Drug Safety

2012 - 2025

Current editor(s): Nitin Joshi

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Volume 47, issue 12, 2024

Short-Term Training, a Useful Approach for Sustainable Pharmacovigilance Knowledge Development in Tanzania, Kenya, Ethiopia and Rwanda pp. 1193-1202

Eugène Puijenbroek, Abbie Barry, Christabel Khaemba, Lazare Ntirenganya, Tigist Dires Gebreyesus, Adam Fimbo, Omary Minzi, Eyasu Makonnen, Margaret Oluka, Anastasia Guantai and Eleni Aklillu

A Comparison of Active Pharmacovigilance Strategies Used to Monitor Adverse Events to Antiviral Agents: A Systematic Review pp. 1203-1224

Renato Ferreira-da-Silva, Joana Reis-Pardal, Manuela Pinto, Matilde Monteiro-Soares, Bernardo Sousa-Pinto, Manuela Morato, Jorge Junqueira Polónia and Inês Ribeiro-Vaz

Emergency Department Use of Heart Failure-Exacerbating Medications in Patients with Chronic Heart Failure pp. 1225-1234

Martin F. Casey, Joy Hallmark, Patricia P. Chang, Jo E. Rodgers, Aakash Mehta, Srihari V. Chari, Preston Skersick, Thomas Bohrmann, Parag Goyal and Michelle L. Meyer

A Calculated Risk: Evaluation of QTc Drug–Drug Interaction (DDI) Clinical Decision Support (CDS) Alerts and Performance of the Tisdale Risk Score Calculator pp. 1235-1243

Rachel L. Wasserman, Diane L. Seger, Mary G. Amato, Andrew Y. Hwang, Julie Fiskio and David W. Bates

Examining the Effect of Missing Data and Unmeasured Confounding on External Comparator Studies: Case Studies and Simulations pp. 1245-1263

Gerd Rippin, Héctor Sanz, Wilhelmina E. Hoogendoorn, Nicolás M. Ballarini, Joan A. Largent, Eleni Demas, Douwe Postmus, Theodor Framke, Lukas M. Aguirre Dávila, Chantal Quinten and Francesco Pignatti

Description and Validation of a Novel AI Tool, LabelComp, for the Identification of Adverse Event Changes in FDA Labeling pp. 1265-1274

George A. Neyarapally, Leihong Wu, Joshua Xu, Esther H. Zhou, Oanh Dang, Joann Lee, Dharmang Mehta, Rochelle D. Vaughn, Ellen Pinnow and Hong Fang

Unveiling the Burden of Drug-Induced Impulsivity: A Network Analysis of the FDA Adverse Event Reporting System pp. 1275-1292

Michele Fusaroli, Stefano Polizzi, Luca Menestrina, Valentina Giunchi, Luca Pellegrini, Emanuel Raschi, Daniel Weintraub, Maurizio Recanatini, Gastone Castellani, Fabrizio Ponti and Elisabetta Poluzzi

Paracetamol Dosing Errors in People Aged 12 Years and Over: An Analysis of Over 14,000 Cases Reported to an Australian Poisons Information Centre pp. 1293-1306

Annabelle S. Chidiac, Nicholas A. Buckley, Firouzeh Noghrehchi and Rose Cairns

RETRACTED ARTICLE: Long-Term Safety Analysis of the BBV152 Coronavirus Vaccine in Adolescents and Adults: Findings from a 1-Year Prospective Study in North India pp. 1441-1441

Upinder Kaur, Aakanksha Jaiswal, Ayushi Jaiswal, Kunal Singh, Aditi Pandey, Mayank Chauhan, Mahek Rai, Sangeeta Kansal, Kishor Patwardhan, Vaibhav Jaisawal and Sankha Shubhra Chakrabarti

Volume 47, issue 11, 2024

Adopting STOPP/START Criteria Version 3 in Clinical Practice: A Q&A Guide for Healthcare Professionals pp. 1061-1074

Carlotta Lunghi, Marco Domenicali, Stefano Vertullo, Emanuel Raschi, Fabrizio De Ponti, Graziano Onder and Elisabetta Poluzzi

A Systematic Overview of Contraindications and Special Warnings for Biologic and Targeted Synthetic Disease Modifying Antirheumatic Drugs: Establishing a Framework to Create a “Safety Checklist” pp. 1075-1093

Lykke Skaarup, Elvina Ingrid, Alexandre Sepriano, Elena Nikiphorou, René Østgård, Kim Lauper, Ilona Grosse-Michaelis, Margreet Kloppenburg, Bente Glintborg, David F. L. Liew and Tue W. Kragstrup

Tardive Dyskinesia with Antipsychotic Medication in Children and Adolescents: A Systematic Literature Review pp. 1095-1126

Frank M. C. Besag, Michael J. Vasey, Iffah Salim and Chris Hollis

Identification of Pregnancy Adverse Drug Reactions in Pharmacovigilance Reporting Systems: A Novel Algorithm Developed in EudraVigilance pp. 1127-1136

