Drug Safety

2012 - 2025

Current editor(s): Nitin Joshi

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Volume 43, issue 12, 2020

Liver Injury Associated with the Selective Progesterone Modulator Ulipristal pp. 1201-1204

Einar S. Björnsson

Assessing the Safety of COVID-19 Vaccines: A Primer pp. 1205-1210

Helen Petousis-Harris

Potential Safety Issues with Use of Sodium-Glucose Cotransporter 2 Inhibitors, Particularly in People with Type 2 Diabetes and Chronic Kidney Disease pp. 1211-1221

Tamara Y. Milder, Sophie L. Stocker, Richard O. Day and Jerry R. Greenfield

Post-Marketing Safety Surveillance for the Adjuvanted Recombinant Zoster Vaccine: Methodology pp. 1223-1234

Fernanda Tavares-Da-Silva, Olivia Mahaux, Lionel Holle, François Haguinet, Harry Seifert and Jens-Ulrich Stegmann

Current Evidence on Abuse and Misuse of Gabapentinoids pp. 1235-1254

Staffan Hägg, Anna K. Jönsson and Johan Ahlner

Ipilimumab-Induced Enterocolitis: A Systematic Review and Meta-Analysis pp. 1255-1266

Kelcie Witges, Leigh Anne Shafer, Ryan Zarychanski, Ahmed M. Abou-Setta, Rasheda Rabbani, Orvie Dingwall and Charles N. Bernstein

An Evaluation of Postmarketing Reports of Serious Idiosyncratic Liver Injury Associated with Ulipristal Acetate for the Treatment of Uterine Fibroids pp. 1267-1276

Sarah Kang, Allen Brinker, S. Christopher Jones, Lara Dimick-Santos and Mark I. Avigan

Liver Injury with Ulipristal Acetate: Exploring the Underlying Pharmacological Basis pp. 1277-1285

Milo Gatti, Elisabetta Poluzzi, Fabrizio De Ponti and Emanuel Raschi

Temelimab, an IgG4 Anti-Human Endogenous Retrovirus Monoclonal Antibody: An Early Development Safety Review pp. 1287-1296

Gabrielle Kornmann and François Curtin

Renin–Angiotensin–Aldosterone System Inhibitors and Risk of Death in Patients Hospitalised with COVID-19: A Retrospective Italian Cohort Study of 43,000 Patients pp. 1297-1308

Gianluca Trifirò, Marco Massari, Roberto Da Cas, Francesca Menniti Ippolito, Janet Sultana, Salvatore Crisafulli, Paolo Giorgi Rossi, Massimiliano Marino, Manuel Zorzi, Emanuela Bovo, Olivia Leoni, Monica Ludergnani and Stefania Spila Alegiani

Sex Differences in Reported Adverse Drug Reactions to COVID-19 Drugs in a Global Database of Individual Case Safety Reports pp. 1309-1314

Alem Zekarias, Sarah Watson, Sara Hedfors Vidlin and Birgitta Grundmark

Psychiatric Disorders and Hydroxychloroquine for Coronavirus Disease 2019 (COVID-19): A VigiBase Study pp. 1315-1322

Philippe Garcia, Alexis Revet, Antoine Yrondi, Vanessa Rousseau, Yannick Degboe and François Montastruc

Volume 43, issue 11, 2020

The Work of the Council for International Organizations of Medical Sciences (CIOMS) in Global Pharmacovigilance pp. 1067-1071

Manal M. Younus, Monika Zweygarth, Lembit Rägo and Mira Harrison-Woolrych

Human-Based Errors Involving Smart Infusion Pumps: A Catalog of Error Types and Prevention Strategies pp. 1073-1087

Eric S. Kirkendall, Kristen Timmons, Hannah Huth, Kathleen Walsh and Kristin Melton

Benefit–Risk Assessment of Vaccines. Part I: A Systematic Review to Identify and Describe Studies About Quantitative Benefit–Risk Models Applied to Vaccines pp. 1089-1104

Hugo Arlegui, Kaatje Bollaerts, Francesco Salvo, Vincent Bauchau, Gaëlle Nachbaur, Bernard Bégaud and Nicolas Praet

Benefit-Risk Assessment of Vaccines. Part II: Proposal Towards Consolidated Standards of Reporting Quantitative Benefit-Risk Models Applied to Vaccines (BRIVAC) pp. 1105-1120

Hugo Arlegui, Kaatje Bollaerts, Vincent Bauchau, Gaëlle Nachbaur, Bernard Bégaud and Nicolas Praet

Interstitial Lung Disease as an Adverse Drug Reaction in Japan: Exploration of Regulatory Actions as a Basis for High Reporting pp. 1121-1131

Eiko Iwasa, Yu Fujiyoshi, Yuki Kubota, Ryota Kimura, Rebecca E. Chandler, Henric Taavola, G. Niklas Norén and Rika Wakao

