Drug Safety

2001 - 2026

Current editor(s): Nitin Joshi

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Volume 49, issue 5, 2026

International Society of Pharmacovigilance Advances over Time: Strategies and Results of the Advisory Board from 2022 to 2025 pp. 505-508

Angela Caro-Rojas

Pharmacovigilance Due Diligence in Drug Development: A Practical Playbook for Risk Identification, Compliance Assessment, and Strategic Decision Making pp. 509-518

Ashraf Youssef and Tarek A. Hammad

Physician Awareness of FDA’s Relaxation of REMS-Required Laboratory Testing Requirements and Changes in Prescribing Practices During the COVID-19 Pandemic pp. 519-528

Catherine S. Hwang, Zhigang Lu, Massimiliano Russo, Heidi Zakoul, Gita A. Toyserkani, Esther H. Zhou, Cynthia LaCivita, Gerald J. Dal Pan, Aaron S. Kesselheim and Ameet Sarpatwari

GP Consultations for Herpes Zoster After COVID-19 Vaccination: A Self-Controlled Cohort Study Based on Electronic Health Record Data from the Netherlands pp. 529-539

Rana Jajou, Eugène van Puijenbroek, Jetty Overbeek, Karin Hek, Erik Mulder, Florence van Hunsel and Agnes Kant

Standardizing and Comparing Management Recommendations for Potential Drug–Drug Interactions Across Different Interaction Checkers pp. 541-552

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 and Francesco Salvo

Unsuspected Adverse Drug Reactions to Dermatologic Medications: An Epidemiological Hypothesis-Free Screening Study of Real-World Data in Denmark pp. 553-565

Thomas Delvin, Anette Bygum, Lars Christian Lund, Jacob Harbo Andersen and Jesper Hallas

Assessing the Use of Medical Insurance Claims and Electronic Health Records to Measure COVID-19 Vaccination During Pregnancy pp. 567-580

Matthew M. Coates, Stacey L. Rowe, Sheena G. Sullivan, Flor M. Munoz, Onyebuchi A. Arah and Annette K. Regan

Evaluating COVID-19 Vaccine Masking and Unmasking Methods in Two National Pharmacovigilance Databases pp. 581-590

Oskar Rachwal, Mar Gutiérrez-Lobón, Nuria Sols Cueto, Araceli Nuñez Ventura, Cristina Fernández-Fernández, Florence P. A. M. van Hunsel, Joep H. G. Scholl, María Gordillo-Marañón and Eugène P. van Puijenbroek

Unveiling the Limits of Anticholinergic Burden Scales: A Study of Adverse Drug Reactions in the French Pharmacovigilance Database pp. 591-603

Pauline-Eva Pecquet, Julien Moragny, Valérie Gras, Pauline Schiro, Sylvine Pinel, Solène M. Laville and Sophie Liabeuf

Volume 49, issue 4, 2026

Strengthening Signal Detection in Pharmacovigilance by Using International Nonproprietary Name (INN) Stems pp. 381-387

Raffaella Balocco, Jeffrey K. Aronson, Sarel F. Malan and Albert Figueras

Systematic Review Examining the Effectiveness of Professional, Organisational and Structural Interventions in Primary Care to Reduce Medication-Related Hospitalisations and Deaths pp. 389-403

Hanan Khalil, Brian G. Bell, Richard N. Keers, Penny J. Lewis, Megan Foreman, Amelia Taylor, Barbara Iyen, Aziz Sheikh, Darren M. Ashcroft and Anthony J. Avery

Systematic Review of Active Safety Surveillance of Vaccines and Medicines in Low- and Middle-Income Countries pp. 405-417

Andy Stergachis, Esperança Sevene, Mohammad Gazi Shah Alam, Rebecca E. Chandler, Alexander Precioso, Samatha Mudigonda, Dale Nordenberg and Robert T. Chen

Incretin-Based Drugs and the Risk of Dementia Among Patients with Type 2 Diabetes pp. 419-434

Yun-Han Wang, Kyle Johnson, Sarah Beradid, Hui Yin, Oriana H. Y. Yu, Samy Suissa, Laurent Azoulay and Christel Renoux

