Drug Safety最新文献

{"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":"843-853"},"PeriodicalIF":4.0,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12259765/pdf/","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":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"IQ DILI Consensus Opinion: Best Practices for Rechallenge Following Suspected Drug-Induced Liver Injury in Clinical Trials.","authors":"Klaudia Steplewski, Lucy Walker, Nefeteria Coffee, Maura Fallon, Rie Yonemochi, David Alpers, Don Rockey, James Lewis, Eric Cohen, John Caminis, Judith Hey-Hadavi, Raul Jesus Andrade, Melissa Palmer","doi":"10.1007/s40264-025-01540-x","DOIUrl":"10.1007/s40264-025-01540-x","url":null,"abstract":"<p><p>Rechallenge with study drug after suspected drug-induced liver injury (DILI) during drug development requires a comprehensive assessment of risks and benefits. Lack of universal consensus or societal guidelines makes this decision-making process more challenging and difficult to manage in clinical development. The sparse published literature is biased towards reporting cases of positive rechallenge (recurrent DILI), often with adverse outcomes. The heterogeneity of available data and inconsistent approaches to drug rechallenge likely lead to bias in our perception of the risks of rechallenge, ultimately leaving this topic controversial. The IQ DILI Causality Assessment Working Group, in collaboration with academic and regulatory experts, developed this manuscript with the following objectives: (1) understand and describe current practices via literature review and survey of practices and opinions among drug developers, academic experts, and regulators; (2) propose a consistent and structured approach to decision-making and managing the rechallenge process; (3) facilitate better understanding of the risks and benefits of rechallenge via a standardized approach to collecting rechallenge data, including outcomes and the importance of publishing rechallenge data; and (4) the role of obtaining a liver biopsy, guidance on when a biopsy might be considered, and what histologic findings can assist in making the rechallenge decision. Lastly, knowledge gaps in the drug rechallenge paradigm are highlighted alongside the proposal to standardize the collection and publication of rechallenge data to help address these gaps. This consensus expert opinion does not encourage rechallenge but provides guidance for drug developers to apply a consistent approach to rechallenge.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"855-874"},"PeriodicalIF":4.0,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12259801/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143771407","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":"Investigating Risk of Cancer with Sodium-Glucose Cotransporter 2 Inhibitors: A Disproportionality Analysis in the WHO Global Pharmacovigilance Database Vigibase^®.","authors":"Paul Gautier, Meyer Elbaz, Frédéric Bouisset, Fabien Despas, François Montastruc","doi":"10.1007/s40264-025-01546-5","DOIUrl":"10.1007/s40264-025-01546-5","url":null,"abstract":"<p><strong>Introduction: </strong>Use of sodium-glucose cotransporter 2 inhibitors (SGLT-2is) has significantly increased due to their cardiovascular benefits. Whether SGLT-2is increase risk of cancer has been of concern since first clinical trials, but this question remains unclear because of methodological limitations in previous studies.</p><p><strong>Methods: </strong>We conducted a disproportionality analysis using Vigibase^® between 2014 and 2023 to estimate the association between SGLT-2i use and the risk of reporting of different subtypes of cancers, compared with glucagon like peptide-1 (GLP-1) analogues and dipeptidyl peptidase-4 (DPP-4) inhibitors.</p><p><strong>Results: </strong>Among 644 reported cases of cancer associated with SGLT-2i use, 427 (66.3%) were male, with a mean age of 66.5 ± 9.7 years. Sodium-glucose cotransporter 2 inhibitors showed increased reporting odds ratio for bladder cancer (ROR 4.46, 95% CI 3.23-6.17) and kidney cancer (ROR 1.84, 95% CI 1.25-2.69), but not for all other cancer subtypes.</p><p><strong>Conclusion: </strong>In this disproportionality analysis with a hypothesis-generating approach, SGLT-2is are associated with an increased risk of reporting bladder and kidney cancer. There is a need of an urgent clarification of this signal with further long-term observational studies.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"933-941"},"PeriodicalIF":4.0,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12259762/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143977716","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":"Signal Monitoring for Adverse Events Following Immunisation with COVID-19 Vaccines During the SARS-CoV-2 Pandemic: An Evaluation of the South African Surveillance System.","authors":"Chenoa Sankar, Stephen Evans, Johanna Catharina Meyer, Hannah May Gunter, Victoria Sekiti, Kerrigan McCarthy","doi":"10.1007/s40264-025-01547-4","DOIUrl":"10.1007/s40264-025-01547-4","url":null,"abstract":"<p><strong>Introduction: </strong>Monitoring of adverse events following immunisation (AEFI) is recommended for post-licensure surveillance. We investigated whether the South African surveillance system could detect signals of disproportionate reporting and whether these signals aligned with globally identified AEFI and adverse events of special interest (AESI) post-coronavirus disease-2019 (COVID-19) vaccination.