The Potential Teratogenicity Alert for Women Conceiving on Dolutegravir-Based Regimens: An Assessment of Risk Communication by an Urban HIV Clinic in Uganda and Choices made by Women pp. 1133-1140

Eva Agnes Odongpiny Laker, Arnold Arinaitwe, Noela Owarwo, Annet Onzia, Benson Nasasira, Abdullah Wailagala, Ivan Kalule, Godwin Anguzu, Agnes Kiragga, Kay Seden, Isaac Lwanga, Barbara Castelnuovo, Rachel Musomba and Mohammed Lamorde

Pharmaceutical Benefit–Risk Perception and Age Differences in the USA and Germany pp. 1141-1156

Dominic H. P. Balog-Way, Darrick Evensen and Ragnar E. Löfstedt

Community Pharmacists’ Views and Experiences with ADR Reporting for Complementary Medicines: A Qualitative Study in New Zealand pp. 1157-1170

Joanne Barnes and Rachael Butler

E-Learning in Pharmacovigilance: An Evaluation of Microlearning-Based Modules Developed by Uppsala Monitoring Centre pp. 1171-1180

Anna Hegerius, Pia Caduff-Janosa, Ruth Savage and Johan Ellenius

Safety of the Geneva Cocktail, a Cytochrome P450 and P-Glycoprotein Phenotyping Cocktail, in Healthy Volunteers from Three Different Geographic Origins pp. 1181-1189

Victoria Rollason, Médéric Mouterde, Youssef Daali, Martina Čížková, Edita Priehodová, Iva Kulichová, Helena Posová, Jitka Petanová, Anwar Mulugeta, Eyasu Makonnen, Abir Al-Habsi, Robin Davidson, Khalid K. Al-Balushi, Khalid Al-Thihli, Marie Cerná, Said Al-Yahyaee, Viktor Černý, Getnet Yimer, Estella S. Poloni and Jules Desmeules

Direct Oral Anticoagulants and Interstitial Lung Disease: Emerging Clues from Pharmacovigilance pp. 1191-1194

Emanuel Raschi, Michele Fusaroli, Igor Diemberger and Elisabetta Poluzzi

Volume 43, issue 10, 2020

Real-World Data on Bleeding Risk and Anticoagulation in Patients with IPF Treated with Antifibrotics pp. 953-955

Elisabeth Bendstrup and Meena Kalluri

Neuroprotective Cationic Arginine-Rich Peptides (CARPs): An Assessment of Their Clinical Safety pp. 957-969

Adam B. Edwards, Frank L. Mastaglia, Neville W. Knuckey and Bruno P. Meloni

Anticoagulant Use and Bleeding Risk in Central European Patients with Idiopathic Pulmonary Fibrosis (IPF) Treated with Antifibrotic Therapy: Real-World Data from EMPIRE pp. 971-980

Abigél M. Kolonics-Farkas, Martina Šterclová, Nesrin Mogulkoc, Jan Kus, Marta Hájková, Veronika Müller, Dragana Jovanovic, Jasna Tekavec-Trkanjec, Simona Littnerová, Karel Hejduk and Martina Vašáková

Evaluation of a Web-Based, ‘Purchase Event’ Intensive Monitoring Method for Pharmacovigilance of Natural Health Products: Lessons and Insights from Development Work in New Zealand pp. 981-998

Joanne Barnes, Jane L. Sheridan, Christine Yang Dong, Linda Härmark, Sunita Vohra and Mira Harrison-Woolrych

Risk Factor Considerations in Statistical Signal Detection: Using Subgroup Disproportionality to Uncover Risk Groups for Adverse Drug Reactions in VigiBase pp. 999-1009

Lovisa Sandberg, Henric Taavola, Yasunori Aoki, Rebecca Chandler and G. Niklas Norén

The Effect of Positively Framing Side-Effect Risk in Two Different Formats on Side-Effect Expectations, Informed Consent and Credibility: A Randomised Trial of 16- to 75-Year-Olds in England pp. 1011-1022

Rebecca K. Webster and G. James Rubin

Comparative Outcomes Between Direct Oral Anticoagulants, Warfarin, and Antiplatelet Monotherapy Among Chinese Patients with Atrial Fibrillation: A Population-Based Cohort Study pp. 1023-1033

Xue Li, Swathi Pathadka, Kenneth K. C. Man, Vanessa W. S. Ng, Chung Wah Siu, Ian C. K. Wong, Esther W. Chan and Wallis C. Y. Lau

Use of Pregabalin and Worsening Heart Failure: A Nationwide Cohort Study pp. 1035-1044

Marie Lund, Gry Poulsen, Björn Pasternak, Niklas Worm Andersson, Mads Melbye and Henrik Svanström

Onapristone Extended Release: Safety Evaluation from Phase I–II Studies with an Emphasis on Hepatotoxicity pp. 1045-1055

