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Content
August 2021, Volume 44, Issue 8
- 843-852 Enhancing Pharmacovigilance from the US Experience: Current Practices and Future Opportunities
by Veronique F. Kugener & Eric S. Freedland & Kenneth I. Maynard & Omar Aimer & Peggy S. Webster & Maribel Salas & Maxine Gossell-Williams - 853-861 Capturing Data in Rare Disease Registries to Support Regulatory Decision Making: A Survey Study Among Industry and Other Stakeholders
by Carla J. Jonker & Sieta T. Vries & H. Marijke Berg & Patricia McGettigan & Arno W. Hoes & Peter G. M. Mol - 863-875 Association Between Prenatal Opioid Exposure and Neurodevelopmental Outcomes in Early Childhood: A Retrospective Cohort Study
by Xuerong Wen & Oluwadolapo D. Lawal & Nicholas Belviso & Kelly L. Matson & Shuang Wang & Brian J. Quilliam & Kimford J. Meador - 877-888 Prevalence, Nature, Severity and Preventability of Adverse Drug Events in Mental Health Settings: Findings from the MedicAtion relateD harm in mEntal health hospitals (MADE) Study
by Ghadah H. Alshehri & Darren M. Ashcroft & Joanne Nguyen & Mark Hann & Richard Jones & Kristof Seaton & Graham Newton & Richard N. Keers - 889-897 Reporting of Thromboembolic Events with JAK Inhibitors: Analysis of the FAERS Database 2010–2019
by Juliana Setyawan & Nassir Azimi & Vibeke Strand & Andres Yarur & Moshe Fridman - 899-915 Cardiovascular Risk in Users of Mirabegron Compared with Users of Antimuscarinic Treatments for Overactive Bladder: Findings from a Non-Interventional, Multinational, Cohort Study
by Veena Hoffman & Jesper Hallas & Marie Linder & Andrea V. Margulis & Brandon T. Suehs & Alejandro Arana & Kelesitse Phiri & Cheryl Enger & Libby Horter & Ingvild Odsbu & Morten Olesen & Susana Perez-Gutthann & Yihua Xu & Nina Sahlertz Kristiansen & Kwame Appenteng & Stefan de Vogel & John D. Seeger
July 2021, Volume 44, Issue 7
- 725-732 Emerging Skin Toxicities in Patients with Breast Cancer Treated with New Cyclin-Dependent Kinase 4/6 Inhibitors: A Systematic Review
by Martina Silvestri & Antonio Cristaudo & Aldo Morrone & Claudia Messina & Luigi Bennardo & Steven Paul Nisticò & Maria Mariano & Norma Cameli - 733-742 Risk Minimization of Antibody–Drug Conjugates in Oncology: A Review
by Fabio A. Lievano & Linda J. Scarazzini & Jerzy E. Tyczynski & Charles M. Schubert & Cheryl L. Renz - 743-751 A Multi-modal Approach to Evaluate the Impact of Risk Evaluation and Mitigation Strategy (REMS) Programs
by Ameet Sarpatwari & Mayookha Mitra-Majumdar & Katsiaryna Bykov & Jerry Avorn & Steven Woloshin & Gita A. Toyserkani & Cynthia LaCivita & Claudia Manzo & Esther H. Zhou & Ellen Pinnow & Gerald J. Dal Pan & Joshua J. Gagne & Krista F. Huybrechts & William B. Feldman & Kristyn Chin & Aaron S. Kesselheim - 753-763 Risk of Severe Abnormal Uterine Bleeding Associated with Rivaroxaban Compared with Apixaban, Dabigatran and Warfarin
by Efe Eworuke & Laura Hou & Rongmei Zhang & Hui-Lee Wong & Peter Waldron & Abby Anderson & Audrey Gassman & David Moeny & Ting-Ying Huang - 765-785 Signal Detection in EUROmediCAT: Identification and Evaluation of Medication–Congenital Anomaly Associations and Use of VigiBase as a Complementary Source of Reference
by Alana Cavadino & Lovisa Sandberg & Inger Öhman & Tomas Bergvall & Kristina Star & Helen Dolk & Maria Loane & Marie-Claude Addor & Ingeborg Barisic & Clara Cavero-Carbonell & Ester Garne & Miriam Gatt & Babak Khoshnood & Kari Klungsøyr & Anna Latos-Bielenska & Nathalie Lelong & Reneé Lutke & Anna Materna-Kiryluk & Vera Nelen & Amanda Nevill & Mary O’Mahony & Olatz Mokoroa & Anna Pierini & Hanitra Randrianaivo & Anke Rissmann & David Tucker & Awi Wiesel & Lyubov Yevtushok & Joan K Morris - 787-796 Risk of Pregnancy Termination and Congenital Anomalies After Domperidone Exposure: A Study in the EFEMERIS Database
by Mélanie Araujo & Clémentine Vabre & Justine Benevent & Agnès Sommet & Christine Damase-Michel & Caroline Hurault-Delarue & Isabelle Lacroix - 797-809 Comparison of Longitudinal and Cross-Sectional Approaches in Studies About Knowledge, Attitude, and Practices Related to Antibiotic Misuse
