Drug Safety

Article	Citations
Correction to: Review of Over 15 Years Postmarketing Safety Surveillance Spontaneous Data for the Human Rotavirus Vaccine (Rotarix) on Intussusception	96
Validation of a Natural Language Machine Learning Model for Safety Literature Surveillance	90
Authors’ Reply to Mungmunpuntipantip et al.’s Comment on “Description of Frequencies of Reported Adverse Events Following Immunization Among Four Different COVID-19 Vaccine Brands”	86
Role of Drug–Gene Interactions and Pharmacogenetics in Simvastatin-Associated Pulmonary Toxicity	68
Impact of Batoclimab Treatment on LDL-C with and Without Coadministration of Atorvastatin: Results from a Phase I Randomized Study in Healthy Participants	66
Deliberate Self-Poisoning: Real-Time Characterization of Suicidal Habits and Toxidromes in the Food and Drug Administration Adverse Event Reporting System	62
Drug-Induced Liver Injury in the Elderly: Consensus Statements and Recommendations from the IQ-DILI Initiative	61
Post-Marketing Safety Profile of Vortioxetine Using a Cluster Analysis and a Disproportionality Analysis of Global Adverse Event Reports	58
Potential Risk Factors of Drug-Related Problems in Hospital-Based Mental Health Units: A Systematic Review	56
Acknowledgement to Referees	53
Signal Detection and Methodological Limitations in a Real-World Registry: Learnings from the Evaluation of Long-Term Safety Analyses in PSOLAR	52
21st ISoP Annual Meeting “A New Era of Pharmacovigilance: Challenges and Opportunities” 20–23 September 2022 Verona, Italy	50
Study of Natural Products Adverse Reactions (SONAR) in Adults with Mental Health Conditions: A Cross-Sectional Study	48
High-Dimensional Propensity Score-Adjusted Case-Crossover for Discovering Adverse Drug Reactions from Computerized Administrative Healthcare Databases	42
Emergency Department Use of Heart Failure-Exacerbating Medications in Patients with Chronic Heart Failure	41
A Comparison of Active Pharmacovigilance Strategies Used to Monitor Adverse Events to Antiviral Agents: A Systematic Review	41
Comparison of the MOdified NARanjo Causality Scale (MONARCSi) for Individual Case Safety Reports vs. a Reference Standard	37
Early Detection of Hearing Impairment Signals Post-mRNA COVID-19 Vaccination: A Disproportionality Analysis Study on French Pharmacovigilance Database	35
Major Adverse Cardiovascular Events Related to JAK Inhibitors: A Disproportionality Analysis Using the WHO Global Individual Case Safety Database	32
Use of Electrocardiogram Monitoring in Adult Patients Taking High-Risk QT Interval Prolonging Medicines in Clinical Practice: Systematic Review and Meta-analysis	32
Renal Safety of Hydroxyethyl starch 130/0.42 After Cardiac Surgery: A Retrospective Cohort Analysis	30
Comment on: "Proposals for Engaging Patients and Healthcare Professionals in Risk Minimisation from an Analysis of Stakeholder Input to the EU Valproate Assessment Using the Novel Analysing Stakeholde	29
An Integrated Approach for Representing Knowledge on the Potential of Drugs to Cause Acute Kidney Injury	29
Mapping Strategies to Assess and Increase the Validity of Published Disproportionality Signals: A Meta-Research Study	28
Comment on "Drug–Drug Interaction of the Sodium Glucose Co-Transporter 2 Inhibitors with Statins and Myopathy: A Disproportionality Analysis Using Adverse Events Reporting Data"	28

Correction to: Individual Case Safety Report Replication: An Analysis of Case Reporting Transmission Networks	26
Preventable Deaths Involving Medicines: A Systematic Case Series of Coroners’ Reports 2013–22	26
The Rationale for Robust Pharmacovigilance in Monitoring the Safety of Traditional Medicines and Natural Health Products	26
A Disproportionality Analysis of Drug–Drug Interactions of Tizanidine and CYP1A2 Inhibitors from the FDA Adverse Event Reporting System (FAERS)	26
Intracranial Hemorrhage Following Anticoagulant Treatment in Denmark: Spontaneous Adverse Drug Reaction Reports Versus Real-World Data	25
Patient Global Impression of Benefit–Risk (PGI-BR): Incorporating Patients’ Views of Clinical Benefit–Risk into Assessment of New Medicines	24
