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Content
February 2021, Volume 44, Issue 2
- 125-132 Artificial Intelligence, Real-World Automation and the Safety of Medicines
by Andrew Bate & Steve F. Hobbiger - 133-165 Consensus Guidelines: Best Practices for Detection, Assessment and Management of Suspected Acute Drug-Induced Liver Injury During Clinical Trials in Adults with Chronic Viral Hepatitis and Adults with Cirrhosis Secondary to Hepatitis B, C and Nonalcoholic Steatohepatitis
by William R. Treem & Melissa Palmer & Isabelle Lonjon-Domanec & Daniel Seekins & Lara Dimick-Santos & Mark I. Avigan & John F. Marcinak & Ajit Dash & Arie Regev & Eric Maller & Meenal Patwardhan & James H. Lewis & Don C. Rockey & Adrian M. Bisceglie & James W. Freston & Raul J. Andrade & Naga Chalasani - 167-179 A Comparative View of Reported Adverse Effects of Statins in Social Media, Regulatory Data, Drug Information Databases and Systematic Reviews
by Su Golder & Karen Smith & Karen O’Connor & Robert Gross & Sean Hennessy & Graciela Gonzalez-Hernandez - 181-191 Patient Organizations’ Barriers in Pharmacovigilance and Strategies to Stimulate Their Participation
by Katherine Chinchilla & Cristiano Matos & Victoria Hall & Florence Hunsel - 193-209 Proposals for Engaging Patients and Healthcare Professionals in Risk Minimisation from an Analysis of Stakeholder Input to the EU Valproate Assessment Using the Novel Analysing Stakeholder Safety Engagement Tool (ASSET)
by Priya Bahri & Daniel R. Morales & Adrien Inoubli & Jean-Michel Dogné & Sabine M. J. M. Straus - 211-222 Patient-Reported Adverse Events of Radiopharmaceuticals: A Prospective Study of 1002 Patients
by Nanno Schreuder & Niels A. Jacobs & Pieter L. Jager & Jos G. W. Kosterink & Eugène P. Puijenbroek - 223-233 Adverse Drug Reaction Reporting Using a Mobile Device Application by Persons with Multiple Sclerosis: A Cluster Randomized Controlled Trial
by Gilles Defer & Sophie Fedrizzi & Damien Chevanne & François Montastruc & Anais R. Briant & Jean-Jacques Parienti & Laure Peyro-Saint-Paul - 235-244 Real-World Data on Nonmedical Use of Tramadol from Patients Evaluated for Substance Abuse Treatment in the NAVIPPRO Addiction Severity Index—Multimedia Version (ASI-MV®) Network
by Jody L. Green & Taryn Dailey-Govoni & Stephen F. Butler - 245-254 Use of Hydrochlorothiazide and Risk of Melanoma and Nonmelanoma Skin Cancer
by Julie Rouette & Hui Yin & Anton Pottegård & Krishnarajah Nirantharakumar & Laurent Azoulay - 255-257 Sex Differences in Lopinavir Concentrations and Occurrence of Marked QTc Prolongation Episodes in Patients with COVID-19
by Catia Marzolini & Felix Stader & Anne Leuppi-Taegtmeyer & Marcel Stoeckle & Manuel Battegay & Parham Sendi - 259-259 Correction to: A Comparative View of Reported Adverse Effects of Statins in Social Media, Regulatory Data, Drug Information Databases and Systematic Reviews
by Su Golder & Karen Smith & Karen O’Connor & Robert Gross & Sean Hennessy & Graciela Gonzalez-Hernandez
January 2021, Volume 44, Issue 1
- 1-5 How to Investigate a Serious Adverse Event Reported During a Clinical Trial for a COVID-19 Vaccine
by Saad Shakir & Samantha Lane & Miranda Davies - 7-15 Chances and Challenges of Registry-Based Pharmacovigilance in Multiple Sclerosis: Lessons Learnt from the Implementation of the Multicenter REGIMS Registry
by Alexandra Simbrich & Jasmine Thibaut & Laura Khil & Stanislav Maximov & Heinz Wiendl & Klaus Berger - 17-28 Effective Pharmacovigilance System Development: EFPIA-IPVG Consensus Recommendations
by Tanja Peters & Nigel Soanes & Maya Abbas & Jabeen Ahmad & Jean-Christophe Delumeau & Esteban Herrero-Martinez & Mélanie Paramananda & Johanna Piper & Fairouz Smail-Aoudia & Willemijn Spuij & Tina Veizovic & Gillian Winstanley - 29-40 Efficacy and Safety of Bevacizumab Plus Oxaliplatin- or Irinotecan-Based Doublet Backbone Chemotherapy as the First-Line Treatment of Metastatic Colorectal Cancer: A Systematic Review and Meta-analysis
by Tianshu Ren & Shu Wang & Zexu Shen & Chang Xu & Yingshi Zhang & Fuhai Hui & Xingshun Qi & Qingchun Zhao - 41-51 Understanding and Responding to Prescribing Patterns of Sodium Valproate-Containing Medicines in Pregnant Women and Women of Childbearing Age in Western Cape, South Africa
by Ushma Mehta & Mariette Smith & Emma Kalk & Helen Hayes & Annoesjka Swart & Lawrence Tucker & Renier Coetzee & Andrew Boulle & Marc Blockman - 53-62 Patterns of Benzodiazepine Use and Excess Risk of All-Cause Mortality in the Elderly: A Nationwide Cohort Study
by Clément Mathieu & Pierre Joly & Hélène Jacqmin-Gadda & Mathilde Wanneveich & Bernard Bégaud & Antoine Pariente - 63-72 Introduction or Discontinuation of Additional Risk Minimisation Measures During the Life Cycle of Medicines in Europe
by Reynold D. C. Francisca & Emna Baba & Christina E. Hoeve & Inge M. Zomerdijk & Miriam C. J. M. Sturkenboom & Sabine M. J. M. Straus - 73-82 Dissemination of Direct Healthcare Professional Communications on Medication Errors for Medicinal Products in the EU: An Explorative Study on Relevant Factors
by Christina E. Hoeve & Esther Vries & Peter G. M. Mol & Miriam C. J. M. Sturkenboom & Sabine M. J. M. Straus - 83-94 ADE Eval: An Evaluation of Text Processing Systems for Adverse Event Extraction from Drug Labels for Pharmacovigilance
by Samuel Bayer & Cheryl Clark & Oanh Dang & John Aberdeen & Sonja Brajovic & Kimberley Swank & Lynette Hirschman & Robert Ball - 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