Content
May 2024, Volume 47, Issue 5
- 405-418 The Role of the European Medicines Agency in the Safety Monitoring of COVID-19 Vaccines and Future Directions in Enhancing Vaccine Safety Globally
by Irina Caplanusi & Agnieszka Szmigiel & Menno van der Elst & Marie Louise Schougaard Christiansen & Steffen Thirstrup & Cosimo Zaccaria & Bénédicte Cappelli & Georgy Genov & Sabine Straus - 419-438 Tacrolimus-Induced Neurotoxicity After Transplant: A Literature Review
by Paige Verona & Jocelyn Edwards & Kassidy Hubert & Federica Avorio & Vincenzina Lo Re & Roberta Stefano & Anna Carollo & Heather Johnson & Alessio Provenzani - 439-451 Drug-Drug Interactions Between Glucagon-Like Peptide 1 Receptor Agonists and Oral Medications: A Systematic Review
by Bronya Calvarysky & Idit Dotan & Daniel Shepshelovich & Avi Leader & Talia Diker Cohen - 453-464 In Utero Exposure to Antibiotics and Risk of Serious Infections in the First Year of Life
by Mylène Tisseyre & Mathis Collier & Nathanaël Beeker & Florentia Kaguelidou & Jean-Marc Treluyer & Laurent Chouchana - 465-474 Risk of Systemic Inflammatory Response Syndrome Following Preoperative Glucocorticoids Administration in Patients After Percutaneous Nephrolithotomy: A Retrospective Cohort Study
by Jingping Hu & Chaojin Chen & Xiaoyue Li & Xiangyang Zang & Jie Ke & Shaoli Zhou & Haiyan Mai & Chulian Gong - 475-485 A Comparison of Signals of Designated Medical Events and Non-designated Medical Events: Results from a Scoping Review
by Daniele Sartori & Jeffrey K. Aronson & Nils Erlanson & G. Niklas Norén & Igho J. Onakpoya - 487-493 Safety of Simultaneous Administration of Bivalent mRNA COVID-19 and Influenza Vaccines in the Vaccine Adverse Event Reporting System (VAERS)
by Pedro L. Moro & Carol Ennulat & Hannah Brown & Gina Woody & Bicheng Zhang & Paige Marquez & Emily Jane Woo & John R. Su - 495-511 Using Social Media as a Source of Real-World Data for Pharmaceutical Drug Development and Regulatory Decision Making
by Didrik Wessel & Nicolai Pogrebnyakov - 513-513 Correction to: Drug-Induced Liver Injury in the Elderly: Consensus Statements and Recommendations from the IQ-DILI Initiative
by 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 & M. Isabel Lucena
April 2024, Volume 47, Issue 4
- 289-299 The Critical Intersect of Regulations, Health Technology Assessment, and Drug Safety Assessments
by Wen-Wen Yang & Yi-Chen Juan & Grace Hui-Min Wu & Raoh-Fang Pwu - 301-319 Drug-Induced Liver Injury in the Elderly: Consensus Statements and Recommendations from the IQ-DILI Initiative
by 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 & M Isabel Lucena - 321-332 Consensus Guidelines: Best Practices for the Prevention, Detection and Management of Hepatitis B Virus Reactivation in Clinical Trials with Immunosuppressive/Immunomodulatory Therapy
by 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 & Mark I. Avigan - 333-354 Drug-Induced Progressive Multifocal Leukoencephalopathy (PML): A Systematic Review and Meta-Analysis
by Lorenzo Vittorio Rindi & Drieda Zaçe & Neva Braccialarghe & Barbara Massa & Virginia Barchi & Roberta Iannazzo & Ilenia Fato & Francesco Maria & Dimitra Kontogiannis & Vincenzo Malagnino & Loredana Sarmati & Marco Iannetta - 355-363 Drug-Gene Risk Stratification in Patients with Suspected Drug-Induced Interstitial Lung Disease
by Marjolein Drent & Petal A. Wijnen & Naomi T. Jessurun & Ankie M. Harmsze & Otto Bekers & Aalt Bast - 365-375 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
by Gaël Santos & Raghavendra Devadiga & Chun Soo Kim & Joon Bang - 377-387 Sociodemographic Characteristics of Adverse Event Reporting in the USA: An Ecologic Study
by Monica A. Muñoz & Gerald J. Dal Pan & Yu-Jung Jenny Wei & Hong Xiao & Chris Delcher & Andrew Giffin & Nabila Sadiq & Almut G. Winterstein - 389-400 Exploring the Role of Guidelines in Contributing to Medication Errors: A Descriptive Analysis of National Patient Safety Incident Data
by Matthew D. Jones & Shaojun Liu & Freyja Powell & Asma Samsor & Felicity Chao Ru Ting & Nikolaos Veliotis & Yin Mei Wong & Bryony Dean Franklin & Sara Garfield - 401-402 Comment on “Serially Combining Epidemiological Designs Does Not Improve Overall Signal Detection in Vaccine Safety Surveillance”
by Wan-Ting Huang & Robert T. Chen & Caroline Cassard - 403-404 Authors’ Response to Huang et al.’s Comment on “Serially Combining Epidemiological Designs Does Not Improve Overall Signal Detection in Vaccine Safety Surveillance”
by Fan Bu & Faaizah Arshad & George Hripcsak & Patrick B. Ryan & Martijn J. Schuemie & Marc A. Suchard
March 2024, Volume 47, Issue 3
- 195-204 The COVID-19 International Drug Pregnancy Registry (COVID-PR): Protocol Considerations
by Diego F. Wyszynski & Aris T. Papageorghiou & Cheryl Renz & Torri D. Metz & Sonia Hernández-Díaz - 205-216 An Overview of Regression Models for Adverse Events Analysis
by Elsa Coz & Mathieu Fauvernier & Delphine Maucort-Boulch - 217-225 Promoting Collaboration of Regulators and Patients in Improving Drug Safety and Regulatory Decision Making
by Yoong Khean Khoo & John C. W. Lim & Wei Chuen Tan-Koi & Nokuthula Sikhethiwe Kitikiti & Ai Ling Sim-Devadas - 227-236 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
by 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 & Ursula Winterfeld - 237-249 International Trends in Adverse Drug Event-Related Mortality from 2001 to 2019: An Analysis of the World Health Organization Mortality Database from 54 Countries
by Toshihiro Koyama & Shunya Iinuma & Michio Yamamoto & Takahiro Niimura & Yuka Osaki & Sayoko Nishimura & Ko Harada & Yoshito Zamami & Hideharu Hagiya - 251-260 Risk of Major Bleeding Associated with Concomitant Direct-Acting Oral Anticoagulant and Clopidogrel Use: A Retrospective Cohort Study