The Use of Multiple Medications During Pregnancy Among an Ethnically Diverse Population in South-Eastern Melbourne: A Retrospective Analysis to Explore Potential Risks and Complications	22
Call to action: Pharmaceutical residues in the environment: threats to ecosystems and human health	21
Factors Contributing to Best Practices for Patient Involvement in Pharmacovigilance in Europe: A Stakeholder Analysis	21
Long-Term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis	21
COVID-19 Vaccines and Heavy Menstrual Bleeding: The Impact of Media Attention on Reporting to EudraVigilance	21
BAHAMA: A Bayesian Hierarchical Model for the Detection of MedDRA®-Coded Adverse Events in Randomized Controlled Trials	21
β-Blockers and the Risk of Depression: A Matched Case–Control Study	20
Pregnancy and Infant Outcomes in Women with Multiple Sclerosis Exposed to Glatiramer Acetate Therapy: An Extended 4-Year Safety Update	20
A Scoping Review of Non-Medical and Extra-Medical Use of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)	20
Effectiveness of Transformer-Based Large Language Models in Identifying Adverse Drug Reaction Relations from Unstructured Discharge Summaries in Singapore	20
Pharmacovigilance in the Age of Legalized Cannabis: Using Social Media to Monitor Drug–Drug Interactions Between Immunosuppressants and Cannabis-Derived Products	19
The ISoP PatEG-SIG for Promoting Patient Engagement in Pharmacovigilance: A Change of Paradigm is Needed	19
Safety Profile of GSK’s Inactivated Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany and Spain: Passive Enhanced Safety Surveillance Study for the 2019/2020 Influenza Season	19
Prevalence of Use of Traditional, Complementary and Alternative Medicine by the General Population: A Systematic Review of National Studies Published from 2010 to 2019	19
Correction to: A Landscape Analysis of Post-Marketing Studies Registered in the EU PAS Register and ClinicalTrials.gov Focusing on Pregnancy Outcomes or Breastfeeding Effects: A Contribution from the	19
Correction to: Comment on: “Should Antidepressants be Avoided in Pregnancy?”	19
Effectiveness and Respiratory Adverse Events Following Inactivated and mRNA COVID-19 Vaccines in Patients with COPD and Asthma: A Chinese Population-Based Study	19
Correction to: Development and Validation of ICD‑10‑CM‑based Algorithms for Date of Last Menstrual Period, Pregnancy Outcomes, and Infant Outcomes	19
Correction to: Artificial Intelligence Based on Machine Learning in Pharmacovigilance: A Scoping Review	18
Safety of COVID-19 Vaccines Among the Paediatric Population: Analysis of the European Surveillance Systems and Pivotal Clinical Trials	17
Long-Term Safety Analysis of the ChAdOx1-nCoV-19 Corona Virus Vaccine: Results from a Prospective Observational Study in Priority Vaccinated Groups in North India	17
Principles and Practice of Pharmacovigilance and Drug Safety	17
Post-Marketing Surveillance of CAR-T-Cell Therapies: Analysis of the FDA Adverse Event Reporting System (FAERS) Database	17
Predictive Models for Identifying Adult Patients at High Risk of Developing Opioid-Related Harms: a Systematic Review	16
Maternal and Early-Life Exposure to Antibiotics and the Risk of Autism and Attention-Deficit Hyperactivity Disorder in Childhood: a Swedish Population-Based Cohort Study	16
Unveiling the Burden of Drug-Induced Impulsivity: A Network Analysis of the FDA Adverse Event Reporting System	16
Quality of MedDRA® Coding in a Sample of COVID-19 Vaccine Medication Error Data	15
Correction to: Sharing Adverse Drug Event Reports Between Hospitals and Community Pharmacists to Inform Re-dispensing: An Analysis of Reports and Process Outcomes	15
Nephrotoxicity of Amoxicillin and Third-Generation Cephalosporins: An Updated Review	15
Signals of Possibly Persistent Gustatory, Olfactory and Auditory Adverse Drug Reactions to Antibiotic Drugs: A Disproportionality Analysis Using the EudraVigilance Database	15
Safety and Tolerability of Intravenous Immunoglobulin in Chronic Inflammatory Demyelinating Polyneuropathy: Results of the ProCID Study	15
SGLT2 Inhibitor Use and Risk of Breast Cancer Among Adult Women with Type 2 Diabetes	15
