Drug Safety最新文献

{"title":"Navigating Diverging Perspectives: Reasoning, Evidence, and Decision-Making in Drug Safety.","authors":"Tarek A Hammad, Simon Davies","doi":"10.1007/s40264-025-01537-6","DOIUrl":"https://doi.org/10.1007/s40264-025-01537-6","url":null,"abstract":"<p><p>Decision making in drug safety is a complex and iterative process that requires the integration of diverse evidence sources, scientific reasoning, and clinical judgment. Diverging opinions among stakeholders-including pharmacovigilance professionals, regulatory authorities, clinical researchers, statisticians, and epidemiologists-often stem from differences in data interpretation, methodological approaches, and thresholds for concern or action. This paper examines the key sources of these divergences and presents a structured framework to enhance alignment in drug safety decision making. The proposed framework outlines three core dimensions: evidence assessment, interpretation, and action. It distinguishes between quantitative aspects, such as effect magnitude and measurement error, and qualitative considerations, including contextual interpretation and risk thresholds. The framework also underscores the importance of multidisciplinary collaboration, as safety professionals must actively engage with other scientific and regulatory stakeholders to ensure a comprehensive evaluation of the evidence. A fundamental challenge in pharmacovigilance is the need to communicate the complexities of drug safety assessment to a broader audience, including those who may not be familiar with the nuances of safety decision making. This paper aims to serve not only as a resource for new pharmacovigilance professionals, but also as a tool to facilitate clearer communication between disciplines. By adopting a structured approach and fostering open dialogue, drug safety professionals can enhance transparency and improve regulatory and clinical decision-making processes.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143613978","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 Frequency of Drug-Induced Liver Injury Due to Antibiotics Among Hospitalised Patients.","authors":"Robert A Björnsson, Sigurdur Sölvi Sigurdsson, Dagur Tjörvi Arnarson, Egill Logason, Einar Stefan Björnsson","doi":"10.1007/s40264-025-01541-w","DOIUrl":"https://doi.org/10.1007/s40264-025-01541-w","url":null,"abstract":"<p><strong>Introduction: </strong>Most epidemiological studies have found antibiotics to be the most common cause of drug-induced liver injury (DILI). It is unclear what the risk of DILI is associated with different antibiotics.</p><p><strong>Objective: </strong>The aim of the study was to assess the frequency of DILI due to the most commonly used antibiotics among inpatients, in a population-based setting.</p><p><strong>Methods: </strong>Patients who were treated with the 14 most-used antibiotics at Landspitali University Hospital Iceland 2012-2023, with concomitant: > 5 × upper limit of normal (ULN) of alanine aminotransferase (ALT) and/or > 2 × ULN of alkaline phosphatase (ALP), were identified. If DILI was a potential cause, the Revised Electronic Causality Assessment Method (RECAM) method was used to determine likelihood of DILI.</p><p><strong>Results: </strong>Overall 2292 patients fulfilled the inclusion criteria, 52 of whom were found to have DILI, median age 67 (range 21-93) years, 58% females, 17 (33%) with jaundice and three (5.8%) died of liver failure. The most commonly implicated agent was amoxicillin/clavulanate (n = 23) in 1:1327 users (0.075%), ceftriaxone (n = 8) 1:3779 (0.02%), cefazolin (n = 7) 1: 6363 (0.016%), cloxacillin 1:6024 (n = 4) (0.017%), piperacillin/tazobactam (n = 2) 1:1551 (0.097%), vancomycin (n = 2) 1:1966 (0.076%), trimethoprim-sulfamethoxazole (TMP/SMX) (n = 3) 1:1096 (0.091%) and ciprofloxacin (n = 1) 1:10,938 (0.009%). In two cases, more than one antibiotic was considered likely.</p><p><strong>Conclusions: </strong>Drug-induced liver injury was found to be a rare adverse effect of antibiotics in a population-based setting. Overall, 33% presented with jaundice but three died of liver failure, all due to amoxicillin/clavulanate, which was the most common cause occurring in around 1 in 1300 users. However, TMP/SMX was associated with the highest proportional risk of DILI.