Sexual Dysfunctions Associated with Proton Pump Inhibitors: Insights from VigiBase, the World Health Organization Pharmacovigilance Database pp. 435-447

Salvatore Crisafulli, Francesco Ciccimarra, Fabio Scapini, Luca L’Abbate, Emmanuele A. Jannini, Maria Cristina De Martino, Elisa Giannetta, Jordi Mestres, Marco Tuccori and Gianluca Trifirò

Causal Inference Tools for Pharmacovigilance: Using Causal Graphs to Identify and Address Biases in Disproportionality Analysis pp. 449-469

Michele Fusaroli, Joseph Mitchell, Annette Rudolph, Elena Rocca and Riccardo Fusaroli

Medications Associated with Increased Risk of Hypoglycemia in Older Adults on Sulfonylureas: A High-Throughput Case-Crossover-Based Screening Study pp. 471-480

Sungho Bea, Elisabetta Patorno, Georg Hahn, Julie M. Paik, Deborah J. Wexler and Katsiaryna Bykov

MCSG: A Method for Simultaneous Disproportionality Analysis and Background Rate Estimation in Large Pharmacovigilance Databases pp. 481-491

Matt Bright, Elpida Kontsioti, Munir Pirmohamed, Yifan Zhou and Simon Maskell

Sexual Dysfunction in Male Patients After Initiating Treatment with Antidepressants pp. 493-503

Lukas Westphal, Débora D. Gräf, Haoxin Le, Christine E. Hallgreen and Morten Andersen

Volume 49, issue 3, 2026

Pharmacovigilance Through Fresh Eyes: The International Society of Pharmacovigilance Student Community's Role in Shaping the Future of Pharmacovigilance pp. 259-262

Hager Saleh, Ibrahim Mohammed Amidu, Zerin Ziaudeen, Ryan James Walker and Manal Younus

Navigating Non-interventional Post-authorization Studies in East Asia: Regulatory Challenges, Opportunities, and Future Directions pp. 263-271

Jami Peters, Ayad K. Ali, Maria Moitinho de Almeida, Keiko Asao, Tarek A. Hammad, Xintong He, Alexander Michel, Annalisa Rubino, Sono Sawada, Rachel E. Sobel and Stefan de Vogel

Algorithms to Identify Major Congenital Malformations in Routinely Collected Healthcare Data: A Systematic Review pp. 273-289

Melanie H. Jacobson, Meritxell Sabidó, Ana Sofia Afonso, Adebola Ajao, Eman A. Alghamdi, Susan E. Andrade, Dimitri Bennett, Vineetkumar Kharat, Marie-Laure Kürzinger, Maryline Le Noan-Lainé, Ditte Mølgaard-Nielsen, Gayle Murray, Elena Rivero-Ferrer and Sandra Lopez-Leon

Comparative Risk of Acute Kidney Injury with Piperacillin–Tazobactam Plus Teicoplanin Versus Piperacillin–Tazobactam Plus Vancomycin: A Systematic Review and Meta-Analysis pp. 291-302

Shahd Mohammad, Haneen Ghazal, Wafaa Rahimeh, Maqsood Khan, Mosab Al Balas and Faris El-Dahiyat

Content Analysis of Promotional Materials for Prescription Drugs Authorized Under Emergency Use Authorization pp. 303-311

Bridget Kelly, Kathryn J. Aikin, Helen W. Sullivan, Gabe Madson, Anne-Celine Jeffroy-Menard, Diamond Hawkins, Kathy Vu, Shirley Liu, Lauren McCormack and Sandra Crouse Quinn

Choosing an Index Date for Untreated Patients in External Comparator Studies pp. 313-324

Luis Antunes, Gerd Rippin, Eleanor Ralphs, Artis Luguzis, Kellyn Arnold and Hopin Lee

Drugs Withdrawn from the Canadian Market for Safety and Effectiveness Reasons, 1990–2024: A Cross-Sectional Study pp. 325-335

Joel Lexchin

Implied ADR-Admissions: A Cohort Study Introducing a Novel Administrative Data Approach for Identifying Drug-Related Hospitalisations pp. 337-351

