Content
January 2021, Volume 44, Issue 1
- 95-105 Global Safety Database Summary of COVID-19-Related Drug Utilization-Safety Surveillance: A Sponsor’s Perspective
by Elena Beyzarov & Yan Chen & Rob Julg & Karen Naim & Jigna Shah & William W. Gregory & Ayman Ayoub & Patrick Caubel - 107-119 Frequency and Associated Costs of Anaphylaxis- and Hypersensitivity-Related Adverse Events for Intravenous Iron Products in the USA: An Analysis Using the US Food and Drug Administration Adverse Event Reporting System
by Henry Trumbo & Karolina Kaluza & Syed Numan & Lawrence T. Goodnough - 121-123 Follow-up on the Use of Advanced Analytics for Clinical Quality Assurance: Bootstrap Resampling to Enhance Detection of Adverse Event Under-Reporting
by Björn Koneswarakantha & Yves Barmaz & Timothé Ménard & Donato Rolo
December 2020, Volume 43, Issue 12
- 1201-1204 Liver Injury Associated with the Selective Progesterone Modulator Ulipristal
by Einar S. Björnsson - 1205-1210 Assessing the Safety of COVID-19 Vaccines: A Primer
by Helen Petousis-Harris - 1211-1221 Potential Safety Issues with Use of Sodium-Glucose Cotransporter 2 Inhibitors, Particularly in People with Type 2 Diabetes and Chronic Kidney Disease
by Tamara Y. Milder & Sophie L. Stocker & Richard O. Day & Jerry R. Greenfield - 1223-1234 Post-Marketing Safety Surveillance for the Adjuvanted Recombinant Zoster Vaccine: Methodology
by Fernanda Tavares-Da-Silva & Olivia Mahaux & Lionel Holle & François Haguinet & Harry Seifert & Jens-Ulrich Stegmann - 1235-1254 Current Evidence on Abuse and Misuse of Gabapentinoids
by Staffan Hägg & Anna K. Jönsson & Johan Ahlner - 1255-1266 Ipilimumab-Induced Enterocolitis: A Systematic Review and Meta-Analysis
by Kelcie Witges & Leigh Anne Shafer & Ryan Zarychanski & Ahmed M. Abou-Setta & Rasheda Rabbani & Orvie Dingwall & Charles N. Bernstein - 1267-1276 An Evaluation of Postmarketing Reports of Serious Idiosyncratic Liver Injury Associated with Ulipristal Acetate for the Treatment of Uterine Fibroids
by Sarah Kang & Allen Brinker & S. Christopher Jones & Lara Dimick-Santos & Mark I. Avigan - 1277-1285 Liver Injury with Ulipristal Acetate: Exploring the Underlying Pharmacological Basis
by Milo Gatti & Elisabetta Poluzzi & Fabrizio De Ponti & Emanuel Raschi - 1287-1296 Temelimab, an IgG4 Anti-Human Endogenous Retrovirus Monoclonal Antibody: An Early Development Safety Review
by Gabrielle Kornmann & François Curtin - 1297-1308 Renin–Angiotensin–Aldosterone System Inhibitors and Risk of Death in Patients Hospitalised with COVID-19: A Retrospective Italian Cohort Study of 43,000 Patients
by 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 & Stefania Spila Alegiani - 1309-1314 Sex Differences in Reported Adverse Drug Reactions to COVID-19 Drugs in a Global Database of Individual Case Safety Reports
by Alem Zekarias & Sarah Watson & Sara Hedfors Vidlin & Birgitta Grundmark - 1315-1322 Psychiatric Disorders and Hydroxychloroquine for Coronavirus Disease 2019 (COVID-19): A VigiBase Study
by Philippe Garcia & Alexis Revet & Antoine Yrondi & Vanessa Rousseau & Yannick Degboe & François Montastruc
November 2020, Volume 43, Issue 11
- 1067-1071 The Work of the Council for International Organizations of Medical Sciences (CIOMS) in Global Pharmacovigilance
by Manal M. Younus & Monika Zweygarth & Lembit Rägo & Mira Harrison-Woolrych - 1073-1087 Human-Based Errors Involving Smart Infusion Pumps: A Catalog of Error Types and Prevention Strategies
by Eric S. Kirkendall & Kristen Timmons & Hannah Huth & Kathleen Walsh & Kristin Melton - 1089-1104 Benefit–Risk Assessment of Vaccines. Part I: A Systematic Review to Identify and Describe Studies About Quantitative Benefit–Risk Models Applied to Vaccines
by Hugo Arlegui & Kaatje Bollaerts & Francesco Salvo & Vincent Bauchau & Gaëlle Nachbaur & Bernard Bégaud & Nicolas Praet - 1105-1120 Benefit-Risk Assessment of Vaccines. Part II: Proposal Towards Consolidated Standards of Reporting Quantitative Benefit-Risk Models Applied to Vaccines (BRIVAC)
by Hugo Arlegui & Kaatje Bollaerts & Vincent Bauchau & Gaëlle Nachbaur & Bernard Bégaud & Nicolas Praet - 1121-1131 Interstitial Lung Disease as an Adverse Drug Reaction in Japan: Exploration of Regulatory Actions as a Basis for High Reporting
by Eiko Iwasa & Yu Fujiyoshi & Yuki Kubota & Ryota Kimura & Rebecca E. Chandler & Henric Taavola & G. Niklas Norén & Rika Wakao - 1133-1140 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
by 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 & Mohammed Lamorde - 1141-1156 Pharmaceutical Benefit–Risk Perception and Age Differences in the USA and Germany
by Dominic H. P. Balog-Way & Darrick Evensen & Ragnar E. Löfstedt - 1157-1170 Community Pharmacists’ Views and Experiences with ADR Reporting for Complementary Medicines: A Qualitative Study in New Zealand
by Joanne Barnes & Rachael Butler - 1171-1180 E-Learning in Pharmacovigilance: An Evaluation of Microlearning-Based Modules Developed by Uppsala Monitoring Centre
by Anna Hegerius & Pia Caduff-Janosa & Ruth Savage & Johan Ellenius - 1181-1189 Safety of the Geneva Cocktail, a Cytochrome P450 and P-Glycoprotein Phenotyping Cocktail, in Healthy Volunteers from Three Different Geographic Origins