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143613980","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":"Might We Come Together on a Paradigm Shift to Manage ICSRs with a Decentralized Data Model?","authors":"Lucinda Smith, Michael Glaser, Dieter Kempf, Xaymara Roman, Charlotte Artlich, Mayur A Patel, Andrew Bate","doi":"10.1007/s40264-025-01539-4","DOIUrl":"10.1007/s40264-025-01539-4","url":null,"abstract":"<p><p>The current practice of managing and sharing individual case safety reports (ICSRs) across the patient safety ecosystem, established in the 1960s, has become burdened with ICSR duplication and replication and can result in a fragmented understanding of product safety profiles. For this article, we have defined duplication as multiple representations of the same case within the same database and replication as various representations of the same case across numerous databases. Evolving safety regulations and increasing case volumes signal a need for a new path forward that is sustainable and enhances public health. While there is no question that ICSRs are a crucial component of safety surveillance, stakeholders must evaluate their management to ensure they are fit for purpose in a modern ecosystem. This article aims to embark on that path by proposing a conceptual decentralized ICSR management model to facilitate multi-stakeholder collaboration around new working models to mitigate duplication and replication, allow ecosystem stakeholders to access the latest source of truth on demand, facilitate more meaningful safety analysis and interpretation, and ultimately enable a real-time learning healthcare system to improve patient safety and health outcomes. It describes the feasibility analysis results and subsequently conducted proof of concept (PoC) based on a decentralized system architecture supporting such a decentralized model. It outlines considerations, challenges, and opportunities compared with the current state related to case management and signal management processes.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-03-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143582184","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":"Opinion Mining of Erowid's Experience Reports on LSD and Psilocybin-Containing Mushrooms.","authors":"Ahmed Al-Imam, Riccardo Lora, Marek A Motyka, Erica Marletta, Michele Vezzaro, Jerzy Moczko, Manal Younus, Michal Michalak","doi":"10.1007/s40264-025-01530-z","DOIUrl":"https://doi.org/10.1007/s40264-025-01530-z","url":null,"abstract":"<p><strong>Background: </strong>Psychedelics are gaining attention for their therapeutic potential in modern and personalized medicine. Online forums such as Erowid provide valuable user insights, but analyses of these experiences using natural language processing (NLP) remain scarce.</p><p><strong>Objective: </strong>This study aims to utilize NLP, including sentiment and lexicon analysis, to examine user-generated experience reports on psilocybin-containing mushrooms and LSD from the Erowid forum.</p><p><strong>Methods: </strong>Data from 2188 Erowid users (1161 psilocybin mushrooms and 1027 LSD) was collected via automated web scraping with XPath, CSS selectors, and Selenium WebDriver. The dataset included report titles, substances, and demographics. Sentiment analysis utilized BERT, RoBERTa, and VADER models. Preprocessing involved tokenization, lemmatization, part-of-speech tagging, and stop-word filtering. Lexicon analysis identified themes through recurring n-grams, visualized using Python.</p><p><strong>Results: </strong>User demographics revealed comparable ages for psilocybin mushrooms (23.8 ± 0.9 years) and LSD users (20.0 ± 0.6 years), with a predominance of male users. The BERT model predominantly labeled experiences as negative (unfavorable), particularly for mushroom users (p = 0.001). VADER indicated more positive experiences for mushroom users (p < 0.001), while RoBERTa mainly classified experiences as negative or neutral. Significant gender differences were found only with VADER, where more male users expressed positive opinions about psilocybin mushrooms (74.09% versus 65.52%, p < 0.021). The VADER model yielded more polarized results, whereas RoBERTa's cautious classifications indicate its suitability for analyzing lengthy and complex psychedelic reports. Further, RoBERTa outperformed other transformer-based models, achieving the highest accuracy. Lexicon analysis revealed emotional, sensory, and temporal themes, with psilocybin reports emphasizing introspection and time dilation phenomenon, while LSD reports highlighted memory issues and cognitive disorientation.</p><p><strong>Conclusions: </strong>Sentiment analysis showed that VADER produced more polarized results, while RoBERTa offered cautious classifications with the highest accuracy. Lexicon analysis revealed shared themes, with mushroom reports focusing on introspection and time dilation perception, while those of LSD emphasized cognitive disturbances. This study highlights the value of these analyses in understanding psychedelic experiences, informing harm reduction, and guiding policy-making.