James H. Lewis, Paul H. Cottu, Martin Lehr, Evan Dick, Todd Shearer, William Rencher, Alice S. Bexon, Mario Campone, Andrea Varga and Antoine Italiano

Determining Which of Several Simultaneously Administered Vaccines Increase Risk of an Adverse Event pp. 1057-1065

Shirley V. Wang, Kristina Stefanini, Edwin Lewis, Sophia R. Newcomer, Bruce Fireman, Matthew F. Daley, Jason M. Glanz, Jonathan Duffy, Eric Weintraub and Martin Kulldorff

Volume 43, issue 9, 2020

Thromboembolism and Janus Kinase Inhibitors pp. 831-833

Fowzia Ibrahim and David L. Scott

Use of Social Media for Pharmacovigilance Activities: Key Findings and Recommendations from the Vigi4Med Project pp. 835-851

Bissan Audeh, Florelle Bellet, Marie-Noëlle Beyens, Agnès Lillo-Le Louët and Cédric Bousquet

Drug Safety in Geriatric Patients: Current Status and Proposed Way Forward pp. 853-866

Giovanni Furlan, Pia Caduff-Janosa, Laura Sottosanti, Emiliano Cappello, Giulia Valdiserra and Marco Tuccori

Pathophysiology of Drug-Induced Hypomagnesaemia pp. 867-880

Periklis Katopodis, Emmanouil Karteris and Konstantinos P. Katopodis

Thromboembolic Safety Reporting of Tofacitinib and Baricitinib: An Analysis of the WHO VigiBase pp. 881-891

Enriqueta Vallejo-Yagüe, Stefan Weiler, Raphael Micheroli and Andrea M. Burden

Combining Social Media and FDA Adverse Event Reporting System to Detect Adverse Drug Reactions pp. 893-903

Ying Li, Antonio Jimeno Yepes and Cao Xiao

Information Visualization Platform for Postmarket Surveillance Decision Support pp. 905-915

Jonathan Spiker, Kory Kreimeyer, Oanh Dang, Debra Boxwell, Vicky Chan, Connie Cheng, Paula Gish, Allison Lardieri, Eileen Wu, Suranjan De, Jarushka Naidoo, Harold Lehmann, Gary L. Rosner, Robert Ball and Taxiarchis Botsis

Patient-Reported Burden of Adverse Drug Reactions Attributed to Biologics Used for Immune-Mediated Inflammatory Diseases pp. 917-925

Jette A. Lint, Naomi T. Jessurun, Renske C. F. Hebing, Frank Hoentjen, Sander W. Tas, Harald E. Vonkeman, Martijn B. A. Doorn, Annemieke Sobels, Phyllis I. Spuls, Eugene P. Puijenbroek, Michael T. Nurmohamed and Bart J. F. Bemt

Channeling Bias in the Analysis of Risk of Myocardial Infarction, Stroke, Gastrointestinal Bleeding, and Acute Renal Failure with the Use of Paracetamol Compared with Ibuprofen pp. 927-942

Rachel B. Weinstein, Patrick B. Ryan, Jesse A. Berlin, Martijn J. Schuemie, Joel Swerdel and Daniel Fife

Association Between Intravitreal Aflibercept and Serious Non-ocular Haemorrhage Compared with Intravitreal Ranibizumab: A Multicentre Observational Cohort Study pp. 943-952

Janet Sultana, Francesco Giorgianni, Giulia Scondotto, Valentina Ientile, Pasquale Cananzi, Olivia Leoni, Sebastiano Walter Pollina Addario, Giovanbattista Sarro, Adele Francesco, Maria Rosa Puzo, Christel Renoux and Gianluca Trifirò

Volume 43, issue 8, 2020

Azithromycin in COVID-19 Patients: Pharmacological Mechanism, Clinical Evidence and Prescribing Guidelines pp. 691-698

Janet Sultana, Paola Maria Cutroneo, Salvatore Crisafulli, Gabriele Puglisi, Gaetano Caramori and Gianluca Trifirò

The Impact of the COVID-19 “Infodemic” on Drug-Utilization Behaviors: Implications for Pharmacovigilance pp. 699-709

Marco Tuccori, Irma Convertino, Sara Ferraro, Emiliano Cappello, Giulia Valdiserra, Daniele Focosi and Corrado Blandizzi

Critical Assessment of Pharmacokinetic Drug–Drug Interaction Potential of Tofacitinib, Baricitinib and Upadacitinib, the Three Approved Janus Kinase Inhibitors for Rheumatoid Arthritis Treatment pp. 711-725

Vijayabhaskar Veeravalli, Ranjeet P. Dash, Jennifer A. Thomas, R. Jayachandra Babu, Lakshmi Mohan Vamsi Madgula and Nuggehally R. Srinivas

Effect of Bempedoic Acid on Serum Uric Acid and Related Outcomes: A Systematic Review and Meta-analysis of the available Phase 2 and Phase 3 Clinical Studies pp. 727-736