by 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 & Jules Desmeules - 1191-1194 Direct Oral Anticoagulants and Interstitial Lung Disease: Emerging Clues from Pharmacovigilance
by Emanuel Raschi & Michele Fusaroli & Igor Diemberger & Elisabetta Poluzzi
October 2020, Volume 43, Issue 10
- 953-955 Real-World Data on Bleeding Risk and Anticoagulation in Patients with IPF Treated with Antifibrotics
by Elisabeth Bendstrup & Meena Kalluri - 957-969 Neuroprotective Cationic Arginine-Rich Peptides (CARPs): An Assessment of Their Clinical Safety
by Adam B. Edwards & Frank L. Mastaglia & Neville W. Knuckey & Bruno P. Meloni - 971-980 Anticoagulant Use and Bleeding Risk in Central European Patients with Idiopathic Pulmonary Fibrosis (IPF) Treated with Antifibrotic Therapy: Real-World Data from EMPIRE
by Abigél M. Kolonics-Farkas & Martina Šterclová & Nesrin Mogulkoc & Jan Kus & Marta Hájková & Veronika Müller & Dragana Jovanovic & Jasna Tekavec-Trkanjec & Simona Littnerová & Karel Hejduk & Martina Vašáková - 981-998 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
by Joanne Barnes & Jane L. Sheridan & Christine Yang Dong & Linda Härmark & Sunita Vohra & Mira Harrison-Woolrych - 999-1009 Risk Factor Considerations in Statistical Signal Detection: Using Subgroup Disproportionality to Uncover Risk Groups for Adverse Drug Reactions in VigiBase
by Lovisa Sandberg & Henric Taavola & Yasunori Aoki & Rebecca Chandler & G. Niklas Norén - 1011-1022 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
by Rebecca K. Webster & G. James Rubin - 1023-1033 Comparative Outcomes Between Direct Oral Anticoagulants, Warfarin, and Antiplatelet Monotherapy Among Chinese Patients with Atrial Fibrillation: A Population-Based Cohort Study
by Xue Li & Swathi Pathadka & Kenneth K. C. Man & Vanessa W. S. Ng & Chung Wah Siu & Ian C. K. Wong & Esther W. Chan & Wallis C. Y. Lau - 1035-1044 Use of Pregabalin and Worsening Heart Failure: A Nationwide Cohort Study
by Marie Lund & Gry Poulsen & Björn Pasternak & Niklas Worm Andersson & Mads Melbye & Henrik Svanström - 1045-1055 Onapristone Extended Release: Safety Evaluation from Phase I–II Studies with an Emphasis on Hepatotoxicity
by James H. Lewis & Paul H. Cottu & Martin Lehr & Evan Dick & Todd Shearer & William Rencher & Alice S. Bexon & Mario Campone & Andrea Varga & Antoine Italiano - 1057-1065 Determining Which of Several Simultaneously Administered Vaccines Increase Risk of an Adverse Event
by Shirley V. Wang & Kristina Stefanini & Edwin Lewis & Sophia R. Newcomer & Bruce Fireman & Matthew F. Daley & Jason M. Glanz & Jonathan Duffy & Eric Weintraub & Martin Kulldorff
September 2020, Volume 43, Issue 9
- 831-833 Thromboembolism and Janus Kinase Inhibitors
by Fowzia Ibrahim & David L. Scott - 835-851 Use of Social Media for Pharmacovigilance Activities: Key Findings and Recommendations from the Vigi4Med Project
by Bissan Audeh & Florelle Bellet & Marie-Noëlle Beyens & Agnès Lillo-Le Louët & Cédric Bousquet - 853-866 Drug Safety in Geriatric Patients: Current Status and Proposed Way Forward
by Giovanni Furlan & Pia Caduff-Janosa & Laura Sottosanti & Emiliano Cappello & Giulia Valdiserra & Marco Tuccori - 867-880 Pathophysiology of Drug-Induced Hypomagnesaemia
by Periklis Katopodis & Emmanouil Karteris & Konstantinos P. Katopodis - 881-891 Thromboembolic Safety Reporting of Tofacitinib and Baricitinib: An Analysis of the WHO VigiBase
by Enriqueta Vallejo-Yagüe & Stefan Weiler & Raphael Micheroli & Andrea M. Burden - 893-903 Combining Social Media and FDA Adverse Event Reporting System to Detect Adverse Drug Reactions
by Ying Li & Antonio Jimeno Yepes & Cao Xiao - 905-915 Information Visualization Platform for Postmarket Surveillance Decision Support
by 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 & Taxiarchis Botsis - 917-925 Patient-Reported Burden of Adverse Drug Reactions Attributed to Biologics Used for Immune-Mediated Inflammatory Diseases
by 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 & Bart J. F. Bemt - 927-942 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
by Rachel B. Weinstein & Patrick B. Ryan & Jesse A. Berlin & Martijn J. Schuemie & Joel Swerdel & Daniel Fife - 943-952 Association Between Intravitreal Aflibercept and Serious Non-ocular Haemorrhage Compared with Intravitreal Ranibizumab: A Multicentre Observational Cohort Study
by 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 & Gianluca Trifirò
August 2020, Volume 43, Issue 8
- 691-698 Azithromycin in COVID-19 Patients: Pharmacological Mechanism, Clinical Evidence and Prescribing Guidelines
by Janet Sultana & Paola Maria Cutroneo & Salvatore Crisafulli & Gabriele Puglisi & Gaetano Caramori & Gianluca Trifirò - 699-709 The Impact of the COVID-19 “Infodemic” on Drug-Utilization Behaviors: Implications for Pharmacovigilance
by Marco Tuccori & Irma Convertino & Sara Ferraro & Emiliano Cappello & Giulia Valdiserra & Daniele Focosi & Corrado Blandizzi - 711-725 Critical Assessment of Pharmacokinetic Drug–Drug Interaction Potential of Tofacitinib, Baricitinib and Upadacitinib, the Three Approved Janus Kinase Inhibitors for Rheumatoid Arthritis Treatment
