Therapeutic Advances in Drug Safety最新文献

{"title":"Drug- and patient-specific neurological risk profiles of α1-adrenergic blockers: evidence from FAERS and external validation in JADER.","authors":"Xin Hai, Lulu Huang","doi":"10.1177/20420986261444611","DOIUrl":"https://doi.org/10.1177/20420986261444611","url":null,"abstract":"<p><strong>Background: </strong>α1-Adrenergic blockers are widely used in older patients, yet nervous system adverse events associated with these agents are often considered nonspecific and remain insufficiently characterized at the population level.</p><p><strong>Objectives: </strong>To evaluate nervous system adverse events associated with α1-adrenergic blockers using real-world pharmacovigilance data, assess drug-specific and patient-specific risks, and translate findings into clinically interpretable risk profiles.</p><p><strong>Design: </strong>A retrospective, observational pharmacovigilance study.</p><p><strong>Methods: </strong>We conducted an integrated pharmacovigilance analysis using the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) as the discovery dataset and the Japanese Adverse Drug Event Report (JADER) database for external validation. Hierarchical signal detection within the Medical Dictionary for Regulatory Activities (MedDRA) nervous system organ class was used to construct a data-driven composite endpoint. Multivariable logistic regression with least absolute shrinkage and selection operator (LASSO)-guided feature selection estimated adjusted associations for five α1-adrenergic blockers while accounting for age, sex, and major comorbidities. Model performance and calibration were evaluated in JADER. Individualized risk portraits were generated across clinically relevant patient profiles.</p><p><strong>Results: </strong>Several α1-adrenergic blockers demonstrated significant and heterogeneous associations with nervous system adverse events in FAERS after adjustment. External validation in JADER showed consistent effect directions for drugs with sufficient exposure and acceptable calibration. Risk portrait analyses revealed marked risk stratification by age and comorbidity burden, with the highest predicted reporting probability observed among elderly patients with multiple comorbidities.</p><p><strong>Conclusion: </strong>This integrated pharmacovigilance framework provides a structured and clinically interpretable assessment of nervous system safety among α1-adrenergic blockers, highlighting the importance of agent-specific and patient-specific risk evaluation.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"17 ","pages":"20420986261444611"},"PeriodicalIF":3.4,"publicationDate":"2026-04-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13133441/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147820734","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The administration of proton pump inhibitors with the CDK4/6 inhibitor abemaciclib does not affect the clinical outcome of metastatic breast cancer patients.","authors":"Stefania Crucitta, Paola Cinacchi, Irene Bargagna, Pamela Biondani, Elena Giontella, Michela Palleschi, Claudia Omarini, Lorenzo Belluzzi, Lucia Angelini, Icro Meattini, Luca Visani, Stefania Stucci, Camillo Porta, Andrea Fontana, Ugo De Giorgi, Stefano Fogli, Romano Danesi, Marzia Del Re","doi":"10.1177/20420986251414591","DOIUrl":"https://doi.org/10.1177/20420986251414591","url":null,"abstract":"<p><strong>Background: </strong>CDK4/6 inhibitors abemaciclib, palbociclib, and ribociclib have rapidly become an established oral treatment for patients with ER+, HER2- locally advanced or metastatic breast cancer. The use of the oral route offers convenience and flexibility to the patient; however, the co-administration of proton pump inhibitors (PPIs) to mitigate gastrointestinal adverse events induced by anticancer treatments may decrease drug solubility, bioavailability, and potentially impact treatment efficacy.</p><p><strong>Objectives: </strong>The present study was aimed at investigating whether PPIs may affect the progression-free survival (PFS) of patients treated with abemaciclib.</p><p><strong>Design: </strong>Multicenter observational cohort study on clinical data collected retrospectively.</p><p><strong>Methods: </strong>Patients with ER-positive/HER2-negative mBC candidates for a first-line treatment with abemaciclib as per clinical practice were enrolled. Patients were classified as \"no concomitant PPIs\" or \"concomitant PPIs\" if PPI administration covered not less than 2/3 of the treatment period with abemaciclib. All clinical interventions were made according to clinical practice.</p><p><strong>Results: </strong>One hundred eight patients were enrolled in this study; 66 belonged to the \"no concomitant PPIs\" group and 42 to the \"concomitant PPIs\" group. No statistically significant difference in PFS was found between the two groups (<i>p</i> = 0.77). Likewise, no difference in PFS was observed in endocrine-sensitive or -resistant mBC in the presence or absence of concomitant PPI treatment. No correlation with adverse events, including hematological or gastrointestinal toxicities, was found.