Drug Safety

2012 - 2025

Current editor(s): Nitin Joshi

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Volume 46, issue 12, 2023

Sodium-Glucose Cotransporter 2 Inhibitor-Associated “Ketoacidosis” Versus “Diabetic Ketoacidosis”: The Importance of Accurate Terminology pp. 1303-1305

Tamara Y. Milder, David A. Milder, Jerry R. Greenfield and Richard O. Day

The Role of ISoP in the Advancement of Pharmacovigilance in Low-and Middle-Income Countries (LMICs) pp. 1307-1312

Mohamed A. Elhawary, Comfort K. Ogar, Mónica Tarapués, Angela Caro, Helen Byomire Ndagije, Ghita Benabdallah, Houda Sefiani and Hadir Rostom

Pulmonary Toxicity Associated with Immune Checkpoint Inhibitors-Based Therapy: Current Perspectives and Future Directions pp. 1313-1322

Baohui Hong, Jiabing Zheng, Rong Chen, Caiyun Zheng, Bin Du, Ruping Ni and Jing Yang

The Effect of Sex on the Incidence, Latency, Duration and Perceived Burden of Adverse Events Following Seasonal Influenza Vaccination in the Netherlands pp. 1323-1334

P. Slingerland, Florence P. A. M. Hunsel, T. Lieber, L. Balveren and J. W. Duijster

Supporting Pharmacovigilance Signal Validation and Prioritization with Analyses of Routinely Collected Health Data: Lessons Learned from an EHDEN Network Study pp. 1335-1352

Oskar Gauffin, Judith S. Brand, Sara Hedfors Vidlin, Daniele Sartori, Suvi Asikainen, Martí Català, Etir Chalabi, Daniel Dedman, Ana Danilovic, Talita Duarte-Salles, Maria Teresa García Morales, Saara Hiltunen, Annika M. Jödicke, Milan Lazarevic, Miguel A. Mayer, Jelena Miladinovic, Joseph Mitchell, Andrea Pistillo, Juan Manuel Ramírez-Anguita, Carlen Reyes, Annette Rudolph, Lovisa Sandberg, Ruth Savage, Martijn Schuemie, Dimitrije Spasic, Nhung T. H. Trinh, Nevena Veljkovic, Ankica Vujovic, Marcel Wilde, Alem Zekarias, Peter Rijnbeek, Patrick Ryan, Daniel Prieto-Alhambra and G. Niklas Norén

Drug Utilisation Patterns of Alternatives to Ranitidine-Containing Medicines in Patients Treated with Ranitidine: A Network Analysis of Data from Six European National Databases pp. 1353-1362

Johnmary T. Arinze, Maria A. J. Ridder, Dina Vojinovic, Hanne Ballegooijen, Emanuil Markov, Talita Duarte-Salles, Peter Rijnbeek and Katia M. C. Verhamme

Comparative Analysis of Information Provided in German Adverse Drug Reaction Reports Sent by Physicians, Pharmacists and Consumers pp. 1363-1379

Patrick Christ, Diana Dubrall, Matthias Schmid and Bernhardt Sachs

Impact of Covid-19 Vaccination on Spontaneous Pharmacovigilance Reporting in France pp. 1381-1389

Sibylle Germay, Allison Singier, Francesco Salvo and Antoine Pariente

Long-Term Real-World Post-approval Safety Data of Multiple Biosimilars from One Marketing-Authorization Holder After More than 18 Years Since Their First Biosimilar Launch pp. 1391-1404

Sreedhar Sagi, Pradeep Anjaneya, Sameer Kalsekar, Andrea Kottke and Hillel P. Cohen

Volume 46, issue 11, 2023

Managing Cardiovascular and Cancer Risk Associated with JAK Inhibitors pp. 1049-1071

Victor Yang, Tue W. Kragstrup, Christopher McMaster, Pankti Reid, Namrata Singh, Stine R. Haysen, Philip C. Robinson and David F. L. Liew

Evolution of Cross-Sectional Survey Protocol Quality Over Time: A Case Series of Index U.S. REMS Knowledge Survey Protocols (2007–2020) pp. 1073-1087

Gita A. Toyserkani, Samuel B. Ewusie, Philip Turk, Janifer Quick and Elaine H. Morrato

An Exploratory Study of the Impact of COVID-19 Vaccine Spontaneous Reporting on Masking Signal Detection in EudraVigilance pp. 1089-1103

Benjamin Micallef, Jean-Michel Dogné, Janet Sultana, Sabine M. J. M. Straus, Robert Nisticò, Anthony Serracino-Inglott and John-Joseph Borg

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? pp. 1105-1116

Victoria Odeleye, Omar Masarweh, Jorge Restrepo, Carlos A Alvarez and Ishak A. Mansi

Development and Application of a Data-Driven Signal Detection Method for Surveillance of Adverse Event Variability Across Manufacturing Lots of Biologics pp. 1117-1131

Joshua T. Wilde, Stacy Springs, Jacqueline M. Wolfrum and Retsef Levi

Adverse Drug Reactions to Opioids: A Study in a National Pharmacovigilance Database pp. 1133-1148