by Vijayabhaskar Veeravalli & Ranjeet P. Dash & Jennifer A. Thomas & R. Jayachandra Babu & Lakshmi Mohan Vamsi Madgula & Nuggehally R. Srinivas - 727-736 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
by Arrigo F. G. Cicero & Roberto Pontremoli & Federica Fogacci & Francesca Viazzi & Claudio Borghi - 737-743 Oxycodone, Hydromorphone, and the Risk of Suicide: A Retrospective Population-Based Case–Control Study
by Graham Mazereeuw & Tara Gomes & Erin M. Macdonald & Simon Greaves & Ping Li & Muhammad M. Mamdani & Donald A. Redelmeier & David N. Juurlink - 745-749 Communicating Adverse Drug Reaction Insights Through Patient Organizations: Experiences from a Pilot Study in the Netherlands
by Linda Härmark & Gerda Weits & Rietje Meijer & Federica Santoro & G. Niklas Norén & Florence van Hunsel - 751-766 Safety Profile of Ceftazidime–Avibactam: Pooled Data from the Adult Phase II and Phase III Clinical Trial Programme
by Karen Cheng & Paul Newell & Joseph W. Chow & Helen Broadhurst & David Wilson & Katrina Yates & Angela Wardman - 767-774 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
by Antoine Pariente & Vanessa Labat & Yohann Mansiaux & Francesco Salvo & Bernard Bégaud & Emanuel Raschi & Jean-Luc Faillie & Louis Létinier & Julien Bezin - 775-785 A Feasibility Study of Drug–Drug Interaction Signal Detection in Regular Pharmacovigilance
by Sara Hult & Daniele Sartori & Tomas Bergvall & Sara Hedfors Vidlin & Birgitta Grundmark & Johan Ellenius & G. Niklas Norén - 787-795 Detecting Medicine Safety Signals Using Prescription Sequence Symmetry Analysis of a National Prescribing Data Set
by Clare E. King & Nicole L. Pratt & Nichole Craig & Loc Thai & Margaret Wilson & Neillan Nandapalan & Lisa Kalisch Ellet & Eirene C. Behm - 797-808 Prospective Evaluation of Adverse Event Recognition Systems in Twitter: Results from the Web-RADR Project
by Lucie M. Gattepaille & Sara Hedfors Vidlin & Tomas Bergvall & Carrie E. Pierce & Johan Ellenius - 809-821 Lopinavir-Ritonavir in the Treatment of COVID-19: A Dynamic Systematic Benefit-Risk Assessment
by Vicki Osborne & Miranda Davies & Samantha Lane & Alison Evans & Jacqueline Denyer & Sandeep Dhanda & Debabrata Roy & Saad Shakir - 823-823 Correction to: Communicating Adverse Drug Reaction Insights Through Patient Organizations: Experiences from a Pilot Study in the Netherlands
by Linda Härmark & Gerda Weits & Rietje Meijer & Federica Santoro & G. Niklas Norén & Florence van Hunsel - 825-825 Correction to: Comparing Acute Kidney Injury Reports Among Antibiotics: A Pharmacovigilance Study of the FDA Adverse Event Reporting System (FAERS)
by Taylor M. Patek & Chengwen Teng & Kaitlin E. Kennedy & Carlos A. Alvarez & Christopher R. Frei - 827-829 Correction to: Safety Communication Tools and Healthcare Professionals’ Awareness of Specific Drug Safety Issues in Europe: A Survey Study
by 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 & Peter G. M. Mol
July 2020, Volume 43, Issue 7
- 611-614 Does Ibuprofen Worsen COVID-19?
by Nicholas Moore & Bruce Carleton & Patrick Blin & Pauline Bosco-Levy & Cecile Droz - 615-617 Drug-Induced Liver Injury and COVID-19 Infection: The Rules Remain the Same
by Alexandre Olry & Lucy Meunier & Bénédicte Délire & Dominique Larrey & Yves Horsmans & Hervé Louët - 619-622 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
by Joanne Barnes - 623-633 A Framework for Methodological Choice and Evidence Assessment for Studies Using External Comparators from Real-World Data
by Christen M. Gray & Fiona Grimson & Deborah Layton & Stuart Pocock & Joseph Kim - 635-643 Pregnancy Outcomes During the Clinical Development Program of Cladribine in Multiple Sclerosis: An Integrated Analysis of Safety
by Gavin Giovannoni & Andrew Galazka & Regina Schick & Thomas Leist & Giancarlo Comi & Xavier Montalban & Doris Damian & Fernando Dangond & Stuart Cook - 645-656 Remdesivir in Treatment of COVID-19: A Systematic Benefit–Risk Assessment
by Miranda Davies & Vicki Osborne & Samantha Lane & Debabrata Roy & Sandeep Dhanda & Alison Evans & Saad Shakir - 657-660 A New Drug–Drug Interaction Between Hydroxychloroquine and Metformin? A Signal Detection Study
by Jean-Louis Montastruc & Pierre-Louis Toutain - 661-668 Evidence of Clinically Meaningful Drug–Drug Interaction With Concomitant Use of Colchicine and Clarithromycin
by Lorenzo Villa Zapata & Philip D. Hansten & John R. Horn & Richard D. Boyce & Sheila Gephart & Vignesh Subbian & Andrew Romero & Daniel C. Malone - 669-675 Rates and Costs of Dispensing Naloxone to Patients at High Risk for Opioid Overdose in the United States, 2014–2018
by Rachel E. Barenie & Joshua J. Gagne & Aaron S. Kesselheim & Ajinkya Pawar & Angela Tong & Jing Luo & Brian T. Bateman - 677-690 Drug Safety Issues Covered by Lay Media: A Cohort Study of Direct Healthcare Provider Communications Sent between 2001 and 2015 in The Netherlands
by Esther Vries & Petra Denig & Sieta T. Vries & Taco B. M. Monster & Jacqueline G. Hugtenburg & Peter G. M. Mol
June 2020, Volume 43, Issue 6
- 507-509 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)?
