Drug Safety

2012 - 2025

Current editor(s): Nitin Joshi

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Volume 48, issue 7, 2025

REMS Logic Model: A Pragmatic Framework for Incorporating Drug Safety into Clinical Practice pp. 715-718

Gita A. Toyserkani, Suzanne B. Robottom and Elaine H. Morrato

Mitigation and Management of Common Toxicities Associated with the Administration of CAR-T Therapies in Oncology Patients pp. 719-737

Jonathan Renninger, Lisa Kurz and Heather Stein

QT Interval, Antipsychotics and Correlates Among Patients with Schizophrenia: Cross-Sectional Data from the Multicentric Real-World FACE-SZ pp. 739-752

Mona Gerentes, Mohamed Lajnef, Andrei Szöke, Bruno Aouizerate, Fabrice Berna, Maud Cléry, Isabelle Chéreau, Nathalie Coulon, Julia Clauss-Kobayashi, Eric Fakra, Jean-Michel Dorey, Caroline Dubertret, Guillaume Fond, Ophélia Godin, Tudi Goze, Christophe Lançon, Marion Leboyer, Sylvain Leignier, Pierre-Michel Llorca, Jasmina Mallet, David Misdrahi, Nicolas Oriol, Romain Rey, Paul Roux, Benoit Schorr, Mathieu Urbach, Etienne Véry, Franck Schürhoff and Baptiste Pignon

Stakeholders’ Perspectives Toward the Use of Patient Registry Data for Decision-Making on Medicines: A Cross-Sectional Survey pp. 753-765

Fabian Windfuhr, Sieta T. Vries, Maria Melinder, Tanja Dahlqvist, Diogo Almeida, Bruno Sepodes, Carla Torre, Björn Wettermark and Peter G. M. Mol

Narrative Search Engine for Case Series Assessment Supported by Artificial Intelligence Query Suggestions pp. 767-779

Alem Zekarias, Eva-Lisa Meldau, Shachi Bista, Joana Félix China and Lovisa Sandberg

Understanding the Work of the Pharmacovigilance Risk Assessment Committee (PRAC): A Quantitative Review of the Post-Authorisation Safety Evaluation of Antidiabetic Drugs from 2012 to 2022 pp. 781-794

Haoxin Le, Per Sindahl, Morten Andersen and Christine E. Hallgreen

The Frequency of Drug-Induced Liver Injury Due to Antibiotics Among Hospitalised Patients pp. 795-804

Robert A Björnsson, Sigurdur Sölvi Sigurdsson, Dagur Tjörvi Arnarson, Egill Logason and Einar Stefan Björnsson

Off-the-Shelf Large Language Models for Causality Assessment of Individual Case Safety Reports: A Proof-of-Concept with COVID-19 Vaccines pp. 805-820

Andrea Abate, Elisa Poncato, Maria Antonietta Barbieri, Greg Powell, Andrea Rossi, Simay Peker, Anders Hviid, Andrew Bate and Maurizio Sessa

Using Mixed Methods to Evaluate Risk Minimisation Programs in Europe and the USA: An Innovative Blueprint pp. 821-838

Meredith Y. Smith, Rachel Davis, Priya Bahri, Delphine Saragoussi, Viviana Nguyen, Gita A. Toyserkani and Alison Hamilton

Comment on “Drug-Induced Cognitive Impairment” pp. 839-840

Chaker Ben Salem

Authors’ reply to Chaker Ben Salem’s comment on: “Drug-Induced Cognitive Impairment” pp. 841-841

Arne Reimers, Per Odin and Hanna Ljung

Volume 48, issue 6, 2025

Navigating Diverging Perspectives: Reasoning, Evidence, and Decision-Making in Drug Safety pp. 587-593

Tarek A. Hammad and Simon Davies

Aggregation of Adverse Event Terms for Signal Detection and Labeling in Clinical Trials pp. 595-606

Richard C. Zink, Rebecca Lyzinski and Geoffrey Mann

Evidence-Based Design of Prescription Medication Information: An Updated Scoping Review pp. 607-641

