Articles

1. Composite Plot for Visualizing Aminotransferase and Bilirubin Changes in Clinical Trials of Subjects with Abnormal Baseline Values

   • Bereket Tesfaldet
   • Tejas Patel
   • Eileen Navarro Almario

   Original Research Article Open access 20 April 2024

   

2. COVID-19 Vaccines and Heavy Menstrual Bleeding: The Impact of Media Attention on Reporting to EudraVigilance

   • María Gordillo-Marañón
   • Agnieszka Szmigiel
   • Sabine Straus

   Original Research Article Open access 12 April 2024

   

3. Enzalutamide: Understanding and Managing Drug Interactions to Improve Patient Safety and Drug Efficacy

   • Brandon W. Lennep
   • Jesse Mack
   • Alicia K. Morgans

   Review Article Open access 12 April 2024

   

4. Lessons Learned on Observed-to-Expected Analysis Using Spontaneous Reports During Mass Vaccination

   • María Gordillo-Marañón
   • Gianmario Candore
   • Xavier Kurz

   Current Opinion Open access 09 April 2024

5. Behavioral Science: Enhancing Our Approach to the Development of Effective Additional Risk Minimization Strategies

   • Joanne Treacy
   • Elaine H. Morrato
   • Jeremy Jokinen

   Leading Article 09 April 2024

   

6. Fatal Intoxications with Zopiclone—A Cause for Concern?

   • Lova Tralla
   • Sara Gustavsson
   • Fredrik C. Kugelberg

   Original Research Article Open access 27 March 2024

   

7. Angiotensin Receptor Blockers and the Risk of Suspected Drug-Induced Liver Injury: A Retrospective Cohort Study Using Electronic Health Record-Based Common Data Model in South Korea

   • Hyunjoo Kim
   • Nayeong Son
   • Eunkyung Euni Lee

   Original Research Article Open access 21 March 2024

   

8. Peer Review in Pharmacovigilance: Lens on Disproportionality Analysis

   • Emanuel Raschi
   • Francesco Salvo
   • Charles Khouri

   Editorial 18 March 2024

9. The Role of Mitochondria in Statin-Induced Myopathy

   • Gavin Bell
   • Anastasia Thoma
   • Adam P. Lightfoot

   Review Article 16 March 2024

   

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 Influenza Vaccine (Fluarix Tetra) for Subjects Aged 6 Months and Older

    • Gaël Dos Santos
    • Raghavendra Devadiga
    • Joon Bang

    Original Research Article Open access 14 March 2024 Pages: 365 - 375

    

11. The Problems with Online Health Product Sales: How can Regulations be Improved?

    • Yi Jing Sng
    • Daryl Kwok
    • Cheng Leng Chan

    Leading Article 14 March 2024

12. The Role of Pharmacogenomics in Rare Diseases

    • Alice Man
    • Gabriella S. S. Groeneweg
    • Bruce C. Carleton

    Current Opinion 14 March 2024

13. Drug–Drug Interactions and Actual Harm to Hospitalized Patients: A Multicentre Study Examining the Prevalence Pre- and Post-Electronic Medication System Implementation

    • Ling Li
    • Jannah Baker
    • Melissa T. Baysari

    Original Research Article Open access 13 March 2024

    

14. The Reporting Recommendations Intended for Pharmaceutical Risk Minimization Evaluation Studies: Standards for Reporting of Implementation Studies Extension (RIMES-SE)

    • Meredith Y. Smith
    • Elaine H. Morrato
    • Almut G. Winterstein

    Original Research Article Open access 13 March 2024

    

15. Drug-Gene Risk Stratification in Patients with Suspected Drug-Induced Interstitial Lung Disease

    • Marjolein Drent
    • Petal A. Wijnen
    • Aalt Bast

    Original Research Article Open access 09 March 2024 Pages: 355 - 363

    

16. Using Social Media as a Source of Real-World Data for Pharmaceutical Drug Development and Regulatory Decision Making

    • Didrik Wessel
    • Nicolai Pogrebnyakov

    Original Research Article Open access 06 March 2024 Pages: 495 - 511

    

17. Authors’ Response to Huang et al.’s Comment on “Serially Combining Epidemiological Designs Does Not Improve Overall Signal Detection in Vaccine Safety Surveillance”

    • Fan Bu
    • Faaizah Arshad
    • Marc A. Suchard

    Letter to the Editor 05 March 2024 Pages: 403 - 404

18. Comment on “Serially Combining Epidemiological Designs Does Not Improve Overall Signal Detection in Vaccine Safety Surveillance”