by Y. Joseph Hwang & Hsien-Yen Chang & Thomas Metkus & Kathleen M. Andersen & Sonal Singh & G. Caleb Alexander & Hemalkumar B. Mehta - 261-270 Validation of a Novel Method to Assess the Clinical Quality of Information in Pregnancy-Related Pharmacovigilance Case Reports: A ConcePTION Project
by Yrea R. J. Rijt-Weetink & Toine C. G. Egberts & Florence P. A. M. Hunsel & David J. Lewis & Laura M. Yates & Ursula Winterfeld & Eugène P. Puijenbroek - 271-284 Enhancing Transparency in Defining Studied Drugs: The Open-Source Living DiAna Dictionary for Standardizing Drug Names in the FAERS
by Michele Fusaroli & Valentina Giunchi & Vera Battini & Stefano Puligheddu & Charles Khouri & Carla Carnovale & Emanuel Raschi & Elisabetta Poluzzi - 285-286 The Moroccan Experience of Implementing a University Curriculum for the Pharmacovigilance of Herbal Medicines (Phytovigilance)
by Souad Skalli - 287-288 Correction to: The Moroccan Experience of Implementing a University Curriculum for the Pharmacovigilance of Herbal Medicines (Phytovigilance)
by Souad Skalli
February 2024, Volume 47, Issue 2
- 113-116 Appeal for Increasing the Impact of Pharmacovigilance
by Agnes C. Kant - 117-123 The Unseen Hand: AI-Based Prescribing Decision Support Tools and the Evaluation of Drug Safety and Effectiveness
by 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 & Juan M. Hincapie-Castillo - 125-133 SGLT2 Inhibitor Use and Risk of Breast Cancer Among Adult Women with Type 2 Diabetes
by Fengge Wang & Michael Hendryx & Nianjun Liu & Aurelian Bidulescu & Anirban K. Mitra & Juhua Luo - 135-146 Effectiveness and Respiratory Adverse Events Following Inactivated and mRNA COVID-19 Vaccines in Patients with COPD and Asthma: A Chinese Population-Based Study
by 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 & Esther Wai Yin Chan - 147-159 Enhancing Pharmacovigilance in Côte d'Ivoire: Impact of GSK’s Training and Mentoring Pilot Project in the Abidjan Region
by Yolanda Guerra Mendoza & Viviane Jusot & Félix Adou & Martin Ota & Diego Mpia Elenge & Tasim Begum & Nkululeko Mdladla & Olga Menang & Jean Claude Yavo & Mamadou Kamagaté - 161-171 A Descriptive Analysis of Adverse Event Reports from the Quebec Cannabis Registry
by Yasmina Hachem & Yola Moride & Anne-Marie Castilloux & Genaro Castillon & Maja Kalaba & Andrée Néron & Rihab Gamaoun & Marc O. Martel & Pierre Beaulieu & Mark Ware & Antonio Vigano - 173-182 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
by Guojun Dong & Andrew Bate & François Haguinet & Gabriel Westman & Luise Dürlich & Anders Hviid & Maurizio Sessa - 183-192 Implementation of a Taxonomy-Based Framework for the Selection of Appropriate Drugs and Outcomes for Real-World Data Signal Detection Studies
by Astrid Coste & Angel YS Wong & Charlotte Warren-Gash & Julian Matthewman & Andrew Bate & Ian J. Douglas - 193-193 Correction to: Patient-Reported Reasons for Antihypertensive Medication Change: A Quantitative Study Using Social Media
by Cristina Micale & Su Golder & Karen O’Connor & Davy Weissenbacher & Robert Gross & Sean Hennessy & Graciela Gonzalez-Hernandez
January 2024, Volume 47, Issue 1
- 1-22 Industry Review of Best Practices for Risk Management of Drug-Induced Liver Injury from Development to Real-World Use
by Loreta Marquez & Ritu Raheja & May Chan-Liston & John Marcinak & Alvin Estilo & Liliam Pineda Salgado & Jason Jiang & Curtis Chang & Paul Beninger - 23-28 Cognitive Safety is Largely Ignored in Clinical Drug Trials: A Study of Registered Study Protocols
by Arne Reimers & Hanna Ljung - 29-38 Intravenous Medication Administration Safety with Smart Infusion Pumps in the Neonatal Intensive Care Unit: An Observational Study
by Kumiko O. Schnock & Sara E. Rostas & Catherine S. Yoon & Stuart Lipsitz & David W. Bates & Patricia C. Dykes - 39-57 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
by 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 & Proton Rahman - 59-70 Chronic Obstructive Pulmonary Disease Adverse Event Signals Associated with Potential Inhibitors of Glutathione Peroxidase 1: A Sequence Symmetry Analysis
by Jack L. Janetzki & Matthew J. Sykes & Michael B. Ward & Nicole L. Pratt - 71-80 Validation of a Natural Language Machine Learning Model for Safety Literature Surveillance
by Jiyoon Park & Malek Djelassi & Daniel Chima & Robert Hernandez & Vladimir Poroshin & Ana-Maria Iliescu & Douglas Domalik & Noel Southall - 81-91 Patient-Reported Reasons for Antihypertensive Medication Change: A Quantitative Study Using Social Media
by Cristina Micale & Su Golder & Karen O’Connor & Davy Weissenbacher & Robert Gross & Sean Hennessy & Graciela Gonzalez-Hernandez - 93-102 Application of an Innovative Data Mining Approach Towards Safe Polypharmacy Practice in Older Adults
by Yi Shi & Chien-Wei Chiang & Kathleen T. Unroe & Ximena Oyarzun-Gonzalez & Anna Sun & Yuedi Yang & Katherine M. Hunold & Jeffrey Caterino & Lang Li & Macarius Donneyong & Pengyue Zhang - 103-111 Proceedings of the International Ambulatory Drug Safety Symposium: Munich, Germany, June 2023
by 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 & Tobias Dreischulte
December 2023, Volume 46, Issue 12
- 1303-1305 Sodium-Glucose Cotransporter 2 Inhibitor-Associated “Ketoacidosis” Versus “Diabetic Ketoacidosis”: The Importance of Accurate Terminology
by Tamara Y. Milder & David A. Milder & Jerry R. Greenfield & Richard O. Day - 1307-1312 The Role of ISoP in the Advancement of Pharmacovigilance in Low-and Middle-Income Countries (LMICs)
by Mohamed A. Elhawary & Comfort K. Ogar & Mónica Tarapués & Angela Caro & Helen Byomire Ndagije & Ghita Benabdallah & Houda Sefiani & Hadir Rostom - 1313-1322 Pulmonary Toxicity Associated with Immune Checkpoint Inhibitors-Based Therapy: Current Perspectives and Future Directions