Cosimo Zaccaria, Loris Piccolo, María Gordillo-Marañón, Gilles Touraille and Corinne Vries

Enhanced Safety Surveillance of GSK’s Inactivated Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany, and Spain During the 2022/2023 Influenza Season pp. 1137-1148

Ignacio Salamanca Cueva, Jennifer E. Gerber, Andrew Hastie, Carlos Brotons, Falko Panzer, Jean-Yves Pirçon, Paul Talsma, Tamara Eckermann, Vanja Nikic, Xavier Martinez Gomez and Hannah Alsdurf

Optimal Significance Levels and Sample Sizes for Signal Detection Methods Based on Non-constant Hazards pp. 1149-1156

Odile Sauzet, Julia Dyck and Victoria Cornelius

Acute Appendicitis After COVID-19 Vaccines in Italy: A Self-Controlled Case Series Study pp. 1157-1169

Cristina Morciano, Marco Massari, Maria Cutillo, Valeria Belleudi, Gianluca Trifirò, Nadia Mores, Ester Sapigni, Aurora Puccini, Giovanna Zanoni, Manuel Zorzi, Giuseppe Monaco, Olivia Leoni, Stefania Del Zotto, Sarah Samez, Flavia Mayer, Giuseppe Marano, Francesca Menniti Ippolito, Roberto Da Cas, Giuseppe Traversa and Stefania Spila Alegiani

The Methodological Quality of Observational Studies Examining the Risk of Pregnancy Drug Use on Congenital Malformations Needs Substantial Improvement: A Cross-Sectional Survey pp. 1171-1188

Yulong Jia, Jing Wang, Chunrong Liu, Peng Zhao, Yan Ren, Yiquan Xiong, GuoWei Li, Meng Chen, Xin Sun and Jing Tan

Volume 47, issue 10, 2024

Use of the Sentinel System to Examine Medical Product Use and Outcomes During Pregnancy pp. 931-940

Jennifer G. Lyons, Mayura U. Shinde, Judith C. Maro, Andrew Petrone, Austin Cosgrove, Maria E. Kempner, Susan E. Andrade, Jamila Mwidau, Danijela Stojanovic, José J. Hernández-Muñoz and Sengwee Toh

The STAR Compass to Guide Future Pharmacovigilance Based on a 10-Year Review of the Strengthened EU System pp. 941-956

Priya Bahri, Georgy Genov, Peter Arlett, Viola Macolić Šarinić, Evdokia Korakianiti, Alexis Nolte, Martin Huber and Sabine M. J. M. Straus

Pharmacovigilance in Pregnancy Studies, Exposures and Outcomes Ascertainment, and Findings from Low- and Middle-Income Countries: A Scoping Review pp. 957-990

Jenine Shafi, Maneet K. Virk, Emma Kalk, James G. Carlucci, Audrey Chepkemoi, Caitlin Bernard, Megan S. McHenry, Edwin Were, John Humphrey, Mary-Ann Davies, Ushma C. Mehta and Rena C. Patel

Safety and Effectiveness of COVID-19 Vaccines During Pregnancy: A Living Systematic Review and Meta-analysis pp. 991-1010

Agustín Ciapponi, Mabel Berrueta, Fernando J. Argento, Jamile Ballivian, Ariel Bardach, Martin E. Brizuela, Noelia Castellana, Daniel Comandé, Sami Gottlieb, Beate Kampmann, Agustina Mazzoni, Edward P. K. Parker, Juan M. Sambade, Katharina Stegelmann, Xu Xiong, Andy Stergachis and Pierre Buekens

What is the Safety of COVID-19 Vaccines in Immunocompromised Patients? Results from the European “Covid Vaccine Monitor” Active Surveillance Study pp. 1011-1023

Chiara Bellitto, Nicoletta Luxi, Francesco Ciccimarra, Luca L’Abbate, Monika Raethke, Florence Hunsel, Thomas Lieber, Erik Mulder, Fabio Riefolo, Felipe Villalobos, Nicolas H. Thurin, Francisco B. Marques, Kathryn Morton, Fergal O’Shaughnessy, Simona Sonderlichová, Andreea Farcas, Giele-Eshuis Janneke, Miriam C. Sturkenboom and Gianluca Trifirò

Real-World Effectiveness and Safety of Tixagevimab–Cilgavimab: A Target Trial Emulation Study pp. 1025-1037

Vincent Ka Chun Yan, Yu Yang, Eric Yuk Fai Wan, Francisco Tsz Tsun Lai, Celine Sze Ling Chui, Xue Li, Carlos King Ho Wong, Ivan Fan Ngai Hung, Chak Sing Lau, Ian Chi Kei Wong and Esther Wai Yin Chan

Pregnancy Outcomes in Patients Treated with Upadacitinib: Analysis of Data from Clinical Trials and Postmarketing Reports pp. 1039-1049