Miriam Schechner, Marietta Rottenkolber, Clara Weglage, Vita Brišnik, Annette Haerdtlein, Bruce Guthrie, Ulrich Jaehde, Eva Grill and Tobias Dreischulte

Statistical Methods for Multi-jurisdictional Australian Vaccine Safety Investigations of Rare Adverse Events pp. 353-365

Hannah J. Morgan, Lauren Bloomfield, Hazel J. Clothier, Sera Ngeh, Gemma Cadby, Dale Carcione, James H. Boyd, Gonzalo Sepulveda Kattan, Jim P. Buttery and Paul Effler

Harm to Children from Prescribing and Administration Errors in Acute Care: A Multidisciplinary Panel Assessment pp. 367-379

Virginia Mumford, Magdalena R. Raban, Erin Fitzpatrick, Amanda Woods, Alison Merchant, Tim Badgery-Parker, Ling Li, Peter Gates, Richard O. Day, Geoffrey Ambler, Luciano Dalla-Pozza, Madlen Gazarian, Alan Gardo, Peter Barclay, Les White and Johanna I. Westbrook

Volume 49, issue 2, 2026

The Promise and Challenge of Large Language Models for Pharmacovigilance pp. 145-146

Lynette Hirschman

Charting and Sidestepping the Pitfalls of Disproportionality Analysis pp. 147-162

Michele Fusaroli, Daniele Sartori, Eugène P. van Puijenbroek and G. Niklas Norén

Navigating Medical Device Safety: Current Status, Challenges, and Future Regulatory Directions pp. 163-175

Omar Aimer and Catherine Baldridge

Leveraging Large Language Models in Extracting Drug Safety Information from Prescription Drug Labels pp. 177-193

Undina Gisladottir, Michael Zietz, Sophia Kivelson, Yutaro Tanaka, Gaurav Sirdeshmukh, Kathleen LaRow Brown and Nicholas P. Tatonetti

Characteristics and Risk Factors of Medication Incidents Across Stages of Medication Management in Residential Aged Care: A Longitudinal Cohort Study of 5700 Reported Incidents pp. 195-206

S. Sandun M. Silva, Nasir Wabe, Magdalena Z. Raban, Amy D. Nguyen, Guogui Huang, Ying Xu, Crisostomo Mercado, Desiree C. Firempong and Johanna I. Westbrook

Anticholinergic Drug Use in Elderly Patients: Compliance with STOPP-START and BEERS Criteria in Spain—A Descriptive Study pp. 207-215

Javier Santandreu, Francisco Félix Caballero and Elena González-Burgos

R Value-Based Criteria Outperform Alkaline Phosphatase Less than Twice Normal in Identifying Hy’s Law Cases in Clinical Trials pp. 217-224

Jasmine Amirzadegan, Edwige Chiogo Vouffo, Ling Lan, Eileen Navarro Almario, Mark I. Avigan and Paul H. Hayashi

Exploring the Reliability of Detecting Drug–Drug Interactions that Increase the Risk of Gestational Diabetes in Adverse Event Reporting Systems pp. 225-238

Robiyanto Robiyanto, Jim W. Barrett, Lovisa Sandberg, Boukje C. Raemaekers, G. Niklas Norén, Catharina C. M. Schuiling-Veninga, Eelko Hak and Eugène P. van Puijenbroek

Characterizing the FDA Adverse Event Reporting System (FAERS) as a Network to Improve Pattern Discovery pp. 239-251

Raechel Davis, Oanh Dang, Suranjan De and Robert Ball

Comment on: Association of GLP1-Receptor Agonists with Risk of Hepatocellular Carcinoma: A Retrospective Cohort Study pp. 253-254

Chien-Hsiang Weng, Philip A. Chan, Joseph Magagnoli and Charles L. Bennett

Authors’ Response to Weng et al.’s Comment on “Association of GLP1-Receptor Agonists with Risk of Hepatocellular Carcinoma: A Retrospective Cohort Study” pp. 255-257