by Baohui Hong & Jiabing Zheng & Rong Chen & Caiyun Zheng & Bin Du & Ruping Ni & Jing Yang - 1323-1334 The Effect of Sex on the Incidence, Latency, Duration and Perceived Burden of Adverse Events Following Seasonal Influenza Vaccination in the Netherlands
by P. Slingerland & Florence P. A. M. Hunsel & T. Lieber & L. Balveren & J. W. Duijster - 1335-1352 Supporting Pharmacovigilance Signal Validation and Prioritization with Analyses of Routinely Collected Health Data: Lessons Learned from an EHDEN Network Study
by 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 & G. Niklas Norén - 1353-1362 Drug Utilisation Patterns of Alternatives to Ranitidine-Containing Medicines in Patients Treated with Ranitidine: A Network Analysis of Data from Six European National Databases
by Johnmary T. Arinze & Maria A. J. Ridder & Dina Vojinovic & Hanne Ballegooijen & Emanuil Markov & Talita Duarte-Salles & Peter Rijnbeek & Katia M. C. Verhamme - 1363-1379 Comparative Analysis of Information Provided in German Adverse Drug Reaction Reports Sent by Physicians, Pharmacists and Consumers
by Patrick Christ & Diana Dubrall & Matthias Schmid & Bernhardt Sachs - 1381-1389 Impact of Covid-19 Vaccination on Spontaneous Pharmacovigilance Reporting in France
by Sibylle Germay & Allison Singier & Francesco Salvo & Antoine Pariente - 1391-1404 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
by Sreedhar Sagi & Pradeep Anjaneya & Sameer Kalsekar & Andrea Kottke & Hillel P. Cohen
November 2023, Volume 46, Issue 11
- 1049-1071 Managing Cardiovascular and Cancer Risk Associated with JAK Inhibitors
by Victor Yang & Tue W. Kragstrup & Christopher McMaster & Pankti Reid & Namrata Singh & Stine R. Haysen & Philip C. Robinson & David F. L. Liew - 1073-1087 Evolution of Cross-Sectional Survey Protocol Quality Over Time: A Case Series of Index U.S. REMS Knowledge Survey Protocols (2007–2020)
by Gita A. Toyserkani & Samuel B. Ewusie & Philip Turk & Janifer Quick & Elaine H. Morrato - 1089-1103 An Exploratory Study of the Impact of COVID-19 Vaccine Spontaneous Reporting on Masking Signal Detection in EudraVigilance
by Benjamin Micallef & Jean-Michel Dogné & Janet Sultana & Sabine M. J. M. Straus & Robert Nisticò & Anthony Serracino-Inglott & John-Joseph Borg - 1105-1116 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?
by Victoria Odeleye & Omar Masarweh & Jorge Restrepo & Carlos A Alvarez & Ishak A. Mansi - 1117-1131 Development and Application of a Data-Driven Signal Detection Method for Surveillance of Adverse Event Variability Across Manufacturing Lots of Biologics
by Joshua T. Wilde & Stacy Springs & Jacqueline M. Wolfrum & Retsef Levi - 1133-1148 Adverse Drug Reactions to Opioids: A Study in a National Pharmacovigilance Database
by Moa Gustafsson & Cristiano Matos & João Joaquim & Joep Scholl & Florence Hunsel - 1149-1159 Levothyroxine Treatment Among Pregnant Women and Risk of Seizure in Children: A Population-Based Cohort Study
by Grace Mengqin Ge & Kenneth K. C. Man & Edmund C. L. Cheung & Patrick Ip & Wing Cheong Leung & Annie W. C. Kung & Ching-Lung Cheung & Ian C. K. Wong - 1161-1172 Sharing Adverse Drug Event Reports Between Hospitals and Community Pharmacists to Inform Re-dispensing: An Analysis of Reports and Process Outcomes
by Amber Cragg & Serena S. Small & Erica Lau & Adrianna Rowe & Anthony Lau & Katherine Butcher & Corinne M. Hohl
October 2023, Volume 46, Issue 10
- 921-926 Challenges and Opportunities in Accessing and Analysing FAERS Data: A Call Towards a Collaborative Approach
by Valentina Giunchi & Michele Fusaroli & Manfred Hauben & Emanuel Raschi & Elisabetta Poluzzi - 927-949 Clinical Guidance on the Monitoring and Management of Trastuzumab Deruxtecan (T-DXd)-Related Adverse Events: Insights from an Asia-Pacific Multidisciplinary Panel
by 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 & Rebecca Dent - 951-960 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
by Eun-Yeong Cho & Jung-Eun Cho & Seung Hun Jang & Ki-Eun Hwang - 961-974 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
by Christabel Khaemba & Abbie Barry & Wyckliff P. Omondi & Elvis Kirui & Margaret Oluka & Gurumurthy Parthasarathi & Sammy M. Njenga & Anastacia Guantai & Eleni Aklillu - 975-989 Automated Classification of Quality Defect Issues Relating to Substandard Medicines Using a Hybrid Machine Learning and Rule-Based Approach
by 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 & Pei San Ang - 991-1005 Real-World Safety and Efficacy of Biosimilar CT-P13 in Patients with Immune-Mediated Inflammatory Diseases: Integrated Analysis of Three Japanese Prospective Observational Studies
by Tsutomu Takeuchi & Kiyohiro Nishikawa & Fumika Yamada & Akimichi Morita & Mamitaro Ohtsuki & Yasuo Suzuki & Mamoru Watanabe & Hisashi Yamanaka & Toshifumi Hibi - 1007-1020 Duration of Effectiveness Evaluation of Additional Risk Minimisation Measures for Centrally Authorised Medicinal Products in the EU Between 2012 and 2021
by Sharon C. M. Essink & Inge M. Zomerdijk & Sabine M. J. M. Straus & Helga Gardarsdottir & Marie L. Bruin - 1021-1037 A Multi-method Exploratory Evaluation of a Service Designed to Improve Medication Safety for Patients with Monitored Dosage Systems Following Hospital Discharge
by Fatema A. Alqenae & Douglas Steinke & Hilary Belither & Peter Robertson & Jennifer Bartlett & Jack Wilkinson & Steven D. Williams & Lawrence Brad & Mark Jeffries & Darren M. Ashcroft & Richard N. Keers - 1039-1047 Development of a Framework Structuring Themes in the Course of Adverse Drug Reactions from a Patient’s Perspective
by Jette A. Lint & Marlieke Sonnenberg & Harald E. Vonkeman & Bart J. F. Bemt & Eugene P. Puijenbroek & Naomi T. Jessurun
September 2023, Volume 46, Issue 9
- 819-833 Cardiovascular Toxicity of Immune Checkpoint Inhibitors: A Guide for Clinicians