</p><p><strong>Conclusion: </strong>This study demonstrates that the administration of PPIs to patients treated with abemaciclib is not associated with clinically significant drug-drug interactions on PFS.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"17 ","pages":"20420986251414591"},"PeriodicalIF":3.4,"publicationDate":"2026-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13111899/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147781975","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Incidence, risk factors, and prediction model of piperacillin/tazobactam-associated hypokalemia in neonates.","authors":"Jun Wan, Shiteng Lin, Wei Zhuang, Weida Chen, Yanting Huang, Zhiyi Huang, Wanlong Lin, Yao Chen","doi":"10.1177/20420986261434697","DOIUrl":"https://doi.org/10.1177/20420986261434697","url":null,"abstract":"<p><strong>Background: </strong>Maintaining optimal potassium levels is critical in neonates. Piperacillin/tazobactam (TZP) is associated with hypokalemia in adults, but neonatal data are limited.</p><p><strong>Objectives: </strong>This study aimed to investigate the incidence, severity, and determinants of TZP-associated hypokalemia (TAH) in neonates and develop a predictive model for early detection.</p><p><strong>Design: </strong>Retrospective cohort study.</p><p><strong>Methods: </strong>Neonates treated with TZP between January 2019 and December 2024 at Xiamen Women and Children's Hospital were included. Demographic, laboratory, and medication data were extracted. Naranjo probability scores assessed TAH causality. Multivariate logistic regression identified predictors, and a nomogram predicted TAH occurrence. Nomogram performance was evaluated.</p><p><strong>Results: </strong>Among 1027 neonates initially screened, 358 met the inclusion criteria and were ultimately included in the analysis. The incidence of TAH in this cohort was 20.4% (73/358). Independent predictors included higher baseline serum creatinine (<i>p</i> = 0.012, OR 1.02, 95% CI 1.00-1.03), dopamine use (<i>p</i> = 0.002, OR 3.37, 95% CI 1.54-7.36), and lower serum calcium (<i>p</i> = 0.049, OR 0.31, 95% CI 0.10-0.99) was a protective factor. The nomogram showed good predictive accuracy (AUC = 0.771) and net benefit. High-risk neonates had a higher hypokalemia incidence (log-rank test <i>p</i> < 0.001).</p><p><strong>Conclusion: </strong>Higher baseline serum creatinine, dopamine use, and lower serum calcium are independent predictors of neonatal TAH. The nomogram offers a user-friendly tool for TAH prediction, facilitating early detection and management in clinical practice. This study supports early detection, diagnosis, and intervention for neonatal TAH.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"17 ","pages":"20420986261434697"},"PeriodicalIF":3.4,"publicationDate":"2026-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13058186/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147646385","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Rebound hypertension following prolonged oxymetazoline use: a signal-generating case report.","authors":"Domenico Merante","doi":"10.1177/20420986261435799","DOIUrl":"https://doi.org/10.1177/20420986261435799","url":null,"abstract":"<p><p>Topical nasal decongestants containing α-adrenergic agonists such as oxymetazoline are widely available over the counter and are generally perceived as safe when used as directed. Manufacturer instructions typically recommend limited dosing frequency and short-term use (e.g. up to twice daily for no more than 3-7 days, depending on product labelling). This report describes a signal-generating case of clinically significant but reversible hypertension temporally associated with prolonged use of oxymetazoline nasal spray in a previously normotensive adult. After 16 consecutive days of exposure exceeding the manufacturer-recommended duration and frequency stated on the product packaging, the patient developed diastolic-predominant hypertension peaking at 160/110 mmHg, accompanied by headache and autonomic symptoms. Serial fasting-morning home blood pressure measurements obtained using a validated automated upper-arm device documented the onset, peak and progressive normalization of blood pressure following discontinuation of oxymetazoline without initiating antihypertensive therapy, consistent with a positive dechallenge. The temporal relationship between exposure and blood pressure elevation, together with the plausible pharmacological mechanism involving systemic α-adrenergic vasoconstriction, supports classification as a probable adverse drug reaction. Prolonged oxymetazoline nasal spray use may represent an under-recognized safety risk and a potential confounder in the evaluation of new-onset hypertension. Clinicians should routinely inquire about over-the-counter medication use and duration when assessing unexplained blood pressure elevations.