Moa Gustafsson, Cristiano Matos, João Joaquim, Joep Scholl and Florence Hunsel

Levothyroxine Treatment Among Pregnant Women and Risk of Seizure in Children: A Population-Based Cohort Study pp. 1149-1159

Grace Mengqin Ge, Kenneth K. C. Man, Edmund C. L. Cheung, Patrick Ip, Wing Cheong Leung, Annie W. C. Kung, Ching-Lung Cheung and Ian C. K. Wong

Sharing Adverse Drug Event Reports Between Hospitals and Community Pharmacists to Inform Re-dispensing: An Analysis of Reports and Process Outcomes pp. 1161-1172

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

Volume 46, issue 10, 2023

Challenges and Opportunities in Accessing and Analysing FAERS Data: A Call Towards a Collaborative Approach pp. 921-926

Valentina Giunchi, Michele Fusaroli, Manfred Hauben, Emanuel Raschi and Elisabetta Poluzzi

Clinical Guidance on the Monitoring and Management of Trastuzumab Deruxtecan (T-DXd)-Related Adverse Events: Insights from an Asia-Pacific Multidisciplinary Panel pp. 927-949

Joanne Wing Yan Chiu, Soo Chin Lee, James Chung-man Ho, Yeon Hee Park, Ta-Chung Chao, Sung-Bae Kim, Elgene Lim, Ching-Hung Lin, Sherene Loi, Su Ying Low, Lynette Li San Teo, Winnie Yeo and Rebecca Dent

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 pp. 951-960

Eun-Yeong Cho, Jung-Eun Cho, Seung Hun Jang and Ki-Eun Hwang

Comparative Safety Surveillance of Triple (IDA) Versus Dual Therapy (DA) in Mass Drug Administration for Elimination of Lymphatic Filariasis in Kenya: A Cohort Event Monitoring Study pp. 961-974

Christabel Khaemba, Abbie Barry, Wyckliff P. Omondi, Elvis Kirui, Margaret Oluka, Gurumurthy Parthasarathi, Sammy M. Njenga, Anastacia Guantai and Eleni Aklillu

Automated Classification of Quality Defect Issues Relating to Substandard Medicines Using a Hybrid Machine Learning and Rule-Based Approach pp. 975-989

Desmond Chun Hwee Teo, Yiting Huang, Sreemanee Raaj Dorajoo, Michelle Sau Yuen Ng, Chih Tzer Choong, Doris Sock Tin Phuah, Dorothy Hooi Myn Tan, Filina Meixuan Tan, Huilin Huang, Maggie Siok Hwee Tan, Suan Tian Koh, Jalene Wang Woon Poh and Pei San Ang

Real-World Safety and Efficacy of Biosimilar CT-P13 in Patients with Immune-Mediated Inflammatory Diseases: Integrated Analysis of Three Japanese Prospective Observational Studies pp. 991-1005

Tsutomu Takeuchi, Kiyohiro Nishikawa, Fumika Yamada, Akimichi Morita, Mamitaro Ohtsuki, Yasuo Suzuki, Mamoru Watanabe, Hisashi Yamanaka and Toshifumi Hibi

Duration of Effectiveness Evaluation of Additional Risk Minimisation Measures for Centrally Authorised Medicinal Products in the EU Between 2012 and 2021 pp. 1007-1020

Sharon C. M. Essink, Inge M. Zomerdijk, Sabine M. J. M. Straus, Helga Gardarsdottir and Marie L. Bruin

A Multi-method Exploratory Evaluation of a Service Designed to Improve Medication Safety for Patients with Monitored Dosage Systems Following Hospital Discharge pp. 1021-1037

Fatema A. Alqenae, Douglas Steinke, Hilary Belither, Peter Robertson, Jennifer Bartlett, Jack Wilkinson, Steven D. Williams, Lawrence Brad, Mark Jeffries, Darren M. Ashcroft and Richard N. Keers

Development of a Framework Structuring Themes in the Course of Adverse Drug Reactions from a Patient’s Perspective pp. 1039-1047

Jette A. Lint, Marlieke Sonnenberg, Harald E. Vonkeman, Bart J. F. Bemt, Eugene P. Puijenbroek and Naomi T. Jessurun

Volume 46, issue 9, 2023

Cardiovascular Toxicity of Immune Checkpoint Inhibitors: A Guide for Clinicians pp. 819-833

Emanuel Raschi, Simone Rossi, Andrea Giglio, Michele Fusaroli, Flavio Burgazzi, Rita Rinaldi and Luciano Potena

Safety and Tolerability of Intravenous Immunoglobulin in Chronic Inflammatory Demyelinating Polyneuropathy: Results of the ProCID Study pp. 835-845

David R. Cornblath, Pieter A. van Doorn, Hans-Peter Hartung, Ingemar S. J. Merkies, Hans D. Katzberg, Doris Hinterberger and Elisabeth Clodi