Uma Mahadevan, Gweneth Levy, Lianne Gensler, Mira Ali, Ana P. Lacerda, Lani Wegrzyn, Hannah Palac, Tina Bhutani-Jacques, Millie Long, Megan E. B. Clowse, Alexa B. Kimball, Christina Chambers and Anthony R. Scialli

The PrescIT platform: An interoperable Clinical Decision Support System for ePrescription to Prevent Adverse Drug Reactions and Drug-Drug Interactions pp. 1051-1059

Pantelis Natsiavas, George Nikolaidis, Jenny Pliatsika, Achilles Chytas, George Giannios, Haralampos Karanikas, Margarita Grammatikopoulou, Martha Zachariadou, Vlasios Dimitriadis, Spiros Nikolopoulos and Ioannis Kompatsiaris

Volume 47, issue 9, 2024

Proceedings of the Canadian Medication Appropriateness and Deprescribing Network’s 2023 National Meeting pp. 829-839

Tiphaine Pierson, Verna Arcand, Barbara Farrell, Camille L. Gagnon, Larry Leung, Lisa M. McCarthy, Andrea L. Murphy, Nav Persaud, Lalitha Raman-Wilms, James L. Silvius, Michael A. Steinman, Cara Tannenbaum, Wade Thompson, Johanna Trimble, Cheryl A. Sadowski and Emily G. McDonald

Bridging the Evidence Gap: Sotrovimab Use in Pregnancy and the Need for Comprehensive Drug Safety Data pp. 841-842

Ursula Winterfeld

Use of Sotrovimab in Pregnancy: Experiences from the COVID-19 International Drug Pregnancy Registry pp. 843-851

Diego F. Wyszynski, Lydia Demetriou, Cheryl Renz, Shirin Aliabadi, Dragutin Rafailovic, Lee P. Shulman, Myriam Drysdale and Keele E. Wurst

Key Opinion Leaders’ Interviews to Inform the Future of Benefit–Risk Planning in the Medical Total Product Life Cycle of Global Pharmaceutical and Medical Device Organizations pp. 853-868

Arianna Simonetti, Susan Colilla, Brian Edwards, Jürgen Kübler, Leila Lackey, Lisa Rodriguez, Susan Talbot, Hong Yang, William Wang, Danae Williams and James Matthew Higginson

Targeting CCL24 in Inflammatory and Fibrotic Diseases: Rationale and Results from Three CM-101 Phase 1 Studies pp. 869-881

Adi Mor, Scott Friedman, Sharon Hashmueli, Amnon Peled, Massimo Pinzani, Matthew Frankel and Rifaat Safadi

Post-Conceptional Exposure to Clomiphene Citrate and Congenital Malformations: A Cohort Study pp. 883-894

Rebeccah Nehard, Catherine Vauzelle, Delphine Beghin, Mathilde Latour, Elisabeth Elefant, Bénédicte Coulm and Benoît Marin

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-exposure pp. 895-907

Vera Battini, Marianna Cocco, Maria Antonietta Barbieri, Greg Powell, Carla Carnovale, Emilio Clementi, Andrew Bate and Maurizio Sessa

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 pp. 909-919

Mufaddal Mahesri, Ameet Sarpatwari, Krista F. Huybrechts, Joyce Lii, Su Been Lee, Gita A. Toyserkani, Cynthia LaCivita, Esther H. Zhou, Gerald J. Dal Pan, Aaron S. Kesselheim and Katsiaryna Bykov

Can We Ask ChatGPT About Drug Safety? Appropriateness of ChatGPT Responses to Questions About Drug Use and Adverse Reactions Received by Pharmacovigilance Centers pp. 921-923

Antoine Pariente, Francesco Salvo, Virginie Bres and Jean-Luc Faillie

Correction to: Sharing Adverse Drug Event Reports Between Hospitals and Community Pharmacists to Inform Re-dispensing: An Analysis of Reports and Process Outcomes pp. 925-930

Amber Cragg, Serena S. Small, Erica Lau, Adrianna Rowe, Anthony Lau, Katherine Butcher and Corinne M. Hohl

Volume 47, issue 8, 2024

Competing Benefits and Competing Hazards: The Benefit to Harm Balance in Individual Patients in Rational Therapeutics pp. 721-731

Robin E. Ferner and Jeffrey K. Aronson

Behavioral Science: Enhancing Our Approach to the Development of Effective Additional Risk Minimization Strategies pp. 733-743

Joanne Treacy, Elaine H. Morrato, Robert Horne, Michael S. Wolf, Ameet Bakhai, Marie-Claire Wilson, Mark Lightowler, Sibel Guerler and Jeremy Jokinen

Antipsychotic-Related DRESS Syndrome: Analysis of Individual Case Safety Reports of the WHO Pharmacovigilance Database pp. 745-757