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143540563","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":"Signals of Possibly Persistent Gustatory, Olfactory and Auditory Adverse Drug Reactions to Antibiotic Drugs: A Disproportionality Analysis Using the EudraVigilance Database.","authors":"Sara Ferraro, Emiliano Cappello, Marco Fornili, Irma Convertino, Marco Bonaso, Ersilia Lucenteforte, Marco Tuccori","doi":"10.1007/s40264-024-01491-9","DOIUrl":"10.1007/s40264-024-01491-9","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;In 2018, the European Medicines Agency issued some risk minimisation measures related to unresolved adverse drug reactions (ADRs) reported for fluoroquinolones, including sensory ADRs. Spontaneous reporting databases frequently report unresolved outcomes for gustatory, olfactory and auditory (GOA) ADRs. However, such a high volume of unresolved GOA ADRs could reflect an under-investigated clinical issue or an intrinsic difficulty in the outcome assessment.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objectives: &lt;/strong&gt;The objectives of the study were: (1) to investigate whether unresolved outcomes are reported more frequently for GOA ADRs than for other ADRs to systemic antibiotics and (2) to identify possible signals of unresolved GOA ADRs for systemic antibiotics.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;We used the EudraVigilance database to extract the number of ADRs to systemic antibiotics of the Anatomical Therapeutic Chemical class J01 up to February 2019. We classified ADRs in \"non-GOA ADRs\" and \"GOA ADRs\". Adverse drug reactions were categorised in three groups according to the outcome: defined, persistent/permanent (unresolved) and undetermined ADRs. We performed disproportionality analyses with the case/non-case methodology, by calculating the crude reporting odds ratio (ROR) and 95% confidence interval (CI). Cases were all persistent/permanent ADRs, and non-cases were defined and undetermined ADRs. For the first objective, index groups were gustatory or olfactory or auditory ADRs, while reference group included all non-GOA ADRs. For the second objective, we performed a disproportionality analysis by using the sub-set of GOA ADRs. Index and reference groups varied with subgroups of drugs and drug class, so that each drug and drug class was compared with the others. We conducted two sensitivity analyses for each analysis by varying the case definition.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;We extracted 748,798 ADRs, including 10,770 GOA ADRs. The first analysis showed that GOA ADRs were reported more frequently as unresolved events compared with all other ADRs (ROR: 2.68 95% CI 2.51-2.85; ROR: 5.20 95% CI 4.66-5.81; and ROR: 2.64 (95% CI 2.51-2.79, respectively). Gustatory ADRs were reported more frequently as unresolved for doxycycline (ROR: 1.69, 95% CI 1.18-2.41, p = 0.0038), azithromycin (ROR: 2.07, 95% CI 1.58-2.72, p &lt; 0.0001) and levofloxacin (ROR: 1.59, 95% CI 1.22-2.07, p &lt; 0.001) compared with GOA ADRs of all other antibiotics. Olfactory ADRs were reported more frequently as unresolved for doxycycline (ROR: 2.4, 95% CI 1.26-4.58, p = 0.0078) and levofloxacin (ROR: 1.92, 95% CI 1.28-2.86, p = 0.0014). Auditory ADRs were reported more frequently as unresolved for doxycycline (ROR: 1.52, 95% CI 1.09-2.12, p = 0.013) and clarithromycin (ROR: 1.31, 95% CI 1.09-1.59, p = 0.0049).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;We tested and used an appropriate expected frequency standard, which allows us to identify possible signals of unresolved GOA ADRs","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"217-231"},"PeriodicalIF":4.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142603784","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":"Advances in Drug Safety: Highlights from the 23rd Annual Meeting of the International Society of Pharmacovigilance.","authors":"Omar Aimer, Maribel Salas, Tarek A Hammad, Rania Mouchantaf, Katarina Ilic, Maxine Gossell-Williams, Ushma Mehta, Robert W Platt, Bruce Carleton","doi":"10.1007/s40264-024-01507-4","DOIUrl":"10.1007/s40264-024-01507-4","url":null,"abstract":"","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"305-309"},"PeriodicalIF":4.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142845957","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":"Pharmacovigilance in the Community: A Special-Interest Group of the International Society of Pharmacovigilance.","authors":"Mohamed A Elhawary, Rebecca Noss, Loubna Alj, Manal Younus, Mayada Alkhakany, Hadir Rostom, Angela Caro-Rojas, Thamir M Alshammari","doi":"10.1007/s40264-024-01513-6","DOIUrl":"10.1007/s40264-024-01513-6","url":null,"abstract":"","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"203-207"},"PeriodicalIF":4.