Finding Needles in the Haystack: Clinical Utility Score for Prioritisation (CUSP), an Automated Approach for Identifying Spontaneous Reports with the Highest Clinical Utility pp. 847-855

Vijay Kara, Greg Powell, Olivia Mahaux, Aparna Jayachandra, Naashika Nyako, Christopher Golds and Andrew Bate

Mapping Strategies to Assess and Increase the Validity of Published Disproportionality Signals: A Meta-Research Study pp. 857-866

Michele Fusaroli, Francesco Salvo, Claire Bernardeau, Maryam Idris, Charles Dolladille, Antoine Pariente, Elisabetta Poluzzi, Emanuel Raschi and Charles Khouri

Adverse Events Following the BNT162b2 mRNA COVID-19 Vaccine (Pfizer-BioNTech) in Aotearoa New Zealand pp. 867-879

Muireann Walton, Vadim Pletzer, Thomas Teunissen, Thomas Lumley and Timothy Hanlon

Disproportionality Analysis of Abemaciclib in the FDA Adverse Event Reporting System: A Real-World Post-Marketing Pharmacovigilance Assessment pp. 881-895

Yamin Shu, Lei Wang, Yiling Ding and Qilin Zhang

The QTc-Bazett Interval in Former Very Preterm Infants in Adolescence and Young Adulthood is Not Different from Term-Born Controls pp. 897-904

Jill Vanthienen, Marine Vassilev Petrov, Thuy Mai Luu, Anik Cloutier, Anke Raaijmakers, Jan A. Staessen, Zhenyu Zhang, Thomas Salaets, Annouschka Laenen, Anne Smits, Anne-Monique Nuyt, Adrien Flahault and Karel Allegaert

Use of Bisphosphonates and the Risk of Skin Ulcer: A National Cohort Study Using Data from the French Health Care Claims Database pp. 905-916

Clément Jambon-Barbara, Claire Bernardeau, Julien Bezin, Matthieu Roustit, Sophie Blaise, Jean-Luc Cracowski and Charles Khouri

Comment on: “Deliberate Self-Poisoning: Real-Time Characterisation of Suicidal Habits and Toxidromes in the Food and Drug Administration Adverse Event Reporting System” pp. 917-918

Emiliano Cappello, Giulia Valdiserra, Marco Bonaso, Sara Ferraro, Irma Convertino and Marco Tuccori

Authors’ Reply to Cappello et al. Comment on: “Deliberate Self-Poisoning: Real-Time Characterization of Suicidal Habits and Toxidromes in the Food and Drug Administration Adverse Event Reporting System” pp. 919-920

Michele Fusaroli, Guido Pelletti, Valentina Giunchi, Emanuel Raschi, Fabrizio De Ponti, Susi Pelotti and Elisabetta Poluzzi

Volume 46, issue 8, 2023

Future of ChatGPT in Pharmacovigilance pp. 711-713

Hanyin Wang, Yanyi Jenny Ding and Yuan Luo

Nephrotoxicity of Amoxicillin and Third-Generation Cephalosporins: An Updated Review pp. 715-724

Anne-Sophie Garnier, Guillaume Drablier, Marie Briet and Jean-François Augusto

Use of Electronic Health Record Data for Drug Safety Signal Identification: A Scoping Review pp. 725-742

Sharon E. Davis, Luke Zabotka, Rishi J. Desai, Shirley V. Wang, Judith C. Maro, Kevin Coughlin, José J. Hernández-Muñoz, Danijela Stojanovic, Nigam H. Shah and Joshua C. Smith

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 pp. 743-751

Fahed Al-Azzawi, Israa Mahmoud, François Haguinet, Andrew Bate and Maurizio Sessa

Hospitalisations Related to Adverse Drug Reactions in Switzerland in 2012–2019: Characteristics, In-Hospital Mortality, and Spontaneous Reporting Rate pp. 753-763

Patrick E. Beeler, Thomas Stammschulte and Holger Dressel

Provision and Characterization of a Corpus for Pharmaceutical, Biomedical Named Entity Recognition for Pharmacovigilance: Evaluation of Language Registers and Training Data Sufficiency pp. 765-779

Jürgen Dietrich and Philipp Kazzer

Automatic Extraction of Comprehensive Drug Safety Information from Adverse Drug Event Narratives in the Korea Adverse Event Reporting System Using Natural Language Processing Techniques pp. 781-795

Siun Kim, Taegwan Kang, Tae Kyu Chung, Yoona Choi, YeSol Hong, Kyomin Jung and Howard Lee

Serially Combining Epidemiological Designs Does Not Improve Overall Signal Detection in Vaccine Safety Surveillance pp. 797-807

Faaizah Arshad, Martijn J. Schuemie, Fan Bu, Evan P. Minty, Thamir M. Alshammari, Lana Y. H. Lai, Talita Duarte-Salles, Stephen Fortin, Fredrik Nyberg, Patrick B. Ryan, George Hripcsak, Daniel Prieto-Alhambra and Marc A. Suchard