Proceedings of the International Ambulatory Drug Safety Symposium: Munich, Germany, June 2023	15
Quantitative Prediction of Adverse Event Probability Due to Pharmacokinetic Interactions	15
Use of Bisphosphonates and the Risk of Skin Ulcer: A National Cohort Study Using Data from the French Health Care Claims Database	15
Optimizing Safety Surveillance for COVID-19 Vaccines at the National Pharmacovigilance Centre Lareb: One Year of COVID-19 Vaccine Experience	14
The Extent of Medication-Related Hospital Admissions in Australia: A Review from 1988 to 2021	14
Assessment of Pharmacovigilance Across University Hospitals in Morocco	14
Systematising Pharmacovigilance Engagement of Patients, Healthcare Professionals and Regulators: A Practical Decision Guide Derived from the International Risk Governance Framework for Engagement Even	14
Cannabinoid-Related Acute Pancreatitis: An Update from International Literature and Individual Case Safety Reports	14
Safety and Effectiveness of COVID-19 Vaccines During Pregnancy: A Living Systematic Review and Meta-analysis	13
Real-World Safety and Efficacy of Biosimilar CT-P13 in Patients with Immune-Mediated Inflammatory Diseases: Integrated Analysis of Three Japanese Prospective Observational Studies	13
Disproportionality Analysis and Characterisation of Medication Errors in EudraVigilance: Exploring Findings on Sexes and Age Groups	13
Development and Validation of ICD-10-CM-based Algorithms for Date of Last Menstrual Period, Pregnancy Outcomes, and Infant Outcomes	13

Evolution of Cross-Sectional Survey Protocol Quality Over Time: A Case Series of Index U.S. REMS Knowledge Survey Protocols (2007–2020)	13
Core Data Elements for Pregnancy Pharmacovigilance Studies Using Primary Source Data Collection Methods: Recommendations from the IMI ConcePTION Project	13
Paracetamol Dosing Errors in People Aged 12 Years and Over: An Analysis of Over 14,000 Cases Reported to an Australian Poisons Information Centre	13
Timing Matters: A Machine Learning Method for the Prioritization of Drug–Drug Interactions Through Signal Detection in the FDA Adverse Event Reporting System and Their Relationship with Time of Co-exp	12
NSAIDs and COVID-19: A Systematic Review and Meta-analysis	12
The Role of the European Medicines Agency in the Safety Monitoring of COVID-19 Vaccines and Future Directions in Enhancing Vaccine Safety Globally	12
Maternal Complications and Prescription Opioid Exposure During Pregnancy: Using Marginal Structural Models	12
Adverse Events to SARS-CoV-2 (COVID-19) Vaccines and Policy Considerations that Inform the Funding of Safety Surveillance in Low- and Middle-Income Countries: A Mixed Methods Study	12
Authors’ Response to Huang et al.’s Comment on “Serially Combining Epidemiological Designs Does Not Improve Overall Signal Detection in Vaccine Safety Surveillance”	12
A Descriptive Analysis of Adverse Event Reports from the Quebec Cannabis Registry	12
Future of ChatGPT in Pharmacovigilance	12
An Exploratory Study of the Impact of COVID-19 Vaccine Spontaneous Reporting on Masking Signal Detection in EudraVigilance	12
Implementation of a Taxonomy-Based Framework for the Selection of Appropriate Drugs and Outcomes for Real-World Data Signal Detection Studies	12
Real-World Monitoring of COVID-19 Vaccines: An Industry Expert View on the Successes, Challenges, and Future Opportunities	11
A Drug Similarity-Based Bayesian Method for Early Adverse Drug Event Detection	11
What is the Safety of COVID-19 Vaccines in Immunocompromised Patients? Results from the European “Covid Vaccine Monitor” Active Surveillance Study	11
Enzalutamide: Understanding and Managing Drug Interactions to Improve Patient Safety and Drug Efficacy	11
Smart Safety Surveillance (3S): Multi-Country Experience of Implementing the 3S Concepts and Principles	11
Fatal Intoxications with Zopiclone—A Cause for Concern?	11
Signaling COVID-19 Vaccine Adverse Events	11
A Mixed-Methods Evaluation to Identify Industry Knowledge Needs and Challenges in Health Product Defect and Recall Reporting in Singapore	11