Arrigo F. G. Cicero, Roberto Pontremoli, Federica Fogacci, Francesca Viazzi and Claudio Borghi

Oxycodone, Hydromorphone, and the Risk of Suicide: A Retrospective Population-Based Case–Control Study pp. 737-743

Graham Mazereeuw, Tara Gomes, Erin M. Macdonald, Simon Greaves, Ping Li, Muhammad M. Mamdani, Donald A. Redelmeier and David N. Juurlink

Communicating Adverse Drug Reaction Insights Through Patient Organizations: Experiences from a Pilot Study in the Netherlands pp. 745-749

Linda Härmark, Gerda Weits, Rietje Meijer, Federica Santoro, G. Niklas Norén and Florence van Hunsel

Safety Profile of Ceftazidime–Avibactam: Pooled Data from the Adult Phase II and Phase III Clinical Trial Programme pp. 751-766

Karen Cheng, Paul Newell, Joseph W. Chow, Helen Broadhurst, David Wilson, Katrina Yates and Angela Wardman

DPP-4 Inhibitors in Combination with Lipid-Lowering Agents and Risk of Serious Muscular Injury: A Nested Case-Control Study in a Nationwide Cohort of Patients with Type 2 Diabetes Mellitus pp. 767-774

Antoine Pariente, Vanessa Labat, Yohann Mansiaux, Francesco Salvo, Bernard Bégaud, Emanuel Raschi, Jean-Luc Faillie, Louis Létinier and Julien Bezin

A Feasibility Study of Drug–Drug Interaction Signal Detection in Regular Pharmacovigilance pp. 775-785

Sara Hult, Daniele Sartori, Tomas Bergvall, Sara Hedfors Vidlin, Birgitta Grundmark, Johan Ellenius and G. Niklas Norén

Detecting Medicine Safety Signals Using Prescription Sequence Symmetry Analysis of a National Prescribing Data Set pp. 787-795

Clare E. King, Nicole L. Pratt, Nichole Craig, Loc Thai, Margaret Wilson, Neillan Nandapalan, Lisa Kalisch Ellet and Eirene C. Behm

Prospective Evaluation of Adverse Event Recognition Systems in Twitter: Results from the Web-RADR Project pp. 797-808

Lucie M. Gattepaille, Sara Hedfors Vidlin, Tomas Bergvall, Carrie E. Pierce and Johan Ellenius

Lopinavir-Ritonavir in the Treatment of COVID-19: A Dynamic Systematic Benefit-Risk Assessment pp. 809-821

Vicki Osborne, Miranda Davies, Samantha Lane, Alison Evans, Jacqueline Denyer, Sandeep Dhanda, Debabrata Roy and Saad Shakir

Correction to: Communicating Adverse Drug Reaction Insights Through Patient Organizations: Experiences from a Pilot Study in the Netherlands pp. 823-823

Linda Härmark, Gerda Weits, Rietje Meijer, Federica Santoro, G. Niklas Norén and Florence van Hunsel

Correction to: Comparing Acute Kidney Injury Reports Among Antibiotics: A Pharmacovigilance Study of the FDA Adverse Event Reporting System (FAERS) pp. 825-825

Taylor M. Patek, Chengwen Teng, Kaitlin E. Kennedy, Carlos A. Alvarez and Christopher R. Frei

Correction to: Safety Communication Tools and Healthcare Professionals’ Awareness of Specific Drug Safety Issues in Europe: A Survey Study pp. 827-829

Sieta T. de Vries, Maartje J. M. van der Sar, Anna Marie Coleman, Yvette Escudero, Alfonso Rodríguez Pascual, Miguel-Ángel Maciá Martínez, Amelia Cupelli, Ilaria Baldelli, Ivana Šipić, Adriana Andrić, Line Michan, Petra Denig and Peter G. M. Mol

Volume 43, issue 7, 2020

Does Ibuprofen Worsen COVID-19? pp. 611-614

Nicholas Moore, Bruce Carleton, Patrick Blin, Pauline Bosco-Levy and Cecile Droz

Drug-Induced Liver Injury and COVID-19 Infection: The Rules Remain the Same pp. 615-617

Alexandre Olry, Lucy Meunier, Bénédicte Délire, Dominique Larrey, Yves Horsmans and Hervé Louët

The International Society of Pharmacovigilance (ISoP) Special Interest Group on Herbal and Traditional Medicines: Towards Progress in Pharmacovigilance for Herbal and Traditional Medicines and Other “Natural Health” Products pp. 619-622

Joanne Barnes

A Framework for Methodological Choice and Evidence Assessment for Studies Using External Comparators from Real-World Data pp. 623-633

Christen M. Gray, Fiona Grimson, Deborah Layton, Stuart Pocock and Joseph Kim

Pregnancy Outcomes During the Clinical Development Program of Cladribine in Multiple Sclerosis: An Integrated Analysis of Safety pp. 635-643