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"17 ","pages":"20420986261435799"},"PeriodicalIF":3.4,"publicationDate":"2026-04-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13053975/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147639928","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Agglomerative clustering-based drugs graded for the risk signals of drug-induced cognitive disorder: a study on the FAERS database.","authors":"Bo Lv, Junping Han, Yunli Yu, Yuedong Li","doi":"10.1177/20420986261438241","DOIUrl":"https://doi.org/10.1177/20420986261438241","url":null,"abstract":"<p><strong>Background: </strong>Drug-induced cognitive disorder (DICD) is a harmful adverse event influenced by individual factors such as age, gender, and weight. These characteristics make regression models with drug selection, such as Lasso regression, more appropriate than disproportionality analysis for mining the FDA Adverse Event Reporting System (FAERS) data. However, focusing solely on the drugs with the highest risk signals may underestimate the drugs with moderate risk signals.</p><p><strong>Objectives: </strong>To develop a novel method for evaluating drug-associated DICD risk signals that addresses key limitations of existing approaches-specifically, the underestimation of drugs with non-top risk signals and the challenges posed by sparse data across numerous candidate drugs.</p><p><strong>Design: </strong>An agglomerative clustering-based model (ACM) was developed to stratify drugs by risk signals of DICD, and its performance was compared with conventional Lasso logistic regression.</p><p><strong>Methods: </strong>In the ACM, drugs with similar risk levels were grouped into clusters, preserving information by avoiding the exclusion of drugs with moderate risk signals. Model performance was assessed using both receiver operating characteristic analysis and decision curve analysis.</p><p><strong>Results: </strong>The ACM model outperformed Lasso logistic regression. Finasteride was identified in the first cluster of DICD risk signals, consistent with Lasso regression. However, Carbidopa/Levodopa, Topiramate, and Clonazepam were identified in the second cluster of DICD risk signals, which were not detected by Lasso regression.</p><p><strong>Conclusion: </strong>By moving beyond an exclusive focus on drugs with top risk signals, the ACM workflow demonstrated superior predictive performances and provided a more comprehensive assessment of drug-related risk signals. This approach facilitates the detection and evaluation of drugs with moderate risk signals, enhancing their applicability in clinical practice.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"17 ","pages":"20420986261438241"},"PeriodicalIF":3.4,"publicationDate":"2026-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13051095/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147634252","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Monitoring of QTc in subjects hospitalized for 1 year in an acute psychiatric ward treated with clotiapine and other associated antipsychotics: a retrospective study.","authors":"Rosaria Di Lorenzo, Andrea Santoro, Jessica Bonisoli, Carolina Bottone, Paola Ferri, Sergio Rovesti","doi":"10.1177/20420986261430214","DOIUrl":"https://doi.org/10.1177/20420986261430214","url":null,"abstract":"<p><strong>Background: </strong>Many antipsychotic medications are responsible for prolonging QTc, a risk factor for sudden death, which is one of the main causes of reduced life expectancy in patients with mental health disorders.</p><p><strong>Objectives: </strong>To evaluate the cardiac safety profile of clotiapine in a naturalistic setting.</p><p><strong>Design: </strong>This observational, retrospective study included 70 subjects hospitalized at the Service of Psychiatry Diagnosis and Care in Modena from February 1, 2023 to July 31, 2024, treated with clotiapine.</p><p><strong>Methods: </strong>Demographic and clinical data were collected, along with electrocardiographic measurements (QTc) taken at the start of treatment (T0), after at least 7 days of therapy (T1), and at further follow-up (T2) after 7-21 days. Prolongation was considered when QTc exceeded 500 ms or an increase of 60 ms compared to baseline, according to international standards.</p><p><strong>Results: </strong>QTc prolongation was limited (<i>m</i> = 4.59 ms), representing an increase of 1.07%, without reaching thresholds of significant clinical risk. Subjects with an increase equal to or greater than the median (<i>M</i> = 3.5) of QTc increase at T1 accounted for half of the sample, and only one patient had an increase greater than 60 ms.