{"title":"Theoretical Framework and Key Considerations for Time-to-Onset Analysis in Spontaneous Reporting Systems.","authors":"Yoshihiro Noguchi, Yoko Ino, Satoshi Yokoyama, Tomoya Tachi, Tomoaki Yoshimura","doi":"10.1007/s40264-026-01677-3","DOIUrl":"https://doi.org/10.1007/s40264-026-01677-3","url":null,"abstract":"<p><p>Spontaneous reporting databases play a central role in pharmacovigilance for monitoring the safety of drugs and vaccines. Conventional statistical signal detection has relied primarily on disproportionality analyses based on reporting frequencies, whereas information on the timing of adverse event onset has not been fully exploited. Time to onset (TTO), defined as the interval between the initiation of drug administration and the occurrence of an adverse event, provides complementary information that captures temporal patterns of event manifestation beyond simple occurrence counts. This review summarizes the definition, calculation, characteristics, and limitations of TTO analyses in spontaneous reporting databases and provides an overview of statistical signal detection methods incorporating TTO information. In particular, nonparametric distribution-comparison approaches, such as the Kolmogorov-Smirnov and Anderson-Darling tests, are well suited to spontaneous reporting data, in which the underlying population and exposure size are unknown. These methods enable the detection of abnormalities in the temporal structure of adverse event onset that may not be identifiable through frequency-based analyses alone. Furthermore, disproportionality analysis and TTO-based approaches are not competing methods but complementary strategies that capture different dimensions of safety signals-reporting frequency and temporal patterns-and their combined use may improve both sensitivity and interpretability of signal detection. The review also discusses survival analysis-based methods and Weibull modeling for TTO data, outlining their theoretical background and applications while emphasizing their inherent limitations when applied to spontaneous reporting systems. Because of reporting bias, incomplete time information, and the absence of non-event cases, such methods should not be used to estimate population-level risks or to infer causality. In conclusion, TTO analyses using spontaneous reporting databases should be positioned as exploratory tools for characterizing onset patterns, generating hypotheses, and informing the design of subsequent epidemiological and safety studies, rather than as a direct basis for clinical or regulatory decision making.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2026-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147873838","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}
Drug SafetyPub Date : 2026-05-09DOI: 10.1007/s40264-026-01667-5
E Lyn Lee, Fraser Ogle, Jyadeep Nagra, Sofia Su Ye, Jeff Harrison, Joanne Barnes
{"title":"Assessing Natural Health Product-Drug Interactions and Coding Feasibility: Analysis of a New Zealand General Population Dataset from an Online Market Research Panel.","authors":"E Lyn Lee, Fraser Ogle, Jyadeep Nagra, Sofia Su Ye, Jeff Harrison, Joanne Barnes","doi":"10.1007/s40264-026-01667-5","DOIUrl":"https://doi.org/10.1007/s40264-026-01667-5","url":null,"abstract":"<p><strong>Introduction: </strong>Natural health products (NHPs) include complementary/alternative medicines, dietary supplements, nutraceuticals, and traditional medicines. Natural health products are often self-prescribed and used alongside conventional medicines, raising safety concerns.</p><p><strong>Aims: </strong>This study aims to explore NHP-conventional medicine (NHP-drug) combinations used by respondents in New Zealand (NZ), identify those with the potential to cause NHP-drug interactions, and assesses the feasibility of coding NHPs using the WHODrug dictionary.</p><p><strong>Methods: </strong>A dataset from a pilot study on NHP use in NZ was analysed. Data on NHP and conventional medicine use were descriptively analysed. Where possible, specific product ingredient lists were verified. Two coders independently assigned WHODrug Global codes to each NHP and conventional medicine. Fleiss' Kappa measured inter-coder agreement.</p><p><strong>Results: </strong>Of 992 participants, 381 (38.4%) were current NHP users, reporting 1-18 NHPs. Among them, 271 (71.1%) used conventional medicines concurrently. Natural health product-drug combinations with potential interactions were found with fish oil, coenzyme Q10, turmeric, and glucosamine. An interaction involving fish oil and warfarin was rated as 'may result in significant hazard.' One-third (33.1%) of NHPs could not be coded using WHODrug. Codability agreement was higher for conventional medicines (93.7%) than for NHPs (63.5%). Fleiss' Kappa indicated moderate agreement for NHPs (κ = 0.576) and very good agreement for conventional medicines (κ = 0.911).</p><p><strong>Conclusion: </strong>Substantial concurrent NHP-drug use was identified, including combinations with potential adverse reactions. A larger, nationally representative dataset on NHP exposures in NZ is needed. Current challenges in coding NHPs highlight the need for standardised, comprehensive coding tools in future research for comprehensive analysis.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2026-05-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147863636","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}