Collection of Data on Adverse Events Related to Medicinal Products: A Survey Among Registries in the ENCePP Resources Database	11
Pediatric Drug Safety Surveillance: A 10-Year Analysis of Adverse Drug Reaction Reporting Data in Calabria, Southern Italy	11
Early Detection of Adverse Drug Reaction Signals by Association Rule Mining Using Large-Scale Administrative Claims Data	11
Machine Learning in Causal Inference: Application in Pharmacovigilance	11
The PrescIT platform: An interoperable Clinical Decision Support System for ePrescription to Prevent Adverse Drug Reactions and Drug-Drug Interactions	11
Spontaneous Reporting to Regulatory Authorities of Suspected Adverse Drug Reactions to COVID-19 Vaccines Over Time: The Effect of Publicity	11
The QTc-Bazett Interval in Former Very Preterm Infants in Adolescence and Young Adulthood is Not Different from Term-Born Controls	11
Development and Application of an Active Pharmacovigilance Framework Based on Electronic Healthcare Records from Multiple Centers in Korea	11
Use of Sotrovimab in Pregnancy: Experiences from the COVID-19 International Drug Pregnancy Registry	10
Cardiovascular Risk in Users of Mirabegron Compared with Users of Antimuscarinic Treatments for Overactive Bladder: Findings from a Non-Interventional, Multinational, Cohort Study	10
An 8-Year Prospective, Observational, Multi-centre Post-Marketing Safety Surveillance Study Conducted in South Korea (2014–2022) Following the Introduction of GSK’s Inactivated Quadrivalent Seasonal I	10
Chemobrain in Breast Cancer: Mechanisms, Clinical Manifestations, and Potential Interventions	10
Application of an Innovative Data Mining Approach Towards Safe Polypharmacy Practice in Older Adults	10
Anti-tumor Necrosis Factor-Alpha Therapy and Hypoglycemia: A Real-World Pharmacovigilance Analysis	10
A Population-Based Study of SGLT2 Inhibitor-Associated Postoperative Diabetic Ketoacidosis in Patients with Type 2 Diabetes	10
Association of Strict Versus Lenient Cholesterol Lowering with Cardiac Outcomes, Diabetes Progression and Complications, and Mortality in Patients with Diabetes Treated with Statins: Is Less More?	10
Efficacy and Safety of Anticoagulants in Patients with Atrial Fibrillation and History of Falls or Risk of Falls: A Systematic Review and Multilevel Meta-Analysis	10
QT Interval, Antipsychotics and Correlates Among Patients with Schizophrenia: Cross-Sectional Data from the Multicentric Real-World FACE-SZ	10
Prenatal exposure to pregabalin, birth outcomes and neurodevelopment – a population-based cohort study in four Nordic countries	10
OpenPVSignal Knowledge Graph: Pharmacovigilance Signal Reports in a Computationally Exploitable FAIR Representation	9
COVID-19 Vaccination in Pregnancy, Paediatrics, Immunocompromised Patients, and Persons with History of Allergy or Prior SARS-CoV-2 Infection: Overview of Current Recommendations and Pre- and Post-Mar	9
Compliance with Prescribing and Dispensing Conditions for Valproate and Related Substances in Girls and Women of Childbearing Potential: A Survey of Community Pharmacists in France	9
Improving Data Collection in Pregnancy Safety Studies: Towards Standardisation of Data Elements in Pregnancy Reports from Public and Private Partners, A Contribution from the ConcePTION Project	9
Pregnancy, Fetal, and Infant Outcomes Following Maternal Exposure to Glatiramer Acetate During Pregnancy and Breastfeeding	9
Association Between Prenatal Opioid Exposure and Neurodevelopmental Outcomes in Early Childhood: A Retrospective Cohort Study	9
Mitigation and Management of Common Toxicities Associated with the Administration of CAR-T Therapies in Oncology Patients	9
Advances in Drug Safety: Highlights from the 23rd Annual Meeting of the International Society of Pharmacovigilance	9
Capturing Data in Rare Disease Registries to Support Regulatory Decision Making: A Survey Study Among Industry and Other Stakeholders	9
Combining Machine Learning with a Rule-Based Algorithm to Detect and Identify Related Entities of Documented Adverse Drug Reactions on Hospital Discharge Summaries	9
Artificial Intelligence Based on Machine Learning in Pharmacovigilance: A Scoping Review	9
