Frontiers in drug safety and regulation最新文献

{"title":"A real-world disproportionality analysis of roflumilast using the US food and drug administration adverse event reporting system data.","authors":"Baiqing Huang, Yirou Ma, Wenli Wang, Shaorui Gu, Xisheng Wang","doi":"10.3389/fdsfr.2025.1721656","DOIUrl":"10.3389/fdsfr.2025.1721656","url":null,"abstract":"<p><strong>Introduction: </strong>Roflumilast, a selective phosphodiesterase-4 inhibitor, is prescribed to reduce exacerbations in severe COPD, but its real-world safety profile remains insufficiently characterized.</p><p><strong>Methods: </strong>We conducted a retrospective pharmacovigilance study using the FDA Adverse Event Reporting System (FAERS). Reports from 2004 to 2025Q1 listing roflumilast as the primary suspect were extracted, deduplicated, and analyzed. Disproportionality analysis employed four algorithms-Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS). Safety signals were defined by established thresholds. Time-to-onset and Weibull modeling were applied to assess temporal patterns.</p><p><strong>Results: </strong>A total of 3,140 reports were identified, primarily involving older COPD patients. The median time-to-onset was 4 days (IQR 0-34), with 72% occurring within 30 days. Thirty Preferred Terms met signal criteria. Frequent signals included diarrhoea, weight decreased, nausea, dyspnoea, insomnia, and headache. Psychiatric events such as depression and suicidal ideation were notable. The strongest disproportionality was observed for gastroduodenal ulcer (ROR 47.1) and COPD (ROR 25.7). System Organ Class enrichment was most evident in gastrointestinal, psychiatric, and respiratory disorders.</p><p><strong>Discussion/conclusion: </strong>This real-world analysis confirms roflumilast's established adverse effects (gastrointestinal upset, weight loss, insomnia) and highlights concerning psychiatric signals. Most events occurred early, underscoring the need for close monitoring during treatment initiation. The use of multiple disproportionality methods enhances signal detection robustness and supports ongoing pharmacovigilance in clinical practice.</p>","PeriodicalId":521057,"journal":{"name":"Frontiers in drug safety and regulation","volume":"5 ","pages":"1721656"},"PeriodicalIF":0.0,"publicationDate":"2025-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12740929/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145852126","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The use of observed-to-expected analyses as a signal detection tool in COVID-19 vaccine safety surveillance: lessons learned from an industry perspective.","authors":"Laurence Serradell, Antonella Fretta, Jenny Nachbar, Jill Dreyfus, Diana Garofalo, Arianna Lucini, Susan Mather, Daina Esposito, Anne-Laure Chabanon, Vincent Bauchau, Sarah Sellers","doi":"10.3389/fdsfr.2025.1650992","DOIUrl":"10.3389/fdsfr.2025.1650992","url":null,"abstract":"<p><p>During the pandemic, the accelerated review and authorization of coronavirus disease 19 (COVID-19) vaccines by regulatory authorities elicited the need for rapid and thorough worldwide signal detection and evaluation. To meet this need, the European Medicines Agency and other health authorities expected that, in addition to routine signal detection, COVID-19 vaccine manufacturers should leverage observed-to-expected (O/E) analyses unconventionally as a quantitative method for signal detection of adverse events of special interest (AESIs). The objective of O/E analyses in vaccine signal detection was to determine if AESIs were occurring at a higher-than-expected rate in the vaccinated population in comparison with an unexposed population. The use of O/E was intended to mitigate the challenge of analyzing large volumes of individual case safety reports (ICSRs) received over a very short period following mass vaccination campaigns. The \"Beyond COVID-19 Monitoring Excellence\" (BeCOME) initiative, a non-competitive voluntary initiative launched in 2022 by COVID-19 vaccine Marketing Authorization Holders (MAHs) and key stakeholders, was established to align systems, enhance processes, and foster innovation in post-marketing vaccine monitoring, building on lessons from the pandemic. A dedicated working group was created to review and share MAHs' experience on O/E analyses used as an additional tool for signal detection during the COVID-19 pandemic. This review presents the industry perspective on using O/E analyses for COVID-19 vaccine signal detection, including challenges and limitations encountered, and proposes best practices for future improvement. Despite the priority and resources devoted to O/E analyses, no <i>de novo</i> signals resulting in the identification of safety concerns were detected using this methodology during the COVID-19 pandemic. O/E analyses are most useful when source data are accurate and there is a high level of confidence in the assumptions and parameters used. In the context of the COVID-19 pandemic, confidence in certain assumptions and parameters was low, limiting the value of O/E analyses in signal detection. Nevertheless, O/E analyses applied for signal refinement, as traditionally used, proved to be useful. Industry experiences support maintaining O/E analyses as a tool for signal refinement and standardizing methodological approaches as much as possible to enhance its future application and comparability across stakeholders.