Drug SafetyPub Date : 2026-05-05DOI: 10.1007/s40264-026-01676-4
Miranda Davies, Linda Härmark
{"title":"Current Challenges in Monitoring the Safety and Utilisation of the Glucagon-Like Peptide-1 Receptor Agonists (GLP-1 RAs): A UK Perspective.","authors":"Miranda Davies, Linda Härmark","doi":"10.1007/s40264-026-01676-4","DOIUrl":"https://doi.org/10.1007/s40264-026-01676-4","url":null,"abstract":"","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2026-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147835171","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}
Drug SafetyPub Date : 2026-05-01Epub Date: 2025-12-16DOI: 10.1007/s40264-025-01640-8
Ashraf Youssef, Tarek A Hammad
{"title":"Pharmacovigilance Due Diligence in Drug Development: A Practical Playbook for Risk Identification, Compliance Assessment, and Strategic Decision Making.","authors":"Ashraf Youssef, Tarek A Hammad","doi":"10.1007/s40264-025-01640-8","DOIUrl":"10.1007/s40264-025-01640-8","url":null,"abstract":"<p><p>In the pharmaceutical industry, due diligence (DD) is a critical, cross-functional process used to evaluate the scientific and regulatory viability of products, particularly during in-licensing or acquisition. Among the various dimensions assessed, safety evaluation plays a pivotal role in determining whether a product is likely to achieve regulatory approval, maintain a favourable benefit-risk balance, and support sustainable market access. This article focuses on the unique role of pharmacovigilance (PV) and safety experts in the DD process. It outlines the key safety-related questions that must be addressed, highlights potential red flags-such as organ-specific toxicities, labelling liabilities, or risk management burdens-and provides practical considerations for evaluating the robustness of the safety data package. Drawing on extensive industry experience and regulatory precedents, this manuscript offers structured guidance for an area where no formal framework exists. It emphasizes the importance of forecasting the likelihood of achieving a positive benefit-risk profile and identifying foreseeable safety-related barriers-ranging from boxed warnings to withdrawal risk-that could delay approval or diminish product value. By proposing a systematic approach to safety DD, including a playbook and an inclusive checklist with colour-coded categorization framework, this paper aims to support more informed, proactive, and risk-calibrated decision making in pharmaceutical transactions.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"509-518"},"PeriodicalIF":3.8,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13086678/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145762468","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}
Drug SafetyPub Date : 2026-05-01Epub Date: 2025-12-11DOI: 10.1007/s40264-025-01638-2
Rana Jajou, Eugène van Puijenbroek, Jetty Overbeek, Karin Hek, Erik Mulder, Florence van Hunsel, Agnes Kant
{"title":"GP Consultations for Herpes Zoster After COVID-19 Vaccination: A Self-Controlled Cohort Study Based on Electronic Health Record Data from the Netherlands.","authors":"Rana Jajou, Eugène van Puijenbroek, Jetty Overbeek, Karin Hek, Erik Mulder, Florence van Hunsel, Agnes Kant","doi":"10.1007/s40264-025-01638-2","DOIUrl":"10.1007/s40264-025-01638-2","url":null,"abstract":"<p><strong>Background and objective: </strong>Several systematic reviews and meta-analyses have been published with conflicting results on the risk of herpes zoster after coronavirus disease 2019 (COVID-19) vaccination. We aimed to study the risk of herpes zoster after COVID-19 vaccination using electronic health record data of general practices, from a large cohort in the Netherlands.</p><p><strong>Methods: </strong>Persons aged ≥ 12 years who received at least one COVID-19 vaccination and were registered in the general practice databases of PHARMO and Nivel Primary Care Database were included. This study used a self-controlled design comparing the risk of herpes zoster in the risk period (28 days after COVID-19 vaccination) with the control period. Poisson regression was used to calculate incidence rate ratios, adjusting for severe acute respiratory syndrome coronavirus 2 infection.