Author’s Reply to Kuss and Rathmann’s Comment on: “Drug-Drug Interaction of the Sodium Glucose Co-transporter 2 Inhibitors with Statins and Myopathy: A Disproportionality Analysis Using Adverse Events	9
The Critical Intersect of Regulations, Health Technology Assessment, and Drug Safety Assessments	8
Behavioral Science: Enhancing Our Approach to the Development of Effective Additional Risk Minimization Strategies	8
Challenges in the Implementation of EU Risk Minimisation Measures for Medicinal Products in Clinical Practice Guidelines: Mixed Methods Multi-Case Study	8
Evaluation of Data Quality and Utility of the Japan Drug Information Institute in Pregnancy (JDIIP) Consultation Case Database for Pregnancy Pharmacovigilance	8
Risk of Systemic Inflammatory Response Syndrome Following Preoperative Glucocorticoids Administration in Patients After Percutaneous Nephrolithotomy: A Retrospective Cohort Study	8
A Framework for Promoting Safety Monitoring of Herbal Medicines: The International Society of Pharmacovigilance Special Interest Group on Herbal and Traditional Medicines	8
Consensus Obtained for the Nephrotoxic Potential of 167 Drugs in Adult Critically Ill Patients Using a Modified Delphi Method	8
Postoperative Respiratory Events in Surgical Patients Exposed to Opioid Analgesic Shortages Compared to Fully Matched Patients Non-exposed to Shortages	8
Appeal for Increasing the Impact of Pharmacovigilance	8
Correction to: Machine Learning in Causal Inference: Application in Pharmacovigilance	8
Is There an Increased Risk of Hepatotoxicity with Metamizole? A Comparative Cohort Study in Incident Users	8
Prescribing Patterns of Codeine and Alternative Medicines in Children in Europe	8
Facilitators and Barriers to Uptake of the Med Safety Mobile App for Adverse Drug Reaction Reporting by Health Workers in Uganda: A Qualitative Study	7
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	7
Leveraging Natural Language Processing and Machine Learning Methods for Adverse Drug Event Detection in Electronic Health/Medical Records: A Scoping Review	7
REMS Logic Model: A Pragmatic Framework for Incorporating Drug Safety into Clinical Practice	7
The Risk of Preoperative Central Nervous System-Acting Medications on Delirium Following Hip or Knee Surgery: A Matched Case-Control Study	7
Dispensing of Potentially Harmful Prescription Drugs in 1.8 Million Pregnant Women in France: A Nationwide Study Based on Two Risk Classification Systems	7
Eritrean Pharmacovigilance System: Key Strategies, Success Stories, Challenges and Lessons Learned	7
Tardive Dyskinesia with Antipsychotic Medication in Children and Adolescents: A Systematic Literature Review	7
Prevalence, Causes and Severity of Medication Administration Errors in the Neonatal Intensive Care Unit: A Systematic Review and Meta-Analysis	7
Duration of Effectiveness Evaluation of Additional Risk Minimisation Measures for Centrally Authorised Medicinal Products in the EU Between 2012 and 2021	7
The International Society of Pharmacovigilance Vaccines Special Interest Group: Challenges and Opportunities	7
Prenatal and Early Childhood Exposure to Proton Pump Inhibitors and Antibiotics and the Risk of Childhood Cancer: A Nationwide Population-Based Cohort Study	7
The REporting of A Disproportionality Analysis for DrUg Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Explanation and Elaboration	6
Adverse Drug Events in Ambulatory Care: A Cross-Sectional Study	6
Enhanced Safety Surveillance of GSK’s Inactivated Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany, and Spain During the 2022/2023 Influenza Season	6
Detection Algorithms for Simple Two-Group Comparisons Using Spontaneous Reporting Systems	6

Comment on: "Should Antidepressants be Avoided in Pregnancy?"	6
Validation of Artificial Intelligence to Support the Automatic Coding of Patient Adverse Drug Reaction Reports, Using Nationwide Pharmacovigilance Data	6
Competing Benefits and Competing Hazards: The Benefit to Harm Balance in Individual Patients in Rational Therapeutics	6
Conundrum of Clinical QTc Monitoring	6