Renato de Filippis, John M. Kane, Elena Arzenton, Ugo Moretti, Emanuel Raschi, Gianluca Trifirò, Corrado Barbui, Pasquale De Fazio, Chiara Gastaldon and Georgios Schoretsanitis

Dipeptidyl Peptidase-4 Inhibitors and the Risk of Gallbladder and Bile Duct Disease Among Patients with Type 2 Diabetes: A Population-Based Cohort Study pp. 759-769

Samantha B. Shapiro, Hui Yin, Oriana H. Y. Yu and Laurent Azoulay

Predictors of Adverse Drug Reaction-Related Hospitalisations Among People with Dementia: A Retrospective Case-Control Study pp. 771-781

Anum Saqib Zaidi, Gregory M. Peterson, Colin M. Curtain and Mohammed S. Salahudeen

COVID-19 Vaccines and Heavy Menstrual Bleeding: The Impact of Media Attention on Reporting to EudraVigilance pp. 783-798

María Gordillo-Marañón, Agnieszka Szmigiel, Vladimíra Yalmanová, Irina Caplanusi, Georgy Genov, David Benee Olsen and Sabine Straus

Risk of Mortality Associated with Potentially Inappropriate Medication Use Including Opioids in Older Adults pp. 799-807

Carina D’Aiuto, Carlotta Lunghi, Line Guénette, Djamal Berbiche, Karine Bertrand and Helen-Maria Vasiliadis

Comparators in Pharmacovigilance: A Quasi-Quantification Bias Analysis pp. 809-819

Christopher A. Gravel, William Bai and Antonios Douros

Comment on: “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” pp. 821-822

Rita Avó-Baião, Raquel Vareda and Andreia Lopes

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-Based Cohort Study” pp. 823-825

Nele Brusselaers

Correction to: Using Social Media as a Source of Real‑World Data for Pharmaceutical Drug Development and Regulatory Decision Making pp. 827-827

Didrik Wessel and Nicolai Pogrebnyakov

Volume 47, issue 7, 2024

Peer Review in Pharmacovigilance: Lens on Disproportionality Analysis pp. 601-605

Emanuel Raschi, Francesco Salvo, Andrew Bate, Fabrizio De Ponti, Elisabetta Poluzzi, Marco Tuccori, Eugène Puijenbroek, Nitin Joshi and Charles Khouri

Lessons Learned on Observed-to-Expected Analysis Using Spontaneous Reports During Mass Vaccination pp. 607-615

María Gordillo-Marañón, Gianmario Candore, Karin Hedenmalm, Kate Browne, Robert Flynn, Loris Piccolo, Aniello Santoro, Cosimo Zaccaria and Xavier Kurz

Enzalutamide: Understanding and Managing Drug Interactions to Improve Patient Safety and Drug Efficacy pp. 617-641

Brandon W. Lennep, Jesse Mack, Srinivasu Poondru, Elizabeth Hood, Brooke D. Looney, Monique Williams, Judeth J. Bianco and Alicia K. Morgans

The Role of Mitochondria in Statin-Induced Myopathy pp. 643-653

Gavin Bell, Anastasia Thoma, Iain P. Hargreaves and Adam P. Lightfoot

The Reporting Recommendations Intended for Pharmaceutical Risk Minimization Evaluation Studies: Standards for Reporting of Implementation Studies Extension (RIMES-SE) pp. 655-671

Meredith Y. Smith, Elaine H. Morrato, Nallely Mora, Viviana Nguyen, Hilary Pinnock and Almut G. Winterstein

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 pp. 673-686

Hyunjoo Kim, Nayeong Son, Dahee Jeong, Myungsik Yoo, In Young Choi, Wona Choi, Yeon Woong Chung, Sung Woo Ko, Seonjeong Byun, Sun Im, Da Woon Sim, Jewon Seo, Min-Gyu Kang, Jun Kyu Lee, Young-Gyun Seo, Hye-Ji An, Yeesuk Kim, Sungeu Chae, Dae Won Jun, Dong-Jin Chang, Seong Geun Kim, Siyeon Yi, Hyeon-Jong Yang, Inho Lee, Hye Jung Park, Jae-Hyun Lee, Bonggi Kim and Eunkyung Euni Lee

Fatal Intoxications with Zopiclone—A Cause for Concern? pp. 687-697

Lova Tralla, Sara Gustavsson, Carl Söderberg, Anna K. Jönsson and Fredrik C. Kugelberg

Composite Plot for Visualizing Aminotransferase and Bilirubin Changes in Clinical Trials of Subjects with Abnormal Baseline Values pp. 699-710

Bereket Tesfaldet, Tejas Patel, Minjun Chen, Frank Pucino, Lilliam Rosario, Paul Hayashi and Eileen Navarro Almario

The Safety of Ixekizumab in Chinese Adults with Moderate-to-Severe Plaque Psoriasis: Analyses from a Prospective, Single-Arm, Multicenter, 12-Week Observational Study pp. 711-719