by Emanuel Raschi & Simone Rossi & Andrea Giglio & Michele Fusaroli & Flavio Burgazzi & Rita Rinaldi & Luciano Potena - 835-845 Safety and Tolerability of Intravenous Immunoglobulin in Chronic Inflammatory Demyelinating Polyneuropathy: Results of the ProCID Study
by David R. Cornblath & Pieter A. van Doorn & Hans-Peter Hartung & Ingemar S. J. Merkies & Hans D. Katzberg & Doris Hinterberger & Elisabeth Clodi - 847-855 Finding Needles in the Haystack: Clinical Utility Score for Prioritisation (CUSP), an Automated Approach for Identifying Spontaneous Reports with the Highest Clinical Utility
by Vijay Kara & Greg Powell & Olivia Mahaux & Aparna Jayachandra & Naashika Nyako & Christopher Golds & Andrew Bate - 857-866 Mapping Strategies to Assess and Increase the Validity of Published Disproportionality Signals: A Meta-Research Study
by Michele Fusaroli & Francesco Salvo & Claire Bernardeau & Maryam Idris & Charles Dolladille & Antoine Pariente & Elisabetta Poluzzi & Emanuel Raschi & Charles Khouri - 867-879 Adverse Events Following the BNT162b2 mRNA COVID-19 Vaccine (Pfizer-BioNTech) in Aotearoa New Zealand
by Muireann Walton & Vadim Pletzer & Thomas Teunissen & Thomas Lumley & Timothy Hanlon - 881-895 Disproportionality Analysis of Abemaciclib in the FDA Adverse Event Reporting System: A Real-World Post-Marketing Pharmacovigilance Assessment
by Yamin Shu & Lei Wang & Yiling Ding & Qilin Zhang - 897-904 The QTc-Bazett Interval in Former Very Preterm Infants in Adolescence and Young Adulthood is Not Different from Term-Born Controls
by 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 & Karel Allegaert - 905-916 Use of Bisphosphonates and the Risk of Skin Ulcer: A National Cohort Study Using Data from the French Health Care Claims Database
by Clément Jambon-Barbara & Claire Bernardeau & Julien Bezin & Matthieu Roustit & Sophie Blaise & Jean-Luc Cracowski & Charles Khouri - 917-918 Comment on: “Deliberate Self-Poisoning: Real-Time Characterisation of Suicidal Habits and Toxidromes in the Food and Drug Administration Adverse Event Reporting System”
by Emiliano Cappello & Giulia Valdiserra & Marco Bonaso & Sara Ferraro & Irma Convertino & Marco Tuccori - 919-920 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”
by Michele Fusaroli & Guido Pelletti & Valentina Giunchi & Emanuel Raschi & Fabrizio De Ponti & Susi Pelotti & Elisabetta Poluzzi
August 2023, Volume 46, Issue 8
- 711-713 Future of ChatGPT in Pharmacovigilance
by Hanyin Wang & Yanyi Jenny Ding & Yuan Luo - 715-724 Nephrotoxicity of Amoxicillin and Third-Generation Cephalosporins: An Updated Review
by Anne-Sophie Garnier & Guillaume Drablier & Marie Briet & Jean-François Augusto - 725-742 Use of Electronic Health Record Data for Drug Safety Signal Identification: A Scoping Review
by 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 & Joshua C. Smith - 743-751 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
by Fahed Al-Azzawi & Israa Mahmoud & François Haguinet & Andrew Bate & Maurizio Sessa - 753-763 Hospitalisations Related to Adverse Drug Reactions in Switzerland in 2012–2019: Characteristics, In-Hospital Mortality, and Spontaneous Reporting Rate
by Patrick E. Beeler & Thomas Stammschulte & Holger Dressel - 765-779 Provision and Characterization of a Corpus for Pharmaceutical, Biomedical Named Entity Recognition for Pharmacovigilance: Evaluation of Language Registers and Training Data Sufficiency
by Jürgen Dietrich & Philipp Kazzer - 781-795 Automatic Extraction of Comprehensive Drug Safety Information from Adverse Drug Event Narratives in the Korea Adverse Event Reporting System Using Natural Language Processing Techniques
by Siun Kim & Taegwan Kang & Tae Kyu Chung & Yoona Choi & YeSol Hong & Kyomin Jung & Howard Lee - 797-807 Serially Combining Epidemiological Designs Does Not Improve Overall Signal Detection in Vaccine Safety Surveillance
by 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 & Marc A. Suchard - 809-811 Comment on “Rates of Autoimmune Diseases in European Healthcare Databases: A Contribution of the ADVANCE Project”
by Jürgen O. Kirchner - 813-815 Authors’ Reply to Juergen O Kirchner’s Comment on “Incidence Rates of Autoimmune Diseases in European Healthcare Databases: A Contribution of the ADVANCE Project”
by Corinne Willame & Daniel Weibel & Miriam C. J. M. Sturkenboom - 817-817 Correction to: Comment on: “Should Antidepressants be Avoided in Pregnancy?”
by Alain Braillon & Susan Bewley & Aubrey Blumsohn & Florian Naudet
July 2023, Volume 46, Issue 7
- 619-623 The ISoP PatEG-SIG for Promoting Patient Engagement in Pharmacovigilance: A Change of Paradigm is Needed
by Manal M. Younus & Mayada Alkhakany & Priya Bahri & Angela Caro & Hadir Rostom & Helen Byomire Ndagije & Mohamed A. Elhawary - 625-636 Factors Associated with Underreporting of Adverse Drug Reactions by Health Care Professionals: A Systematic Review Update
by Patricia García-Abeijon & Catarina Costa & Margarita Taracido & Maria Teresa Herdeiro & Carla Torre & Adolfo Figueiras - 637-646 Safety and Effectiveness of Rasagiline in Chinese Patients with Parkinson’s Disease: A Prospective, Multicenter, Non-interventional Post-marketing Study
by Wen Su & Zhanhua Liang & Wei Mao & Ming Shao & Xingyue Hu & Yuncheng Wu & Wenshi Wei & Zhenguo Liu & Kezhong Zhang & Beisha Tang & Shuai Cao & Zhuolun Song & Haibo Chen - 647-660 Development and Application of an Active Pharmacovigilance Framework Based on Electronic Healthcare Records from Multiple Centers in Korea
by 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 & Ju Han Kim - 661-675 Prenatal exposure to pregabalin, birth outcomes and neurodevelopment – a population-based cohort study in four Nordic countries