</p><p><strong>Methods: </strong>This retrospective pharmacovigilance study undertook disproportionality analysis of the National Department of Health AEFI database from the start of the COVID-19 vaccine rollout on 17 May 2021 to 31 December 2022. We complemented this with AEFI reports for vaccines not on the routine Expanded Programme on Immunisation schedule, to address potential masking of signals due to the high reporting rate of COVID-19 vaccine AEFI.</p><p><strong>Results: </strong>During the study period, 3846 AEFI were reported for 37,537,009 doses of COVID-19 vaccines (BNT162b2 and Ad26.COV2.S) administered. The overall reporting rate was 10.2 per 100,000 doses, 18.1/100,000 and 7.9/100,000 for Ad26.COV2.S and BNT162b2, respectively. Comparison with other countries suggests underreporting. Disproportionate reporting signals were obtained for three and seven AEFI following BNT162b2 and Ad26.COV2.S vaccines, respectively. An additional three AEFI signals from Ad26.COV2.S emerged in the augmented dataset, indicating masking. All Ad26.COV2.S signals, and one BNT162b2 signal, appear in the vaccines' product information. Among nine AESI evaluated, myocarditis/pericarditis presented as a signal of disproportionate reporting following BNT162b2 vaccination.</p><p><strong>Conclusions: </strong>This study is one of the first from a lower-middle-income country, using a spontaneous reporting system for signal detection post-COVID-19 vaccination. Signals aligned with those reported globally. The study highlights the need to further investigate underreporting, masking, and system attributes for system strengthening.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"909-922"},"PeriodicalIF":4.0,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12259799/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143987243","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":"Major Adverse Cardiovascular Events Related to JAK Inhibitors: A Disproportionality Analysis Using the WHO Global Individual Case Safety Database.","authors":"Raffaella Di Napoli, Christophe Richez, Cristina Scavone, Allison Singier, Maxime Demourgues, Annamaria Mascolo, Annalisa Capuano, Francesco Salvo","doi":"10.1007/s40264-025-01535-8","DOIUrl":"10.1007/s40264-025-01535-8","url":null,"abstract":"<p><strong>Background: </strong>Rheumatoid arthritis (RA) is commonly treated with Janus kinase inhibitors (JAKis) and anti-tumor necrosis factor-α (anti-TNFα), but the cardiovascular safety profiles of these drugs remain unclear.</p><p><strong>Objective: </strong>The aim of this study was to describe the individual case safety reports of major adverse cardiac events (MACE) or stroke and to determine whether there was a difference in the frequency of reporting of cardiovascular events between JAKis and anti-TNFα used in RA.</p><p><strong>Methods: </strong>A case/non-case study was conducted using the WHO VigiBase^® database. Descriptive analysis was performed, the time to onset (TTO) of MACE was calculated, and the reporting odds ratio (ROR) was used to estimate the frequency of MACE reports associated with JAKis versus anti-TNFα in RA.</p><p><strong>Results: </strong>A total of 18,099 cases of MACE were identified, of which 2543 (14%) were associated with JAKis, predominantly in women (65.4%) and in patients aged ≥65 years (49.9%). The median time to onset was 210 days (IQR 60-510) for JAKis and 690 days (210-1460) for anti-TNFα. JAKis were associated with higher odds of reporting MACE (ROR 1.38 [95% CI 1.32-1.44]), mainly due to non-fatal stroke (1.65 [1.55-1.75]). Stroke as a whole showed similar results (1.62 [1.53-1.72]). The ROR of MACE was also slightly increased in patients aged <65 years treated with JAKis (1.29 [1.21-1.39]).</p><p><strong>Conclusions: </strong>Compared with anti-TNFα, JAKis were more associated with MACE, especially stroke, and with a shorter time to onset. These data support the hypothesis of a different cardiovascular reporting frequency between JAKis and anti-TNFα. In patients with identified cardiovascular risk, anti-TNFα should be preferred to JAKis until more definitive results are available.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"943-952"},"PeriodicalIF":4.0,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12259736/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143691565","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 Mixed-Methods Evaluation to Identify Industry Knowledge Needs and Challenges in Health Product Defect and Recall Reporting in Singapore.","authors":"Pei San Ang, Michelle Sau Yuen Ng, Desmond Chun Hwee Teo, Sreemanee Raaj Dorajoo, Filina Meixuan Tan, Alice Qunyuan Mai, Wayne Guo Wei Ng, Jalene Wang Woon Poh, Chih Tzer Choong","doi":"10.1007/s40264-025-01544-7","DOIUrl":"10.1007/s40264-025-01544-7","url":null,"abstract":"<p><strong>Introduction: </strong>Health product defects are complex issues affecting the quality standards of health products and indirectly impact public health outcomes. It is crucial for the pharmaceutical industry to be clear of the reporting and case management requirements for such issues. The Health Sciences Authority of Singapore used a mixed-methods evaluation strategy, combining an online questionnaire and face-to-face focus group discussions to identify areas for knowledge enhancement and challenges faced by the industry regarding product defect reporting and recall procedures. These findings were used to plan training workshops.