Drug Safety最新文献

{"title":"Using Mixed Methods to Evaluate Risk Minimisation Programs in Europe and the USA: An Innovative Blueprint.","authors":"Meredith Y Smith, Rachel Davis, Priya Bahri, Delphine Saragoussi, Viviana Nguyen, Gita A Toyserkani, Alison Hamilton","doi":"10.1007/s40264-025-01533-w","DOIUrl":"10.1007/s40264-025-01533-w","url":null,"abstract":"<p><strong>Background: </strong>Significant methodological shortcomings have been documented to date in risk minimisation program evaluations for medicinal products, including overreliance on survey methods alone. Recently updated guidances from the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) recommend the use of frameworks and mixed methods designs to improve the rigor of these assessments.</p><p><strong>Objective: </strong>The purpose of this paper was to exemplify how a mixed methods approach, guided by an implementation science framework, can be used to design the evaluation of a risk minimisation program.</p><p><strong>Methods: </strong>We selected the Practical, Robust, Implementation and Sustainability Model (PRISM) as the implementation science framework to guide our mixed methods approach. PRISM provides a comprehensive and systematic approach to measuring the key domains relevant to the implementation and outcomes of a risk minimisation program. We mapped the PRISM domains to the evaluation dimensions described in the EMA and FDA guidances. We then specified a mixed methods evaluation design and data collection methods using a fictitious risk minimisation program as a case study for illustrative purposes.</p><p><strong>Results: </strong>On the basis of our case study, we developed quantitative and qualitative measures, including specific items for surveys and interviews, for both formative and summative evaluations. For both the formative and summative evaluations, measures focussed on assessing (1) contextual factors that could affect program implementation and impact and (2) outcomes including implementability and acceptability as well as degree of program reach, adoption, implementation, effectiveness and maintenance.</p><p><strong>Conclusions: </strong>Mixed methods, guided by a well-established implementation science framework, can be applied to ensure comprehensive formative and summative evaluations that provide fit-for-purpose information that may inform regulatory decision-making.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"821-838"},"PeriodicalIF":4.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12174294/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143613981","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The 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":"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":"795-804"},"PeriodicalIF":4.0,"publicationDate":"2025-07-01","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":"Narrative Search Engine for Case Series Assessment Supported by Artificial Intelligence Query Suggestions.","authors":"Alem Zekarias, Eva-Lisa Meldau, Shachi Bista, Joana Félix China, Lovisa Sandberg","doi":"10.1007/s40264-025-01529-6","DOIUrl":"10.1007/s40264-025-01529-6","url":null,"abstract":"<p><strong>Introduction: </strong>Manual identification of case narratives with specific relevant information can be challenging when working with large numbers of adverse event reports (case series). The process can be supported with a search engine, but building search queries often remains a manual task. Suggesting terms to add to the search query could support assessors in the identification of case narratives within a case series.</p><p><strong>Objective: </strong>The aim of this study is to explore the feasibility of identifying case narratives containing specific characteristics with a narrative search engine supported by artificial intelligence (AI) query suggestions.</p><p><strong>Methods: </strong>The narrative search engine uses Best Match 25 (BM25) and suggests additional query terms from two word embedding models providing English and biomedical words to a human in the loop. We calculated the percentage of relevant narratives retrieved by the system (recall) and the percentage of retrieved narratives relevant to the search (precision) on an evaluation dataset including narratives from VigiBase, the World Health Organization global database of adverse event reports for medicines and vaccines. Exact-match search and BM25 search with the Relevance Model (RM3), an alternative way to expand queries, were used as comparators.</p><p><strong>Results: </strong>The gold standard included 55/750 narratives labelled as relevant. Our narrative search engine retrieved on average 56.4% of the relevant narratives (recall), which is higher when compared with exact-match search (21.8%), without a significant drop in precision  (54.5% to 43.1%). The recall is also higher as compared with RM3 (34.4%).