Systematic Evaluation of Australian Risk Management Plans for Biologic Medicines	6
Authors' response to Tran et al.'s comment on “The Use of Multiple Medications During Pregnancy Among an Ethnically Diverse Population in South-Eastern Melbourne: A Retrospective Analysis to Explore P	6
IQ DILI Consensus Opinion: Best Practices for Rechallenge Following Suspected Drug-Induced Liver Injury in Clinical Trials	6
Drug-Gene Risk Stratification in Patients with Suspected Drug-Induced Interstitial Lung Disease	6
The COVID-19 International Drug Pregnancy Registry (COVID-PR): Protocol Considerations	6
Weight Gain During Antipsychotic Treatment in Children, Adolescents, and Adults: A Disproportionality Analysis in the Global Pharmacovigilance Database, Vigibase®	6
Prevalence and Preventability of Adverse Medicine Events in a Sample of Australian Aged-Care Residents: A Secondary Analysis of Data from the ReMInDAR Trial	6
Predictors of Adverse Drug Reaction-Related Hospitalisations Among People with Dementia: A Retrospective Case-Control Study	6
The Frequency of Drug-Induced Liver Injury Due to Antibiotics Among Hospitalised Patients	6
Montelukast and Nightmares: Further Characterisation Using Data from VigiBase	6
What Factors Make EU Regulators Want to Communicate Drug Safety Issues Related to SGLT2 Inhibitors? An Online Survey Study	6
Proceedings of the Canadian Medication Appropriateness and Deprescribing Network’s 2023 National Meeting	6
Intelligent Telehealth in Pharmacovigilance: A Future Perspective	6
Drug–Drug Interactions and Actual Harm to Hospitalized Patients: A Multicentre Study Examining the Prevalence Pre- and Post-Electronic Medication System Implementation	6
Validation of an ICD-9-Based Algorithm to Identify Stillbirth Episodes from Medicaid Claims Data	6
Patient Safety Incidents Related to the Use of Parenteral Nutrition in All Patient Groups: A Systematic Scoping Review	6
Enhancing Transparency in Defining Studied Drugs: The Open-Source Living DiAna Dictionary for Standardizing Drug Names in the FAERS	6
Handling of New Drug Safety Information in the Dutch Hospital Setting: A Mixed Methods Approach	5
Incidence of Acute Renal Failure in Patients Using Levetiracetam Versus Other Antiseizure Medications: A Voluntary Post-Authorization Safety Study	5
Incidence, Pathogenesis, and Management of Proton Pump Inhibitor-Induced Nephrotoxicity	5
Aggregation of Adverse Event Terms for Signal Detection and Labeling in Clinical Trials	5
Peer Review in Pharmacovigilance: Lens on Disproportionality Analysis	5
Factors Associated with Underreporting of Adverse Drug Reactions by Health Care Professionals: A Systematic Review Update	5
Motives to Report Adverse Drug Reactions to the National Agency: A Survey Study among Healthcare Professionals and Patients in Croatia, The Netherlands, and the UK	5
Investigating Risk of Cancer with Sodium-Glucose Cotransporter 2 Inhibitors: A Disproportionality Analysis in the WHO Global Pharmacovigilance Database Vigibase®	5
Detectability of Medication Errors With a STOPP/START-Based Medication Review in Older People Prior to a Potentially Preventable Drug-Related Hospital Admission	5
Drug-Induced Liver Injury: Highlights and Controversies in the Recent Literature	5
Post-Authorization Safety Study of Hospitalization for Acute Kidney Injury in Patients with Type 2 Diabetes Exposed to Dapagliflozin in a Real-World Setting	5
Cohort Event Monitoring of Adverse Reactions to COVID-19 Vaccines in Seven European Countries: Pooled Results on First Dose	5
The Reporting of a Disproportionality Analysis for Drug Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Development and Statement	5
Safety of Apremilast in Patients with Psoriasis and Psoriatic Arthritis: Findings from the UK Clinical Practice Research Datalink	4
Enhancing Pharmacovigilance in Côte d'Ivoire: Impact of GSK’s Training and Mentoring Pilot Project in the Abidjan Region	4
Clinical Relatedness and Stability of vigiVec Semantic Vector Representations of Adverse Events and Drugs in Pharmacovigilance	4
Performance and Reproducibility of Large Language Models in Named Entity Recognition: Considerations for the Use in Controlled Environments	4