</p><p><strong>Results: </strong>There were 2,098,683 COVID-19 vaccinated persons aged ≥ 12 years included, of whom 1,058,646 (50.4%) were female. An increased risk for herpes zoster was found after all the doses grouped together and the third dose of all COVID-19 vaccination (adjusted incidence rate ratio: all doses 1.07, 95% confidence interval [CI] 1.02-1.13 and third dose 1.21, 95% CI 1.05-1.38). After stratification on vaccine type, all doses and the third dose of messenger RNA vaccination (adjusted incidence rate ratio: all doses 1.06, 95% CI 1.00-1.12 and third dose 1.21, 95% CI 1.05-1.40) showed an increased risk.</p><p><strong>Conclusions: </strong>Our study showed a slight increased risk of herpes zoster when taking into account all doses and all types of vaccines. After stratification on vaccine type, no increased risk of herpes zoster after the primary vaccination series and a slightly elevated risk after the third/booster vaccination with a messenger RNA vaccine were found.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"529-539"},"PeriodicalIF":3.8,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13086897/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145721884","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}
Drug SafetyPub Date : 2026-05-01Epub Date: 2026-01-05DOI: 10.1007/s40264-025-01637-3
Lelio Crupi, Louis Letinier, Vianney Jouhet, Sébastien Cossin, Antoine Pariente, Clement Mathieu, Guillaume L Martin, François Konschelle, Julie Rouanet, Massimo Carollo, Gianluca Trifirò, Emanuela Esposito, Francesco Salvo
{"title":"Standardizing and Comparing Management Recommendations for Potential Drug-Drug Interactions Across Different Interaction Checkers.","authors":"Lelio Crupi, Louis Letinier, Vianney Jouhet, Sébastien Cossin, Antoine Pariente, Clement Mathieu, Guillaume L Martin, François Konschelle, Julie Rouanet, Massimo Carollo, Gianluca Trifirò, Emanuela Esposito, Francesco Salvo","doi":"10.1007/s40264-025-01637-3","DOIUrl":"10.1007/s40264-025-01637-3","url":null,"abstract":"<p><strong>Background: </strong>Potential drug-drug interactions (pDDIs) are frequent in clinical care, particularly among older patients. Accurate identification and management of pDDIs are essential for patient safety. Prescribers often rely on interaction checkers (ICs) to screen for pDDIs. However, these tools may provide inconsistent recommendations, potentially leading to suboptimal clinical decisions.</p><p><strong>Objective: </strong>This study aimed to develop a standardized approach for classifying and prioritizing pDDIs based on the clinical relevance of their management recommendations and to compare how these pDDIs are categorized across ICs.</p><p><strong>Methods: </strong>A scale was developed through a structured iterative process to classify pDDIs into four management categories (high priority, intermediate priority, low priority, data unavailable), based on the management recommendations extracted from six ICs. This scale was applied to 218 real-world pDDIs identified from 1923 patients, and the agreement was primarily assessed using Gwet's AC1.</p><p><strong>Main results: </strong>Overall agreement among the ICs was moderate (Gwet's AC1 = 0.44; 95% CI 0.39-0.50), with values ranging from 0.58 (0.51, 0.65) to 0.38 (0.31, 0.44) in leave-one-out analyses. The agreement was higher in binary analyses dichotomizing the scale into high- and intermediate-priority versus low-priority pDDIs (AC1 = 0.72; 95% CI 0.65-0.79), and in the classification of high-priority versus all other pDDIs (AC1 = 0.62; 95% CI 0.54-0.69).</p><p><strong>Conclusion: </strong>This study developed and tested a structured approach to systematically compare pDDI management across ICs and prioritize clinically relevant interactions. Its application revealed a generally limited agreement between ICs, pointing to the need for harmonized approaches and further studies to support more consistent, evidence-aligned pDDI management.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"541-552"},"PeriodicalIF":3.8,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145905796","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}
Drug SafetyPub Date : 2026-05-01Epub Date: 2026-01-28DOI: 10.1007/s40264-025-01634-6
Catherine S Hwang, Zhigang Lu, Massimiliano Russo, Heidi Zakoul, Gita A Toyserkani, Esther H Zhou, Cynthia LaCivita, Gerald J Dal Pan, Aaron S Kesselheim, Ameet Sarpatwari