</p><p><strong>Methods: </strong>A self-administered online survey was emailed to representatives of all pharmaceutical companies with registered medicines and/or vaccines, or cell, tissue and gene therapy products (CTGTPs) in Singapore. The aim was to find out the challenges faced with product defect reporting and recall procedures. Two face-to-face focus group discussions were conducted with selected companies, specifically those that conducted product recalls between September 2022 and August 2024. A two-day online industry training workshop was held in October 2024. Pre- and post-workshop quizzes, including self-rating questions, were conducted to quantify the participants' baseline knowledge and what they gained from the workshop.</p><p><strong>Results: </strong>In total, 136 out of 463 individuals (29.4%) completed the online survey questionnaire for medicines and vaccines, while 24 out of 42 individuals (57.1%) completed the survey for CTGTPs. Seventeen industry professionals were invited for two focus group discussions. Participants provided feedback on existing processes, and requested clearer guidelines and examples on reportable defects, to aid their internal decision-making. The training workshop saw 318 and 271 industry professionals in attendance over two days, respectively, with 160 participating in both pre- and post-workshop quizzes. There was an improvement in average quiz scores ranging from 4.5% to 25.0% post-workshop. Participants' self-ratings also improved from a median of 3 (out of 5) to median of 4 from pre- to post-workshop.</p><p><strong>Conclusions: </strong>The series of evaluations revealed an enhanced understanding of regulatory requirements in industry professionals through a combination of surveys, focus group discussions and tailored training workshops. These initiatives can equip the industry with knowledge to make informed decisions and enhance overall compliance with product defect reporting and recall procedures. The findings would be used to streamline our processes related to defect and recall.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"875-892"},"PeriodicalIF":4.0,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143958839","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":"A Drug Similarity-Based Bayesian Method for Early Adverse Drug Event Detection.","authors":"Yi Shi, Yuedi Yang, Ruoqi Liu, Anna Sun, Xueqiao Peng, Lang Li, Ping Zhang, Pengyue Zhang","doi":"10.1007/s40264-025-01545-6","DOIUrl":"10.1007/s40264-025-01545-6","url":null,"abstract":"<p><strong>Introduction: </strong>Biochemical drug similarity-based methods demonstrate successes in predicting adverse drug events (ADEs) in preclinical settings and enhancing signals of ADEs in real-world data mining. Despite these successes, drug similarity-based ADE detection shall be expanded with false-positive control and evaluated under a time-to-detection setting.</p><p><strong>Methods: </strong>We tested a drug similarity-based Bayesian method for early ADE detection with false-positive control. Under the tested method, prior distribution of ADE probability of a less frequent drug could be derived from frequent drugs with a high biochemical similarity, and posterior probability of null hypothesis could be used for signal detection and false-positive control. We evaluated the tested and reference methods by mining relatively newer drugs in real-world data (e.g., the US Food and Drug Administration (FDA)'s Adverse Event Reporting System (FAERS) data) and conducting a simulation study.</p><p><strong>Results: </strong>In FAERS analysis, the times to achieve a same probability of detection for drug-labeled ADEs following initial drug reporting were 5 years and ≥ 7 years for the tested method and reference methods, respectively. Additionally, the tested method compared with reference methods had higher AUC values (0.57-0.79 vs. 0.32-0.71), especially within 3 years following initial drug reporting. In a simulation study, the tested method demonstrated proper false-positive control, and had higher probabilities of detection (0.31-0.60 vs. 0.11-0.41) and AUC values (0.88-0.95 vs. 0.69-0.86) compared with reference methods. Additionally, we identified different types of drug similarities had a comparable performance in high-throughput ADE mining.</p><p><strong>Conclusion: </strong>The drug similarity-based Bayesian ADE detection method might be able to accelerate ADE detection while controlling the false-positive rate.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"923-931"},"PeriodicalIF":4.0,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12259350/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143985825","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":"Evaluation of Mortality in Users of Pimavanserin Compared with Other Atypical Antipsychotics in Patients with Parkinson's Disease Psychosis: An Update.","authors":"Sapna Rao, Lisa J McQuay, Joan Forns, Rebecca MacKay, Heather E Danysh, Dilesh Doshi, Victor Abler, Mary S Anthony, J Bradley Layton","doi":"10.1007/s40264-025-01543-8","DOIUrl":"10.1007/s40264-025-01543-8","url":null,"abstract":"<p><strong>Introduction: </strong>Pimavanserin is the only antipsychotic medication approved in the USA to specifically treat hallucinations and delusions associated with Parkinson's disease psychosis (PDP).