Andrea M. Russell, Rebecca Lovett, Abigail Vogeley, Denise A. Nunes, Carolyn McKelvie, Wayne Middleton and Michael Wolf

Delphi Method Consensus on Statistical Analysis and Reporting Recommendations for Single-Arm Pregnancy Medication Safety Studies Investigating Pregnancy, Birth and Neonatal Health Outcomes: A Contribution from IMI-ConcePTION pp. 643-654

Jonathan L. Richardson, Alan Moore, Michael Stellfeld, Yvonne Geissbühler, Ursula Winterfeld, Guillaume Favre, Christina Chambers, Evelin Beck, Marlies Onken, Katarina Dathe, Michael Ceulemans, Orna Diav-Citrin, Svetlana Shechtman, Alison M. Oliver, Kenneth K. Hodson, Dee-Dee Shiller, Amalia Alexe, Eugène P. Puijenbroek, David J. Lewis and Laura M. Yates

Leveraging FDA Labeling Documents and Large Language Model to Enhance Annotation, Profiling, and Classification of Drug Adverse Events with AskFDALabel pp. 655-665

Leihong Wu, Hong Fang, Yanyan Qu, Joshua Xu and Weida Tong

Effectiveness of Transformer-Based Large Language Models in Identifying Adverse Drug Reaction Relations from Unstructured Discharge Summaries in Singapore pp. 667-677

Yen Ling Koon, Yan Tung Lam, Hui Xing Tan, Desmond Hwee Chun Teo, Jing Wei Neo, Aaron Jun Yi Yap, Pei San Ang, Celine Ping Wei Loke, Mun Yee Tham, Siew Har Tan, Sally Leng Bee Soh, Belinda Qin Pei Foo, Zheng Jye Ling, James Luen Wei Yip and Sreemanee Raaj Dorajoo

Are Causal Statements Reported in Pharmacovigilance Disproportionality Analyses Using Individual Case Safety Reports Exaggerated in Related Citations? A Meta-epidemiological Study pp. 679-688

Claire Bernardeau, Bruno Revol, Francesco Salvo, Michele Fusaroli, Emanuel Raschi, Jean-Luc Cracowski, Matthieu Roustit and Charles Khouri

Pharmacogenetic Testing in the Outpatient Setting in Switzerland: A Descriptive Study Using Swiss Claims Data pp. 689-696

Nina L. Wittwer, Christoph R. Meier, Carola A. Huber, Henriette E. Meyer zu Schwabedissen, Samuel Allemann and Cornelia Schneider

Pregnancy and Infant Outcomes in Women with Multiple Sclerosis Exposed to Glatiramer Acetate Therapy: An Extended 4-Year Safety Update pp. 697-713

Sigal Kaplan, Andra Ghimpeteanu and Claudia Florentina Dragut

Volume 48, issue 5, 2025

Emerging Tools to Support DILI Assessment in Clinical Trials with Abnormal Baseline Serum Liver Tests or Pre-existing Liver Diseases pp. 443-453

Jasmine Amirzadegan, Bereket Tesfaldet, Y. Veronica Pei, Eileen Navarro Almario, Mark I. Avigan and Paul H. Hayashi

Drug Induced Liver Injury: Highlights and Controversies in the 2023 Literature pp. 455-488

Harjit Singh, Bryce F. Kunkle, Angela R. Troia, Advait M. Suvarnakar, Ade C. Waterman, Yadana Khin, Serena Y. Korkmaz, Corinne E. O’Connor and James H. Lewis

Sequential Epidemiological Analyses of Real-World Data: A Tool for Prospective Drug Safety Surveillance from the Rofecoxib Example pp. 489-502

Saad Hanif Abbasi, Lars Christian Lund, Jesper Hallas and Anton Pottegård

Risk of Fracture Associated with Pregabalin or Mirogabalin Use: A Case-Case-Time-Control Study Based on Japanese Health Insurance Claims Data pp. 503-511

Hinako Wakabayashi, Toshiki Fukasawa, Satomi Yoshida, Kairi Ri, Soichiro Masuda, Takayuki Anno and Koji Kawakami