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142946484","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":"Performance and Reproducibility of Large Language Models in Named Entity Recognition: Considerations for the Use in Controlled Environments.","authors":"Jürgen Dietrich, André Hollstein","doi":"10.1007/s40264-024-01499-1","DOIUrl":"10.1007/s40264-024-01499-1","url":null,"abstract":"<p><strong>Introduction: </strong>Recent artificial intelligence (AI) advances can generate human-like responses to a wide range of queries, making them a useful tool for healthcare applications. Therefore, the potential use of large language models (LLMs) in controlled environments regarding efficacy, reproducibility, and operability will be of paramount interest.</p><p><strong>Objective: </strong>We investigated if and how GPT 3.5 and GPT 4 models can be directly used as a part of a GxP validated system and compared the performance of externally hosted GPT 3.5 and GPT 4 against LLMs, which can be hosted internally. We explored zero-shot LLM performance for named entity recognition (NER) and relation extraction tasks, investigated which LLM has the best zero-shot performance to be used potentially for generating training data proposals, evaluated the LLM performance of seven entities for medical NER in zero-shot experiments, selected one model for further performance improvement (few-shot and fine-tuning: Zephyr-7b-beta), and investigated how smaller open-source LLMs perform in contrast to GPT models and to a small fine-tuned T5 Base.</p><p><strong>Methods: </strong>We performed reproducibility experiments to evaluate if LLMs can be used in controlled environments and utilized guided generation to use the same prompt across multiple models. Few-shot learning and quantized low rank adapter (QLoRA) fine-tuning were applied to further improve LLM performance.</p><p><strong>Results and conclusion: </strong>We demonstrated that zero-shot GPT 4 performance is comparable with a fine-tuned T5, and Zephyr performed better than zero-shot GPT 3.5, but the recognition of product combinations such as product event combination was significantly better by using a fine-tuned T5. Although Open AI launched recently GPT versions to improve the generation of consistent output, both GPT variants failed to demonstrate reproducible results. The lack of reproducibility together with limitations of external hosted systems to keep validated systems in a state of control may affect the use of closed and proprietary models in regulated environments. However, due to the good NER performance, we recommend using GPT for creating annotation proposals for training data as a basis for fine-tuning.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"287-303"},"PeriodicalIF":4.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11829833/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142806427","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":"Empowering African Expertise: Enhancing Safety Data Integration and Signal Detection for COVID-19 Vaccines Through the African Union Smart Safety Surveillance Joint Signal Management Group.","authors":"Victoria Prudence Nambasa, Hannah May Gunter, Modupe Bamidele Adeyemo, Neetesh Yanish Bhawaneedin, Marc Blockman, George Tsey Sabblah, John Owusu Gyapong, Eric Muriithi Guantai, Tamrat Abebe, Workeabeba Abebe, Henry Jeremy Lawson, Mercedes Chawada Leburu, Abdullahi Mohammed, Kwame Amponsa-Achiano, Mafora Florah Matlala, Uchenna Geraldine Elemuwa, Hudu Mogtari, Alexander Kwadwo Nyarko, Marione Schönfeldt, Mercy Kamupira, Kerrigan McCarthy, Yohannes Lakew Tefera, Asnakech Alemu, Kabir Mawashi Yusuf, Obi Emelife, Ladji Sidibe, Kudakwashe Dandajena, Kenneth Onu, Mojisola Christianah Adeyeye, Delese Mimi Darko, Heran Gerba, Boitumelo Semete, Fred Siyoi, Aggrey Ambali, Johanna Catharina Meyer","doi":"10.1007/s40264-024-01493-7","DOIUrl":"10.1007/s40264-024-01493-7","url":null,"abstract":"<p><strong>Introduction: </strong>The COVID-19 pandemic accelerated new vaccine development. Limited safety data necessitated robust global safety surveillance to accurately identify and promptly communicate potential safety issues. The African Union Smart Safety Surveillance (AU-3S) program established the Joint Signal Management (JSM) group to support identification of potential vaccine safety concerns in five pilot countries (Ethiopia, Ghana, Kenya, Nigeria, South Africa), accounting for approximately 35% of the African population.</p><p><strong>Objective: </strong>Our objective was to provide an overview of the JSM group's role in supporting signal management activities for the AU-3S program during the COVID-19 pandemic.</p><p><strong>Methods: </strong>Spontaneous, electronically reported COVID-19 vaccine adverse events following immunization (AEFI) from each country's safety data were integrated into the interim Data Integration and Signal Detection system. Statistical disproportionality methods were used to identify and review vaccine-event combinations (VECs) for potential safety concerns. The JSM group-which comprised pharmacovigilance and subject matter experts from National Medicine Regulatory Authorities, Expanded Programs on Immunization, and vaccine safety committees-conducted signal detection activities on cross-country safety data and provided recommendations.