</p>","PeriodicalId":521057,"journal":{"name":"Frontiers in drug safety and regulation","volume":"5 ","pages":"1650992"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12703077/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145770547","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Background incidence rates from electronic healthcare databases for vaccine safety monitoring: review of challenges from the COVID-19 vaccination campaign and proposal for best practices.","authors":"Sonja Gandhi-Banga, Laurence Serradell, Deborah Layton, Jill Dreyfus, Nicolas Praet, Diana C Garofalo, Vincent Bauchau, Scott P Kelly, Lin Li","doi":"10.3389/fdsfr.2025.1651090","DOIUrl":"10.3389/fdsfr.2025.1651090","url":null,"abstract":"<p><p>Background incidence rates (BIRs) are essential for contextualizing adverse event rates in vaccine safety monitoring, particularly through observed-to-expected (O/E) analyses. The unprecedented rapid development of vaccines during the coronavirus disease 2019 (COVID-19) pandemic necessitated rigorous and continuous safety monitoring. While BIRs are traditionally obtained from literature reviews, the pandemic accelerated the large-scale generation of BIRs from electronic healthcare databases through various initiatives such as the vACCine covid-19 monitoring readinESS (ACCESS) and the Biologics Effectiveness and Safety (BEST) to support COVID-19 vaccine safety surveillance strategies. The Beyond COVID-19 Monitoring Excellence (BeCOME) initiative, launched in 2022, established seven working groups, including one focused on best practices for BIR generation and utilization in pharmacovigilance activities. The BeCOME BIR working group conducted a targeted literature review to enable focused analysis of challenges that emerged during large-scale vaccination campaigns through December 2023. The group also used structured group discussion following the nominal group technique over 10 months to develop consensus-based judgments on critical factors for BIR best practices. The findings were organized into four domains: key initiatives summary, pandemic-related challenges, implications for O/E analyses, and best practice recommendations. To identify key BIR initiatives supporting COVID-19 vaccine safety assessment, the review employed multiple strategies including scientific literature examination, public health authority website reviews, and reference list searches; data on study characteristics, limitations, challenges, and recommendations were extracted. The targeted review focused on five major initiatives, such as ACCESS and BEST, that generated BIRs for adverse events of special interest (AESIs) during the pandemic. The group identified persistent challenges during the vaccination campaign including timeliness constraints during rapid vaccine deployment, substantial heterogeneity across data sources, inconsistent case definitions, limited information for key subpopulations, and difficulties addressing emerging AESIs. These challenges directly impacted O/E analyses, potentially leading to biased safety signal assessments. We propose a coordinated action plan among key stakeholders to establish sustainable mechanisms for regular BIR delivery with methodological improvements, develop consensus on best practices for BIR selection, and secure resources to ensure pandemic preparedness. Implementing these recommendations will strengthen vaccine safety monitoring systems for both routine vaccination programs and future public health emergencies.</p>","PeriodicalId":521057,"journal":{"name":"Frontiers in drug safety and regulation","volume":"5 ","pages":"1651090"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12702953/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145770580","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Post-approval safety studies of vaccines in pregnancy: available regulatory guidance and next steps towards the more efficient generation of safety evidence.","authors":"Sarah C MacDonald, Adrienne P Guignard, Flor M Munoz, Eileen O Dareng, Kourtney J Davis, Marina Amaral de Avila Machado, Shahar Shmuel, Laura Taddei, Lydie Marcelon","doi":"10.3389/fdsfr.2025.1648854","DOIUrl":"10.3389/fdsfr.2025.1648854","url":null,"abstract":"<p><strong>Background: </strong>The \"Beyond COVID-19 Monitoring Excellence\" (BeCOME) initiative was established to leverage the successful multi-stakeholder collaborations achieved during the COVID-19 pandemic to increase efficiencies for future pandemic preparedness. At the first BeCOME cross-stakeholder meeting, the following key challenge was identified: Inconsistent guidance from regulatory authorities on the conduct of post-marketing safety studies in pregnant people.