</p><p><strong>Objective: </strong>To compare mortality risk in patients with PDP after initiation of pimavanserin or comparator atypical antipsychotics in an overall PDP cohort and in a subcohort of patients residing in long-term care or skilled nursing facilities (LTC/SNFs).</p><p><strong>Methods: </strong>This cohort study identified patients aged ≥ 65 years with PDP initiating pimavanserin or a comparator antipsychotic in US Medicare claims (2016-2021). Cox proportional hazards models were used to estimate hazard ratios (HRs) comparing all-cause mortality in the propensity score-matched treatment groups. Cumulative incidence curves, time period-specific relative risk, and risk difference estimates evaluated risk over time.</p><p><strong>Results: </strong>In this follow-up analysis, we identified 4384 pimavanserin initiators and 28,042 comparator initiators in the overall PDP cohort, and 921 pimavanserin initiators and 7963 comparator initiators in the LTC/SNF subcohort. After matching, the overall PDP cohort had 4381 patients in each treatment group, and the LTC/SNF subcohort had 905 patients in each group. The matched HR for mortality (pimavanserin versus comparator) was 0.76 (95% CI 0.68-0.85) in the overall PDP cohort and 0.90 (95% CI 0.74-1.10) in the LTC/SNF subcohort. In the overall PDP cohort, time period-specific relative risks and risk differences showed that pimavanserin initiators had a lower risk of mortality throughout the first 365 days of follow-up.</p><p><strong>Conclusion: </strong>In the overall PDP cohort, mortality risk was lower among pimavanserin initiators than comparator antipsychotic initiators.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"893-907"},"PeriodicalIF":4.0,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12259748/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143986737","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 Data Insights into Antidepressant Prescription and Adherence During Pregnancy in Catalonia (Spain).","authors":"Lucía Bellas, Lina Camacho-Arteaga, Maria Giner-Soriano, Albert-Prats-Uribe, Ainhoa Gómez-Lumbreras, Cristina Aguilera, Antonia Agustí","doi":"10.1007/s40264-025-01576-z","DOIUrl":"https://doi.org/10.1007/s40264-025-01576-z","url":null,"abstract":"<p><strong>Background: </strong>Affective disorders, particularly depression, are common among women of childbearing age, and pregnancy often exacerbates symptoms. Antidepressants are often required for treatment, but adherence during pregnancy is variable. Although some studies suggest potential risks to the foetus, many cannot rule out confounding by indication. In this context, understanding real-world patterns of antidepressant prescription and adherence during pregnancy is essential to inform clinical practice and ensure adequate mental healthcare.</p><p><strong>Objective: </strong>The aim of the present study was to characterise the use of antidepressants in a cohort of pregnant women using electronic health records.</p><p><strong>Methods: </strong>This observational cohort drug-utilisation study assessed antidepressant prescription patterns, adherence and persistence among pregnant women using data from the SIDIAP (Information System for the Development of Research in Primary Care) database in Catalonia from January 2011 to June 2020.</p><p><strong>Results: </strong>Among 99,605 pregnancies, 14.9% involved antidepressant prescriptions, but only 5.8% of these were collected from pharmacies. The median pregnancy duration was 38.4 weeks, and the median maternal age was 33.5 years. Anxiety was the most common health issue associated with an antidepressant prescription. Paroxetine was the most frequently prescribed antidepressant, although sertraline usage increased over time. Antidepressant prescriptions and adherence decreased during pregnancy, with an increase in the postpartum period. About 11.6% of pregnancies involved a concurrent prescription of another antidepressant, and 29.2% of women resumed antidepressant use after pregnancy. Women who initiated antidepressants during pregnancy were more likely to persist with treatment than those with pre-existing prescriptions.</p><p><strong>Conclusions: </strong>Our study describes antidepressant use during pregnancy in Catalonia. It is remarkable that there is a notable gap between antidepressant prescriptions and dispensations. Given the risks of untreated maternal depression, strengthening primary care with adequate resources and personalised support is essential for improving perinatal mental healthcare.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144590655","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 Value of Sensitivity Analyses in Assessing the Risk of Two Rare Neurological Adverse Events and Pseudoephedrine Use.","authors":"G Caleb Alexander, Francine Chingcuanco, Abhilok Garg, Daniel Budnitz","doi":"10.1007/s40264-025-01575-0","DOIUrl":"https://doi.org/10.1007/s40264-025-01575-0","url":null,"abstract":"","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-07-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144590656","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}