Ying Li, Lin Dang, Chengzhi Lv, Bingjiang Lin, Juan Tao, Nan Yu, Ya Deng, Huiping Wang, Xiaojing Kang, Hui Qin, Rong Chen, Jinnan Li, Yunsheng Liang, Yanhua Liang and Yuling Shi

Volume 47, issue 6, 2024

A Framework for Promoting Safety Monitoring of Herbal Medicines: The International Society of Pharmacovigilance Special Interest Group on Herbal and Traditional Medicines pp. 515-520

Souad Skalli, Angela Caro-Rojas, Hadir Rostom and Mohamed A. Elhawary

The Role of Pharmacogenomics in Rare Diseases pp. 521-528

Alice Man, Gabriella S. S. Groeneweg, Colin J. D. Ross and Bruce C. Carleton

The Problems with Online Health Product Sales: How can Regulations be Improved? pp. 529-533

Yi Jing Sng, Daryl Kwok, Eugene Goh, Annie Tan, Jessica Teo and Cheng Leng Chan

Detection Algorithms for Simple Two-Group Comparisons Using Spontaneous Reporting Systems pp. 535-543

Yoshihiro Noguchi and Tomoaki Yoshimura

Risk Factors Associated with Medication Administration Errors in Children: A Prospective Direct Observational Study of Paediatric Inpatients pp. 545-556

Johanna I. Westbrook, Ling Li, Amanda Woods, Tim Badgery-Parker, Virginia Mumford, Alison Merchant, Erin Fitzpatrick and Magdalena Z. Raban

Drug–Drug Interactions and Actual Harm to Hospitalized Patients: A Multicentre Study Examining the Prevalence Pre- and Post-Electronic Medication System Implementation pp. 557-569

Ling Li, Jannah Baker, Renee Quirk, Danielle Deidun, Maria Moran, Ahmed Abo Salem, Nanda Aryal, Bethany A. Dort, Wu Yi Zheng, Andrew Hargreaves, Paula Doherty, Sarah N. Hilmer, Richard O. Day, Johanna I. Westbrook and Melissa T. Baysari

Not Just Another Reporting Guideline? Here’s Why READUS-PV is a Major Step Forward pp. 571-573

Yoon K. Loke

The Reporting of a Disproportionality Analysis for Drug Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Development and Statement pp. 575-584

Michele Fusaroli, Francesco Salvo, Bernard Begaud, Thamir M. AlShammari, Andrew Bate, Vera Battini, Andreas Brueckner, Gianmario Candore, Carla Carnovale, Salvatore Crisafulli, Paola Maria Cutroneo, Charles Dolladille, Milou-Daniel Drici, Jean-Luc Faillie, Adam Goldman, Manfred Hauben, Maria Teresa Herdeiro, Olivia Mahaux, Katrin Manlik, François Montastruc, Yoshihiro Noguchi, G. Niklas Norén, Roberta Noseda, Igho J. Onakpoya, Antoine Pariente, Elisabetta Poluzzi, Myriam Salem, Daniele Sartori, Nhung T. H. Trinh, Marco Tuccori, Florence Hunsel, Eugène Puijenbroek, Emanuel Raschi and Charles Khouri

The REporting of A Disproportionality Analysis for DrUg Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Explanation and Elaboration pp. 585-599

Michele Fusaroli, Francesco Salvo, Bernard Begaud, Thamir M. AlShammari, Andrew Bate, Vera Battini, Andreas Brueckner, Gianmario Candore, Carla Carnovale, Salvatore Crisafulli, Paola Maria Cutroneo, Charles Dolladille, Milou-Daniel Drici, Jean-Luc Faillie, Adam Goldman, Manfred Hauben, Maria Teresa Herdeiro, Olivia Mahaux, Katrin Manlik, François Montastruc, Yoshihiro Noguchi, G. Niklas Norén, Roberta Noseda, Igho J. Onakpoya, Antoine Pariente, Elisabetta Poluzzi, Myriam Salem, Daniele Sartori, Nhung T. H. Trinh, Marco Tuccori, Florence Hunsel, Eugène Puijenbroek, Emanuel Raschi and Charles Khouri

Volume 47, issue 5, 2024

The Role of the European Medicines Agency in the Safety Monitoring of COVID-19 Vaccines and Future Directions in Enhancing Vaccine Safety Globally pp. 405-418

Irina Caplanusi, Agnieszka Szmigiel, Menno van der Elst, Marie Louise Schougaard Christiansen, Steffen Thirstrup, Cosimo Zaccaria, Bénédicte Cappelli, Georgy Genov and Sabine Straus

Tacrolimus-Induced Neurotoxicity After Transplant: A Literature Review pp. 419-438

Paige Verona, Jocelyn Edwards, Kassidy Hubert, Federica Avorio, Vincenzina Lo Re, Roberta Stefano, Anna Carollo, Heather Johnson and Alessio Provenzani