</p><p><strong>Objectives: </strong>This article aims to describe examples of post-approval safety studies sponsored by marketing authorization holders (MAHs) for vaccines in pregnancy, analyze existing regulatory guidelines for these studies, and identify areas warranting more detailed guidance.</p><p><strong>Example studies: </strong>Fifteen vaccine post-approval safety studies in pregnant people with publicly available methodology were identified from the European Union (EU) Post-authorisation Study (PAS) Register and supplemented by a literature search. Studies were selected to cover both primary data collection and secondary use of data, as well as for vaccines recommended and not recommended during pregnancy. The identified studies varied in their type (active vs. passive surveillance), comparators, outcomes, exposure windows, target sample sizes, and study durations.</p><p><strong>Existing guidance: </strong>Five applicable guidance documents were identified from two health authorities [the United States (US) Food and Drug Administration (FDA) and the European Medicines Agency (EMA)], ranging in publication date from 2005-2023. Available guidance from both agencies included robust discussions of comparator groups, outcomes, and exposure periods. However, vaccine-specific recommendations were notably lacking.</p><p><strong>Actionable recommendations: </strong>Additional vaccine-specific guidance is needed across regulatory authorities. Key areas of focus should include: the selection of study design by vaccine type, appropriate comparators for vaccine research, vaccine-specific recommendations for ascertaining exposure, a harmonized and prioritized list of outcomes, greater understanding of the role of outcome validation, pre-defined target minimal detectable risks by priority outcomes, appropriate durations of follow-up, additional guidance regarding the implementation of multi-stakeholder collaborations, and a framework for the use of rapid cycle analyses.</p><p><strong>Conclusion: </strong>There is wide variation in study designs and approaches for assessing vaccine safety in pregnancy post-approval, influenced by differences in vaccines, target populations, sponsors, and study periods. Harmonizing regulatory guidance and standards will enhance the consistency of data collection, as well as the comparability and validity of study conclusions.</p>","PeriodicalId":521057,"journal":{"name":"Frontiers in drug safety and regulation","volume":"5 ","pages":"1648854"},"PeriodicalIF":0.0,"publicationDate":"2025-11-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12690392/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145746591","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Discrepancies in regulations in post-marketing safety surveillance of drug-device combination products in the EU and US: a review.","authors":"Joan D'souza, Mukesh Nandave, Ruth Blöchlinger","doi":"10.3389/fdsfr.2025.1609455","DOIUrl":"10.3389/fdsfr.2025.1609455","url":null,"abstract":"<p><p>This article captures the differences in regulations in post-marketing safety surveillance in drug device combinations in the US and the EU. Drug-device combinations have improved the landscape of health care through both drug effectiveness and personalized medicine. Regulatory frameworks in the U.S. and E.U. ensure these products are safe and effective. In the E.U., combination products are officially regulated according to their primary mode of action (PMOA) as per EU MDR 2017/745 and MPD 2001/83/E.C., executed by the European Medicines Agency (EMA) and National Competent Authorities (NCAs). Products are classified as integral, co-packaged, or cross-labeled, with extensive pre-marketing assessment and post-marketing surveillance. In the United States, the combination products are regulated per 21 CFR 3.2(e) by the Office of Combination Products (OCP) and lead centers (CDER, CDRH, CBER), which ensure adequate compliance. Post-marketing surveillance, risk management, and safety signal identification, are key features of the FDA's Adverse Event Reporting System (FAERS) and Risk Evaluation and Mitigation Strategies (REMS). While the E.U. and U.S. have robust regulatory frameworks for drug-device combination products, they differ in their approaches, leading to challenges in global harmonization. In