by 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 & Gunnar Toft - 677-687 Expert Consensus on the Nephrotoxic Potential of 195 Medications in the Non-intensive Care Setting: A Modified Delphi Method
by 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 & Sandra L. Kane-Gill - 689-702 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
by 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 & Olaf Klungel - 703-710 Sustained Decline of Direct General Practitioner Reporting of Adverse Drug Reactions in Australia and Paucity in Details of Australian Reports in Safety Advisories
by Ian W. Boyd & John McEwen
June 2023, Volume 46, Issue 6
- 517-532 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
by 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 & Janet Sultana - 533-543 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
by Kasper Bonnesen & Lars Pedersen & Vera Ehrenstein & Marie Stjerne Grønkjær & Henrik Toft Sørensen & Jesper Hallas & Timothy Lee Lash & Morten Schmidt - 545-552 Cardiovascular Toxicities Associated with Anaplastic Lymphoma Kinase Inhibitors: A Disproportionality Analysis of the WHO Pharmacovigilance Database (VigiBase)
by 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 & Keisuke Ishizawa - 553-563 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
by Upinder Kaur & Zeba Fatima & Kalika Maheshwari & Vikas Sahni & Amol Dehade & Anju KL & Ashish Kumar Yadav & Sangeeta Kansal & Vaibhav Jaisawal & Sankha Shubhra Chakrabarti - 565-574 Facilitators and Barriers to Uptake of the Med Safety Mobile App for Adverse Drug Reaction Reporting by Health Workers in Uganda: A Qualitative Study
by Ronald Kiguba & Henry Zakumumpa & Helen B. Ndagije & Norah Mwebaza & Ronald Ssenyonga & Phil Tregunno & Kendal Harrison & Munir Pirmohamed - 575-585 Safety of COVID-19 Vaccines Among the Paediatric Population: Analysis of the European Surveillance Systems and Pivotal Clinical Trials
by 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 & Miriam Sturkenboom - 587-599 The Effect of Metformin on Chemotherapy-Induced Toxicities in Non-diabetic Breast Cancer Patients: A Randomised Controlled Study
by Manar A. Serageldin & Amira B. Kassem & Yasser El-Kerm & Maged W. Helmy & Mahmoud M. El-Mas & Noha A. El-Bassiouny - 601-614 Identifying Safety Subgroups at Risk: Assessing the Agreement Between Statistical Alerting and Patient Subgroup Risk
by Olivia Mahaux & Greg Powell & François Haguinet & Paulina Sobczak & Namrata Saini & Allen Barry & Amira Mustafa & Andrew Bate - 615-616 Comment on: "Should Antidepressants be Avoided in Pregnancy?"
by Alain Braillon & Susan Bewley & Aubrey Blumsohn & Florian Naudet - 617-618 Authors’ Reply to Braillon et al. ’s Comment on “Should Antidepressants be Avoided in Pregnancy?”
by Frank M. C. Besag & Michael J. Vasey
May 2023, Volume 46, Issue 5
- 435-437 Erice Manifesto 2022: On the Surveillance of Potential Harms Caused by Food Supplements in Europe
by 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 & Gwenn Vo Van Regnault - 439-448 Implications of Non-Specific Effects for Testing, Approving, and Regulating Vaccines
by 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 & Peter Aaby - 449-456 Drug–Drug Interactions and the Risk of Emergency Hospitalizations: A Nationwide Population-Based Study
by Louis Létinier & Julien Bezin & Ana Jarne & Antoine Pariente - 457-465 Validation of an ICD-9-Based Algorithm to Identify Stillbirth Episodes from Medicaid Claims Data
by Sabina O. Nduaguba & Nicole E. Smolinski & Thuy N. Thai & Steven T. Bird & Sonja A. Rasmussen & Almut G. Winterstein - 467-478 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
by Lembris L. Njotto & Johanna Simin & Romina Fornes & Ingvild Odsbu & Isabelle Mussche & Steven Callens & Lars Engstrand & Robin Bruyndonckx & Nele Brusselaers - 479-491 Core Data Elements for Pregnancy Pharmacovigilance Studies Using Primary Source Data Collection Methods: Recommendations from the IMI ConcePTION Project
by 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 & Laura M. Yates - 493-500 Prevalence and Preventability of Adverse Medicine Events in a Sample of Australian Aged-Care Residents: A Secondary Analysis of Data from the ReMInDAR Trial
by 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 & Elizabeth E. Roughead - 501-507 Quality of MedDRA® Coding in a Sample of COVID-19 Vaccine Medication Error Data
by Katarina Kralova & Carol-Ann Wilson & Nicolas Richebourg & Joan D’souza - 509-512 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"
by Oliver Kuss & Wolfgang Rathmann - 513-514 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”
by John-Michael Gamble & Wajd Alkabbani - 515-515 Correction to: Development and Validation of ICD‑10‑CM‑based Algorithms for Date of Last Menstrual Period, Pregnancy Outcomes, and Infant Outcomes
by Andrea K. Chomistek & Kelesitse Phiri & Michael C. Doherty & Jenna F. Calderbank & Stephanie E. Chiuve & Brenda Hinman McIlroy & Michael C. Snabes & Cheryl Enger & John D. Seeger
April 2023, Volume 46, Issue 4
- 327-333 Real-World Monitoring of COVID-19 Vaccines: An Industry Expert View on the Successes, Challenges, and Future Opportunities
by Vincent Bauchau & Kourtney Davis & Sarah Frise & Corinne Jouquelet-Royer & Jamie Wilkins - 335-342 Preventable Deaths Involving Medicines: A Systematic Case Series of Coroners’ Reports 2013–22
by Harrison S. France & Jeffrey K. Aronson & Carl Heneghan & Robin E. Ferner & Anthony R. Cox & Georgia C. Richards - 343-355 Is PEGylation of Drugs Associated with Hypersensitivity Reactions? An Analysis of the Italian National Spontaneous Adverse Drug Reaction Reporting System
by Salvatore Crisafulli & Paola Maria Cutroneo & Nicoletta Luxi & Andrea Fontana & Carmen Ferrajolo & Pasquale Marchione & Laura Sottosanti & Giovanna Zanoni & Ugo Moretti & Silvia Franzè & Paola Minghetti & Gianluca Trifirò - 357-370 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