Gavin Giovannoni, Andrew Galazka, Regina Schick, Thomas Leist, Giancarlo Comi, Xavier Montalban, Doris Damian, Fernando Dangond and Stuart Cook

Remdesivir in Treatment of COVID-19: A Systematic Benefit–Risk Assessment pp. 645-656

Miranda Davies, Vicki Osborne, Samantha Lane, Debabrata Roy, Sandeep Dhanda, Alison Evans and Saad Shakir

A New Drug–Drug Interaction Between Hydroxychloroquine and Metformin? A Signal Detection Study pp. 657-660

Jean-Louis Montastruc and Pierre-Louis Toutain

Evidence of Clinically Meaningful Drug–Drug Interaction With Concomitant Use of Colchicine and Clarithromycin pp. 661-668

Lorenzo Villa Zapata, Philip D. Hansten, John R. Horn, Richard D. Boyce, Sheila Gephart, Vignesh Subbian, Andrew Romero and Daniel C. Malone

Rates and Costs of Dispensing Naloxone to Patients at High Risk for Opioid Overdose in the United States, 2014–2018 pp. 669-675

Rachel E. Barenie, Joshua J. Gagne, Aaron S. Kesselheim, Ajinkya Pawar, Angela Tong, Jing Luo and Brian T. Bateman

Drug Safety Issues Covered by Lay Media: A Cohort Study of Direct Healthcare Provider Communications Sent between 2001 and 2015 in The Netherlands pp. 677-690

Esther Vries, Petra Denig, Sieta T. Vries, Taco B. M. Monster, Jacqueline G. Hugtenburg and Peter G. M. Mol

Volume 43, issue 6, 2020

Should Patients Receiving ACE Inhibitors or Angiotensin Receptor Blockers be Switched to Other Antihypertensive Drugs to Prevent or Improve Prognosis of Novel Coronavirus Disease 2019 (COVID-19)? pp. 507-509

Gianluca Trifirò, Salvatore Crisafulli, Giuseppe Andò, Giorgio Racagni and Filippo Drago

The Role of Pharmacovigilance and ISoP During the Global COVID-19 Pandemic pp. 511-512

Rebecca E Chandler, Deirdre McCarthy, Jean-Christophe Delumeau and Mira Harrison-Woolrych

Erice Call for Change: Utilising Patient Experiences to Enhance the Quality and Safety of Healthcare pp. 513-515

Elena Rocca and Rani Lill Anjum

Prevalence and Nature of Medication Errors and Medication-Related Harm Following Discharge from Hospital to Community Settings: A Systematic Review pp. 517-537

Fatema A. Alqenae, Douglas Steinke and Richard N. Keers

Benzodiazepine Use and Risk of Acute Angle-Closure Glaucoma: A Population-Based Case-Crossover Study pp. 539-547

Woo Jung Kim, Junqing Li, In-Sun Oh, Inmyung Song, Eun Lee, Kee Namkoong and Ju-Young Shin

Identifying Drugs Inducing Prematurity by Mining Claims Data with High-Dimensional Confounder Score Strategies pp. 549-559

Romain Demailly, Sylvie Escolano, Françoise Haramburu, Pascale Tubert-Bitter and Ismaïl Ahmed

Fluoroquinolone-Induced Photosensitivity: A Chemical Fragment-Based Approach by a Case/Non-case Study in VigiBase® pp. 561-566

Yoann Zelmat, Vanessa Rousseau, Leila Chebane, Jean-Louis Montastruc, Haleh Bagheri and Agnès Sommet

Leveraging Human Genetics to Identify Safety Signals Prior to Drug Marketing Approval and Clinical Use pp. 567-582

Rebecca N. Jerome, Meghan Morrison Joly, Nan Kennedy, Jana K. Shirey-Rice, Dan M. Roden, Gordon R. Bernard, Kenneth J. Holroyd, Joshua C. Denny and Jill M. Pulley

Enhancing Pharmacovigilance in Sub-Saharan Africa Through Training and Mentoring: A GSK Pilot Initiative in Malawi pp. 583-593

Viviane Jusot, Frider Chimimba, Nettie Dzabala, Olga Menang, Joy Cole, Gregory Gardiner, Opokua Ofori-Anyinam, Olakunle Oladehin, Cecilia Sambakunsi, Mphatso Kawaye, Jens-Ulrich Stegmann and Yolanda Guerra Mendoza

Patterns of Inpatient Antibiotic Use Among Public Hospitals in Hong Kong from 2000 to 2015 pp. 595-606

Celine S. L. Chui, Benjamin J. Cowling, Wey Wen Lim, Christopher K. M. Hui, Esther W. Chan, Ian C. K. Wong and Peng Wu

A Disproportionality Analysis of the Adverse Drug Events Associated with Lurasidone in Paediatric Patients Using the US FDA Adverse Event Reporting System (FAERS) pp. 607-609