Drug-Drug Interactions Between Glucagon-Like Peptide 1 Receptor Agonists and Oral Medications: A Systematic Review pp. 439-451

Bronya Calvarysky, Idit Dotan, Daniel Shepshelovich, Avi Leader and Talia Diker Cohen

In Utero Exposure to Antibiotics and Risk of Serious Infections in the First Year of Life pp. 453-464

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

Risk of Systemic Inflammatory Response Syndrome Following Preoperative Glucocorticoids Administration in Patients After Percutaneous Nephrolithotomy: A Retrospective Cohort Study pp. 465-474

Jingping Hu, Chaojin Chen, Xiaoyue Li, Xiangyang Zang, Jie Ke, Shaoli Zhou, Haiyan Mai and Chulian Gong

A Comparison of Signals of Designated Medical Events and Non-designated Medical Events: Results from a Scoping Review pp. 475-485

Daniele Sartori, Jeffrey K. Aronson, Nils Erlanson, G. Niklas Norén and Igho J. Onakpoya

Safety of Simultaneous Administration of Bivalent mRNA COVID-19 and Influenza Vaccines in the Vaccine Adverse Event Reporting System (VAERS) pp. 487-493

Pedro L. Moro, Carol Ennulat, Hannah Brown, Gina Woody, Bicheng Zhang, Paige Marquez, Emily Jane Woo and John R. Su

Using Social Media as a Source of Real-World Data for Pharmaceutical Drug Development and Regulatory Decision Making pp. 495-511

Didrik Wessel and Nicolai Pogrebnyakov

Correction to: Drug-Induced Liver Injury in the Elderly: Consensus Statements and Recommendations from the IQ-DILI Initiative pp. 513-513

Eric B. Cohen, Meenal Patwardhan, Ritu Raheja, David H. Alpers, Raul J. Andrade, Mark I. Avigan, James H. Lewis, Don C. Rockey, Francis Chui, Alexandru M. Iacob, Camila C. Linardi, Arie Regev, Jesse Shick and M. Isabel Lucena

Volume 47, issue 4, 2024

The Critical Intersect of Regulations, Health Technology Assessment, and Drug Safety Assessments pp. 289-299

Wen-Wen Yang, Yi-Chen Juan, Grace Hui-Min Wu and Raoh-Fang Pwu

Drug-Induced Liver Injury in the Elderly: Consensus Statements and Recommendations from the IQ-DILI Initiative pp. 301-319

Eric B. Cohen, Meenal Patwardhan, Ritu Raheja, David H. Alpers, Raul J. Andrade, Mark I. Avigan, James H. Lewis, Don C. Rockey, Francis Chui, Alexandru M. Iacob, Camila C. Linardi, Arie Regev, Jesse Shick and M Isabel Lucena

Consensus Guidelines: Best Practices for the Prevention, Detection and Management of Hepatitis B Virus Reactivation in Clinical Trials with Immunosuppressive/Immunomodulatory Therapy pp. 321-332

Eric B. Cohen, Arie Regev, Anju Garg, Adrian M. Bisceglie, James H. Lewis, John M. Vierling, Judith Hey-Hadavi, Klaudia Steplewski, Anna Fettiplace, Chunlin L. Chen, Nonko Pehlivanov, Stuart Kendrick and Mark I. Avigan

Drug-Induced Progressive Multifocal Leukoencephalopathy (PML): A Systematic Review and Meta-Analysis pp. 333-354

Lorenzo Vittorio Rindi, Drieda Zaçe, Neva Braccialarghe, Barbara Massa, Virginia Barchi, Roberta Iannazzo, Ilenia Fato, Francesco Maria, Dimitra Kontogiannis, Vincenzo Malagnino, Loredana Sarmati and Marco Iannetta

Drug-Gene Risk Stratification in Patients with Suspected Drug-Induced Interstitial Lung Disease pp. 355-363

Marjolein Drent, Petal A. Wijnen, Naomi T. Jessurun, Ankie M. Harmsze, Otto Bekers and Aalt Bast

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 pp. 365-375

Gaël Santos, Raghavendra Devadiga, Chun Soo Kim and Joon Bang

Sociodemographic Characteristics of Adverse Event Reporting in the USA: An Ecologic Study pp. 377-387

Monica A. Muñoz, Gerald J. Dal Pan, Yu-Jung Jenny Wei, Hong Xiao, Chris Delcher, Andrew Giffin, Nabila Sadiq and Almut G. Winterstein

Exploring the Role of Guidelines in Contributing to Medication Errors: A Descriptive Analysis of National Patient Safety Incident Data pp. 389-400

Matthew D. Jones, Shaojun Liu, Freyja Powell, Asma Samsor, Felicity Chao Ru Ting, Nikolaos Veliotis, Yin Mei Wong, Bryony Dean Franklin and Sara Garfield