</p><p><strong>Conclusion: </strong>Clotiapine treatment, also in combination with haloperidol, had minimal prolongation of QTc within the limits of clinical safety. A stabilization of QTc over time was observed, indicating a possible adaptation to treatment. Methodological limitations of this study call for further research.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"17 ","pages":"20420986261430214"},"PeriodicalIF":3.4,"publicationDate":"2026-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13039576/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147609892","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Psychedelic exposure in pregnancy: a scoping review to inform perinatal drug safety and clinical counseling.","authors":"Ovie Martin Albert, Alexander Arthur","doi":"10.1177/20420986261436104","DOIUrl":"https://doi.org/10.1177/20420986261436104","url":null,"abstract":"<p><p>Psychedelic and psychedelic-adjacent substances, including 3,4-methylenedioxymethamphetamine (MDMA) and classic serotonergic hallucinogens, are undergoing renewed therapeutic investigation and remain in non-medical use. Inadvertent exposure during early, unrecognized pregnancy is clinically plausible, yet pregnancy-specific safety evidence is limited. To map and synthesize the extent, characteristics, and limitations of primary human evidence on prenatal exposure to MDMA, psilocybin, and classic hallucinogens (lysergic acid diethylamide (LSD), mescaline/peyote, and <i>N,N</i>-dimethyltryptamine (DMT)/ayahuasca), and to identify clinically relevant evidence gaps for perinatal counseling and pharmacovigilance. Peer-reviewed primary human studies (cohort, case-control, cross-sectional, case series, case reports, and brief reports) describing prenatal exposure with reported maternal, obstetric, neonatal, congenital anomaly, or child neurodevelopmental outcomes were included. Animal and preconception-only studies were excluded. MEDLINE, Embase, PsycINFO, CINAHL, and the Cochrane Library were searched from inception to March 2025. Supplementary methods included Google Scholar screening and citation tracking. Data were charted in duplicate using a standardized form and synthesized descriptively by substance and outcome domain. Consistent with scoping methodology, no formal risk-of-bias assessment or meta-analysis was undertaken. Twenty-three primary human sources (1968-2020) met inclusion criteria: MDMA (<i>n</i> = 11), LSD (<i>n</i> = 11), and mescaline/peyote (<i>n</i> = 1). No eligible primary human pregnancy outcome studies were identified for psilocybin or DMT/ayahuasca. The evidence base was heterogeneous and predominantly comprised small cohorts, teratology service follow-up reports, and case-based publications, frequently limited by self-reported exposure, polysubstance confounding, and inconsistent outcome definitions. Human evidence on prenatal psychedelic exposure remains sparse and methodologically constrained. Absence of data for several substances should not be interpreted as evidence of safety. Clinicians should counsel with explicit acknowledgment of uncertainty while supporting harm reduction and appropriate follow-up. Structured perinatal pharmacovigilance and ethically designed evidence-generation strategies are needed as therapeutic psychedelic research expands.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"17 ","pages":"20420986261436104"},"PeriodicalIF":3.4,"publicationDate":"2026-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13039613/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147609869","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Treating hearts and minds: adverse cardiovascular effects of psychiatric medications.","authors":"Asdaq Shabbir Raja, Stephen J Leslie, Elizabeth Buist, Gordon F Rushworth, Ian L Megson, Neil McNamara","doi":"10.1177/20420986261418947","DOIUrl":"10.1177/20420986261418947","url":null,"abstract":"<p><p>Cardiovascular disease (CVD) is one of the leading causes of death in patients with severe mental illness (SMI), being ~3.3 times higher than in the general population. The adverse cardiovascular effects of psychiatric medications have short- and long-term consequences that contribute to higher rates of cardiovascular death in patients experiencing SMI. By understanding these adverse effects, clinicians can better address cardiovascular health inequalities in patients with SMI from a pharmacological perspective. This review highlights both the short- and long-term adverse cardiovascular effects of psychiatric medications. These adverse effects include QTc prolongation and torsades de pointes (TdP), which are phenomena associated with certain selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants (TCAs) and antipsychotics. Increasing QT dispersion and induction of Brugada phenotype, both associated with serious cardiac arrhythmias and sudden death, can occur with certain antipsychotics (e.g. trifluoperazine), certain TCAs (e.g. amitriptyline), certain SSRIs (e.g. fluoxetine), methylphenidate and