</p><p><strong>Conclusions: </strong>Our study demonstrates that a narrative search engine supported by AI query suggestions can be a viable alternative to an exact-match search and BM25 search with RM3, since it can facilitate the retrieval of additional relevant narratives during signal assessments.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"767-779"},"PeriodicalIF":4.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12174168/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143633822","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":"Comment on \"Drug-Induced Cognitive Impairment\".","authors":"Chaker Ben Salem","doi":"10.1007/s40264-025-01567-0","DOIUrl":"10.1007/s40264-025-01567-0","url":null,"abstract":"","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"839-840"},"PeriodicalIF":4.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144246991","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":"REMS Logic Model: A Pragmatic Framework for Incorporating Drug Safety into Clinical Practice.","authors":"Gita A Toyserkani, Suzanne B Robottom, Elaine H Morrato","doi":"10.1007/s40264-025-01542-9","DOIUrl":"10.1007/s40264-025-01542-9","url":null,"abstract":"","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"715-718"},"PeriodicalIF":4.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12174204/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143987240","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":"Understanding the Work of the Pharmacovigilance Risk Assessment Committee (PRAC): A Quantitative Review of the Post-Authorisation Safety Evaluation of Antidiabetic Drugs from 2012 to 2022.","authors":"Haoxin Le, Per Sindahl, Morten Andersen, Christine E Hallgreen","doi":"10.1007/s40264-025-01536-7","DOIUrl":"10.1007/s40264-025-01536-7","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;The Pharmacovigilance Risk Assessment Committee (PRAC) plays a central role in the European Union's pharmacovigilance system, evaluating drug safety through several procedures and activities. Despite its central role, few studies have quantitatively investigated the PRAC's activities from a system's perspective.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aims to map PRAC's evaluation of safety signals and concerns using antidiabetic products as a case. It characterises the drugs and adverse events involved, analyses the PRAC-led regulatory procedures where the safety signals and concerns were evaluated, and provides a comprehensive review of PRAC meeting minutes.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;From PRAC meeting minutes, we retrieved information on all antidiabetic drug-related adverse events discussed from 2012 to 2022. We identified drug-adverse event evaluations based on the discussion content. These were described by drug classes, System Organ Classes, PRAC procedures, and the evaluation outcomes corresponding to recommendations for regulatory actions. We also analysed the sequence of PRAC-led procedures and activities addressing drug-adverse event pairs across meeting minutes.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;A total of 321 drug-adverse event pairs were identified, with 14 pairs associated with drug classes. Second-generation antidiabetic agents, including sodium-glucose transport protein-2 inhibitors, glucagon-like peptide-1 receptor agonists, and dipeptidyl peptidase 4 inhibitors, were the most frequently discussed. Of these, 62 pairs underwent multiple evaluations, resulting in a total of 413 evaluations. In 48% of evaluations, no regulatory action was required. Most evaluations (97%) were concluded in a single procedure, and 66% were concluded in one meeting. Periodic safety update reports accounted for 54% of drug-adverse event evaluations and updates to product information were the most frequent outcome. Signal assessment and prioritisation procedures, while less common, resulted in more diverse recommendations for regulatory action. Referrals were infrequent (N = 5) and were often triggered by the signal assessment and prioritisation procedure.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Periodic safety update reports are the primary source for PRAC evaluations of safety signals although they are not intended for notification of new urgent safety information. Compared with periodic safety update reports, the signal assessment and prioritisation procedure evaluates fewer signals but leads to a wider range of regulatory actions, from risk minimisation measures to referrals. This difference may be attributed to the fact that signals detected in periodic safety update reports are not intended for urgent safety issues, these should be assessed through the signal assessment and prioritisation procedure, as the latter involves real-time signal management, whereas the periodic safety update reports are conducted at pr","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"781-794"},"PeriodicalIF":4.