{"title":"Physician Awareness of FDA's Relaxation of REMS-Required Laboratory Testing Requirements and Changes in Prescribing Practices During the COVID-19 Pandemic.","authors":"Catherine S Hwang, Zhigang Lu, Massimiliano Russo, Heidi Zakoul, Gita A Toyserkani, Esther H Zhou, Cynthia LaCivita, Gerald J Dal Pan, Aaron S Kesselheim, Ameet Sarpatwari","doi":"10.1007/s40264-025-01634-6","DOIUrl":"10.1007/s40264-025-01634-6","url":null,"abstract":"<p><strong>Background: </strong>The US Food and Drug Administration (FDA) requires pharmaceutical manufacturers to implement Risk Evaluation and Mitigation Strategy (REMS) programs for certain medications that carry serious safety risks. One possible REMS requirement is routine monitoring via laboratory tests. However, in March 2020, the FDA issued a temporary enforcement discretion policy enabling prescribers to apply medical judgment for completing REMS-required laboratory testing.</p><p><strong>Objective: </strong>We aimed to assess whether physicians were aware of the FDA's temporary policy and if they changed their laboratory testing practices during the coronavirus disease 2019 pandemic.</p><p><strong>Methods: </strong>We designed a survey of US physicians prescribing one of seven medications: ambrisentan, bosentan, clozapine, isotretinoin, lenalidomide, pomalidomide, and thalidomide. The study was conducted over two waves, May 2022 to October 2022 and October 2022 to January 2023. Multivariable logistic regression modeling was used to examine predictors of each outcome.</p><p><strong>Results: </strong>The combined response rate between the two waves of survey administration was 21%. Among 949 physician respondents, 438 (47%; 927 question respondents) reported awareness and 192 (21%; 926 question respondents) reported changing practices. Among the 438 physicians who reported awareness, 176 (40%) reported changing practices. Characteristics associated with awareness included sex (female vs male, odds ratio [OR] = 1.92, 95% confidence interval [CI] 1.37-2.69); recency of medical school graduation (25-34 vs ≤ 15 years, OR = 0.50, 95% CI 0.31-0.81); practice setting (academic hospital vs outpatient group, OR = 0.58, 95% CI 0.37-0.88); prescribing experience (≥ 21 vs ≤10 patients, OR = 2.92, 95% CI 2.06-4.14); and timing of survey completion (wave 2 vs wave 1, OR = 0.47, 95% CI 0.34-0.66). Characteristics associated with practice changes included race (Asian vs White, OR = 0.62, 95% CI 0.38-0.99) and awareness of FDA's policy (yes vs no, OR = 14.07, 95% CI 7.93-24.96), in addition to sex (female vs male, OR = 1.99, 95% CI 1.31-3.01), recency of medical school graduation (≥ 35 vs < 15 years: OR = 0.53, 95% CI 0.30-0.93), and timing of survey completion (wave 2 vs wave 1: OR = 0.58, 95% CI 0.34-0.99).</p><p><strong>Conclusions: </strong>Although policy awareness was correlated with laboratory practice changes, fewer than half of physicians who were aware of the FDA's policy reported changing their practices.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"519-528"},"PeriodicalIF":3.8,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146060999","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}
Drug SafetyPub Date : 2026-05-01Epub Date: 2025-12-05DOI: 10.1007/s40264-025-01639-1
Thomas Delvin, Anette Bygum, Lars Christian Lund, Jacob Harbo Andersen, Jesper Hallas
{"title":"Unsuspected Adverse Drug Reactions to Dermatologic Medications: An Epidemiological Hypothesis-Free Screening Study of Real-World Data in Denmark.","authors":"Thomas Delvin, Anette Bygum, Lars Christian Lund, Jacob Harbo Andersen, Jesper Hallas","doi":"10.1007/s40264-025-01639-1","DOIUrl":"10.1007/s40264-025-01639-1","url":null,"abstract":"<p><strong>Background: </strong>Many adverse drug reactions (ADRs) to dermatological drugs may be underrecognized due to limitations in traditional surveillance. Systematic, hypothesis-free screening for such ADRs using real-world data is an underutilized approach in dermatology.</p><p><strong>Objective: </strong>The aim was to systematically screen commonly used dermatological drugs for potential unknown ADR signals using nationwide Danish health register data and to evaluate sequence symmetry analysis (SSA) as an epidemiological screening method in pharmacovigilance. This evaluation focuses on identifying key signals for dedicated follow-up studies, not on an exhaustive analysis of all potential associations.</p><p><strong>Methods: </strong>A nationwide, register-based, hypothesis-free screening study using Danish national health registers was conducted. The study cohort comprised 5,877,711 Danish residents prescribed dermatological drugs or relevant immunosuppressants linked to a dermatological indication between 1996 and 2022. Data were analyzed from 1995 to 2024. Exposures were the first dispensation of included dermatological drugs. The primary outcome measure was the trend-adjusted sequence ratio (SR), an estimate of the incidence rate ratio for rare events, with 95% confidence intervals (CIs), for incident drug-drug and drug-diagnosis pairs within ±12-month windows of exposure initiation. To assess directionality, supplementary case-crossover (CCO) analyses were performed on top-ranked signals, estimating odds ratios (ORs) with 95% CIs.