the EU, no single regulatory authority oversees the entire lifecycle of combination products. The MDR focuses on device performance and risk management while the EMA focuses on medicinal product efficacy and safety. The drug safety reporting system EudraVigilance focuses on the medicinal component, with EUDRAMED. In the U.S., the FDA oversees these products, with the Center for Drug Evaluation and Research (CDER) or the Center for Devices and Radiological Health (CDRH) determining the regulatory path whether the product acts primarily as a drug or a device. Misalignment between the EU and US frameworks creates issues for global harmonization, affecting access, manufacturing, and patient safety. International cooperation and the implementation of standardized guidelines are crucial for advancing global healthcare and ensuring the efficacy and safety of drug-device combination products. This article aims to discuss discrepancies in regulation between the US and EU and discuss the feasibility of the current problems.</p>","PeriodicalId":521057,"journal":{"name":"Frontiers in drug safety and regulation","volume":"5 ","pages":"1609455"},"PeriodicalIF":0.0,"publicationDate":"2025-11-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12690297/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145746594","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The role of MedDRA in global pharmacovigilance and public health during COVID-19: pandemic preparedness and response.","authors":"Brian O'Hare, Heba Ibrahim, Patrick Revelle","doi":"10.3389/fdsfr.2025.1607642","DOIUrl":"10.3389/fdsfr.2025.1607642","url":null,"abstract":"<p><p>The COVID-19 pandemic has had a profound impact on global public health, infecting over 770 million individuals and resulting in more than 6.9 million deaths worldwide. In response, the rapid development of novel vaccines became critical to controlling the spread of the virus and safeguarding public health. The accelerated rollout of these vaccines required an expedited evaluation of their quality, efficacy, and safety. This article highlights the role of the Medical Dictionary for Regulatory Activities Maintenance and Support Services Organization (MedDRA MSSO) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the terminology owner, in addressing the pandemic's challenges. The authors discuss MSSO's swift adaptation of its standard procedures to the pandemic's needs to develop and maintain MedDRA COVID-19 terms and tools. Through close collaboration with the ICH and expert working groups, the MSSO facilitated the development and timely updating of MedDRA terms and tools tailored to COVID-19, supporting global efforts in diagnosis, prognosis, and novel vaccine safety monitoring. The integration of these MedDRA terms and tools has been crucial in the timely reporting, coding, and analysis of adverse events following immunization (AEFIs), thereby facilitating public health responses worldwide and enabling the ongoing evaluation and safety assurance of COVID-19 vaccines.</p>","PeriodicalId":521057,"journal":{"name":"Frontiers in drug safety and regulation","volume":"5 ","pages":"1607642"},"PeriodicalIF":0.0,"publicationDate":"2025-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12685813/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145728329","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reporting rates of abnormal uterine bleeding after COVID-19 vaccination in South Korea.","authors":"Jae Min Lee, Seung Geun Yeo, Sung Soo Kim, Dong Choon Park","doi":"10.3389/fdsfr.2025.1658412","DOIUrl":"10.3389/fdsfr.2025.1658412","url":null,"abstract":"<p><strong>Introduction: </strong>Abnormal uterine bleeding after COVID-19 vaccination has been reported, but few studies have characterized population-level reporting rates. We evaluated AUB reporting in South Korea.</p><p><strong>Methods: </strong>We analyzed suspected adverse reactions reported to the Korea Disease Control and Prevention Agency from 26 February 2021 to 29 June 2023 (week 121). Cases with AUB were identified, and reporting rates were compared across vaccine types and doses.</p><p><strong>Results: </strong>During the study period, 135,894,788 doses were administered, with 483,391 suspected adverse reactions (356 per 100,000) and 6,288 AUB reports (4.9 per 100,000). AUB ranked 15th among reported adverse events. Reporting rates varied by manufacturer and dose.</p><p><strong>Discussion: </strong>These descriptive pharmacovigilance findings do not estimate incidence or imply causality. Prospective, controlled studies are needed to clarify causal relationships and to inform diagnostic and management protocols for AUB after vaccination.