Network Analysis and Machine Learning for Signal Detection and Prioritization Using Electronic Healthcare Records and Administrative Databases: A Proof of Concept in Drug-Induced Acute Myocardial Infarction pp. 513-526

Maria Antonietta Barbieri, Andrea Abate, Olivér M. Balogh, Mátyás Pétervári, Péter Ferdinandy, Bence Ágg, Vera Battini, Marianna Cocco, Andrea Rossi, Carla Carnovale, Manuela Casula, Edoardo Spina and Maurizio Sessa

Assessment of Pharmacovigilance Across University Hospitals in Morocco pp. 527-539

Hind Hamzaoui, Anna Shaum, Imad Cherkaoui, Latifa Ait Moussa, Houda Sefiani, Ismail Talibi, Ghita Benabdallah, Omar Salman, Seth Ferrey and Rachida Soulaymani Bencheikh

A Longitudinal Post-authorization Safety Study of Golimumab in Treatment of Ulcerative Colitis: A Cohort Study in Denmark and Sweden, 2013–2021 pp. 541-558

Annette Kjær Ersbøll, Zhiping Huang, Deanna D. Hill, Simone Møller Hede, Vibeke Andersen, Kristian Bolin, Marie Skov Kristensen, Suzan Esslinger, Frida Richter Hansen, Erik Hertervig, Lila Kallio, Thora Majlund Kjærulff, Stine Kloster, Alexis Krumme, James D. Lewis, Laila Mehkri, Niels Qvist, Lau Caspar Thygesen, Cindy Weinstein and Anders Green

Opinion Mining of Erowid’s Experience Reports on LSD and Psilocybin-Containing Mushrooms pp. 559-575

Ahmed Al-Imam, Riccardo Lora, Marek A. Motyka, Erica Marletta, Michele Vezzaro, Jerzy Moczko, Manal Younus and Michal Michalak

Multi-Stakeholder Call to Action for the Future of Vaccine Post-Marketing Monitoring: Proceedings from the First Beyond COVID-19 Monitoring Excellence (BeCOME) Conference pp. 577-585

Vincent Bauchau, Kaatje Bollaerts, Phil Bryan, Jim Buttery, Kourtney Davis, Robert T. Chen, Daniel R. Feikin, Antonella Fretta, Sarah Frise, Sonja Gandhi-Banga, Hector S. Izurieta, Corinne Jouquelet-Royer, Alena Khromava, Lin Li, Raj Long, Sarah MacDonald, Lydie Marcelon, Robert Massouh, Wilhelmine Meeraus, Flor M. Munoz, Karen Naim, Dale Nordenberg, Hanna Nohynek, Heather Rubino, Daniel A. Salmon, Sarah Sellers, Laurence Serradell, Laurence Torcel-Pagnon and Jamie Wilkins

Volume 48, issue 4, 2025

Call to action: Pharmaceutical residues in the environment: threats to ecosystems and human health pp. 315-320

Carlotta Lunghi, Maria Rosa Valetto, Anna Barra Caracciolo, Irene Bramke, Sergio Caroli, Paola Bottoni, Sara Castiglioni, Salvatore Crisafulli, Laura Cuzzolin, Paola Deambrosis, Valentina Giunchi, Jacopo Grisotto, Antonio Marcomini, Ugo Moretti, Vitalia Murgia, Jayesh Pandit, Stefano Polesello, Elisabetta Poluzzi, Roberto Romizi, Nicoletta Scarpa, Giovanna Scroccaro, Raffaella Sorrentino, Anders Sundström, John Wilkinson and Giovanna Paolone

Leveraging Natural Language Processing and Machine Learning Methods for Adverse Drug Event Detection in Electronic Health/Medical Records: A Scoping Review pp. 321-337

Su Golder, Dongfang Xu, Karen O’Connor, Yunwen Wang, Mahak Batra and Graciela Gonzalez Hernandez