Kate E. Rees, Te-yuan Chyou and Prasad S. Nishtala

Volume 43, issue 5, 2020

Chloroquine for COVID-19 Infection pp. 393-394

Nicholas Moore

Hyperkeratotic Skin Adverse Events Induced by Anticancer Treatments: A Comprehensive Review pp. 395-408

Maria Vastarella, Gabriella Fabbrocini and Vincent Sibaud

Safety of Eosinophil-Depleting Therapy for Severe, Eosinophilic Asthma: Focus on Benralizumab pp. 409-425

David J. Jackson, Stephanie Korn, Sameer K. Mathur, Peter Barker, Venkata G. Meka, Ubaldo J. Martin and James G. Zangrilli

Quality of Reporting on the Evaluation of Risk Minimization Programs: A Systematic Review pp. 427-446

Andrea M. Russell, Elaine H. Morrato, Rebecca M. Lovett and Meredith Y. Smith

Developing Predictive Models to Determine Patients in End-of-Life Care in Administrative Datasets pp. 447-455

Joel N. Swerdel, Jenna M. Reps, Daniel Fife and Patrick B. Ryan

An Evaluation of Postmarketing Reports with an Outcome of Death in the US FDA Adverse Event Reporting System pp. 457-465

Kathryn Marwitz, S. Christopher Jones, Cindy M. Kortepeter, Gerald J. Dal Pan and Monica A. Muñoz

Adverse Events in Twitter-Development of a Benchmark Reference Dataset: Results from IMI WEB-RADR pp. 467-478

Juergen Dietrich, Lucie M. Gattepaille, Britta Anne Grum, Letitia Jiri, Magnus Lerch, Daniele Sartori and Antoni Wisniewski

Disproportionality Analysis for Pharmacovigilance Signal Detection in Small Databases or Subsets: Recommendations for Limiting False-Positive Associations pp. 479-487

Ola Caster, Yasunori Aoki, Lucie M. Gattepaille and Birgitta Grundmark

Sex Differences in Adverse Drug Reactions of Metformin: A Longitudinal Survey Study pp. 489-495

Sieta T. Vries, Petra Denig, Corine Ekhart, Peter G. M. Mol and Eugene P. Puijenbroek

Systemic Adverse Events Associated with Compounded Topical Pain Products pp. 497-501

Jenny Kim, Karen Konkel, S. Christopher Jones and Lynda McCulley

Comment on ‘Reported Severe Hypersensitivity Reactions after Intravenous Iron Administration in the European Economic Area (EEA) Before and After Implementation of Risk Minimization Measures’ pp. 503-505

Philip Schaffalitzky de Muckadell and Claes Christian Strom

Volume 43, issue 4, 2020

ISoP Fellowships: Recognising Contributions to the Goals of ISoP pp. 297-300

Deirdre McCarthy and Mira Harrison-Woolrych

Coronary Risks Associated with Diclofenac and Other NSAIDs: An Update pp. 301-318

Nicholas Moore

Patient-Reported Adverse Events of Radiopharmaceuticals: Development and Validation of a Questionnaire pp. 319-328

Nanno Schreuder, Quincy Hoog, Sieta T. Vries, Pieter L. Jager, Jos G. W. Kosterink and Eugène P. Puijenbroek

Towards Automating Adverse Event Review: A Prediction Model for Case Report Utility pp. 329-338

Monica A. Muñoz, Gerald J. Dal Pan, Yu-Jung Jenny Wei, Chris Delcher, Hong Xiao, Cindy M. Kortepeter and Almut G. Winterstein

Comparative Assessment of the National Pharmacovigilance Systems in East Africa: Ethiopia, Kenya, Rwanda and Tanzania pp. 339-350

Abbie Barry, Sten Olsson, Omary Minzi, Emile Bienvenu, Eyasu Makonnen, Appolinary Kamuhabwa, Margaret Oluka, Anastasia Guantai, Ulf Bergman, Eugène Puijenbroek, Parthasarathi Gurumurthy and Eleni Aklillu

Investigating Overlap in Signals from EVDAS, FAERS, and VigiBase® pp. 351-362

Ulrich Vogel, John Stekelenborg, Brian Dreyfus, Anju Garg, Marian Habib, Romana Hosain and Antoni Wisniewski

Hypoglycemia Associated with Antibiotics Alone and in Combination with Sulfonylureas and Meglitinides: An Epidemiologic Surveillance Study of the FDA Adverse Event Reporting System (FAERS) pp. 363-369

Kaitlin E. Kennedy, Chengwen Teng, Taylor M. Patek and Christopher R. Frei

Utility of a Computerized ICD-10 Algorithm to Identify Idiosyncratic Drug-Induced Liver Injury Cases in the Electronic Medical Record pp. 371-377

Amoah Yeboah-Korang, Jeremy Louissaint, Irene Tsung, Sharmila Prabhu and Robert J. Fontana