by Comfort K. Ogar & Jonathan Quick & Hannah N. Gilbert & Rick A. Vreman & Aukje K. Mantel-Teeuwisse & Jean Claude Mugunga - 371-389 Early Detection of Adverse Drug Reaction Signals by Association Rule Mining Using Large-Scale Administrative Claims Data
by Hiroki Yamamoto & Gen Kayanuma & Takuya Nagashima & Chihiro Toda & Kazuki Nagayasu & Shuji Kaneko - 391-404 Cohort Event Monitoring of Adverse Reactions to COVID-19 Vaccines in Seven European Countries: Pooled Results on First Dose
by 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 & Miriam Sturkenboom - 405-416 Impact of European Union Label Changes for Fluoroquinolone-Containing Medicinal Products for Systemic and Inhalation Use: Post-Referral Prescribing Trends
by 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 & Deborah Layton - 417-418 The Rationale for Robust Pharmacovigilance in Monitoring the Safety of Traditional Medicines and Natural Health Products
by Rhiannon Braund - 433-433 Correction to: Artificial Intelligence Based on Machine Learning in Pharmacovigilance: A Scoping Review
by Benjamin Kompa & Joe B. Hakim & Anil Palepu & Kathryn Grace Kompa & Michael Smith & Paul A. Bain & Stephen Woloszynek & Jeffery L. Painter & Andrew Bate & Andrew L. Beam
March 2023, Volume 46, Issue 3
- 223-242 Colchicine Drug Interaction Errors and Misunderstandings: Recommendations for Improved Evidence-Based Management
by Philip D. Hansten & Malinda S. Tan & John R. Horn & Ainhoa Gomez-Lumbreras & Lorenzo Villa-Zapata & Richard D. Boyce & Vignesh Subbian & Andrew Romero & Sheila Gephart & Daniel C. Malone - 243-255 What Factors Make EU Regulators Want to Communicate Drug Safety Issues Related to SGLT2 Inhibitors? An Online Survey Study
by Sonia Roldan Munoz & Douwe Postmus & Sieta T. Vries & Liana Gross-Martirosyan & Priya Bahri & Hans Hillege & Peter G. M. Mol - 257-271 Comparative Safety Analysis of Opioid Agonist Treatment in Pregnant Women with Opioid Use Disorder: A Population-Based Study
by Shuang Wang & Kimford J. Meador & Jayne Pawasauskas & Adam K. Lewkowitz & Kristina E. Ward & Todd N. Brothers & Abraham Hartzema & Brian J. Quilliam & Xuerong Wen - 273-281 Effect of Previous Anticoagulant Treatment on Risk of COVID-19
by Maruxa Zapata-Cachafeiro & Ángela Prieto-Campo & Manuel Portela-Romero & Eduardo Carracedo-Martínez & Martina Lema-Oreiro & María Piñeiro-Lamas & Somnath Chaudhuri & Ángel Salgado-Barreira & Adolfo Figueiras - 283-295 Deliberate Self-Poisoning: Real-Time Characterization of Suicidal Habits and Toxidromes in the Food and Drug Administration Adverse Event Reporting System
by Michele Fusaroli & Guido Pelletti & Valentina Giunchi & Chiara Pugliese & Mattia Bartolucci & Elena Narmine Necibi & Emanuel Raschi & Fabrizio Ponti & Susi Pelotti & Elisabetta Poluzzi - 297-308 The COVID-19 Vaccines International Pregnancy Exposure Registry (C-VIPER): Protocol and Methodological Considerations
by Diego F. Wyszynski & Mondira Bhattacharya & Oscar Martínez-Pérez & Anthony R. Scialli & Melissa Tassinari & Naor Bar-Zeev & Cheryl Renz & Sonia Hernández-Díaz - 309-318 Use of Structured Electronic Health Records Data Elements for the Development of Computable Phenotypes to Identify Potential Adverse Events Associated with Intravenous Immunoglobulin Infusion
by 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 & Benjamin A. Goldstein - 319-321 Optimizing Safety Surveillance for COVID-19 Vaccines at the Swedish Medical Products Agency
by Karl Mikael Kälkner & Anders Sundström & Marja-Leena Nurminen & Maria Larsson & Rickard Ljung & Veronica Arthurson - 323-323 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
by Khristina Fauvelle & Jean Joel Bigna - 325-325 Correction to: Individual Case Safety Report Replication: An Analysis of Case Reporting Transmission Networks
by John Stekelenborg & Vijay Kara & Roman Haack & Ulrich Vogel & Anju Garg & Markus Krupp & Kate Gofman & Brian Dreyfus & Manfred Hauben & Andrew Bate
February 2023, Volume 46, Issue 2
- 109-120 Signals of Adverse Drug Reactions Communicated by Pharmacovigilance Stakeholders: A Scoping Review of the Global Literature
by Daniele Sartori & Jeffrey K. Aronson & G. Niklas Norén & Igho J. Onakpoya - 121-128 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
by Khristina Fauvelle & Jean Joel Bigna - 129-143 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
by 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 & Christine M. Hunt - 145-155 The Food and Drug Administration’s (FDA’s) Drug Safety Surveillance During the COVID-19 Pandemic
by 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 & Gerald Dal Pan - 157-174 Post-Authorization Safety Study of Hospitalization for Acute Kidney Injury in Patients with Type 2 Diabetes Exposed to Dapagliflozin in a Real-World Setting
by 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 & Alicia Gilsenan - 175-193 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
by 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 & Alicia Gilsenan - 195-208 Mortality in Patients with Parkinson’s Disease-Related Psychosis Treated with Pimavanserin Compared with Other Atypical Antipsychotics: A Cohort Study
by J. Bradley Layton & Joan Forns & Lisa J. McQuay & Heather E. Danysh & Colleen Dempsey & Mary S. Anthony & Mary Ellen Turner - 209-222 Development and Validation of ICD-10-CM-based Algorithms for Date of Last Menstrual Period, Pregnancy Outcomes, and Infant Outcomes
by Andrea K. Chomistek & Kelesitse Phiri & Michael C. Doherty & Jenna F. Calderbank & Stephanie E. Chiuve & Brenda Hinman McIlroy & Michael C. Snabes & Cheryl Enger & John D. Seeger
January 2023, Volume 46, Issue 1
- 1-17 Should Antidepressants be Avoided in Pregnancy?