Drug-Induced Cognitive Impairment pp. 339-361

Arne Reimers, Per Odin and Hanna Ljung

Adverse Drug Events in Ambulatory Care: A Cross-Sectional Study pp. 363-374

Joseph M. Plasek, Mary G. Amato, Abigail Salem, Dinah Foer, Stuart Lipsitz, Gretchen Purcell Jackson, David W. Bates and Li Zhou

Prenatal and Early Childhood Exposure to Proton Pump Inhibitors and Antibiotics and the Risk of Childhood Cancer: A Nationwide Population-Based Cohort Study pp. 375-388

Unnur Gudnadottir, Emma Fransson, Gustaf Ljungman, Anna Wikman, Erika Vlieghe, Lars Engstrand and Nele Brusselaers

Trends in Proton Pump Inhibitor Use in Sweden by Sex and Age: A Drug Utilisation Study pp. 389-400

Nele Brusselaers, Unnur Gudnadottir, Lars Engstrand and Helene E. Lilja

Clinical Relatedness and Stability of vigiVec Semantic Vector Representations of Adverse Events and Drugs in Pharmacovigilance pp. 401-413

Nils Erlanson, Joana Félix China, Henric Taavola and G. Niklas Norén

Use of Reporting Recommendation Intended for Pharmaceutical Risk Minimisation Evaluation Studies (RIMES) Checklist in Risk Minimisation/Mitigation Studies: A Review and Survey pp. 415-423

Samantha E. Duckworth, Sophie Druelles, Emily Brouwer, David A. Brown, Katja M. Hakkarainen and Sonia Guleria

OpenPVSignal Knowledge Graph: Pharmacovigilance Signal Reports in a Computationally Exploitable FAIR Representation pp. 425-436

Achilleas Chytas, George Gavriilides, Anargyros Kapetanakis, Alix Langlais, Marie-Christine Jaulent and Pantelis Natsiavas

Comment on: “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” pp. 437-438

Minh-Hoang Tran and Kim-Huong Truong-Nguyen

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 Potential Risks and Complications” pp. 439-441

Yitayeh Belsti, Aya Mousa, Hannah Jackson, Lisa J. Moran, Kirsten R. Palmer, Raja Ram Dhungana, Emily Callander, Daniel Lorber Rolnik, Helena Teede and Joanne Enticott

Volume 48, issue 3, 2025

Pharmacovigilance in the Community: A Special-Interest Group of the International Society of Pharmacovigilance pp. 203-207

Mohamed A. Elhawary, Rebecca Noss, Loubna Alj, Manal Younus, Mayada Alkhakany, Hadir Rostom, Angela Caro-Rojas and Thamir M. Alshammari

Antiretroviral Use for HIV Prevention During Pregnancy: The Need to Strengthen Regulatory and Surveillance Systems in Africa pp. 209-216

Robin Schaefer, L. Donaldson, A. Chigome, M. Escudeiro dos Santos, S. Lamprianou, N. Ndembi, J. I. Nwokike, P. Nyambayo, V. Palmi, F. Renaud, M. Gonzalez Tome and V. Miller

Signals of Possibly Persistent Gustatory, Olfactory and Auditory Adverse Drug Reactions to Antibiotic Drugs: A Disproportionality Analysis Using the EudraVigilance Database pp. 217-231

Sara Ferraro, Emiliano Cappello, Marco Fornili, Irma Convertino, Marco Bonaso, Ersilia Lucenteforte and Marco Tuccori

Empowering African Expertise: Enhancing Safety Data Integration and Signal Detection for COVID-19 Vaccines Through the African Union Smart Safety Surveillance Joint Signal Management Group pp. 233-249

Victoria Prudence Nambasa, Hannah May Gunter, Modupe Bamidele Adeyemo, Neetesh Yanish Bhawaneedin, Marc Blockman, George Tsey Sabblah, John Owusu Gyapong, Eric Muriithi Guantai, Tamrat Abebe, Workeabeba Abebe, Henry Jeremy Lawson, Mercedes Chawada Leburu, Abdullahi Mohammed, Kwame Amponsa-Achiano, Mafora Florah Matlala, Uchenna Geraldine Elemuwa, Hudu Mogtari, Alexander Kwadwo Nyarko, Marione Schönfeldt, Mercy Kamupira, Kerrigan McCarthy, Yohannes Lakew Tefera, Asnakech Alemu, Kabir Mawashi Yusuf, Obi Emelife, Ladji Sidibe, Kudakwashe Dandajena, Kenneth Onu, Mojisola Christianah Adeyeye, Delese Mimi Darko, Heran Gerba, Boitumelo Semete, Fred Siyoi, Aggrey Ambali and Johanna Catharina Meyer