</p>","PeriodicalId":521057,"journal":{"name":"Frontiers in drug safety and regulation","volume":"5 ","pages":"1658412"},"PeriodicalIF":0.0,"publicationDate":"2025-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12660206/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145650739","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correction: Leveraging real-world data for safety signal detection and risk management in pre- and post-market settings.","authors":"Kathleen M Gavin, Matthew L Sundermann, Alethea Wieland","doi":"10.3389/fdsfr.2025.1729828","DOIUrl":"10.3389/fdsfr.2025.1729828","url":null,"abstract":"<p><p>[This corrects the article DOI: 10.3389/fdsfr.2025.1626822.].</p>","PeriodicalId":521057,"journal":{"name":"Frontiers in drug safety and regulation","volume":"5 ","pages":"1729828"},"PeriodicalIF":0.0,"publicationDate":"2025-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12635489/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145592633","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Leveraging real-world data for safety signal detection and risk management in pre- and post-market settings.","authors":"Kathleen M Gavin, Matthew L Sundermann, Alethea Wieland","doi":"10.3389/fdsfr.2025.1626822","DOIUrl":"10.3389/fdsfr.2025.1626822","url":null,"abstract":"<p><p>The evolving regulatory landscape has increasingly recognized the value of real-world data (RWD) in enhancing drug safety surveillance across the clinical development lifecycle. Enabled by frameworks such as the FDA's Real-World Evidence (RWE) Programs and other international regulatory bodies, sponsors now have expanded opportunities to use RWD to detect, evaluate, and manage safety signals in both pre- and post-market settings. This paper examines how the integration of RWD, particularly through privacy-preserving record linkage (PPRL) methods like tokenization, can improve pharmacovigilance by enabling longitudinal safety monitoring while protecting patient privacy. Traditional safety surveillance methods, such as spontaneous adverse event reporting and aggregate signal detection, are limited by under-reporting and fragmented data sources. In contrast, linked RWD offers more comprehensive, patient-level insights into safety outcomes, including rare events, off-label use, and long-term risks. The paper outlines regulatory considerations for using de-identified, linked RWD in safety reporting, emphasizing the importance of clear protocols, IRB engagement, and legal compliance with HIPAA. It further highlights emerging best practices for integrating RWD into clinical development, such as early regulatory engagement and the incorporation of linked RWD-derived safety signals into risk management plans. Ultimately, we propose that leveraging linked RWD in a privacy-focused manner enables more proactive, scalable, and effective pharmacovigilance. This approach supports earlier detection of safety issues, enhances post-market follow-up, and promotes data continuity between trial and real-world settings, positioning RWD as a cornerstone of modern safety surveillance.</p>","PeriodicalId":521057,"journal":{"name":"Frontiers in drug safety and regulation","volume":"5 ","pages":"1626822"},"PeriodicalIF":0.0,"publicationDate":"2025-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12576344/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145433602","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Communicating medication risks in pregnancy: Towards shared decision making.","authors":"Ursula Winterfeld, Kenneth Hodson, Maya Berlin, Benoît Marin, Michael Ceulemans, Corinna Weber-Schoendorfer, François R Girardin, David Baud, Béatrice Schaad, Alice Panchaud","doi":"10.3389/fdsfr.2025.1712216","DOIUrl":"10.3389/fdsfr.2025.1712216","url":null,"abstract":"<p><p>Medication use during pregnancy is common, yet safety data remain limited, often leading to exaggerated risk perceptions and suboptimal care. Current communication practices are fragmented: product labeling and patient leaflets tend to emphasize potential harms, while specialized resources are underused. We explore the challenges of conveying accurate risk-benefit information and highlight the need for shared decision making. Integrated, evidence-based resources accessible to both healthcare providers and patients can reduce misinformation, improve adherence to essential treatments, and ultimately enhance maternal and child health. The Swiss MAMA-MEDS initiative illustrates how a unified knowledge base can align messaging, address health inequalities, and support patient-centered pregnancy care.</p>","PeriodicalId":521057,"journal":{"name":"Frontiers in drug safety and regulation","volume":"5 ","pages":"1712216"},"PeriodicalIF":0.0,"publicationDate":"2025-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12587009/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145461124","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}