by Frank M. C. Besag & Michael J. Vasey - 19-37 Potential Risk Factors of Drug-Related Problems in Hospital-Based Mental Health Units: A Systematic Review
by Fatima Q. Alshaikhmubarak & Richard N. Keers & Penny J. Lewis - 39-52 Individual Case Safety Report Replication: An Analysis of Case Reporting Transmission Networks
by John Stekelenborg & Vijay Kara & Roman Haack & Ulrich Vogel & Anju Garg & Markus Krupp & Kate Gofman & Brian Dreyfus & Manfred Hauben & Andrew Bate - 53-64 A Population-Based Study of SGLT2 Inhibitor-Associated Postoperative Diabetic Ketoacidosis in Patients with Type 2 Diabetes
by 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 & Carlos King Ho Wong - 65-75 Optimizing Safety Surveillance for COVID-19 Vaccines at the National Pharmacovigilance Centre Lareb: One Year of COVID-19 Vaccine Experience
by Ingrid Oosterhuis & Joep Scholl & Eugène Puijenbroek & Agnes Kant & Florence Hunsel - 77-85 Weight Gain During Antipsychotic Treatment in Children, Adolescents, and Adults: A Disproportionality Analysis in the Global Pharmacovigilance Database, Vigibase®
by Florentia Kaguelidou & Zaba Valtuille & Geneviève Durrieu & Richard Delorme & Hugo Peyre & Jean-Marc Treluyer & François Montastruc & Laurent Chouchana - 87-97 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
by Sonal Singh & Julie Beyrer & Xiaofeng Zhou & Joel Swerdel & Raymond A. Harvey & Kenneth Hornbuckle & Leo Russo & Kanwal Ghauri & Ivan H. Abi-Elias & John S. Cox & Carla Rodriguez-Watson - 99-108 Fully Liquid MenACWY-CRM Vaccine: Results from an Integrated Safety Analysis
by Puneet Vir Singh & Paola Tiberi & Gabriele Filippo Di Domenico & Valerio Romolini & Thembile Mzolo & Marco Costantini & Tauseefullah Akhund & Venere Basile & Maria Lattanzi & Michele Pellegrini
December 2022, Volume 45, Issue 12
- 1449-1456 Gastrointestinal Bleeding on Oral Anticoagulation: What is Currently Known
by Arnar B. Ingason & Johann P. Hreinsson & Einar S. Björnsson - 1457-1476 Prevalence, Causes and Severity of Medication Administration Errors in the Neonatal Intensive Care Unit: A Systematic Review and Meta-Analysis
by Josephine Henry Basil & Chandini Menon Premakumar & Adliah Mhd Ali & Nurul Ain Mohd Tahir & Noraida Mohamed Shah - 1477-1490 mRNA (BNT162b2) and Inactivated (CoronaVac) COVID-19 Vaccination and Risk of Adverse Events and Acute Diabetic Complications in Patients with Type 2 Diabetes Mellitus: A Population-Based Study
by Eric Yuk Fai Wan & Celine Sze Ling Chui & Anna Hoi Ying Mok & Wanchun Xu & Vincent Ka Chun Yan & Francisco Tsz Tsun Lai & Xue Li & Carlos King Ho Wong & Esther Wai Yin Chan & David Tak Wai Lui & Kathryn Choon Beng Tan & Ivan Fan Ngai Hung & Cindy Lo Kuen Lam & Gabriel Matthew Leung & Ian Chi Kei Wong - 1491-1499 Characterization of Serous Retinopathy Associated with Cobimetinib: Integrated Safety Analysis of Four Studies
by Giulio Barteselli & Grant R. Goodman & Yogesh Patel & Ivor Caro & Cloris Xue & Samuel McCallum - 1501-1516 Detectability of Medication Errors With a STOPP/START-Based Medication Review in Older People Prior to a Potentially Preventable Drug-Related Hospital Admission
by Bastiaan T. G. M. Sallevelt & Toine C. G. Egberts & Corlina J. A. Huibers & Jimmy Ietswaart & A. Clara Drenth-van Maanen & Emma Jennings & Cian O’Mahony & Katharina Tabea Jungo & Martin Feller & Nicolas Rodondi & François-Xavier Sibille & Anne Spinewine & Eugène P. Puijenbroek & Ingeborg Wilting & Wilma Knol - 1517-1527 Topiramate Utilization After Phentermine/Topiramate Approval for Obesity Management: Risk Minimization in the Era of Drug Repurposing
by Amir Sarayani & Christian Hampp & Joshua D. Brown & William Troy Donahoo & Almut G. Winterstein - 1529-1538 Comparison of the MOdified NARanjo Causality Scale (MONARCSi) for Individual Case Safety Reports vs. a Reference Standard
by Shaun M. Comfort & Bruce Donzanti & Darren Dorrell & Sunita Dhar & Chris Eden & Francis Donaldson - 1539-1549 Withdrawal Syndrome Following Discontinuation of 28 Antidepressants: Pharmacovigilance Analysis of 31,688 Reports from the WHO Spontaneous Reporting Database
by Chiara Gastaldon & Georgios Schoretsanitis & Elena Arzenton & Emanuel Raschi & Davide Papola & Giovanni Ostuzzi & Ugo Moretti & Erich Seifritz & John M. Kane & Gianluca Trifirò & Corrado Barbui - 1551-1552 Comment on: "A Disproportionality Analysis of Drug–Drug Interactions of Tizanidine and CYP1A2 Inhibitors from the FDA Adverse Event Reporting System (FAERS)"
by Yoshihiro Noguchi - 1553-1555 Authors’ Response to Yoshihiro Noguchi’s Comment on: “A Disproportionality Analysis of Drug-Drug Interactions of Tizanidine and CYP1A2 Inhibitors from the FDA Adverse Event Reporting System (FAERS)”
by Daniel C. Malone & Lorenzo Villa-Zapata & Ainhoa Gómez-Lumbreras & John Horn & Malinda S. Tan & Richard D. Boyce
November 2022, Volume 45, Issue 11
- 1329-1348 Therapeutic Management of Idiosyncratic Drug-Induced Liver Injury and Acetaminophen Hepatotoxicity in the Paediatric Population: A Systematic Review
by Hao Niu & Edmond Atallah & Ismael Alvarez-Alvarez & Inmaculada Medina-Caliz & Guruprasad P. Aithal & Cigdem Arikan & Raul J. Andrade & M. Isabel Lucena - 1349-1362 Efficacy and Safety of Anticoagulants in Patients with Atrial Fibrillation and History of Falls or Risk of Falls: A Systematic Review and Multilevel Meta-Analysis
by Thibaut Galvain & Ruaraidh Hill & Sarah Donegan & Paulo Lisboa & Gregory Y. H. Lip & Gabriela Czanner - 1363-1368 Lost in Translation: A Multilingual Survey of Interlinguistic Variations in Terms Used in Pharmacovigilance
by Jeffrey K. Aronson - 1369-1380 Factors Influencing Preferences and Responses Towards Drug Safety Communications: A Conjoint Experiment Among Hospital-Based Healthcare Professionals in the Netherlands
by Esther Vries & Elisabeth Bakker & Taco B. M. Monster & Petra Denig & Peter G. M. Mol - 1381-1402 Pediatric Drug Safety Surveillance: A 10-Year Analysis of Adverse Drug Reaction Reporting Data in Calabria, Southern Italy
by Christian Leporini & Caterina Sarro & Caterina Palleria & Iolanda Caccavo & Brunella Piro & Rita Citraro & Giovambattista Sarro - 1403-1411 Safety of Apremilast in Patients with Psoriasis and Psoriatic Arthritis: Findings from the UK Clinical Practice Research Datalink