by Gianluca Trifirò & Salvatore Crisafulli & Giuseppe Andò & Giorgio Racagni & Filippo Drago - 511-512 The Role of Pharmacovigilance and ISoP During the Global COVID-19 Pandemic
by Rebecca E Chandler & Deirdre McCarthy & Jean-Christophe Delumeau & Mira Harrison-Woolrych - 513-515 Erice Call for Change: Utilising Patient Experiences to Enhance the Quality and Safety of Healthcare
by Elena Rocca & Rani Lill Anjum - 517-537 Prevalence and Nature of Medication Errors and Medication-Related Harm Following Discharge from Hospital to Community Settings: A Systematic Review
by Fatema A. Alqenae & Douglas Steinke & Richard N. Keers - 539-547 Benzodiazepine Use and Risk of Acute Angle-Closure Glaucoma: A Population-Based Case-Crossover Study
by Woo Jung Kim & Junqing Li & In-Sun Oh & Inmyung Song & Eun Lee & Kee Namkoong & Ju-Young Shin - 549-559 Identifying Drugs Inducing Prematurity by Mining Claims Data with High-Dimensional Confounder Score Strategies
by Romain Demailly & Sylvie Escolano & Françoise Haramburu & Pascale Tubert-Bitter & Ismaïl Ahmed - 561-566 Fluoroquinolone-Induced Photosensitivity: A Chemical Fragment-Based Approach by a Case/Non-case Study in VigiBase®
by Yoann Zelmat & Vanessa Rousseau & Leila Chebane & Jean-Louis Montastruc & Haleh Bagheri & Agnès Sommet - 567-582 Leveraging Human Genetics to Identify Safety Signals Prior to Drug Marketing Approval and Clinical Use
by Rebecca N. Jerome & Meghan Morrison Joly & Nan Kennedy & Jana K. Shirey-Rice & Dan M. Roden & Gordon R. Bernard & Kenneth J. Holroyd & Joshua C. Denny & Jill M. Pulley - 583-593 Enhancing Pharmacovigilance in Sub-Saharan Africa Through Training and Mentoring: A GSK Pilot Initiative in Malawi
by Viviane Jusot & Frider Chimimba & Nettie Dzabala & Olga Menang & Joy Cole & Gregory Gardiner & Opokua Ofori-Anyinam & Olakunle Oladehin & Cecilia Sambakunsi & Mphatso Kawaye & Jens-Ulrich Stegmann & Yolanda Guerra Mendoza - 595-606 Patterns of Inpatient Antibiotic Use Among Public Hospitals in Hong Kong from 2000 to 2015
by Celine S. L. Chui & Benjamin J. Cowling & Wey Wen Lim & Christopher K. M. Hui & Esther W. Chan & Ian C. K. Wong & Peng Wu - 607-609 A Disproportionality Analysis of the Adverse Drug Events Associated with Lurasidone in Paediatric Patients Using the US FDA Adverse Event Reporting System (FAERS)
by Kate E. Rees & Te-yuan Chyou & Prasad S. Nishtala
May 2020, Volume 43, Issue 5
- 393-394 Chloroquine for COVID-19 Infection
by Nicholas Moore - 395-408 Hyperkeratotic Skin Adverse Events Induced by Anticancer Treatments: A Comprehensive Review
by Maria Vastarella & Gabriella Fabbrocini & Vincent Sibaud - 409-425 Safety of Eosinophil-Depleting Therapy for Severe, Eosinophilic Asthma: Focus on Benralizumab
by David J. Jackson & Stephanie Korn & Sameer K. Mathur & Peter Barker & Venkata G. Meka & Ubaldo J. Martin & James G. Zangrilli - 427-446 Quality of Reporting on the Evaluation of Risk Minimization Programs: A Systematic Review
by Andrea M. Russell & Elaine H. Morrato & Rebecca M. Lovett & Meredith Y. Smith - 447-455 Developing Predictive Models to Determine Patients in End-of-Life Care in Administrative Datasets
by Joel N. Swerdel & Jenna M. Reps & Daniel Fife & Patrick B. Ryan - 457-465 An Evaluation of Postmarketing Reports with an Outcome of Death in the US FDA Adverse Event Reporting System
by Kathryn Marwitz & S. Christopher Jones & Cindy M. Kortepeter & Gerald J. Dal Pan & Monica A. Muñoz - 467-478 Adverse Events in Twitter-Development of a Benchmark Reference Dataset: Results from IMI WEB-RADR
by Juergen Dietrich & Lucie M. Gattepaille & Britta Anne Grum & Letitia Jiri & Magnus Lerch & Daniele Sartori & Antoni Wisniewski - 479-487 Disproportionality Analysis for Pharmacovigilance Signal Detection in Small Databases or Subsets: Recommendations for Limiting False-Positive Associations
by Ola Caster & Yasunori Aoki & Lucie M. Gattepaille & Birgitta Grundmark - 489-495 Sex Differences in Adverse Drug Reactions of Metformin: A Longitudinal Survey Study
by Sieta T. Vries & Petra Denig & Corine Ekhart & Peter G. M. Mol & Eugene P. Puijenbroek - 497-501 Systemic Adverse Events Associated with Compounded Topical Pain Products
by Jenny Kim & Karen Konkel & S. Christopher Jones & Lynda McCulley - 503-505 Comment on ‘Reported Severe Hypersensitivity Reactions after Intravenous Iron Administration in the European Economic Area (EEA) Before and After Implementation of Risk Minimization Measures’
by Philip Schaffalitzky de Muckadell & Claes Christian Strom
April 2020, Volume 43, Issue 4
- 297-300 ISoP Fellowships: Recognising Contributions to the Goals of ISoP
by Deirdre McCarthy & Mira Harrison-Woolrych - 301-318 Coronary Risks Associated with Diclofenac and Other NSAIDs: An Update
by Nicholas Moore - 319-328 Patient-Reported Adverse Events of Radiopharmaceuticals: Development and Validation of a Questionnaire
by Nanno Schreuder & Quincy Hoog & Sieta T. Vries & Pieter L. Jager & Jos G. W. Kosterink & Eugène P. Puijenbroek - 329-338 Towards Automating Adverse Event Review: A Prediction Model for Case Report Utility
by Monica A. Muñoz & Gerald J. Dal Pan & Yu-Jung Jenny Wei & Chris Delcher & Hong Xiao & Cindy M. Kortepeter & Almut G. Winterstein - 339-350 Comparative Assessment of the National Pharmacovigilance Systems in East Africa: Ethiopia, Kenya, Rwanda and Tanzania
by Abbie Barry & Sten Olsson & Omary Minzi & Emile Bienvenu & Eyasu Makonnen & Appolinary Kamuhabwa & Margaret Oluka & Anastasia Guantai & Ulf Bergman & Eugène Puijenbroek & Parthasarathi Gurumurthy & Eleni Aklillu - 351-362 Investigating Overlap in Signals from EVDAS, FAERS, and VigiBase®
by Ulrich Vogel & John Stekelenborg & Brian Dreyfus & Anju Garg & Marian Habib & Romana Hosain & Antoni Wisniewski - 363-369 Hypoglycemia Associated with Antibiotics Alone and in Combination with Sulfonylureas and Meglitinides: An Epidemiologic Surveillance Study of the FDA Adverse Event Reporting System (FAERS)
by Kaitlin E. Kennedy & Chengwen Teng & Taylor M. Patek & Christopher R. Frei - 371-377 Utility of a Computerized ICD-10 Algorithm to Identify Idiosyncratic Drug-Induced Liver Injury Cases in the Electronic Medical Record
by Amoah Yeboah-Korang & Jeremy Louissaint & Irene Tsung & Sharmila Prabhu & Robert J. Fontana - 379-392 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
by 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 & Ricardo Rojo
March 2020, Volume 43, Issue 3
- 197-210 Drug-Induced Hypophosphatemia: Current Insights
by Efstathia Megapanou & Matilda Florentin & Haralampos Milionis & Moses Elisaf & George Liamis - 211-221 Prenatal Exposure to Macrolides and Risk of Congenital Malformations: A Meta-Analysis
by Narmeen Mallah & Hamid Reza Tohidinik & Mahyar Etminan & Adolfo Figueiras & Bahi Takkouche - 223-232 Fatal Toxicity Indices for Medicine-Related Deaths in New Zealand, 2008–2013
by John S. Fountain & Andrew M. Tomlin & David M. Reith & Murray W. Tilyard - 233-242 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
by Hans-Christian Kolberg & Marco Colleoni & Georgia Savva Demetriou & Patricia Santi & Hans Tesch & Yasuhiro Fujiwara & Zorica Tomasevic & Vladimir Hanes - 243-253 Contribution of Causality Assessment for an Automated Detection of Safety Signals: An Example Using the French Pharmacovigilance Database
by Thomas Berbain & Antoine Pariente & Ghada Miremont-Salamé & Aurélie Grandvuillemin & Joelle Micallef & Laurent Chouchana & Mehdi Benkebil & Hélène Théophile - 255-263 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
by Kevin Klein & Lorna Hazell & Pieter Stolk & Saad Shakir - 265-279 Brand-Specific Enhanced Safety Surveillance of GSK’s Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany and Spain for the 2018/2019 Season
by 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 & Anne Yeakey - 281-290 Spontaneous Fluctuations in Liver Biochemistries in Patients with Compensated NASH Cirrhosis: Implications for Drug Hepatotoxicity Monitoring
by Hani Shamseddeen & Eduardo Vilar-Gomez & Naga Chalasani & Robert P. Myers & G. Mani Subramanian & Harold H. Shlevin & Adam E. Allgood & Eric S. Orman - 291-293 Insight into the Severity of Adverse Drug Reactions as Experienced by Patients
by Leàn Rolfes & Michelle Haaksman & Florence van Hunsel & Eugène van Puijenbroek - 295-296 Follow-Up on the Use of Machine Learning in Clinical Quality Assurance: Can We Detect Adverse Event Under-Reporting in Oncology Trials?