An Integrated Analysis of the Safety of Tofacitinib in Psoriatic Arthritis across Phase III and Long-Term Extension Studies with Comparison to Real-World Observational Data pp. 379-392

Gerd R. Burmester, Jeffrey R. Curtis, Huifeng Yun, Oliver FitzGerald, Kevin L. Winthrop, Valderilio F. Azevedo, William F. C. Rigby, Keith S. Kanik, Cunshan Wang, Pinaki Biswas, Thomas Jones, Niki Palmetto, Thijs Hendrikx, Sujatha Menon and Ricardo Rojo

Volume 43, issue 3, 2020

Drug-Induced Hypophosphatemia: Current Insights pp. 197-210

Efstathia Megapanou, Matilda Florentin, Haralampos Milionis, Moses Elisaf and George Liamis

Prenatal Exposure to Macrolides and Risk of Congenital Malformations: A Meta-Analysis pp. 211-221

Narmeen Mallah, Hamid Reza Tohidinik, Mahyar Etminan, Adolfo Figueiras and Bahi Takkouche

Fatal Toxicity Indices for Medicine-Related Deaths in New Zealand, 2008–2013 pp. 223-232

John S. Fountain, Andrew M. Tomlin, David M. Reith and Murray W. Tilyard

Cardiac Safety of the Trastuzumab Biosimilar ABP 980 in Women with HER2-Positive Early Breast Cancer in the Randomized, Double-Blind, Active-Controlled LILAC Study pp. 233-242

Hans-Christian Kolberg, Marco Colleoni, Georgia Savva Demetriou, Patricia Santi, Hans Tesch, Yasuhiro Fujiwara, Zorica Tomasevic and Vladimir Hanes

Contribution of Causality Assessment for an Automated Detection of Safety Signals: An Example Using the French Pharmacovigilance Database pp. 243-253

Thomas Berbain, Antoine Pariente, Ghada Miremont-Salamé, Aurélie Grandvuillemin, Joelle Micallef, Laurent Chouchana, Mehdi Benkebil and Hélène Théophile

The UK BIO-TRAC Study: A Cross-Sectional Study of Product and Batch Traceability for Biologics in Clinical Practice and Electronic Adverse Drug Reaction Reporting in the UK pp. 255-263

Kevin Klein, Lorna Hazell, Pieter Stolk and Saad Shakir

Brand-Specific Enhanced Safety Surveillance of GSK’s Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany and Spain for the 2018/2019 Season pp. 265-279

Gael Dos Santos, Bach-Yen Nguyen, Silvia Damaso, Lode Godderis, Xavier Martínez-Gómez, Tamara Eckermann, Hugo Loos, Ignacio Salamanca de la Cueva, Vishvesh Shende, Alexander C. Schmidt and Anne Yeakey

Spontaneous Fluctuations in Liver Biochemistries in Patients with Compensated NASH Cirrhosis: Implications for Drug Hepatotoxicity Monitoring pp. 281-290

Hani Shamseddeen, Eduardo Vilar-Gomez, Naga Chalasani, Robert P. Myers, G. Mani Subramanian, Harold H. Shlevin, Adam E. Allgood and Eric S. Orman

Insight into the Severity of Adverse Drug Reactions as Experienced by Patients pp. 291-293

Leàn Rolfes, Michelle Haaksman, Florence van Hunsel and Eugène van Puijenbroek

Follow-Up on the Use of Machine Learning in Clinical Quality Assurance: Can We Detect Adverse Event Under-Reporting in Oncology Trials? pp. 295-296

Timothé Ménard, Björn Koneswarakantha, Donato Rolo, Yves Barmaz, Leszek Popko and Rich Bowling

Volume 43, issue 2, 2020

A New President’s Vision for International Pharmacovigilance pp. 79-81

Mira Harrison-Woolrych

Medical Devices: Definition, Classification, and Regulatory Implications pp. 83-93

Jeffrey K. Aronson, Carl Heneghan and Robin E. Ferner

Medical Devices: Classification and Analysis of Faults Leading to Harms pp. 95-102

Robin E. Ferner and Jeffrey K. Aronson

The Use of Long-Acting Insulin Analogs and the Risk of Colorectal Cancer Among Patients with Type 2 Diabetes: A Population-Based Cohort Study pp. 103-110

Richeek Pradhan, Hui Yin, Oriana H. Y. Yu and Laurent Azoulay

Occurrences and Outcomes of Immune Checkpoint Inhibitors-Induced Vitiligo in Cancer Patients: A Retrospective Cohort Study pp. 111-117

Samy Babai, Anne-Laure Voisin, Célia Bertin, Amandine Gouverneur and Hervé Le-Louet

Development and First Use of the Patient’s Qualitative Assessment of Treatment (PQAT) Questionnaire in Type 2 Diabetes Mellitus to Explore Individualised Benefit–Harm of Drugs Received During Clinical Studies pp. 119-134