    • Wan-Ting Huang
    • Robert T. Chen
    • Caroline Cassard

    Letter to the Editor Open access 05 March 2024 Pages: 401 - 402

19. Risk of Systemic Inflammatory Response Syndrome Following Preoperative Glucocorticoids Administration in Patients After Percutaneous Nephrolithotomy: A Retrospective Cohort Study

    • Jingping Hu
    • Chaojin Chen
    • Chulian Gong

    Original Research Article 05 March 2024 Pages: 465 - 474

    

20. Risk Factors Associated with Medication Administration Errors in Children: A Prospective Direct Observational Study of Paediatric Inpatients

    • Johanna I. Westbrook
    • Ling Li
    • Magdalena Z. Raban

    Original Research Article Open access 05 March 2024

21. Safety of Simultaneous Administration of Bivalent mRNA COVID-19 and Influenza Vaccines in the Vaccine Adverse Event Reporting System (VAERS)

    • Pedro L. Moro
    • Carol Ennulat
    • John R. Su

    Original Research Article 27 February 2024 Pages: 487 - 493

22. In Utero Exposure to Antibiotics and Risk of Serious Infections in the First Year of Life

    • Mylène Tisseyre
    • Mathis Collier
    • Laurent Chouchana

    Original Research Article 26 February 2024 Pages: 453 - 464

    

23. A Comparison of Signals of Designated Medical Events and Non-designated Medical Events: Results from a Scoping Review

    • Daniele Sartori
    • Jeffrey K. Aronson
    • Igho J. Onakpoya

    Original Research Article Open access 24 February 2024 Pages: 475 - 485

    

24. The Role of the European Medicines Agency in the Safety Monitoring of COVID-19 Vaccines and Future Directions in Enhancing Vaccine Safety Globally

    • Irina Caplanusi
    • Agnieszka Szmigiel
    • Sabine Straus

    Leading Article Open access 23 February 2024 Pages: 405 - 418

    

25. Detection Algorithms for Simple Two-Group Comparisons Using Spontaneous Reporting Systems

    • Yoshihiro Noguchi
    • Tomoaki Yoshimura

    Review Article 22 February 2024

    

26. Correction to: Drug-Induced Liver Injury in the Elderly: Consensus Statements and Recommendations from the IQ-DILI Initiative

    • Eric B. Cohen
    • Meenal Patwardhan
    • M. Isabel Lucena

    Correction Open access 17 February 2024 Pages: 513 - 513

27. Sociodemographic Characteristics of Adverse Event Reporting in the USA: An Ecologic Study

    • Monica A. Muñoz
    • Gerald J. Dal Pan
    • Almut G. Winterstein

    Original Research Article Open access 14 February 2024 Pages: 377 - 387

    

28. Consensus Guidelines: Best Practices for the Prevention, Detection and Management of Hepatitis B Virus Reactivation in Clinical Trials with Immunosuppressive/Immunomodulatory Therapy

    • Eric B. Cohen
    • Arie Regev
    • Mark I. Avigan

    Consensus Statement Open access 14 February 2024 Pages: 321 - 332

29. Tacrolimus-Induced Neurotoxicity After Transplant: A Literature Review

    • Paige Verona
    • Jocelyn Edwards
    • Alessio Provenzani

    Review Article 14 February 2024 Pages: 419 - 438

30. Drug-Induced Progressive Multifocal Leukoencephalopathy (PML): A Systematic Review and Meta-Analysis

    • Lorenzo Vittorio Rindi
    • Drieda Zaçe
    • Marco Iannetta

    Systematic Review 07 February 2024 Pages: 333 - 354

    

31. Exploring the Role of Guidelines in Contributing to Medication Errors: A Descriptive Analysis of National Patient Safety Incident Data

    • Matthew D. Jones
    • Shaojun Liu
    • Sara Garfield

    Original Research Article Open access 02 February 2024 Pages: 389 - 400

    

32. Drug-Drug Interactions Between Glucagon-Like Peptide 1 Receptor Agonists and Oral Medications: A Systematic Review

    • Bronya Calvarysky
    • Idit Dotan
    • Talia Diker Cohen

    Systematic Review Open access 25 January 2024 Pages: 439 - 451

    

33. Correction to: The Moroccan Experience of Implementing a University Curriculum for the Pharmacovigilance of Herbal Medicines (Phytovigilance)

    • Souad Skalli

    Correction 24 January 2024 Pages: 287 - 288

34. Correction to: Patient-Reported Reasons for Antihypertensive Medication Change: A Quantitative Study Using Social Media