by Timothé Ménard & Björn Koneswarakantha & Donato Rolo & Yves Barmaz & Leszek Popko & Rich Bowling
February 2020, Volume 43, Issue 2
- 79-81 A New President’s Vision for International Pharmacovigilance
by Mira Harrison-Woolrych - 83-93 Medical Devices: Definition, Classification, and Regulatory Implications
by Jeffrey K. Aronson & Carl Heneghan & Robin E. Ferner - 95-102 Medical Devices: Classification and Analysis of Faults Leading to Harms
by Robin E. Ferner & Jeffrey K. Aronson - 103-110 The Use of Long-Acting Insulin Analogs and the Risk of Colorectal Cancer Among Patients with Type 2 Diabetes: A Population-Based Cohort Study
by Richeek Pradhan & Hui Yin & Oriana H. Y. Yu & Laurent Azoulay - 111-117 Occurrences and Outcomes of Immune Checkpoint Inhibitors-Induced Vitiligo in Cancer Patients: A Retrospective Cohort Study
by Samy Babai & Anne-Laure Voisin & Célia Bertin & Amandine Gouverneur & Hervé Le-Louet - 119-134 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
by Adam Gater & Matthew Reaney & Amy Findley & Catherine Brun-Strang & Kate Burrows & My-Liên Nguyên-Pascal & Aude Roborel de Climens - 135-145 A Post-Authorization Safety Study of Quetiapine as Antidepressant Treatment in Sweden: Nested Case–Control Analyses of Select Outcomes
by Johan Reutfors & Philip Brenner & Bob Brody & Heather Wray & Morten Andersen & Lena Brandt - 147-161 Exposure to Infliximab During Pregnancy: Post-Marketing Experience
by Anja Geldhof & Jennifer Slater & Michael Clark & Urmila Chandran & Danielle Coppola - 163-177 Effectiveness of Risk Minimization Measures for Fentanyl Buccal Tablet (FENTORA) in Canada: A Mixed-Methods Evaluation Using Surveys, Medical Chart Records and Web Surveillance
by Sigal Kaplan & Aurore Bergamasco & Martin Sergerie & Anne-Marie Castilloux & Yola Moride - 179-187 New Discoveries and Updates on Cutaneous Adverse Drug Reactions Presented at the 24th World Congress of Dermatology, Milan, Italy, 2019
by Felix L. Chan & Neil H. Shear & Nidhi Shah & Cristina Olteanu & Rena Hashimoto & Roni P. Dodiuk-Gad - 189-191 The Role of Unit-Dose Child-Resistant Packaging in Unintentional Childhood Exposures to Buprenorphine–Naloxone Tablets
by Christian Hampp & Maribeth C. Lovegrove & Daniel S. Budnitz & Justin Mathew & Amy Ho & Jana McAninch - 193-193 Comment on “Evaluation of Potential Drug–Drug Interactions in Adults in the Intensive Care Unit: A Systematic Review and Meta-analysis”
by Nusret Uysal & Elif Keskin-Arslan & Hilal Erol & Selin Acar & Yusuf Cem Kaplan - 195-196 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”
by Adrian Wong & Mary Grace Fitzmaurice & Pamela L. Smithburger & Mitchell S. Buckley & Sandra L. Kane-Gill
January 2020, Volume 43, Issue 1
- 1-5 Healthcare Database Networks for Drug Regulatory Policies: International Workshop on the Canadian, US and Spanish Experience and Future Steps for Italy
by Janet Sultana & Francesco Trotta & Antonio Addis & Jeffrey S. Brown & Miguel Gil & Francesca Menniti-Ippolito & Federica Milozzi & Samy Suissa & Gianluca Trifirò - 7-16 Exploratory Study of Signals for Asthma Drugs in Children, Using the EudraVigilance Database of Spontaneous Reports
by Esmé J. Baan & Veronique A. Smet & Christina E. Hoeve & Alexandra C. Pacurariu & Miriam C. J. M. Sturkenboom & Johan C. Jongste & Hettie M. Janssens & Katia M. C. Verhamme - 17-22 Comparing Acute Kidney Injury Reports Among Antibiotics: A Pharmacovigilance Study of the FDA Adverse Event Reporting System (FAERS)
by Taylor M. Patek & Chengwen Teng & Kaitlin E. Kennedy & Carlos A. Alvarez & Christopher R. Frei - 23-33 Adverse Events Associated with Cumulative Corticosteroid Use in Patients with Castration-Resistant Prostate Cancer: An Administrative Claims Analysis
by Neil M. Schultz & David F. Penson & Samuel Wilson & Yan Song & Hongbo Yang & Krishnan Ramaswamy & Benjamin Lowentritt - 35-43 Reported Severe Hypersensitivity Reactions after Intravenous Iron Administration in the European Economic Area (EEA) Before and After Implementation of Risk Minimization Measures
by Lennart Nathell & Annegret Gohlke & Stefan Wohlfeil - 45-55 Description of the Risk Management of Medication Errors for Centrally Authorised Products in the European Union
by Christina E. Hoeve & Reynold D. C. Francisca & Inge Zomerdijk & Miriam C. J. M. Sturkenboom & Sabine M. J. M. Straus - 57-66 Application of Augmented Intelligence for Pharmacovigilance Case Seriousness Determination
by Ramani Routray & Niki Tetarenko & Claire Abu-Assal & Ruta Mockute & Bruno Assuncao & Hanqing Chen & Shenghua Bao & Karolina Danysz & Sameen Desai & Salvatore Cicirello & Van Willis & Sharon Hensley Alford & Vivek Krishnamurthy & Edward Mingle - 67-77 Complementing Observational Signals with Literature-Derived Distributed Representations for Post-Marketing Drug Surveillance
by Justin Mower & Trevor Cohen & Devika Subramanian
December 2019, Volume 42, Issue 12
- 1393-1407 Recommendations for the Use of Social Media in Pharmacovigilance: Lessons from IMI WEB-RADR
by John Stekelenborg & Johan Ellenius & Simon Maskell & Tomas Bergvall & Ola Caster & Nabarun Dasgupta & Juergen Dietrich & Sara Gama & David Lewis & Victoria Newbould & Sabine Brosch & Carrie E. Pierce & Gregory Powell & Alicia Ptaszyńska-Neophytou & Antoni F. Z. Wiśniewski & Phil Tregunno & G. Niklas Norén & Munir Pirmohamed - 1409-1422 Comparative Effectiveness and Safety of Direct Oral Anticoagulants: Overview of Systematic Reviews