particular mood stabilisers (e.g. lithium). Antipsychotics themselves are associated with increased risk of myocarditis, cardiomyopathy, tachycardia, cardiometabolic derangement, hypertension, orthostatic hypotension and bradycardia. Attention deficit Hyperactivity disorder (ADHD) medications contribute to CVD and tachycardia. Acetylcholinesterase inhibitors (AChEIs) contribute towards bradycardia. Hypertension risk is elevated with serotonin-norepinephrine reuptake inhibitors (SNRIs), norepinephrine-dopamine reuptake inhibitors (NDRIs), monoamine oxidase inhibitors (MAOIs), reversible inhibitors of monoamine oxidase A (RIMA) and psychostimulants. Conversely, orthostatic hypotension is associated with certain psychiatric medications, namely TCAs and serotonin antagonist and reuptake inhibitors (SARIs). It is important to note that pharmacokinetic drug-drug interactions, such as inhibition of the cytochrome P450 (CYP450) system, can affect the pharmacodynamic profile of psychiatric medications, thereby increasing the risk of their associated adverse cardiovascular effects. By understanding the main adverse cardiovascular effects of psychiatric medications and prescribing appropriately, clinicians can reduce potential harm in patients with SMI.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"17 ","pages":"20420986261418947"},"PeriodicalIF":3.4,"publicationDate":"2026-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13033885/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147594608","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Antimicrobial stewardship and the antibiotic market: why \"Reserve\" drugs require new economic models.","authors":"Eleonora Castellana, Alessia Tarozzo, Rita Viglianti, Cinzia Molon, Maria Rachele Chiappetta","doi":"10.1177/20420986261435800","DOIUrl":"10.1177/20420986261435800","url":null,"abstract":"","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"17 ","pages":"20420986261435800"},"PeriodicalIF":3.4,"publicationDate":"2026-03-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13009993/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147515009","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The FMB scale: a multifactorial metric to assess the driving hazard of medicines beyond the DRUID system.","authors":"Salvador Borja Ripoll, Vicente Traver, Lola Franco, Teresa Ballester, Úrsula Alvado, Rosa Soriano, Pablo Garate, Ferran Mocholí","doi":"10.1177/20420986261430228","DOIUrl":"10.1177/20420986261430228","url":null,"abstract":"<p><strong>Background: </strong>Driving while undergoing pharmacological treatment poses a significant risk to road safety. The Driving under the Influence of Drugs, Alcohol, and Medicines (DRUID) system, currently used to classify medicines according to their impact on driving ability, has important limitations, including the absence of classification for numerous drugs, low reproducibility, and limited clinical applicability.</p><p><strong>Objectives: </strong>To develop a continuous, multifactorial metric capable of refining the estimation of medication-related driving risk and to assess its preliminary performance compared with the traditional DRUID system.</p><p><strong>Design: </strong>Methodological development and initial validation study.</p><p><strong>Methods: </strong>In this study, we propose a new multifactorial risk scale, validated by healthcare professionals and engineers, which integrates key pharmacological and clinical variables. The scale combines six weighted criteria: DRUID category, frequency and severity of adverse reactions, number of driving-related adverse reactions, marketed dose, treatment initiation versus chronic treatment, and pharmaceutical dosage form. Each variable was normalized to a 0-1 scale to ensure comparability. In addition, correction mechanisms were introduced to avoid bias arising from the presence of multiple adverse reactions with unknown frequencies, ensuring robustness to incomplete data.</p><p><strong>Results: </strong>When applied to different clinically used medicines, the scale showed greater sensitivity and accuracy in discriminating risk compared with the traditional DRUID system, reproducing its qualitative categorization while providing finer intraclass resolution, particularly for medicines situated near risk thresholds.</p><p><strong>Conclusion: </strong>This tool offers a more flexible, reproducible, and clinically applicable approach with the potential for integration into e-prescribing, mobile health applications, and community pharmacy support systems, supporting more nuanced and evidence-based clinical decision-making.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"17 ","pages":"20420986261430228"},"PeriodicalIF":3.4,"publicationDate":"2026-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13009908/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147515004","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}