Adam Gater, Matthew Reaney, Amy Findley, Catherine Brun-Strang, Kate Burrows, My-Liên Nguyên-Pascal and Aude Roborel de Climens

A Post-Authorization Safety Study of Quetiapine as Antidepressant Treatment in Sweden: Nested Case–Control Analyses of Select Outcomes pp. 135-145

Johan Reutfors, Philip Brenner, Bob Brody, Heather Wray, Morten Andersen and Lena Brandt

Exposure to Infliximab During Pregnancy: Post-Marketing Experience pp. 147-161

Anja Geldhof, Jennifer Slater, Michael Clark, Urmila Chandran and Danielle Coppola

Effectiveness of Risk Minimization Measures for Fentanyl Buccal Tablet (FENTORA) in Canada: A Mixed-Methods Evaluation Using Surveys, Medical Chart Records and Web Surveillance pp. 163-177

Sigal Kaplan, Aurore Bergamasco, Martin Sergerie, Anne-Marie Castilloux and Yola Moride

New Discoveries and Updates on Cutaneous Adverse Drug Reactions Presented at the 24th World Congress of Dermatology, Milan, Italy, 2019 pp. 179-187

Felix L. Chan, Neil H. Shear, Nidhi Shah, Cristina Olteanu, Rena Hashimoto and Roni P. Dodiuk-Gad

The Role of Unit-Dose Child-Resistant Packaging in Unintentional Childhood Exposures to Buprenorphine–Naloxone Tablets pp. 189-191

Christian Hampp, Maribeth C. Lovegrove, Daniel S. Budnitz, Justin Mathew, Amy Ho and Jana McAninch

Comment on “Evaluation of Potential Drug–Drug Interactions in Adults in the Intensive Care Unit: A Systematic Review and Meta-analysis” pp. 193-193

Nusret Uysal, Elif Keskin-Arslan, Hilal Erol, Selin Acar and Yusuf Cem Kaplan

Authors’ Reply to Uysal and Colleagues’ Comment on: “Evaluation of Potential Drug–Drug Interactions in Adults in the Intensive Care Unit: A Systematic Review and Meta-Analysis” pp. 195-196

Adrian Wong, Mary Grace Fitzmaurice, Pamela L. Smithburger, Mitchell S. Buckley and Sandra L. Kane-Gill

Volume 43, issue 1, 2020

Healthcare Database Networks for Drug Regulatory Policies: International Workshop on the Canadian, US and Spanish Experience and Future Steps for Italy pp. 1-5

Janet Sultana, Francesco Trotta, Antonio Addis, Jeffrey S. Brown, Miguel Gil, Francesca Menniti-Ippolito, Federica Milozzi, Samy Suissa and Gianluca Trifirò

Exploratory Study of Signals for Asthma Drugs in Children, Using the EudraVigilance Database of Spontaneous Reports pp. 7-16

Esmé J. Baan, Veronique A. Smet, Christina E. Hoeve, Alexandra C. Pacurariu, Miriam C. J. M. Sturkenboom, Johan C. Jongste, Hettie M. Janssens and Katia M. C. Verhamme

Comparing Acute Kidney Injury Reports Among Antibiotics: A Pharmacovigilance Study of the FDA Adverse Event Reporting System (FAERS) pp. 17-22

Taylor M. Patek, Chengwen Teng, Kaitlin E. Kennedy, Carlos A. Alvarez and Christopher R. Frei

Adverse Events Associated with Cumulative Corticosteroid Use in Patients with Castration-Resistant Prostate Cancer: An Administrative Claims Analysis pp. 23-33

Neil M. Schultz, David F. Penson, Samuel Wilson, Yan Song, Hongbo Yang, Krishnan Ramaswamy and Benjamin Lowentritt

Reported Severe Hypersensitivity Reactions after Intravenous Iron Administration in the European Economic Area (EEA) Before and After Implementation of Risk Minimization Measures pp. 35-43

Lennart Nathell, Annegret Gohlke and Stefan Wohlfeil

Description of the Risk Management of Medication Errors for Centrally Authorised Products in the European Union pp. 45-55

Christina E. Hoeve, Reynold D. C. Francisca, Inge Zomerdijk, Miriam C. J. M. Sturkenboom and Sabine M. J. M. Straus

Application of Augmented Intelligence for Pharmacovigilance Case Seriousness Determination pp. 57-66

Ramani Routray, Niki Tetarenko, Claire Abu-Assal, Ruta Mockute, Bruno Assuncao, Hanqing Chen, Shenghua Bao, Karolina Danysz, Sameen Desai, Salvatore Cicirello, Willis Van, Sharon Hensley Alford, Vivek Krishnamurthy and Edward Mingle

Complementing Observational Signals with Literature-Derived Distributed Representations for Post-Marketing Drug Surveillance pp. 67-77

Justin Mower, Trevor Cohen and Devika Subramanian