Early Detection of Hearing Impairment Signals Post-mRNA COVID-19 Vaccination: A Disproportionality Analysis Study on French Pharmacovigilance Database pp. 251-263

Dalil Boulefaa, Haleh Bagheri, Francesco Salvo, Marie-Blanche Rabier, Hélène Geniaux, Marion Lepelley, Fanny Rocher, Julien Mahe, Aurélie Grandvillemuin and Hung Thai- Van

Prenatal Exposure to Proton Pump Inhibitors and Risk of Serious Infections in Offspring During the First Year of Life: A Nationwide Cohort Study pp. 265-277

Mylène Tisseyre, Mathis Collier, Nathanaël Beeker, Florentia Kaguelidou, Jean-Marc Treluyer and Laurent Chouchana

Post-licensure Safety Surveillance of 20-Valent Pneumococcal Conjugate Vaccine (PCV20) Among US Adults in the Vaccine Adverse Event Reporting System (VAERS) pp. 279-286

Mayra Oliveira, Paige Marquez, Carol Ennulat, Phillip Blanc, Kerry Welsh, Narayan Nair, Monica Taminato and Pedro L. Moro

Performance and Reproducibility of Large Language Models in Named Entity Recognition: Considerations for the Use in Controlled Environments pp. 287-303

Jürgen Dietrich and André Hollstein

Advances in Drug Safety: Highlights from the 23rd Annual Meeting of the International Society of Pharmacovigilance pp. 305-309

Omar Aimer, Maribel Salas, Tarek A Hammad, Rania Mouchantaf, Katarina Ilic, Maxine Gossell-Williams, Ushma Mehta, Robert W. Platt and Bruce Carleton

Principles and Practice of Pharmacovigilance and Drug Safety pp. 311-314

Ian W. Boyd

Volume 48, issue 2, 2025

Teratogenic Risk Impact and Mitigation (TRIM): Study Protocol for the Development of a Decision Support Tool to Prioritize Medications for Risk Mitigation pp. 107-117

Almut G. Winterstein, Celeste L. Y. Ewig, Yanning Wang, Nicole E. Smolinski, Gita A. Toyserkani, Cynthia LaCivita, Leila Lackey, Sara Eggers, Esther H. Zhou, Vakaramoko Diaby, Amir Sarayani, Thuy Thai, Judith C. Maro and Sonja A. Rasmussen

Safeguarding Patients in the AI Era: Ethics at the Forefront of Pharmacovigilance pp. 119-127

Ashish Jain, Maribel Salas, Omar Aimer and Zahabia Adenwala

Drug-Induced Hypouricemia pp. 129-142

Chaker Ben Salem, Myriam Agrebi, Dhouha Sahnoun, Neila Fathallah and Houssem Hmouda

Investigation of the Role of Chemical Analysis in Causality Assessment of Herbal and Dietary Supplement-Induced Liver Injury pp. 143-150

Dina Halegoua-DeMarzio, Victor J. Navarro, Ashley Davis, Jawad Ahmad, Bharathi Avula, Huiman Barnhart, A. Sidney Barritt, Herbert L. Bonkovsky, Vincent L. Chen, Gina Choi, Robert J. Fontana, Marwan S. Ghabril, Ikhlas Khan, Christopher Koh, Joseph Odin, Don C. Rockey, Hoss Rostami, Jose Serrano, Averell H. Sherker, Andrew Stolz, Hans L. Tillmann and Raj Vuppalanchi

Incidence of Idiosyncratic Drug-Induced Liver Injury Caused by Prescription Drugs pp. 151-160