Comment on “Rates of Autoimmune Diseases in European Healthcare Databases: A Contribution of the ADVANCE Project” pp. 809-811

Jürgen O. Kirchner

Authors’ Reply to Juergen O Kirchner’s Comment on “Incidence Rates of Autoimmune Diseases in European Healthcare Databases: A Contribution of the ADVANCE Project” pp. 813-815

Corinne Willame, Daniel Weibel and Miriam C. J. M. Sturkenboom

Correction to: Comment on: “Should Antidepressants be Avoided in Pregnancy?” pp. 817-817

Alain Braillon, Susan Bewley, Aubrey Blumsohn and Florian Naudet

Volume 46, issue 7, 2023

The ISoP PatEG-SIG for Promoting Patient Engagement in Pharmacovigilance: A Change of Paradigm is Needed pp. 619-623

Manal M. Younus, Mayada Alkhakany, Priya Bahri, Angela Caro, Hadir Rostom, Helen Byomire Ndagije and Mohamed A. Elhawary

Factors Associated with Underreporting of Adverse Drug Reactions by Health Care Professionals: A Systematic Review Update pp. 625-636

Patricia García-Abeijon, Catarina Costa, Margarita Taracido, Maria Teresa Herdeiro, Carla Torre and Adolfo Figueiras

Safety and Effectiveness of Rasagiline in Chinese Patients with Parkinson’s Disease: A Prospective, Multicenter, Non-interventional Post-marketing Study pp. 637-646

Wen Su, Zhanhua Liang, Wei Mao, Ming Shao, Xingyue Hu, Yuncheng Wu, Wenshi Wei, Zhenguo Liu, Kezhong Zhang, Beisha Tang, Shuai Cao, Zhuolun Song and Haibo Chen

Development and Application of an Active Pharmacovigilance Framework Based on Electronic Healthcare Records from Multiple Centers in Korea pp. 647-660

Seon Choe, Suhyun Lee, Chan Hee Park, Jeong Hoon Lee, Hyo Jung Kim, Sun-ju Byeon, Jeong-Hee Choi, Hyeon-Jong Yang, Da Woon Sim, Bum-Joo Cho, Hoseok Koo, Min-Gyu Kang, Ji Bong Jeong, In Young Choi, Sae-Hoon Kim, Woo Jin Kim, Jae-Woo Jung, Sang-Hoon Lhee, Young-Jin Ko, Hye-Kyung Park, Dong Yoon Kang and Ju Han Kim

Prenatal exposure to pregabalin, birth outcomes and neurodevelopment – a population-based cohort study in four Nordic countries pp. 661-675

Elena Dudukina, Szimonetta Komjáthiné Szépligeti, Pär Karlsson, Kofi Asomaning, Anne Kjersti Daltveit, Katja Hakkarainen, Fabian Hoti, Helle Kieler, Astrid Lunde, Ingvild Odsbu, Matti Rantanen, Johan Reutfors, Laura Saarelainen, Vera Ehrenstein and Gunnar Toft

Expert Consensus on the Nephrotoxic Potential of 195 Medications in the Non-intensive Care Setting: A Modified Delphi Method pp. 677-687

Britney A. Stottlemyer, Kaleab Z. Abebe, Paul M. Palevsky, Linda Fried, Ivonne H. Schulman, Chirag R. Parikh, Emilio Poggio, Edward D. Siew, Orlando M. Gutierrez, Edward Horwitz, Matthew R. Weir, F. Perry Wilson and Sandra L. Kane-Gill

Impact of 2018 EU Risk Minimisation Measures and Revised Pregnancy Prevention Programme on Utilisation and Prescribing Trends of Medicinal Products Containing Valproate: An Interrupted Time Series Study pp. 689-702

Shahab Abtahi, Romin Pajouheshnia, Carlos E. Durán, Judit Riera-Arnau, Magdalena Gamba, Ema Alsina, Vjola Hoxhaj, Morten Andersen, Claudia Bartolini, Sarah Brøgger Kristiansen, Jeremy Brown, Christine Erikstrup Hallgreen, Patricia Garcia-Poza, Helga Gardarsdottir, Rosa Gini, Anna Girardi, Emily Holthuis, Consuelo Huerta, Luisa Ibánez, Giorgio Limoncella, Mar Martín-Pérez, Olga Paoletti, Giuseppe Roberto, Patrick Souverein, Karin M. A. Swart, Kevin Wing, Miriam Sturkenboom and Olaf Klungel

Sustained Decline of Direct General Practitioner Reporting of Adverse Drug Reactions in Australia and Paucity in Details of Australian Reports in Safety Advisories pp. 703-710

Ian W. Boyd and John McEwen

Volume 46, issue 6, 2023

Communicating for the Safe Use of Medicines: Progress and Directions for the 2020s Promoted by the Special Interest Group of the International Society of Pharmacovigilance pp. 517-532