Comment on “Serially Combining Epidemiological Designs Does Not Improve Overall Signal Detection in Vaccine Safety Surveillance” pp. 401-402

Wan-Ting Huang, Robert T. Chen and Caroline Cassard

Authors’ Response to Huang et al.’s Comment on “Serially Combining Epidemiological Designs Does Not Improve Overall Signal Detection in Vaccine Safety Surveillance” pp. 403-404

Fan Bu, Faaizah Arshad, George Hripcsak, Patrick B. Ryan, Martijn J. Schuemie and Marc A. Suchard

Volume 47, issue 3, 2024

The COVID-19 International Drug Pregnancy Registry (COVID-PR): Protocol Considerations pp. 195-204

Diego F. Wyszynski, Aris T. Papageorghiou, Cheryl Renz, Torri D. Metz and Sonia Hernández-Díaz

An Overview of Regression Models for Adverse Events Analysis pp. 205-216

Elsa Coz, Mathieu Fauvernier and Delphine Maucort-Boulch

Promoting Collaboration of Regulators and Patients in Improving Drug Safety and Regulatory Decision Making pp. 217-225

Yoong Khean Khoo, John C. W. Lim, Wei Chuen Tan-Koi, Nokuthula Sikhethiwe Kitikiti and Ai Ling Sim-Devadas

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 pp. 227-236

Guillaume Favre, Jonathan L. Richardson, Alan Moore, Yvonne Geissbühler, Valentine Jehl, Alison Oliver, Svetlana Shechtman, Orna Diav-Citrin, Maya Berlin, Tal Haan, David Baud, Alice Panchaud, Anil Mor, Meritxell Sabidó, Sabrina Souza, Christina Chambers, Yrea R. J. Rijt-Weetink, Eugène P. Puijenbroek, Laura M. Yates, François Girardin, Michael Stellfeld and Ursula Winterfeld

International Trends in Adverse Drug Event-Related Mortality from 2001 to 2019: An Analysis of the World Health Organization Mortality Database from 54 Countries pp. 237-249

Toshihiro Koyama, Shunya Iinuma, Michio Yamamoto, Takahiro Niimura, Yuka Osaki, Sayoko Nishimura, Ko Harada, Yoshito Zamami and Hideharu Hagiya

Risk of Major Bleeding Associated with Concomitant Direct-Acting Oral Anticoagulant and Clopidogrel Use: A Retrospective Cohort Study pp. 251-260

Y. Joseph Hwang, Hsien-Yen Chang, Thomas Metkus, Kathleen M. Andersen, Sonal Singh, G. Caleb Alexander and Hemalkumar B. Mehta

Validation of a Novel Method to Assess the Clinical Quality of Information in Pregnancy-Related Pharmacovigilance Case Reports: A ConcePTION Project pp. 261-270

Yrea R. J. Rijt-Weetink, Toine C. G. Egberts, Florence P. A. M. Hunsel, David J. Lewis, Laura M. Yates, Ursula Winterfeld and Eugène P. Puijenbroek

Enhancing Transparency in Defining Studied Drugs: The Open-Source Living DiAna Dictionary for Standardizing Drug Names in the FAERS pp. 271-284

Michele Fusaroli, Valentina Giunchi, Vera Battini, Stefano Puligheddu, Charles Khouri, Carla Carnovale, Emanuel Raschi and Elisabetta Poluzzi

The Moroccan Experience of Implementing a University Curriculum for the Pharmacovigilance of Herbal Medicines (Phytovigilance) pp. 285-286

Souad Skalli

Correction to: The Moroccan Experience of Implementing a University Curriculum for the Pharmacovigilance of Herbal Medicines (Phytovigilance) pp. 287-288

Souad Skalli

Volume 47, issue 2, 2024

Appeal for Increasing the Impact of Pharmacovigilance pp. 113-116

Agnes C. Kant

The Unseen Hand: AI-Based Prescribing Decision Support Tools and the Evaluation of Drug Safety and Effectiveness pp. 117-123

Harriet Dickinson, Dana Y. Teltsch, Jan Feifel, Philip Hunt, Enriqueta Vallejo-Yagüe, Arti V. Virkud, Katoo M. Muylle, Taichi Ochi, Macarius Donneyong, Joseph Zabinski, Victoria Y. Strauss and Juan M. Hincapie-Castillo

SGLT2 Inhibitor Use and Risk of Breast Cancer Among Adult Women with Type 2 Diabetes pp. 125-133

Fengge Wang, Michael Hendryx, Nianjun Liu, Aurelian Bidulescu, Anirban K. Mitra and Juhua Luo

Effectiveness and Respiratory Adverse Events Following Inactivated and mRNA COVID-19 Vaccines in Patients with COPD and Asthma: A Chinese Population-Based Study pp. 135-146