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12174291/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143536898","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":"Authors' reply to Chaker Ben Salem's comment on: \"Drug-Induced Cognitive Impairment\".","authors":"Arne Reimers, Per Odin, Hanna Ljung","doi":"10.1007/s40264-025-01568-z","DOIUrl":"10.1007/s40264-025-01568-z","url":null,"abstract":"","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"841"},"PeriodicalIF":4.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144246990","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":"Identifying New Candidate Predictors of Mortality in Japanese Patients with Severe Drug Eruptions.","authors":"Shiho Sato, Tadao Ooka, Yoshito Zamami, Hirofumi Hamano, Fumikazu Hayashi, Eri Eguchi, Narumi Funakubo, Tetsuya Ohira","doi":"10.1007/s40264-025-01572-3","DOIUrl":"https://doi.org/10.1007/s40264-025-01572-3","url":null,"abstract":"<p><p>BACKGROUND AND OBJECTIVES: SCORe of Toxic Epidermal Necrolysis (SCORTEN) and ABCD-10 have been developed as scoring systems for predicting mortality associated with Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN). These scores were developed based on a small number of patients; hence, their generalizability requires further exploration. The present study used three algorithms, including a machine learning method, to construct a mortality prediction model for SJS/TEN and to identify new candidate predictors of mortality from severe drug eruptions.</p><p><strong>Methods: </strong>Data from 5966 patients with SJS or TEN were extracted from the Japanese Adverse Drug Event Report Database. A mortality prediction model was then constructed using stepwise regression, L1 regularized-logistic regression, and random forests based on the patient characteristics (e.g., age, sex, primary disease, adverse events, drug classification, route of administration) and outcomes (death).</p><p><strong>Results and discussion: </strong>The mortality prediction models for SJS/TEN identified sex (men), primary disease (hyperlipidemia, diabetes mellitus, renal dysfunction, and malignant tumors), adverse events (renal dysfunction, liver dysfunction, respiratory dysfunction, bacteremia/sepsis, disseminated intravascular coagulation syndrome, shock, and multiple organ failure), number of concomitant drugs, and route of administration (injection) as common factors associated with mortality.</p><p><strong>Conclusions: </strong>Our findings showed that sex, hyperlipidemia as the primary disease, number of concomitant drugs, use of antipyretic analgesics, and route of administration may be considered as predictors of mortality in patients with SJS/TEN. The external validity of these factors needs to be examined in the future.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-06-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144324733","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":"Reporting Adverse Drug Events: A Comparison of an Online Patient Tool Versus Telephone-Based Monitoring in Community Pharmacy Patients in the Netherlands.","authors":"Henok D Habtemariam, Henk-Jan Guchelaar, Lisanne E N Manson, Jesse J Swen, Agnes C Kant, Stefan Böhringer","doi":"10.1007/s40264-025-01571-4","DOIUrl":"https://doi.org/10.1007/s40264-025-01571-4","url":null,"abstract":"<p><strong>Background: </strong>Adverse drug events (ADEs) are events occurring after the administration of a drug. Several authorities are involved in capturing these ADEs to improve pharmacovigilance. These ADEs are reported directly to healthcare professionals or via the telephone, online, or e-mail and are crucial for maintaining drug safety.</p><p><strong>Objective: </strong>Patient-reported adverse drug events (ADEs) are collected using various tools, though not much is known with regard to the comparability of these different methodologies. It is known that telephone-based surveys result in a higher report rate, although it is not known if this has an effect on the type of ADEs that are reported. In this prospective study, we aimed to investigate if there are differences in the number, type, and severity of ADEs reported via telephone and online in an event monitoring setting.</p><p><strong>Methods: </strong>Patients included in Dutch community pharmacies were asked whether they experienced any ADEs via telephone and online (Lareb Intensive Monitoring) surveys as part of the PREPARE study. The PREPARE study was a multicenter study, researching the effect of genotype-guided dosing on the incidence of clinically relevant adverse drug reactions. With the paired data acquired in the PREPARE study, we investigated differences in the number, type, and severity of the reported ADEs.