Ishak A. Mansi and Moheb Boktor

Volume 49, issue 1, 2026

Managing Drug Interactions with Enzalutamide in Patients with Prostate Cancer: A Podcast pp. 1-7

Alicia K. Morgans, Brooke Looney, Jesse Mack and Judeth Bianco

The Impact of COVID-19 and COVID-19 Vaccination on Detection, Assessment, and Management of Suspected Acute Drug‐Induced Liver Injury Occurring during Clinical Trials: Consensus Recommendations from the IQ DILI Initiative pp. 9-25

Melissa Palmer, Daniel Seekins, Mark Avigan, John Marcinak, Don C. Rockey, Arie Regev, Vineet K. Shastri, James H. Lewis and Ajit Dash

Pharmacovigilance in Cell and Gene Therapy: Evolving Challenges in Risk Management and Long-Term Follow-Up pp. 27-53

Emile Youssef, Kari Weddle, Lisa Zimmerman and Dannelle Palmer

A Scoping Review of Published Literature on the Contributions of the Natural Health Products (NHPs) Industry to Pharmacovigilance for NHPs pp. 55-79

Xin Yi Lim, Sanyogita Ram, Shane Scahill and Joanne Barnes

How does the Content and Dissemination of Communications on the Risks of Medicines Affect Prescriber Awareness, Knowledge, and Behaviour: A Systematic Review pp. 81-107

Lucy T. Perry, Annim Mohammad, Ashleigh Hooimeyer, Eliza J. McEwin and Barbara Mintzes

Uncovering the Hidden Hurdles: Exploring Challenges in Pediatric Pharmacovigilance in the Netherlands pp. 109-118

Anne T. M. Dittrich, Yvet Kroeze, Michel A. A. P. Willemsen, Jos M. Th. Draaisma, Eugène P. van Puijenbroek and D. Maroeska W. M. te Loo

The Extent and Magnitude of Bias in Case-Crossover Studies of Real-World Non-transient Medications Patterns: A Simulation Study with Real-World Examples pp. 119-128

Hsiao-Ching Huang, Mina Tadrous, Saria Awadalla, Daniel Touchette, Glen T. Schumock and Todd A. Lee

Advancing Pharmacovigilance Practice in Africa: Moving from Data Collection to Data-Driven Decision Making—Report from the 4th ISoP Africa Chapter Meeting pp. 129-135

Helen Byomire Ndagije, Sheila Ampaire, George Tsey Sabblah, Comfort Ogar, Jayesh Manharlal Pandit, Nimisha Kotecha, Mulugeta Russom, Victoria Prudence Nambasa, Claris Ambale, Dorothy Aywak, Peter U. Bassi, Wangui Mathenge, Johanna C. Meyer, Christabel Khaemba, Emmaculate Kwikiriza, Julius Mayengo, Joanitah Atuhaire, David Nahamya, Omar Aimer and Angela Caro-Rojas

Correction: Advancing Pharmacovigilance Practice in Africa: Moving from Data Collection to Data-Driven Decision Making—Report from the 4th ISoP Africa Chapter Meeting pp. 137-138

Helen Byomire Ndagije, Sheila Ampaire, George Tsey Sabblah, Comfort Ogar, Jayesh Manharlal Pandit, Nimisha Kotecha, Mulugeta Russom, Victoria Prudence Nambasa, Claris Ambale, Dorothy Aywak, Peter U. Bassi, Wangui Mathenge, Johanna C. Meyer, Christabel Khaemba, Emmaculate Kwikiriza, Julius Mayengo, Joanitah Atuhaire, David Nahamya, Omar Aimer and Angela Caro-Rojas

Comment on “Performance and Reproducibility of Large Language Models in Named Entity Recognition: Considerations for the Use in Controlled Environments” pp. 139-141

Théophile Tiffet, Diva Beltramin, Béatrice Trombert-Paviot and Cédric Bousquet

Authors’ response to Tiffet et al.’s comment on “Performance and Reproducibility of Large Language Models in Named Entity Recognition: Considerations for the Use in Controlled Environments” pp. 143-144

Juergen Dietrich and André Hollstein