by Emanuel Raschi & Matteo Bianchin & Milo Gatti & Alessandro Squizzato & Fabrizio De Ponti - 1423-1436 Prevalence and Nature of Medication Errors and Preventable Adverse Drug Events in Paediatric and Neonatal Intensive Care Settings: A Systematic Review
by Anwar A. Alghamdi & Richard N. Keers & Adam Sutherland & Darren M. Ashcroft - 1437-1447 Effectiveness and Safety of Switching Originator and Biosimilar Epoetins in Patients with Chronic Kidney Disease in a Large-Scale Italian Cohort Study
by Valeria Belleudi & Francesco Trotta & Antonio Addis & Ylenia Ingrasciotta & Valentina Ientile & Michele Tari & Rosa Gini & Maurizio Pastorello & Salvatore Scondotto & Pasquale Cananzi & Giuseppe Traversa & Marina Davoli & Gianluca Trifirò - 1449-1469 The Association between Metformin Therapy and Lactic Acidosis
by Isabelle H. S. Kuan & Ruth L. Savage & Stephen B. Duffull & Robert J. Walker & Daniel F. B. Wright - 1471-1485 Measuring the Effectiveness of Safety Warnings on the Risk of Stroke in Older Antipsychotic Users: A Nationwide Cohort Study in Two Large Electronic Medical Records Databases in the United Kingdom and Italy
by Janet Sultana & Andrea Fontana & Francesco Giorgianni & Silvia Tillati & Claudio Cricelli & Alessandro Pasqua & Elisabetta Patorno & Clive Ballard & Miriam Sturkenboom & Gianluca Trifirò - 1487-1498 Data-Driven Identification of Adverse Event Reporting Patterns for Japan in VigiBase, the WHO Global Database of Individual Case Safety Reports
by Rika Wakao & Henric Taavola & Lovisa Sandberg & Eiko Iwasa & Saori Soejima & Rebecca Chandler & G. Niklas Norén - 1499-1506 Rheumatology Common Toxicity Criteria (RCTC): An Update Reflecting Real-World Use
by Christian M. Stach & Victor S. Sloan & Thasia G. Woodworth & Brian Kilgallen & Daniel E. Furst - 1507-1513 Psoriasis After Exposure to Angiotensin-Converting Enzyme Inhibitors: French Pharmacovigilance Data and Review of the Literature
by Brahim Azzouz & Aurore Morel & Lukshe Kanagaratnam & Emmanuelle Herlem & Thierry Trenque - 1515-1516 Comment on: “Patient Registries: An Underused Resource for Medicines Evaluation: Operational Proposals for Increasing the Use of Patient Registries in Regulatory Assessments”
by Ravi Jandhyala - 1517-1518 Authors’ Reply to Ravi Jandhyala’s Comment on “Patient Registries: An Underused Resource for Medicines Evaluation: Operational Proposals for Increasing the Use of Patient Registries in Regulatory Assessments”
by Patricia McGettigan & Carla Alonso Olmo & Kelly Plueschke & Mireia Castillon & Daniel Zondag & Priya Bahri & Xavier Kurz & Peter G. M. Mol
November 2019, Volume 42, Issue 11
- 1287-1295 Multimodal Analysis of FDA Drug Safety Communications: Lessons from Zolpidem
by Aaron S. Kesselheim & Michael S. Sinha & Eric G. Campbell & Sebastian Schneeweiss & Paula Rausch & Brian M. Lappin & Esther H. Zhou & Jerry Avorn & Gerald J. Dal Pan - 1297-1309 Transparent Reporting on Research Using Unstructured Electronic Health Record Data to Generate ‘Real World’ Evidence of Comparative Effectiveness and Safety
by Shirley V. Wang & Olga V. Patterson & Joshua J. Gagne & Jeffrey S. Brown & Robert Ball & Pall Jonsson & Adam Wright & Li Zhou & Wim Goettsch & Andrew Bate - 1311-1327 Benefit-Risk Assessment of Alogliptin for the Treatment of Type 2 Diabetes Mellitus
by Kohei Kaku & Koichi Kisanuki & Mari Shibata & Takashi Oohira - 1329-1342 Prevalence of Medication Errors Among Paediatric Inpatients: Systematic Review and Meta-Analysis
by Peter J. Gates & Melissa T. Baysari & Madlen Gazarian & Magdalena Z. Raban & Sophie Meyerson & Johanna I. Westbrook - 1343-1351 Patient Registries: An Underused Resource for Medicines Evaluation
by Patricia McGettigan & Carla Alonso Olmo & Kelly Plueschke & Mireia Castillon & Daniel Nogueras Zondag & Priya Bahri & Xavier Kurz & Peter G. M. Mol - 1353-1353 Correction to: Patient Registries: An Underused Resource for Medicines Evaluation
by Patricia McGettigan & Carla Alonso Olmo & Kelly Plueschke & Mireia Castillon & Daniel Nogueras Zondag & Priya Bahri & Xavier Kurz & Peter G. M. Mol - 1355-1363 Non-Vitamin K Antagonist Oral Anticoagulants and Angioedema: A Cohort and Case-Crossover Study
by John G. Connolly & Sebastian Schneeweiss & Robert J. Glynn & Joshua J. Gagne - 1365-1376 A Novel Approach to Visualize Risk Minimization Effectiveness: Peeping at the 2012 UK Proton Pump Inhibitor Label Change Using a Rapid Cycle Analysis Tool
by Rachel E. Sobel & William Blackwell & David M. Fram & Andrew Bate - 1377-1386 Identifying the DEAD: Development and Validation of a Patient-Level Model to Predict Death Status in Population-Level Claims Data
by Jenna M. Reps & Peter R. Rijnbeek & Patrick B. Ryan
October 2019, Volume 42, Issue 10
- 1115-1124 Pharmacovigilance as Scientific Discovery: An Argument for Trans-Disciplinarity
by Elena Rocca & Samantha Copeland & I. Ralph Edwards - 1125-1134 Unintended Effects of Communicating About Drug Safety Issues: A Critical Review of the Literature