</p><p><strong>Results: </strong>Patients (N = 525) completed both the telephone and online surveys. Of the 525 patients who completed both surveys, 326 reported ADEs via telephone and 239 online. A visual comparison showed a similar distribution in the type of ADEs among the methods except for less commonly reported types of ADEs and cardiac disorders. The perceived severity of ADEs were proportionally reported as more severe during the telephone survey versus the online survey.</p><p><strong>Conclusions: </strong>Our study showed a clear difference in the number of ADEs reported during telephone and online monitoring. Additionally, the differences in the type of ADEs and the severity distribution of both tools shows that the tools are not exchangeable (CT.gov identifier: NCT03093818).</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-06-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144293526","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":"Identifying Maternal Conditions Leading to Gabapentinoid Prescriptions in Pregnancy Using Electronic Health Records from Six European Countries: A Contribution from the IMI ConcePTION Project.","authors":"Anna-Belle Beau, Olga Paoletti, Justine Bénévent, Marie Beslay, Xavier Moisset, Elisa Ballardini, Laia Barrachina-Bonet, Clara Cavero-Carbonell, Alex Coldea, Laura García-Villodre, Anja Geldhof, Rosa Gini, Mika Gissler, Sue Jordan, Maarit K Leinonen, Marco Manfrini, Visa Martikainen, Vera R Mitter, Joan K Morris, Amanda J Neville, Hedvig Nordeng, Aurora Puccini, Jingping Mo, Christine Damase-Michel","doi":"10.1007/s40264-025-01565-2","DOIUrl":"https://doi.org/10.1007/s40264-025-01565-2","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Introduction and objective: &lt;/strong&gt;Given the recent increase in the prescription and dispensation of gabapentinoids (gabapentin and pregabalin) and the importance of controlling for underlying maternal illnesses in drug safety studies, we aimed to develop algorithms for identifying maternal conditions leading to gabapentinoid prescribing among pregnant women using data from six electronic healthcare data sources across Europe.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;The study was conducted in Finland, France (Haute-Garonne), Italy (Emilia Romagna), Norway, Spain (Valencian region), and Wales (UK), covering three million pregnancies from 2006 to 2020. Algorithms were developed to detect epilepsy, neuropathic pain, and generalized anxiety disorder (GAD) (approved indications for gabapentinoids by the European Medicines Agency, with the exception of gabapentin for GAD) using data ± 1 year around the gabapentinoid prescription date. Data included prescriber specialty, primary and specialized health care diagnoses, and co-prescription/dispensation data. Additional analyses investigated potential unlicensed indications (such as fibromyalgia, restless legs syndrome, bipolar disorder) and potential for abuse (using codes for substance use disorders and alcohol withdrawal).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Gabapentinoids were prescribed/dispensed in 1770 pregnancies (7.7 per 1000) in Spain, 2912 pregnancies (6.6 per 1000) in Wales, 3163 pregnancies (3.6 per 1000) in Norway, 2406 pregnancies (3.0 per 1000) in Finland, 908 pregnancies (2.2 per 1000) in Italy, and 269 pregnancies (1.9 per 1000) in France. A maternal condition related to gabapentinoid prescriptions was identified by the algorithm in 2797 (88.4%) in Norway, 2180 (74.9%) in Wales, 1269 (71.7%) in Spain, 1534 (63.8%) in Finland, 163 (60.6%) in France, and 396 (43.6%) pregnancies in Italy. Anxiety (licensed or unlicensed) was the most commonly captured condition in Wales (70.5%), Spain (51.5%), Finland (42.0%), and Italy (26.2%), whereas neuropathic pain prevailed in Norway (76.9%) and France (49.8%). Epilepsy was the least frequent maternal condition leading to gabapentinoid prescriptions across all data sources (below 15% of all pregnancies). The relative preponderance of these conditions differed between pregabalin and gabapentin. Additionally, unlicensed indications were captured in 0% to 13% of pregnancies, depending on the data source. The analyses of potential for abuse showed that records of alcohol withdrawal and/or substance use disorders (within 1 year before and after the gabapentinoids prescription/dispensation date) were present in 3% of pregnancies in Italy and up to 23% in Wales.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Our study provides valuable insights into gabapentinoid use during pregnancy, with anxiety being the most common condition among pregnant women with gabapentinoid prescriptions in Finland, Italy, Spain, and Wales, whereas neuropathic pain predominated in France and ","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144293525","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}