</p><p><strong>Results: </strong>The screening of 22.5 million incident exposure prescriptions yielded 4010 drug-drug and 22,234 drug-diagnosis pairs. After filtering and review, several potential unknown ADR signals were identified and prioritized. Signals were manually reviewed and categorized by clinical experts to identify plausible novel ADRs. Notable associations (adjusted SR [95% CI]; CCO OR [95% CI]) included isotretinoin with systemic corticosteroids (1.44 [1.35-1.53]; 1.78 [1.61-1.98]) and hemorrhoid treatments (1.58 [1.49-1.68]; 1.83 [1.68-1.98]); azathioprine with bone-modifying drugs (1.42 [1.33-1.53]; 1.57 [1.36-1.81]); terbinafine with lipid-lowering therapy (1.04 [1.01-1.08]; 1.14 [1.07-1.20]) and vitamin B12/folate use (1.20 [1.14-1.26]; 1.12 [1.02-1.22]); and clobetasol with atrial fibrillation/flutter (1.11 [1.06-1.17]; 1.07 [1.00-1.14]).</p><p><strong>Conclusions: </strong>Systematic hypothesis-free screening using SSA on nationwide real-world data can effectively identify potential unknown ADRs for dermatological drugs. The specific signals found in this study potentially have clinical implications and warrant further targeted investigations to support causality. This approach supports the implementation of routine real-world data screening to supplement traditional pharmacovigilance.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"553-565"},"PeriodicalIF":3.8,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145676682","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}
Drug SafetyPub Date : 2026-05-01Epub Date: 2026-01-13DOI: 10.1007/s40264-025-01643-5
Pauline-Eva Pecquet, Julien Moragny, Valérie Gras, Pauline Schiro, Sylvine Pinel, Solène M Laville, Sophie Liabeuf
{"title":"Unveiling the Limits of Anticholinergic Burden Scales: A Study of Adverse Drug Reactions in the French Pharmacovigilance Database.","authors":"Pauline-Eva Pecquet, Julien Moragny, Valérie Gras, Pauline Schiro, Sylvine Pinel, Solène M Laville, Sophie Liabeuf","doi":"10.1007/s40264-025-01643-5","DOIUrl":"10.1007/s40264-025-01643-5","url":null,"abstract":"<p><strong>Background and hypothesis: </strong>The anticholinergic burden is the cumulative effect of drugs with anticholinergic properties and is typically measured using one of several anticholinergic scales. We hypothesised that these scales may not fully capture all the relevant adverse drug reactions (ADRs). By accessing the French national pharmacovigilance database (FPVD) and focusing on drug classes known to induce anticholinergic ADRs, the objectives of the present study were to describe the reported ADRs, characterise the drugs involved, and examine the drugs' classification within anticholinergic scales.</p><p><strong>Methods: </strong>Cases were extracted from the FPVD (1985-2024) when the suspected drug (i) had a high anticholinergic score, according to one or more of 22 anticholinergic burden scales, or (ii) belonged to the same class as the drug identified in (i). The anticholinergic ADRs investigated were confusion, glaucoma, tachycardia, urinary retention, constipation, intestinal obstruction and mydriasis.</p><p><strong>Results: </strong>Of the 101,365 cases reported in the FPVD, regarding the selected drugs, 9629 (9.5%) involved at least one anticholinergic ADR investigated. Patients who experienced at least one anticholinergic ADR had a median age of 61 years (interquartile range: 38-79), and the majority were women (58%). Confusion was the most frequently reported anticholinergic ADR (4603 cases, of which 81% were classified as serious), followed by tachycardia (n = 1541 cases, 70% serious), and urinary retention (1061 cases, 75% serious). It is noteworthy that 98% of the 561 reported cases of intestinal obstruction were classified as serious. The drug classes with the highest number of reports were (by far) anxiolytics, antidepressants, and antipsychotics. Some drugs linked to anticholinergic ADRs in the FPVD were not present in (or were assigned a low score by) commonly used anticholinergic scales, such as the Anticholinergic Cognitive Burden.</p><p><strong>Conclusions: </strong>Anticholinergic ADRs affect both older and younger adults. The existing scoring systems might not fully capture the range of medications involved in real-world anticholinergic-related events.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"591-603"},"PeriodicalIF":3.8,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13086670/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145959152","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}
Drug SafetyPub Date : 2026-05-01Epub Date: 2026-03-24DOI: 10.1007/s40264-026-01659-5
Angela Caro-Rojas
{"title":"International Society of Pharmacovigilance Advances over Time: Strategies and Results of the Advisory Board from 2022 to 2025.","authors":"Angela Caro-Rojas","doi":"10.1007/s40264-026-01659-5","DOIUrl":"10.1007/s40264-026-01659-5","url":null,"abstract":"","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"505-508"},"PeriodicalIF":3.8,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147510174","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}