by Jessica T. DeFrank & Lauren McCormack & Suzanne L. West & Craig Lefebvre & Olivia Burrus - 1135-1148 Comparative Effectiveness and Safety of Direct Oral Anticoagulants in Patients with Atrial Fibrillation: A Systematic Review and Meta-Analysis of Observational Studies
by Antonios Douros & Madeleine Durand & Carla M. Doyle & Sarah Yoon & Pauline Reynier & Kristian B. Filion - 1149-1155 Evaluating Renal Stress Using Pharmacokinetic Urinary Biomarker Data in Critically Ill Patients Receiving Vancomycin and/or Piperacillin–Tazobactam: A Secondary Analysis of the Multicenter Sapphire Study
by Sandra L. Kane-Gill & Marlies Ostermann & Jing Shi & Emily L. Joyce & John A. Kellum - 1157-1165 Intravenous Infusion Administration: A Comparative Study of Practices and Errors Between the United States and England and Their Implications for Patient Safety
by Ann Blandford & Patricia C. Dykes & Bryony Dean Franklin & Dominic Furniss & Galal H. Galal-Edeen & Kumiko O. Schnock & David W. Bates - 1167-1177 Study Design and Cohort Comparability in a Study of Major Cardiovascular Events in New Users of Prucalopride Versus Polyethylene Glycol 3350
by Joan Fortuny & Alicia Gilsenan & Miguel Cainzos-Achirica & Oscar F. Cantero & Robert W. V. Flynn & Luis Garcia-Rodriguez & Bianca Kollhorst & Pär Karlsson & Love Linnér & Thomas M. MacDonald & Estel Plana & Ana Ruigómez & Tania Schink & Ryan Ziemiecki & Elizabeth B. Andrews - 1179-1190 Cardiovascular Safety of Prucalopride in Patients with Chronic Constipation: A Multinational Population-Based Cohort Study
by Alicia Gilsenan & Joan Fortuny & Miguel Cainzos-Achirica & Oscar F. Cantero & Robert W. V. Flynn & Luis Garcia-Rodriguez & Abenah Harding & Bianca Kollhorst & Pär Karlsson & Love Linnér & Thomas M. MacDonald & Ingvild Odsbu & Estel Plana & Ana Ruigómez & Tania Schink & Ryan Ziemiecki & Elizabeth B. Andrews - 1191-1198 Pooling Different Safety Data Sources: Impact of Combining Solicited and Spontaneous Reports on Signal Detection In Pharmacovigilance
by Jeremy D. Jokinen & Rosalind J. Walley & Michael W. Colopy & Thomas S. Hilzinger & Peter Verdru - 1199-1201 The Impact of Litigation-Associated Reports on Signal Identification in the US FDA’s Adverse Event Reporting System
by Monica A. Muñoz & Gerald J. Dal Pan
September 2019, Volume 42, Issue 9
- 1025-1033 Fluoroquinolone Use and the Risk of Collagen-Associated Adverse Events: A Systematic Review and Meta-Analysis
by Xinyu Yu & Ding-sheng Jiang & Jing Wang & Rui Wang & Taiqiang Chen & Kan Wang & Shiyi Cao & Xiang Wei - 1035-1044 Evaluation of Potential Drug–Drug Interactions in Adults in the Intensive Care Unit: A Systematic Review and Meta-Analysis
by Mary Grace Fitzmaurice & Adrian Wong & Hannah Akerberg & Simona Avramovska & Pamela L. Smithburger & Mitchell S. Buckley & Sandra L. Kane-Gill - 1045-1053 Enabling Data-Driven Clinical Quality Assurance: Predicting Adverse Event Reporting in Clinical Trials Using Machine Learning
by Timothé Ménard & Yves Barmaz & Björn Koneswarakantha & Rich Bowling & Leszek Popko - 1055-1069 Auto-Generated Physiological Chain Data for an Ontological Framework for Pharmacology and Mechanism of Action to Determine Suspected Drugs in Cases of Dysuria
by Masayo Hayakawa & Takeshi Imai & Yoshimasa Kawazoe & Kouji Kozaki & Kazuhiko Ohe - 1071-1080 Evaluation of Use of Technologies to Facilitate Medical Chart Review
by Loreen Straub & Joshua J. Gagne & Judith C. Maro & Michael D. Nguyen & Nicolas Beaulieu & Jeffrey S. Brown & Adee Kennedy & Margaret Johnson & Adam Wright & Li Zhou & Shirley V. Wang - 1081-1089 Antidepressants and the Risk of Hemorrhagic Stroke in the Elderly: a Nested Case–Control Study
by Wiebke Schäfer & Christina Princk & Bianca Kollhorst & Tania Schink - 1091-1102 Prevalence, Safety and Long-Term Retention Rates of Biologics in Hong Kong from 2001 to 2015
by Mengqin Ge & Kenneth K. Man & Celine S. Chui & Esther W. Chan & Ian C. Wong & Xue Li - 1103-1114 Randomized Placebo-Controlled Trial Evaluating the Ophthalmic Safety of Single-Dose Tafenoquine in Healthy Volunteers
by Jessica Ackert & Khadeeja Mohamed & Jason S. Slakter & Sherif El-Harazi & Alessandro Berni & Hakop Gevorkyan & Elizabeth Hardaker & Azra Hussaini & Siôn W. Jones & Gavin C. K. W. Koh & Jyoti Patel & Scott Rasmussen & Deborah S. Kelly & David E. Barañano & John T. Thompson & Keith A. Warren & Robert C. Sergott & John Tonkyn & Allen Wolstenholme & Hanna Coleman & Alex Yuan & Stephan Duparc & Justin A. Green
August 2019, Volume 42, Issue 8
- 921-930 Establishing a Framework for the Use of Social Media in Pharmacovigilance in Europe
by Sabine Brosch & Anne-Marie Ferran & Victoria Newbould & Diane Farkas & Marina Lengsavath & Phil Tregunno - 931-939 Standardising the Classification of Harm Associated with Medication Errors: The Harm Associated with Medication Error Classification (HAMEC)
by Peter J. Gates & Melissa T. Baysari & Virginia Mumford & Magdalena Z. Raban & Johanna I. Westbrook - 941-956 Established and Emerging Immunological Complications of Biological Therapeutics in Multiple Sclerosis
by Babak Soleimani & Katy Murray & David Hunt - 957-971 Benefit-Risk Assessment of Obesity Drugs: Focus on Glucagon-like Peptide-1 Receptor Agonists
