar: From Innovation to Impact. Building Trustworthy AI in Pharmacovigilance 4-5 December 2025 | Cambridge, USA & Virtual.","authors":"Omar Aimer, Tarek A Hammad, Jan Petracek, Mohamed Fouda, Angela Caro-Rojas, Andrew Bate, Veronique F Kugener","doi":"10.1007/s40264-026-01660-y","DOIUrl":"10.1007/s40264-026-01660-y","url":null,"abstract":"","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"729-731"},"PeriodicalIF":3.8,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147472924","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":"Giant Cell Arteritis Following COVID-19 Vaccination: A Consumer-Stimulated Analysis.","authors":"Aishwarya N Shetty, John H Mallard, Daneeta Hennessy, Nicholas Wood, Hazel J Clothier, Jim P Buttery","doi":"10.1007/s40264-026-01650-0","DOIUrl":"10.1007/s40264-026-01650-0","url":null,"abstract":"<p><strong>Introduction: </strong>Giant cell arteritis (GCA) is an immune-mediated vasculitis of large and medium arteries, mainly affecting older adults. Prompted by a consumer concern, a few spontaneous reports after coronavirus disease 2019 (COVID-19) vaccination and Australian regulator signal, we investigated a possible association between GCA and vaccination.</p><p><strong>Methods: </strong>This study analysed multiple data sources from January 2021 to September 2024. We reviewed spontaneous GCA reports submitted to the statewide vaccine safety service, Surveillance of Adverse Events following Vaccination in the Community (SAEFVIC), and applied self-controlled case series (SCCS) to two large Australian healthcare datasets [general practice (GP) and linked hospital data]. SCCS used a 1-42-day risk window, stratified by vaccine type, age, and sex. Incident GCA cases were identified via keyword matching and diagnostic codes [Systematized Nomenclature of Medicine Clinical Terms (SNOMED-CT)/International Classification of Diseases Tenth Revision, Australian Modification (ICD-10-AM)].</p><p><strong>Results: </strong>Six cases of GCA were spontaneously reported, four with onset within 42 days postvaccination, all following the adenoviral vectored Vaxzevria® {reporting rate 0.10 [95% confidence interval (CI) 0.03-0.27]}. The proportional reporting ratio signal detection method did not indicate a safety signal. Of 2700 incident cases of GCA identified across primary and hospital care datasets, 293 occurred within 42 days of COVID-19 vaccination. There was no increased risk of GCA following COVID-19 vaccination in either dataset [GP relative incidence (RI): 0.96 (95% CI 0.76, 1.21); hospital RI: 0.79 (95% CI 0.68, 0.91)], including by vaccine type, age, or sex.</p><p><strong>Conclusions: </strong>Using three Australian data sources, this study found no increase in GCA presentations within 6 weeks of COVID-19 vaccination. These consumer-stimulated findings support informed decisions, strengthen vaccine safety evidence, and help clinicians counsel patients.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"705-715"},"PeriodicalIF":3.8,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147644499","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":"Perspective on Better Access to Data and Data Integration in Pharmacovigilance: Information from a Focus Group.","authors":"Florence van Hunsel, Samantha Lane, Dawn Cooper, Taylor Aurelius, Amy Bobbins, Harriet Dickinson, Manfred Hauben, Denise Morris, Eugene van Puijenbroek, Alison Yeomans, Manal Younus, Saad Shakir","doi":"10.1007/s40264-025-01646-2","DOIUrl":"10.1007/s40264-025-01646-2","url":null,"abstract":"<p><p>A focus group organised by the Drug Safety Research Unit (DSRU) International Working Group (IWG) on New Developments in Pharmacovigilance discussed current challenges and opportunities in pharmacovigilance (PV), emphasising the need for a multimodal approach in data analysis and accessibility of diverse data sources for drug safety surveillance. Nine participants, selected purposefully for their multisectoral expertise in PV, discussed the value of various data types, including data from clinical trials and real-world data (RWD), each offering distinct strengths and limitations. Key challenges identified included data standardisation, quality variability, technological barriers and ethical concerns, particularly with data derived from social media. Emerging tools such as knowledge graphs were highlighted for their potential to enhance data integration and signal detection, however further research is required. The group also addressed disparities in data access, with particular attention to regulatory restrictions, limited infrastructure in low-resource settings and restricted access to industry-held data. Proposed solutions included fostering greater data transparency, establishing secure data-sharing platforms and forming collaborative consortia to facilitate responsible and ethical data use. Overall, the discussion underscored the need for improved integration, access and methodological rigour to strengthen PV practices and enhance global drug safety monitoring.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"605-612"},"PeriodicalIF":3.8,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145965616","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}