</p><p><strong>Results: </strong>From April 2021 to December 2023, a total of 48,294 spontaneously reported AEFI were analyzed for six COVID-19 vaccines (NRVV Ad [ChAdOx1 nCoV-19]; Ad26.COV2.S; Elasomeran; Tozinameran; Covid-19 vaccine [Vero Cell], Inactivated; NRVV Ad26 [Gam-Covid-Vac]) administered in Ethiopia (34.6%), Nigeria (30.3%), South Africa (16.9%), Ghana (13.5%), and Kenya (4.7%). Overall, 2,742 VECs were validated. A causal association between the COVID-19 vaccines and the reported AEFI cannot be inferred, as data were reported spontaneously. JSM group recommendations included monitoring for further evidence, no immediate action required, engaging marketing authorization holder(s) for additional information, or sensitizing healthcare providers and/or the public about events. Although no new safety signals were identified, nine safety-related recommendations were issued, including patient and healthcare provider education.</p><p><strong>Conclusions: </strong>The JSM group established a scalable and replicable model for future signal management of other priority health products in low- and middle-income countries, fostering ongoing collaboration and capacity building. Knowledge and experience gained from this pilot initiative will guide stakeholders in future safety surveillance initiatives within the African continent.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"233-249"},"PeriodicalIF":4.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11829835/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143022752","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":"Post-licensure Safety Surveillance of 20-Valent Pneumococcal Conjugate Vaccine (PCV20) Among US Adults in the Vaccine Adverse Event Reporting System (VAERS).","authors":"Mayra Oliveira, Paige Marquez, Carol Ennulat, Phillip Blanc, Kerry Welsh, Narayan Nair, Monica Taminato, Pedro L Moro","doi":"10.1007/s40264-024-01498-2","DOIUrl":"10.1007/s40264-024-01498-2","url":null,"abstract":"<p><strong>Background: </strong>On June 8, 2021, a new 20-valent pneumococcal conjugate vaccine (PCV20, PREVNAR 20^®, Pfizer, Inc.) was licensed for use in adults aged ≥ 18 years by the US Food and Drug Administration (FDA).</p><p><strong>Objective: </strong>To describe reports to the Vaccine Adverse Event Reporting System (VAERS) after administration of the 20-valent pneumococcal conjugate vaccine in adults.</p><p><strong>Methods: </strong>We searched the VAERS for reports of adverse events involving persons aged ≥ 19 years who received PCV20 during October 20, 2021, through December 31, 2023. Our evaluation included automated analysis of reports, clinical review of serious reports and pre-specified events of special interest, empirical Bayesian data mining to assess for disproportionate reporting, and estimation of reporting rates for reports of Guillain-Barré syndrome (GBS).</p><p><strong>Results: </strong>The VAERS received 1976 reports after PCV20 administration in persons aged ≥ 19 years (6% of reports involved serious events). The most common adverse events among persons aged 19-64 years (n = 798) were injection-site reactions (231, 29%), pain (134, 17%), erythema (118, 15%), and fever (117, 15%). For persons aged ≥ 65 years (n = 1178), the most common adverse events were injection-site reactions (417, 35%), pain (180, 15%), pain in extremity (162, 14%), and erythema (158, 13%). A data mining alert (EB05 = 3.812) for the MedDRA Preferred Term \"Guillain-Barre syndrome\" was observed for serious reports. Clinical review verified 11 of 20 GBS reports; 7/11 vaccine recipients were aged ≥ 65 years. Among the 11 verified cases, the median time from vaccination to symptom onset was 14 days. Five persons received another vaccine on the same visit. The reporting rate of GBS after PCV20 receipt was 0.5 cases per million doses distributed. No other safety concern was identified.</p><p><strong>Conclusions: </strong>During the period of this post-licensure review of PCV20, we found most reports were non-serious and comprised mostly local and systemic (e.g., fever) reactions consistent with prelicensure studies. In serious reports, we also identified a data mining alert for GBS after receipt of PCV20, which Centers for Disease Control and Prevention and the FDA are investigating further. No other new or unexpected safety concern was identified.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"279-286"},"PeriodicalIF":4.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11973709/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142812553","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}