Vincent L. Chen, Don C. Rockey, Einar S. Bjornsson, Huiman Barnhart and Jay H. Hoofnagle

Challenges in the Implementation of EU Risk Minimisation Measures for Medicinal Products in Clinical Practice Guidelines: Mixed Methods Multi-Case Study pp. 161-177

Mathias Møllebæk, Helga Gardarsdottir, Alexia-Georgia Bikou, Ana Kodrič, Ana Marta Silva, Armin Andersen, Christos Kontogiorgis, Elita Poplavska, Fariba Ahmadizar, Foteini Dermiki-Gkana, Ieva Rutkovska, Inês Ribeiro Vaz, Mitja Kos, Paula Barão, Renske Grupstra, Teresa Leonardo Alves and Anna Birna Almarsdóttir

Views on the Development and Use of a New Digital Adverse Drug Event Reporting Platform in Australia: A Qualitative Study pp. 179-190

Eyob Alemayehu Gebreyohannes, Christopher Thornton, Myra Thiessen, Sieta T. Vries, Gretchen Coombs, Indae Hwang and Renly Lim

Fracture-Related Safety Reporting of JAK Inhibitors: An Analysis from the WHO Global VigiBase pp. 191-201

Adrian Martinez de la Torre, Andreas Bech Clausen, Andrea M. Burden and Stefan Weiler

Volume 48, issue 1, 2025

Caveats of Covariate Adjustment in Disproportionality Analysis for Best Practices pp. 1-5

Yoshihiro Noguchi, Tomoya Tachi and Tomoaki Yoshimura

Cardiovascular Safety of Romosozumab Compared to Commonly Used Anti-osteoporosis Medications in Postmenopausal Osteoporosis: A Systematic Review and Network Meta-analysis of Randomized Controlled Trials pp. 7-23

Shih-Hao Cheng, William Chu, Wen-Hsiang Chou, Woei-Chyn Chu and Yi-No Kang

Comparative Effectiveness and Safety of Off-Label Underdosed Direct Oral Anticoagulants in Asian Patients with Atrial Fibrillation: A Systematic Review and Meta-analysis pp. 25-42

Pajaree Mongkhon, Noppaket Singkham, Kunyarat Ponok, Natpatsorn Liamsrijan, Wipada Phoosa, Sirayut Phattanasobhon, Laura Fanning, Vichai Senthong and Surasak Saokaew

An Integrated Approach for Representing Knowledge on the Potential of Drugs to Cause Acute Kidney Injury pp. 43-58

Daniel Fernández-Llaneza, Romy M. P. Vos, Joris E. Lieverse, Helen R. Gosselt, Sandra L. Kane-Gill, Teun Gelder and Joanna E. Klopotowska

Disproportionality Analysis and Characterisation of Medication Errors in EudraVigilance: Exploring Findings on Sexes and Age Groups pp. 59-74

Victor Pera, Jan A. Kors, Erik M. Mulligen, Marcel Wilde, Peter R. Rijnbeek and Katia M. C. Verhamme

Qualitative Interviews with Stakeholders in Herbal Pharmacovigilance and Recommendations for Best Practices to be Applied Worldwide pp. 75-86

Corine Ekhart, Sjoerd H. P. Wiarda, Sonja Koppel, Souad Skalli, Waad Alghamdi, Francesca Menniti-Ippolito, Kunwarang Tangchitkhachon, John Samson Mponda, Herman J. Woerdenbag and Florence Hunsel

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 pp. 87-97

Yitayeh Belsti, Aya Mousa, Hannah Jackson, Lisa J. Moran, Kirsten R. Palmer, Raja Ram Dhungana, Emily Callander, Daniel Lorber Rolnik, Helena Teede and Joanne Enticott

Pharmacovigilance in the Age of Legalized Cannabis: Using Social Media to Monitor Drug–Drug Interactions Between Immunosuppressants and Cannabis-Derived Products pp. 99-105

Matthew R. Allen, Gwenyth Portillo Wightman, Zechariah Zhu, Adam Poliak, Davey M. Smith, Mark Dredze and John W. Ayers