    • Cristina Micale
    • Su Golder
    • Graciela Gonzalez-Hernandez

    Correction 17 January 2024 Pages: 193 - 193

35. Drug-Induced Liver Injury in the Elderly: Consensus Statements and Recommendations from the IQ-DILI Initiative

    • Eric B. Cohen
    • Meenal Patwardhan
    • M Isabel Lucena

    Consensus Statement Open access 13 January 2024 Pages: 301 - 319

36. Validation of a Novel Method to Assess the Clinical Quality of Information in Pregnancy-Related Pharmacovigilance Case Reports: A ConcePTION Project

    • Yrea R. J. van Rijt-Weetink
    • Toine C. G. Egberts
    • Eugène P. van Puijenbroek

    Original Research Article Open access 06 January 2024 Pages: 261 - 270

    

37. Enhancing Transparency in Defining Studied Drugs: The Open-Source Living DiAna Dictionary for Standardizing Drug Names in the FAERS

    • Michele Fusaroli
    • Valentina Giunchi
    • Elisabetta Poluzzi

    Original Research Article Open access 04 January 2024 Pages: 271 - 284

    

38. Risk of Major Bleeding Associated with Concomitant Direct-Acting Oral Anticoagulant and Clopidogrel Use: A Retrospective Cohort Study

    • Y. Joseph Hwang
    • Hsien-Yen Chang
    • Hemalkumar B. Mehta

    Original Research Article 23 December 2023 Pages: 251 - 260

    

39. International Trends in Adverse Drug Event-Related Mortality from 2001 to 2019: An Analysis of the World Health Organization Mortality Database from 54 Countries

    • Toshihiro Koyama
    • Shunya Iinuma
    • Hideharu Hagiya

    Original Research Article 22 December 2023 Pages: 237 - 249

    

40. Appeal for Increasing the Impact of Pharmacovigilance

    • Agnes C. Kant

    Editorial 20 December 2023 Pages: 113 - 116

    

41. 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

    • Guillaume Favre
    • Jonathan L. Richardson
    • Ursula Winterfeld

    Original Research Article Open access 19 December 2023 Pages: 227 - 236

42. The Critical Intersect of Regulations, Health Technology Assessment, and Drug Safety Assessments

    • Wen-Wen Yang
    • Yi-Chen Juan
    • Raoh-Fang Pwu

    Leading Article 19 December 2023 Pages: 289 - 299

43. Implementation of a Taxonomy-Based Framework for the Selection of Appropriate Drugs and Outcomes for Real-World Data Signal Detection Studies

    • Astrid Coste
    • Angel YS Wong
    • Ian J. Douglas

    Original Research Article Open access 13 December 2023 Pages: 183 - 192

    

44. Effectiveness and Respiratory Adverse Events Following Inactivated and mRNA COVID-19 Vaccines in Patients with COPD and Asthma: A Chinese Population-Based Study

    • Simon Xiwen Qin
    • Franco Wing Tak Cheng
    • Esther Wai Yin Chan

    Original Research Article Open access 12 December 2023 Pages: 135 - 146

    

45. Promoting Collaboration of Regulators and Patients in Improving Drug Safety and Regulatory Decision Making

    • Yoong Khean Khoo
    • John C. W. Lim
    • Ai Ling Sim-Devadas

    Leading Article 11 December 2023 Pages: 217 - 225

46. SGLT2 Inhibitor Use and Risk of Breast Cancer Among Adult Women with Type 2 Diabetes

    • Fengge Wang
    • Michael Hendryx
    • Juhua Luo

    Original Research Article 09 December 2023 Pages: 125 - 133

    

47. Optimizing Signal Management in a Vaccine Adverse Event Reporting System: A Proof-of-Concept with COVID-19 Vaccines Using Signs, Symptoms, and Natural Language Processing

    • Guojun Dong
    • Andrew Bate
    • Maurizio Sessa

    Original Research Article Open access 07 December 2023 Pages: 173 - 182

    

48. The Unseen Hand: AI-Based Prescribing Decision Support Tools and the Evaluation of Drug Safety and Effectiveness

    • Harriet Dickinson
    • Dana Y. Teltsch
    • the Actionable AI group

    Current Opinion 29 November 2023 Pages: 117 - 123

49. An Overview of Regression Models for Adverse Events Analysis

    • Elsa Coz
    • Mathieu Fauvernier
    • Delphine Maucort-Boulch

    Review Article Open access 25 November 2023 Pages: 205 - 216

    

50. Patient-Reported Reasons for Antihypertensive Medication Change: A Quantitative Study Using Social Media

    • Cristina Micale
    • Su Golder
    • Graciela Gonzalez-Hernandez

    Original Research Article 23 November 2023 Pages: 81 - 91