A Prospective Observational Study on BBV152 Coronavirus Vaccine Use in Adolescents and Comparison with Adults: Interim Results of the First Real-World Safety Analysis	4
Correction: Major Adverse Cardiovascular Events Related to JAK Inhibitors: A Disproportionality Analysis Using the WHO Global Individual Case Safety Database	4
Expert Consensus on the Nephrotoxic Potential of 195 Medications in the Non-intensive Care Setting: A Modified Delphi Method	4
The Reporting Recommendations Intended for Pharmaceutical Risk Minimization Evaluation Studies: Standards for Reporting of Implementation Studies Extension (RIMES-SE)	4
The Safety of Ixekizumab in Chinese Adults with Moderate-to-Severe Plaque Psoriasis: Analyses from a Prospective, Single-Arm, Multicenter, 12-Week Observational Study	4
Use of Primary Care Data in Research and Pharmacovigilance: Eight Scenarios Where Prescription Data are Absent	4
Real-World Safety and Effectiveness of Fluticasone Furoate/Vilanterol in Patients with Asthma and/or Chronic Obstructive Pulmonary Disease: A Post-Marketing Study in Korea	4
A Longitudinal Post-authorization Safety Study of Golimumab in Treatment of Ulcerative Colitis: A Cohort Study in Denmark and Sweden, 2013–2021	4
Targeting CCL24 in Inflammatory and Fibrotic Diseases: Rationale and Results from Three CM-101 Phase 1 Studies	4
Trends in Use and Evidence of Adherence to Risk Evaluation and Mitigation Strategy Pregnancy Testing Requirements for Thalidomide, Lenalidomide, and Pomalidomide in the USA, 2000–2020	4
Should Antidepressants be Avoided in Pregnancy?	4
Hydroxyzine Initiation Following Drug Safety Advisories on Cardiac Arrhythmias in the UK and Canada: A Longitudinal Cohort Study	4
Author’s Reply to Avó-Baião et al.’s Comment on “Maternal and Early-Life Exposure to Antibiotics and the Risk of Autism and Attention-Deficit Hyperactivity Disorder in Childhood: A Swedish Population-	4
The Food and Drug Administration’s (FDA’s) Drug Safety Surveillance During the COVID-19 Pandemic	4
Kidney Damage and Stress Biomarkers for Early Identification of Drug-Induced Kidney Injury: A Systematic Review	4
Sustained Decline of Direct General Practitioner Reporting of Adverse Drug Reactions in Australia and Paucity in Details of Australian Reports in Safety Advisories	4
How Important is Gender in Leadership in Pharmacovigilance? Personal Reflections from the First Female President of the International Society of Pharmacovigilance	4
Not Just Another Reporting Guideline? Here’s Why READUS-PV is a Major Step Forward	4
Development and Evaluation of the Algorithm CErtaInty Tool (ACE-IT) to Assess Electronic Medical Record and Claims-based Algorithms’ Fit for Purpose for Safety Outcomes	4
Cumulative Adverse Event Reporting of Anaphylaxis After mRNA COVID-19 Vaccine (Pfizer-BioNTech) Injections in Japan: The First-Month Report	4
Off-the-Shelf Large Language Models for Causality Assessment of Individual Case Safety Reports: A Proof-of-Concept with COVID-19 Vaccines	3
Post-Authorization Safety Studies of Acute Liver Injury and Severe Complications of Urinary Tract Infection in Patients with Type 2 Diabetes Exposed to Dapagliflozin in a Real-World Setting	3
Patient-Reported Reasons for Switching or Discontinuing Statin Therapy: A Mixed Methods Study Using Social Media	3
Authors’ Response to Yoshihiro Noguchi’s Comment on: “A Disproportionality Analysis of Drug-Drug Interactions of Tizanidine and CYP1A2 Inhibitors from the FDA Adverse Event Reporting System (FAERS)”	3
Phenotype Algorithms for the Identification and Characterization of Vaccine-Induced Thrombotic Thrombocytopenia in Real World Data: A Multinational Network Cohort Study	3
Risk Factors Associated with Medication Administration Errors in Children: A Prospective Direct Observational Study of Paediatric Inpatients	3
Safety of Simultaneous Administration of Bivalent mRNA COVID-19 and Influenza Vaccines in the Vaccine Adverse Event Reporting System (VAERS)	3
Impact of Preventive Strategies on Gastrointestinal Complications in Elderly Patients on Concomitant Use of Oral Anticoagulants and Nonsteroidal Anti-Inflammatory Drugs: A Nationwide Cohort Study	3