by Rasmus M. Christensen & Christian R. Juhl & Signe S. Torekov - 973-992 Mechanisms of Severe Cutaneous Adverse Reactions: Recent Advances
by Teresa Bellón - 993-1003 Bismuth Concentrations in Patients Treated in Real-Life Practice with a Bismuth Subcitrate-Metronidazole-Tetracycline Preparation: The SAPHARY Study
by Estelle Guiard & Bénédicte Lelievre & Magali Rouyer & Frank Zerbib & Bertrand Diquet & Francis Mégraud & François Tison & Emmanuelle Bignon & Régis Lassalle & Cécile Droz-Perroteau & Nicholas Moore & Patrick Blin - 1005-1011 Androgen Deprivation Therapy for Prostate Cancer and the Risk of Rheumatoid Arthritis: A Population-Based Cohort Study
by Adi J. Klil-Drori & Christina Santella & Koray Tascilar & Hui Yin & Armen Aprikian & Laurent Azoulay - 1013-1024 Long-Term Safety and Tolerability of OnabotulinumtoxinA Treatment in Patients with Chronic Migraine: Results of the COMPEL Study
by Paul K. Winner & Andrew M. Blumenfeld & Eric J. Eross & Amelia C. Orejudos & Debbie L. Mirjah & Aubrey Manack Adams & Mitchell F. Brin
July 2019, Volume 42, Issue 7
- 811-812 Inflammation, Monoclonal Antibodies and Depression: Joining the Dots
by David Hunt - 813-825 Sirolimus and mTOR Inhibitors: A Review of Side Effects and Specific Management in Solid Organ Transplantation
by Lee S. Nguyen & Mathieu Vautier & Yves Allenbach & Noel Zahr & Olivier Benveniste & Christian Funck-Brentano & Joe-Elie Salem - 827-847 Drug-Induced Photosensitivity—An Update: Culprit Drugs, Prevention and Management
by Kim M. Blakely & Aaron M. Drucker & Cheryl F. Rosen - 849-868 Pharmacovigilance Systems in Arab Countries: Overview of 22 Arab Countries
by Thamir M. Alshammari & Neslihan Mendi & Khalidah A. Alenzi & Yazed Alsowaida - 869-880 Long-Term Safety and Efficacy of Fecal Microbiota Transplant in Active Ulcerative Colitis
by Xiao Ding & Qianqian Li & Pan Li & Ting Zhang & Bota Cui & Guozhong Ji & Xiang Lu & Faming Zhang - 881-886 Use of a Patient-Friendly Terms List in the Adverse Drug Reaction Report Form: A Database Study
by Sieta T. de Vries & Judy Harrison & Patrick Revelle & Alicia Ptaszynska-Neophytou & Anna Radecka & Gowthamei Ragunathan & Phil Tregunno & Petra Denig & Peter G. M. Mol - 887-895 Exploring the Association between Monoclonal Antibodies and Depression and Suicidal Ideation and Behavior: A VigiBase Study
by Lotte A. Minnema & Thijs J. Giezen & Patrick C. Souverein & Toine C. G. Egberts & Hubert G. M. Leufkens & Helga Gardarsdottir - 897-906 Use of FDA’s Sentinel System to Quantify Seizure Risk Immediately Following New Ranolazine Exposure
by Efe Eworuke & Emily C. Welch & Anne Tobenkin & Judith C. Maro - 907-913 Summary of Torsades de Pointes (TdP) Reports Associated with Intravenous Drug Formulations Containing the Preservative Chlorobutanol
by R. David Woosley & Klaus Romero & Craig W. Heise & Tyler Gallo & Jared Tate & Raymond L. Woosley - 915-917 A Profile of Adverse Drug Reactions of Atazanavir- and Lopinavir-Based Antiretroviral Regimens in Namibia
by Babafunso Aderemi Adenuga & Timothy William Rennie - 919-919 Correction to: Benefit-Risk Assessment of Obesity Drugs: Focus on Glucagon-like Peptide-1 Receptor Agonists
by Rasmus M. Christensen & Christian R. Juhl & Signe S. Torekov
June 2019, Volume 42, Issue 6
- 699-700 Frailty and Drug Safety at Older Ages
by Martin Gulliford - 701-711 Drug-Induced Steatosis and Steatohepatitis: The Search for Novel Serum Biomarkers Among Potential Biomarkers for Non-Alcoholic Fatty Liver Disease and Non-Alcoholic Steatohepatitis
by Lauren Pavlik & Arie Regev & Paul A. Ardayfio & Naga P. Chalasani - 713-719 Identifying Data Elements to Measure Frailty in a Dutch Nationwide Electronic Medical Record Database for Use in Postmarketing Safety Evaluation: An Exploratory Study
by Janet Sultana & Ingrid Leal & Marcel Wilde & Maria Ridder & Johan Lei & Miriam Sturkenboom & Gianluca Trifiro’ - 721-725 A Machine-Learning Algorithm to Optimise Automated Adverse Drug Reaction Detection from Clinical Coding
by Christopher McMaster & David Liew & Claire Keith & Parnaz Aminian & Albert Frauman - 727-741 An Implementation and Visualization of the Tree-Based Scan Statistic for Safety Event Monitoring in Longitudinal Electronic Health Data
by Stephen E. Schachterle & Sharon Hurley & Qing Liu & Kenneth R. Petronis & Andrew Bate - 743-750 A Comparison Study of Algorithms to Detect Drug–Adverse Event Associations: Frequentist, Bayesian, and Machine-Learning Approaches
by Minh Pham & Feng Cheng & Kandethody Ramachandran - 751-768 Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn’s Disease: An Integrated Analysis of Phase II/III Clinical Development Programs
by Subrata Ghosh & Lianne S. Gensler & Zijiang Yang & Chris Gasink & Soumya D. Chakravarty & Kamyar Farahi & Paraneedharan Ramachandran & Elyssa Ott & Bruce E. Strober - 769-784 Evaluation of Antibody Properties and Clinically Relevant Immunogenicity, Anaphylaxis, and Hypersensitivity Reactions in Two Phase III Trials of Tralokinumab in Severe, Uncontrolled Asthma
by Mats Carlsson & Martin Braddock & Yuling Li & Jihong Wang & Weichen Xu & Nicholas White & Ayman Megally & Gillian Hunter & Gene Colice - 785-796 All-Cause Mortality Associated with Tramadol Use: A Case-Crossover Study
by Sohyun Jeong & Ha Jin Tchoe & Junqing Li & Ju-Young Shin