Simon Xiwen Qin, Franco Wing Tak Cheng, Wang Chun Kwok, Lydia W. Y. Fung, Tian Tian Ma, Hei Hang Edmund Yiu, Chloe Bloom, Christine F. McDonald, Ching-Lung Cheung, Francisco Tsz Tsun Lai, Celine Sze Ling Chui, Xue Li, Carlos King Ho Wong, Eric Yuk Fai Wan, Ian Chi Kei Wong and Esther Wai Yin Chan

Enhancing Pharmacovigilance in Côte d'Ivoire: Impact of GSK’s Training and Mentoring Pilot Project in the Abidjan Region pp. 147-159

Yolanda Guerra Mendoza, Viviane Jusot, Félix Adou, Martin Ota, Diego Mpia Elenge, Tasim Begum, Nkululeko Mdladla, Olga Menang, Jean Claude Yavo and Mamadou Kamagaté

A Descriptive Analysis of Adverse Event Reports from the Quebec Cannabis Registry pp. 161-171

Yasmina Hachem, Yola Moride, Anne-Marie Castilloux, Genaro Castillon, Maja Kalaba, Andrée Néron, Rihab Gamaoun, Marc O. Martel, Pierre Beaulieu, Mark Ware and Antonio Vigano

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 pp. 173-182

Guojun Dong, Andrew Bate, François Haguinet, Gabriel Westman, Luise Dürlich, Anders Hviid and Maurizio Sessa

Implementation of a Taxonomy-Based Framework for the Selection of Appropriate Drugs and Outcomes for Real-World Data Signal Detection Studies pp. 183-192

Astrid Coste, Angel YS Wong, Charlotte Warren-Gash, Julian Matthewman, Andrew Bate and Ian J. Douglas

Correction to: Patient-Reported Reasons for Antihypertensive Medication Change: A Quantitative Study Using Social Media pp. 193-193

Cristina Micale, Su Golder, Karen O’Connor, Davy Weissenbacher, Robert Gross, Sean Hennessy and Graciela Gonzalez-Hernandez

Volume 47, issue 1, 2024

Industry Review of Best Practices for Risk Management of Drug-Induced Liver Injury from Development to Real-World Use pp. 1-22

Loreta Marquez, Ritu Raheja, May Chan-Liston, John Marcinak, Alvin Estilo, Liliam Pineda Salgado, Jason Jiang, Curtis Chang and Paul Beninger

Cognitive Safety is Largely Ignored in Clinical Drug Trials: A Study of Registered Study Protocols pp. 23-28

Arne Reimers and Hanna Ljung

Intravenous Medication Administration Safety with Smart Infusion Pumps in the Neonatal Intensive Care Unit: An Observational Study pp. 29-38

Kumiko O. Schnock, Sara E. Rostas, Catherine S. Yoon, Stuart Lipsitz, David W. Bates and Patricia C. Dykes

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 pp. 39-57

Bruce Strober, Laura C. Coates, Mark G. Lebwohl, Atul Deodhar, Evan Leibowitz, Katelyn Rowland, Alexa P. Kollmeier, Megan Miller, Yanli Wang, Shu Li, Soumya D. Chakravarty, Daphne Chan, May Shawi, Ya-Wen Yang, Diamant Thaҫi and Proton Rahman

Chronic Obstructive Pulmonary Disease Adverse Event Signals Associated with Potential Inhibitors of Glutathione Peroxidase 1: A Sequence Symmetry Analysis pp. 59-70

Jack L. Janetzki, Matthew J. Sykes, Michael B. Ward and Nicole L. Pratt

Validation of a Natural Language Machine Learning Model for Safety Literature Surveillance pp. 71-80

Jiyoon Park, Malek Djelassi, Daniel Chima, Robert Hernandez, Vladimir Poroshin, Ana-Maria Iliescu, Douglas Domalik and Noel Southall

Patient-Reported Reasons for Antihypertensive Medication Change: A Quantitative Study Using Social Media pp. 81-91

Cristina Micale, Su Golder, Karen O’Connor, Davy Weissenbacher, Robert Gross, Sean Hennessy and Graciela Gonzalez-Hernandez

Application of an Innovative Data Mining Approach Towards Safe Polypharmacy Practice in Older Adults pp. 93-102

Yi Shi, Chien-Wei Chiang, Kathleen T. Unroe, Ximena Oyarzun-Gonzalez, Anna Sun, Yuedi Yang, Katherine M. Hunold, Jeffrey Caterino, Lang Li, Macarius Donneyong and Pengyue Zhang

Proceedings of the International Ambulatory Drug Safety Symposium: Munich, Germany, June 2023 pp. 103-111

G. Caleb Alexander, Daniel Budnitz, Carmel Hughes, Renke Maas, Alpana Mair, Emily G. McDonald, Andreas D. Meid, Rupert Payne, Hanna M. Seidling, Saad Shakir, Samy Suissa, Cara Tannenbaum, Sebastian Schneeweiss and Tobias Dreischulte