by Rebecca Persson & Myriam Cordey & Maria Paris & Susan Jick - 1413-1421 Medicine-Induced Acute Kidney Injury Findings from Spontaneous Reporting Systems, Sequence Symmetry Analysis and a Case–Control Study with a Focus on Medicines Used in Primary Care
by Elizabeth E. Roughead & Mhairi Kerr & Anna Moffat & Gizat M. Kassie & Nicole Pratt - 1423-1438 Network Analysis for Signal Detection in Spontaneous Adverse Event Reporting Database: Application of Network Weighting Normalization to Characterize Cardiovascular Drug Safety
by Mátyás Pétervári & Bettina Benczik & Olivér M. Balogh & Balázs Petrovich & Bence Ágg & Péter Ferdinandy - 1439-1440 Correction to: Assessing Case Fatality on Cases of Thrombosis with Concurrent Thrombocytopenia Following COVID-19 Vaccine AstraZeneca (Vaxzevria) in the United Kingdom: A Review of Spontaneously Reported Data
by Samantha Lane & Saad Shakir
October 2022, Volume 45, Issue 10
- 1011-1014 Conundrum of Clinical QTc Monitoring
by Marek Malik - 1015-1018 How Important is Gender in Leadership in Pharmacovigilance? Personal Reflections from the First Female President of the International Society of Pharmacovigilance
by Mira Harrison-Woolrych - 1019-1036 High-Dose Intravenous Iron with Either Ferric Carboxymaltose or Ferric Derisomaltose: A Benefit-Risk Assessment
by Johannes M. M. Boots & Rogier A. M. Quax - 1037-1048 Use of Electrocardiogram Monitoring in Adult Patients Taking High-Risk QT Interval Prolonging Medicines in Clinical Practice: Systematic Review and Meta-analysis
by Marijana Putnikovic & Zoe Jordan & Zachary Munn & Corey Borg & Michael Ward - 1049-1056 Impact of Vaccine Hesitancy on Onset, Severity and Type of Self-reported Adverse Events: A French Cross-Sectional Survey
by Charles Khouri & Ayoub Larabi & Pierre Verger & Fatima Gauna & Jean-Luc Cracowski & Jeremy Ward - 1057-1067 Analytical Approaches to Reduce Selection Bias in As-Treated Analyses with Missing In-Hospital Drug Information
by Yeon-Hee Baek & Yunha Noh & In-Sun Oh & Han Eol Jeong & Kristian B. Filion & Hyesung Lee & Ju-Young Shin - 1069-1081 Prescribing Patterns of Codeine and Alternative Medicines in Children in Europe
by Kelly Plueschke & Robert Flynn & Karin Hedenmalm & Aikaterini-Christina Deli & Miguel-Angel Maciá-Martinez & Patricia García-Poza & David Olsen & Pierre Nguyen & Chantal Quinten - 1083-1098 Factors Contributing to Best Practices for Patient Involvement in Pharmacovigilance in Europe: A Stakeholder Analysis
by Monica Hoof & Katherine Chinchilla & Linda Härmark & Cristiano Matos & Pedro Inácio & Florence Hunsel - 1099-1109 A Prospective Observational Study on BBV152 Coronavirus Vaccine Use in Adolescents and Comparison with Adults: Interim Results of the First Real-World Safety Analysis
by Upinder Kaur & Anju K.L & Mayank Chauhan & Aditi Joshi & Agniva Das & Sangeeta Kansal & Vaibhav Jaisawal & Kishor Patwardhan & Sankha Shubhra Chakrabarti
September 2022, Volume 45, Issue 9
- 929-939 Pancreas and Adverse Drug Reactions: A Literature Review
by Konrad Sosnowski & Piotr Nehring & Adam Przybyłkowski - 941-949 Impact of Policy Interventions on Oxycodone Prescribing in Queensland, Australia: An Uncontrolled Interrupted Time Series Study
by William Tumusiime & Caitlin Hardman & Elizabeth McCourt - 951-959 Anti-tumor Necrosis Factor-Alpha Therapy and Hypoglycemia: A Real-World Pharmacovigilance Analysis
by Yu Zhou & Wenhuo Xie & Linyao Wang & Xinyan Zhu & Jianbin Li & Libin Liu & Shuaijun Zhu & Lijing Wang - 961-970 BAHAMA: A Bayesian Hierarchical Model for the Detection of MedDRA®-Coded Adverse Events in Randomized Controlled Trials
by Alma Revers & Michel H. Hof & Aeilko H. Zwinderman - 971-981 Patient-Reported Reasons for Switching or Discontinuing Statin Therapy: A Mixed Methods Study Using Social Media
by Su Golder & Davy Weissenbacher & Karen O’Connor & Sean Hennessy & Robert Gross & Graciela Gonzalez Hernandez - 983-994 Cardiovascular Risks of Diclofenac Versus Other Older COX-2 Inhibitors (Meloxicam and Etodolac) and Newer COX-2 Inhibitors (Celecoxib and Etoricoxib): A Series of Nationwide Emulated Trials
by Morten Schmidt & Henrik Toft Sørensen & Lars Pedersen - 995-1002 Differences in the Recurrence Rate of Immediate Adverse Drug Reactions According to the Components of Alternative Contrast Media: Analysis of Repetitive Computed Tomography Cases in a Single Tertiary Hospital
by Sung-Ryeol Kim & Nak-Hoon Son & Hye Jung Park & Kyung Hee Park & Jung-Won Park & Jae-Hyun Lee - 1003-1008 Assessing Case Fatality on Cases of Thrombosis with Concurrent Thrombocytopenia Following COVID-19 Vaccine AstraZeneca (Vaxzevria) in the United Kingdom: A Review of Spontaneously Reported Data
by Samantha Lane & Saad Shakir - 1009-1010 Correction to: Impact of Policy Interventions on Oxycodone Prescribing in Queensland, Australia: An Uncontrolled Interrupted Time Series Study
by William Tumusiime & Caitlin Hardman & Elizabeth McCourt
August 2022, Volume 45, Issue 8
- 815-837 A Review of Causal Inference for External Comparator Arm Studies
by Gerd Rippin & Nicolás Ballarini & Héctor Sanz & Joan Largent & Chantal Quinten & Francesco Pignatti - 839-852 Kidney Damage and Stress Biomarkers for Early Identification of Drug-Induced Kidney Injury: A Systematic Review
by Ravi J. Desai & Christina L. Kazarov & Adrian Wong & Sandra L. Kane-Gill - 853-862 Combining Machine Learning with a Rule-Based Algorithm to Detect and Identify Related Entities of Documented Adverse Drug Reactions on Hospital Discharge Summaries
by Hui Xing Tan & Chun Hwee Desmond Teo & Pei San Ang & Wei Ping Celine Loke & Mun Yee Tham & Siew Har Tan & Bee Leng Sally Soh & Pei Qin Belinda Foo & Zheng Jye Ling & Wei Luen James Yip & Yixuan Tang & Jisong Yang & Kum Hoe Anthony Tung & Sreemanee Raaj Dorajoo - 863-871 A Disproportionality Analysis of Drug–Drug Interactions of Tizanidine and CYP1A2 Inhibitors from the FDA Adverse Event Reporting System (FAERS)
by Lorenzo Villa-Zapata & Ainhoa Gómez-Lumbreras & John Horn & Malinda S. Tan & Richard D. Boyce & Daniel C. Malone