Priya Bahri, Geoffrey Bowring, Brian D. Edwards, Christopher Anton, Jeffrey K. Aronson, Angela Caro-Rojas, Bruce P. J. Hugman, Peter G. Mol, Gianluca Trifirò, Katarina Ilic, Riadh Daghfous, Irene Fermont, Giovanni Furlan, Wolfgang Gaissmaier, Mohammad Ishaq Geer, Kenneth Y. Hartigan-Go, François Houÿez, Hansjörg Neth, Gediminas Norgela, Yaowares Oppamayun, D. K. Theo Raynor, Mehdi Bouhlel, Federica Santoro and Janet Sultana

Impact of Lifestyle and Socioeconomic Position on the Association Between Non-steroidal Anti-inflammatory Drug Use and Major Adverse Cardiovascular Events: A Case-Crossover Study pp. 533-543

Kasper Bonnesen, Lars Pedersen, Vera Ehrenstein, Marie Stjerne Grønkjær, Henrik Toft Sørensen, Jesper Hallas, Timothy Lee Lash and Morten Schmidt

Cardiovascular Toxicities Associated with Anaplastic Lymphoma Kinase Inhibitors: A Disproportionality Analysis of the WHO Pharmacovigilance Database (VigiBase) pp. 545-552

Takahiro Niimura, Koji Miyata, Hirofumi Hamano, Yuuki Nounin, Hiroto Unten, Masaki Yoshino, Satoru Mitsuboshi, Fuka Aizawa, Kenta Yagi, Toshihiro Koyama, Mitsuhiro Goda, Yasunari Kanda, Yuki Izawa-Ishizawa, Yoshito Zamami and Keisuke Ishizawa

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 pp. 553-563

Upinder Kaur, Zeba Fatima, Kalika Maheshwari, Vikas Sahni, Amol Dehade, Anju Kl, Ashish Kumar Yadav, Sangeeta Kansal, Vaibhav Jaisawal and Sankha Shubhra Chakrabarti

Facilitators and Barriers to Uptake of the Med Safety Mobile App for Adverse Drug Reaction Reporting by Health Workers in Uganda: A Qualitative Study pp. 565-574

Ronald Kiguba, Henry Zakumumpa, Helen B. Ndagije, Norah Mwebaza, Ronald Ssenyonga, Phil Tregunno, Kendal Harrison and Munir Pirmohamed

Safety of COVID-19 Vaccines Among the Paediatric Population: Analysis of the European Surveillance Systems and Pivotal Clinical Trials pp. 575-585

Fariba Ahmadizar, Nicoletta Luxi, Monika Raethke, Sandor Schmikli, Fabio Riefolo, Putri Widi Saraswati, Camelia Bucsa, Alhadi Osman, Megan Liddiard, Francisco Batel Maques, Giuliana Petrelli, Simona Sonderlichová, Nicolas H. Thurin, Felipe Villalobos, Gianluca Trifirò and Miriam Sturkenboom

The Effect of Metformin on Chemotherapy-Induced Toxicities in Non-diabetic Breast Cancer Patients: A Randomised Controlled Study pp. 587-599

Manar A. Serageldin, Amira B. Kassem, Yasser El-Kerm, Maged W. Helmy, Mahmoud M. El-Mas and Noha A. El-Bassiouny

Identifying Safety Subgroups at Risk: Assessing the Agreement Between Statistical Alerting and Patient Subgroup Risk pp. 601-614

Olivia Mahaux, Greg Powell, François Haguinet, Paulina Sobczak, Namrata Saini, Allen Barry, Amira Mustafa and Andrew Bate

Comment on: "Should Antidepressants be Avoided in Pregnancy?" pp. 615-616

Alain Braillon, Susan Bewley, Aubrey Blumsohn and Florian Naudet

Authors’ Reply to Braillon et al. ’s Comment on “Should Antidepressants be Avoided in Pregnancy?” pp. 617-618

Frank M. C. Besag and Michael J. Vasey

Volume 46, issue 5, 2023

Erice Manifesto 2022: On the Surveillance of Potential Harms Caused by Food Supplements in Europe pp. 435-437

Francesca Menniti-Ippolito, Eugenio Aiello, Elena Arzenton, Alessandro Assisi, Urška Blaznik, Jacqueline J. M. Castenmiller, Marta Crevani, Dominique de Clock, Silvia Di Giacomo, Silvia Emendi, Laura Augusta Gonella, Ilaria Ippoliti, Marie Lindquist, Lara Magro, Gabriela Mazzanti, Nadia Mores, Ugo Moretti, Paola Angela Moro, Budimka Novakovic, Emanuel Raschi, Inese Siksna, Maria Rosa Valetto, Annabella Vitalone and Gwenn Vo Van Regnault

Implications of Non-Specific Effects for Testing, Approving, and Regulating Vaccines pp. 439-448

Christine Stabell Benn, Nelly Amenyogbe, Anders Björkman, Jorge Domínguez-Andrés, Eleanor N. Fish, Katie L. Flanagan, Sabra L. Klein, Tobias R. Kollmann, Kirsten Ohm Kyvik, Mihai G. Netea, Naja Hulvej Rod, Frederik Schaltz-Buchholzer, Frank Shann, Liisa Selin, Sanne M. Thysen and Peter Aaby