Dipeptidyl Peptidase-4 Inhibitors and the Risk of Gallbladder and Bile Duct Disease Among Patients with Type 2 Diabetes: A Population-Based Cohort Study	3
Development of a Framework Structuring Themes in the Course of Adverse Drug Reactions from a Patient’s Perspective	3
Factors Influencing Preferences and Responses Towards Drug Safety Communications: A Conjoint Experiment Among Hospital-Based Healthcare Professionals in the Netherlands	3
Inconsistent Safety Outcome Reporting in Randomized Clinical Trials of COVID-19 Vaccines Complicates Informed Medical Decisions	3
Impact of Vaccine Hesitancy on Onset, Severity and Type of Self-reported Adverse Events: A French Cross-Sectional Survey	3
A Multi-method Exploratory Evaluation of a Service Designed to Improve Medication Safety for Patients with Monitored Dosage Systems Following Hospital Discharge	3
Examining the Effect of Missing Data and Unmeasured Confounding on External Comparator Studies: Case Studies and Simulations	3
Pregnancy Outcomes in Patients Treated with Upadacitinib: Analysis of Data from Clinical Trials and Postmarketing Reports	3
Developing an Artificial Intelligence-Guided Signal Detection in the Food and Drug Administration Adverse Event Reporting System (FAERS): A Proof-of-Concept Study Using Galcanezumab and Simulated Data	3
Industry Review of Best Practices for Risk Management of Drug-Induced Liver Injury from Development to Real-World Use	3
Correction to: The Moroccan Experience of Implementing a University Curriculum for the Pharmacovigilance of Herbal Medicines (Phytovigilance)	3
Repeated or Continuous Medically Supervised Ketamine Administration Associated with Hepatobiliary Adverse Events: A Retrospective Case Series	3
The Methodological Quality of Observational Studies Examining the Risk of Pregnancy Drug Use on Congenital Malformations Needs Substantial Improvement: A Cross-Sectional Survey	3
Desloratadine Exposure and Incidence of Seizure: A Nordic Post-authorization Safety Study Using a New-User Cohort Study Design, 2001–2015	3
Comparative Effectiveness and Safety of Off-Label Underdosed Direct Oral Anticoagulants in Asian Patients with Atrial Fibrillation: A Systematic Review and Meta-analysis	3
The Unseen Hand: AI-Based Prescribing Decision Support Tools and the Evaluation of Drug Safety and Effectiveness	3
The COVID-19 Vaccines International Pregnancy Exposure Registry (C-VIPER): Protocol and Methodological Considerations	3
Drug-Drug Interactions Between Glucagon-Like Peptide 1 Receptor Agonists and Oral Medications: A Systematic Review	3
Comparative Safety Analysis of Opioid Agonist Treatment in Pregnant Women with Opioid Use Disorder: A Population-Based Study	3
“Artificial Intelligence” for Pharmacovigilance: Ready for Prime Time?	3
Can We Ask ChatGPT About Drug Safety? Appropriateness of ChatGPT Responses to Questions About Drug Use and Adverse Reactions Received by Pharmacovigilance Centers	3
Drug–Drug Interaction of the Sodium Glucose Co-Transporter 2 Inhibitors with Statins and Myopathy: A Disproportionality Analysis Using Adverse Events Reporting Data	3
The Effectiveness and Value of Written Medicine Information Across Asia and Africa: Systematic Review	3
Cardiovascular Safety of Romosozumab Compared to Commonly Used Anti-osteoporosis Medications in Postmenopausal Osteoporosis: A Systematic Review and Network Meta-analysis of Randomized Controlled Tria	3
Leveraging FDA Labeling Documents and Large Language Model to Enhance Annotation, Profiling, and Classification of Drug Adverse Events with AskFDALabel	3
A Review on Application of DNA Barcoding Technology for Rapid Molecular Diagnostics of Adulterants in Herbal Medicine	3
RELAY, Ramucirumab Plus Erlotinib Versus Placebo Plus Erlotinib in Patients with Untreated, Epidermal Growth Factor Receptor Mutation-Positive, Metastatic Non-Small-Cell Lung Cancer: Safety Profile an	3
Monitoring and Managing Lorlatinib Adverse Events in the Portuguese Clinical Setting: A Position Paper	3
Hip Fracture Risk After Treatment with Tramadol or Codeine: An Observational Study	3