Drug–Drug Interactions and the Risk of Emergency Hospitalizations: A Nationwide Population-Based Study pp. 449-456

Louis Létinier, Julien Bezin, Ana Jarne and Antoine Pariente

Validation of an ICD-9-Based Algorithm to Identify Stillbirth Episodes from Medicaid Claims Data pp. 457-465

Sabina O. Nduaguba, Nicole E. Smolinski, Thuy N. Thai, Steven T. Bird, Sonja A. Rasmussen and Almut G. Winterstein

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. 467-478

Lembris L. Njotto, Johanna Simin, Romina Fornes, Ingvild Odsbu, Isabelle Mussche, Steven Callens, Lars Engstrand, Robin Bruyndonckx and Nele Brusselaers

Core Data Elements for Pregnancy Pharmacovigilance Studies Using Primary Source Data Collection Methods: Recommendations from the IMI ConcePTION Project pp. 479-491

Jonathan L. Richardson, Alan Moore, Rebecca L. Bromley, Michael Stellfeld, Yvonne Geissbühler, Matthew Bluett-Duncan, Ursula Winterfeld, Guillaume Favre, Amalia Alexe, Alison M. Oliver, Yrea R. J. Rijt-Weetink, Kenneth K. Hodson, Bita Rezaallah, Eugene P. Puijenbroek, David J. Lewis and Laura M. Yates

Prevalence and Preventability of Adverse Medicine Events in a Sample of Australian Aged-Care Residents: A Secondary Analysis of Data from the ReMInDAR Trial pp. 493-500

Lisa M. Kalisch Ellett, Gerel Dorj, Andre Q. Andrade, Rebecca L. Bilton, Debra Rowett, Joseph Whitehouse, Renly Lim, Nicole L. Pratt, Thu-Lan Kelly, Nibu Parameswaran Nair, Luke Bereznicki, Imaina Widagdo and Elizabeth E. Roughead

Quality of MedDRA® Coding in a Sample of COVID-19 Vaccine Medication Error Data pp. 501-507

Katarina Kralova, Carol-Ann Wilson, Nicolas Richebourg and Joan D’souza

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" pp. 509-512

Oliver Kuss and Wolfgang Rathmann

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 Reporting Data” pp. 513-514

John-Michael Gamble and Wajd Alkabbani

Correction to: Development and Validation of ICD‑10‑CM‑based Algorithms for Date of Last Menstrual Period, Pregnancy Outcomes, and Infant Outcomes pp. 515-515

Andrea K. Chomistek, Kelesitse Phiri, Michael C. Doherty, Jenna F. Calderbank, Stephanie E. Chiuve, Brenda Hinman McIlroy, Michael C. Snabes, Cheryl Enger and John D. Seeger

Volume 46, issue 4, 2023

Real-World Monitoring of COVID-19 Vaccines: An Industry Expert View on the Successes, Challenges, and Future Opportunities pp. 327-333

Vincent Bauchau, Kourtney Davis, Sarah Frise, Corinne Jouquelet-Royer and Jamie Wilkins

Preventable Deaths Involving Medicines: A Systematic Case Series of Coroners’ Reports 2013–22 pp. 335-342

Harrison S. France, Jeffrey K. Aronson, Carl Heneghan, Robin E. Ferner, Anthony R. Cox and Georgia C. Richards

Is PEGylation of Drugs Associated with Hypersensitivity Reactions? An Analysis of the Italian National Spontaneous Adverse Drug Reaction Reporting System pp. 343-355

Salvatore Crisafulli, Paola Maria Cutroneo, Nicoletta Luxi, Andrea Fontana, Carmen Ferrajolo, Pasquale Marchione, Laura Sottosanti, Giovanna Zanoni, Ugo Moretti, Silvia Franzè, Paola Minghetti and Gianluca Trifirò

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 pp. 357-370

Comfort K. Ogar, Jonathan Quick, Hannah N. Gilbert, Rick A. Vreman, Aukje K. Mantel-Teeuwisse and Jean Claude Mugunga

Early Detection of Adverse Drug Reaction Signals by Association Rule Mining Using Large-Scale Administrative Claims Data pp. 371-389

Hiroki Yamamoto, Gen Kayanuma, Takuya Nagashima, Chihiro Toda, Kazuki Nagayasu and Shuji Kaneko

Cohort Event Monitoring of Adverse Reactions to COVID-19 Vaccines in Seven European Countries: Pooled Results on First Dose pp. 391-404

Monika Raethke, Florence Hunsel, Nicolas H. Thurin, Caroline Dureau-Pournin, Dirk Mentzer, Barbara Kovačić, Nikica Mirošević Skvrce, Evelien Clercq, Martine Sabbe, Gianluca Trifirò, Nicoletta Luxi, Alexia Giovanazzi, Saad Shakir, Olaf H. Klungel, Sandor Schmikli and Miriam Sturkenboom

Impact of European Union Label Changes for Fluoroquinolone-Containing Medicinal Products for Systemic and Inhalation Use: Post-Referral Prescribing Trends pp. 405-416

Nelly F. Ly, Clare Flach, Thom S. Lysen, Emanuil Markov, Hanne Ballegooijen, Peter Rijnbeek, Talita Duarte-Salles, Carlen Reyes, Luis H. John, Leila Karimi, Christian Reich, Sam Salek and Deborah Layton

The Rationale for Robust Pharmacovigilance in Monitoring the Safety of Traditional Medicines and Natural Health Products pp. 417-418

Rhiannon Braund

Correction to: Artificial Intelligence Based on Machine Learning in Pharmacovigilance: A Scoping Review pp. 433-433

Benjamin Kompa, Joe B. Hakim, Anil Palepu, Kathryn Grace Kompa, Michael Smith, Paul A. Bain, Stephen Woloszynek, Jeffery L. Painter, Andrew Bate and Andrew L. Beam

Volume 46, issue 3, 2023

Colchicine Drug Interaction Errors and Misunderstandings: Recommendations for Improved Evidence-Based Management pp. 223-242

Philip D. Hansten, Malinda S. Tan, John R. Horn, Ainhoa Gomez-Lumbreras, Lorenzo Villa-Zapata, Richard D. Boyce, Vignesh Subbian, Andrew Romero, Sheila Gephart and Daniel C. Malone

What Factors Make EU Regulators Want to Communicate Drug Safety Issues Related to SGLT2 Inhibitors? An Online Survey Study pp. 243-255

Sonia Roldan Munoz, Douwe Postmus, Sieta T. Vries, Liana Gross-Martirosyan, Priya Bahri, Hans Hillege and Peter G. M. Mol

Comparative Safety Analysis of Opioid Agonist Treatment in Pregnant Women with Opioid Use Disorder: A Population-Based Study pp. 257-271

Shuang Wang, Kimford J. Meador, Jayne Pawasauskas, Adam K. Lewkowitz, Kristina E. Ward, Todd N. Brothers, Abraham Hartzema, Brian J. Quilliam and Xuerong Wen

Effect of Previous Anticoagulant Treatment on Risk of COVID-19 pp. 273-281

Maruxa Zapata-Cachafeiro, Ángela Prieto-Campo, Manuel Portela-Romero, Eduardo Carracedo-Martínez, Martina Lema-Oreiro, María Piñeiro-Lamas, Somnath Chaudhuri, Ángel Salgado-Barreira and Adolfo Figueiras

Deliberate Self-Poisoning: Real-Time Characterization of Suicidal Habits and Toxidromes in the Food and Drug Administration Adverse Event Reporting System pp. 283-295

Michele Fusaroli, Guido Pelletti, Valentina Giunchi, Chiara Pugliese, Mattia Bartolucci, Elena Narmine Necibi, Emanuel Raschi, Fabrizio Ponti, Susi Pelotti and Elisabetta Poluzzi

The COVID-19 Vaccines International Pregnancy Exposure Registry (C-VIPER): Protocol and Methodological Considerations pp. 297-308

Diego F. Wyszynski, Mondira Bhattacharya, Oscar Martínez-Pérez, Anthony R. Scialli, Melissa Tassinari, Naor Bar-Zeev, Cheryl Renz and Sonia Hernández-Díaz

Use of Structured Electronic Health Records Data Elements for the Development of Computable Phenotypes to Identify Potential Adverse Events Associated with Intravenous Immunoglobulin Infusion pp. 309-318

Jillian H. Hurst, Amanda Brucker, Congwen Zhao, Hannah Driscoll, Haley P. Hostetler, Michael Phillips, Bari Rosenberg, Marc D. Samsky, Isaac Smith, Megan E. Reller, John J. Strouse, Cindy Ke Zhou, Graça M. Dores, Hui-Lee Wong and Benjamin A. Goldstein

Optimizing Safety Surveillance for COVID-19 Vaccines at the Swedish Medical Products Agency pp. 319-321

Karl Mikael Kälkner, Anders Sundström, Marja-Leena Nurminen, Maria Larsson, Rickard Ljung and Veronica Arthurson

Correction: 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 pp. 323-323

Khristina Fauvelle and Jean Joel Bigna

Correction to: Individual Case Safety Report Replication: An Analysis of Case Reporting Transmission Networks pp. 325-325

John Stekelenborg, Vijay Kara, Roman Haack, Ulrich Vogel, Anju Garg, Markus Krupp, Kate Gofman, Brian Dreyfus, Manfred Hauben and Andrew Bate

Volume 46, issue 2, 2023

Signals of Adverse Drug Reactions Communicated by Pharmacovigilance Stakeholders: A Scoping Review of the Global Literature pp. 109-120

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

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 pp. 121-128

Khristina Fauvelle and Jean Joel Bigna

Assessment of the Frequency, Phenotypes, and Outcomes of Acute Liver Injury Associated with Amoxicillin/Clavulanate in 1.4 Million Patients in the Veterans Health Administration pp. 129-143

Ayako Suzuki, Hans Tillmann, James Williams, Ronald G. Hauser, Julie Frund, Mizuki Suzuki, Fred Prior, Guruprasad P. Aithal, M. Isabel Lucena, Raúl J. Andrade, Weida Tong and Christine M. Hunt

The Food and Drug Administration’s (FDA’s) Drug Safety Surveillance During the COVID-19 Pandemic pp. 145-155

Ida-Lina Diak, Kimberley Swank, Kate McCartan, Maya Beganovic, James Kidd, Neha Gada, Rachna Kapoor, Lisa Wolf, Laura Kangas, Jo Wyeth, Toni Salvatore, Melina Fanari, Andrew A. LeBoeuf, Poonam Mishra, Michael D. Blum and Gerald Dal Pan

Post-Authorization Safety Study of Hospitalization for Acute Kidney Injury in Patients with Type 2 Diabetes Exposed to Dapagliflozin in a Real-World Setting pp. 157-174

Catherine B. Johannes, Daniel C. Beachler, J. Bradley Layton, Heather E. Danysh, Ryan Ziemiecki, Alejandro Arana, Jade Dinh, Ling Li, Brian Calingaert, Manel Pladevall-Vila, Phillip R. Hunt, Hungta Chen, Cecilia Karlsson, Kristina Johnsson and Alicia Gilsenan

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 pp. 175-193

Heather E. Danysh, Catherine B. Johannes, Daniel C. Beachler, J. Bradley Layton, Ryan Ziemiecki, Alejandro Arana, Jade Dinh, Ling Li, Brian Calingaert, Manel Pladevall-Vila, Phillip R. Hunt, Hungta Chen, Cecilia Karlsson, Kristina Johnsson and Alicia Gilsenan

Mortality in Patients with Parkinson’s Disease-Related Psychosis Treated with Pimavanserin Compared with Other Atypical Antipsychotics: A Cohort Study pp. 195-208

J. Bradley Layton, Joan Forns, Lisa J. McQuay, Heather E. Danysh, Colleen Dempsey, Mary S. Anthony and Mary Ellen Turner

Development and Validation of ICD-10-CM-based Algorithms for Date of Last Menstrual Period, Pregnancy Outcomes, and Infant Outcomes pp. 209-222

Andrea K. Chomistek, Kelesitse Phiri, Michael C. Doherty, Jenna F. Calderbank, Stephanie E. Chiuve, Brenda Hinman McIlroy, Michael C. Snabes, Cheryl Enger and John D. Seeger

Volume 46, issue 1, 2023

Should Antidepressants be Avoided in Pregnancy? pp. 1-17

Frank M. C. Besag and Michael J. Vasey

Potential Risk Factors of Drug-Related Problems in Hospital-Based Mental Health Units: A Systematic Review pp. 19-37

Fatima Q. Alshaikhmubarak, Richard N. Keers and Penny J. Lewis

Individual Case Safety Report Replication: An Analysis of Case Reporting Transmission Networks pp. 39-52

John Stekelenborg, Vijay Kara, Roman Haack, Ulrich Vogel, Anju Garg, Markus Krupp, Kate Gofman, Brian Dreyfus, Manfred Hauben and Andrew Bate

A Population-Based Study of SGLT2 Inhibitor-Associated Postoperative Diabetic Ketoacidosis in Patients with Type 2 Diabetes pp. 53-64

David Tak Wai Lui, Tingting Wu, Ivan Chi Ho Au, Xiaodong Liu, Matrix Man Him Fung, Chi Ho Lee, Carol Ho Yi Fong, Yu Cho Woo, Brian Hung Hin Lang, Kathryn Choon Beng Tan and Carlos King Ho Wong

Optimizing Safety Surveillance for COVID-19 Vaccines at the National Pharmacovigilance Centre Lareb: One Year of COVID-19 Vaccine Experience pp. 65-75

Ingrid Oosterhuis, Joep Scholl, Eugène Puijenbroek, Agnes Kant and Florence Hunsel

Weight Gain During Antipsychotic Treatment in Children, Adolescents, and Adults: A Disproportionality Analysis in the Global Pharmacovigilance Database, Vigibase® pp. 77-85

Florentia Kaguelidou, Zaba Valtuille, Geneviève Durrieu, Richard Delorme, Hugo Peyre, Jean-Marc Treluyer, François Montastruc and Laurent Chouchana

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 pp. 87-97

Sonal Singh, Julie Beyrer, Xiaofeng Zhou, Joel Swerdel, Raymond A. Harvey, Kenneth Hornbuckle, Leo Russo, Kanwal Ghauri, Ivan H. Abi-Elias, John S. Cox and Carla Rodriguez-Watson

Fully Liquid MenACWY-CRM Vaccine: Results from an Integrated Safety Analysis pp. 99-108

Puneet Vir Singh, Paola Tiberi, Gabriele Filippo Di Domenico, Valerio Romolini, Thembile Mzolo, Marco Costantini, Tauseefullah Akhund, Venere Basile, Maria Lattanzi and Michele Pellegrini