by Narmeen Mallah & Adolfo Figueiras & Bahi Takkouche - 811-823 Safety Profile of the Adjuvanted Recombinant Zoster Vaccine in Immunocompromised Populations: An Overview of Six Trials
by Marta López-Fauqued & Maribel Co-van der Mee & Adriana Bastidas & Pierre Beukelaers & Alemnew F. Dagnew & Juan Jose Fernandez Garcia & Anne Schuind & Fernanda Tavares-da-Silva
June 2021, Volume 44, Issue 6
- 615-617 The International Society of Pharmacovigilance (ISoP) Pharmacogenomic Special Interest Group: Pharmacogenomics in Pharmacovigilance
by Qun-Ying Yue - 619-634 Overview of Causality Assessment for Drug-Induced Liver Injury (DILI) in Clinical Trials
by Juliana Hey-Hadavi & Daniel Seekins & Melissa Palmer & Denise Coffey & John Caminis & Sandzhar Abdullaev & Meenal Patwardhan & Haifa Tyler & Ritu Raheja & Ann Marie Stanley & Liliam Pineda-Salgado & David L. Bourdet & Raul J. Andrade & Paul H. Hayashi & Lara Dimick-Santos & Don C. Rockey & Alvin Estilo - 635-644 Safety and Efficacy of Ivermectin and Doxycycline Monotherapy and in Combination in the Treatment of COVID-19: A Scoping Review
by Subhrojyoti Bhowmick & Amit Dang & B. N. Vallish & Sumit Dang - 645-660 Safety of S1P Modulators in Patients with Immune-Mediated Diseases: A Systematic Review and Meta-Analysis
by Juan S. Lasa & Pablo A. Olivera & Stefanos Bonovas & Silvio Danese & Laurent Peyrin-Biroulet - 661-668 Comparison of Medication Alerts from Two Commercial Applications in the USA
by Sonam N. Shah & Diane L. Seger & Julie M. Fiskio & John R. Horn & David W. Bates - 669-680 Liver Injury Associated with Metamizole Exposure: Features of an Underestimated Adverse Event
by Sabine Weber & Andreas Benesic & Jens Neumann & Alexander L. Gerbes - 681-697 The Use of Subgroup Disproportionality Analyses to Explore the Sensitivity of a Global Database of Individual Case Safety Reports to Known Pharmacogenomic Risk Variants Common in Japan
by Rika Wakao & Ingrid M. Lönnstedt & Yasunori Aoki & Rebecca E. Chandler - 699-709 Signal Detection and Methodological Limitations in a Real-World Registry: Learnings from the Evaluation of Long-Term Safety Analyses in PSOLAR
by Robert Bissonnette & Alice B. Gottlieb & Richard G. Langley & Craig L. Leonardi & Kim A. Papp & David M. Pariser & Jonathan Uy & Kim Parnell Lafferty & Wayne Langholff & Steven Fakharzadeh & Jesse A. Berlin & Emily S. Brouwer & Andrew J. Greenspan & Bruce E. Strober - 711-722 The Safety Profile of Upadacitinib in Patients with Rheumatoid Arthritis in Japan
by Kunihiro Yamaoka & Yoshiya Tanaka & Hideto Kameda & Nasser Khan & Nobuhito Sasaki & Masayoshi Harigai & Yanna Song & Ying Zhang & Tsutomu Takeuchi - 723-723 Correction to: 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
May 2021, Volume 44, Issue 5
- 511-513 An Update of the North American Chapter of the International Society of Pharmacovigilance (NASoP)
by Maxine Gossell-Williams & Veronique F. Kugener & Maribel Salas & Kenneth I. Maynard & Abimbola Cole - 515-530 Upadacitinib in Rheumatoid Arthritis: A Benefit–Risk Assessment Across a Phase III Program
by Philip G. Conaghan & Eduardo Mysler & Yoshiya Tanaka & Barbara Silva-Tillmann & Tim Shaw & John Liu & Ryan Ferguson & Jeffrey V. Enejosa & Stanley Cohen & Peter Nash & William Rigby & Gerd Burmester - 531-539 Population-Based Observational Study of Adverse Drug Event-Related Mortality in the Super-Aged Society of Japan
by Tomoko Funahashi & Toshihiro Koyama & Hideharu Hagiya & Ko Harada & Syunya Iinuma & Soichiro Ushio & Yoshito Zamami & Takahiro Niimura & Kazuaki Shinomiya & Keisuke Ishizawa & Toshiaki Sendo & Shiro Hinotsu & Mitsunobu R. Kano - 541-551 Identification and Validation of Major Cardiovascular Events in the United Kingdom Data Sources Included in a Multi-database Post-authorization Safety Study of Prucalopride
by Ana Ruigómez & Estel Plana & Alicia Gilsenan & Joan Fortuny & Miguel Cainzos-Achirica & Robert W. V. Flynn & Thomas M. MacDonald & Luis Garcia-Rodriguez & Ryan Ziemiecki & Elizabeth B. Andrews - 553-564 Public Perspectives of Using Social Media Data to Improve Adverse Drug Reaction Reporting: A Mixed-Methods Study
by Alexander Bulcock & Lamiece Hassan & Sally Giles & Caroline Sanders & Goran Nenadic & Stephen Campbell & Will Dixon - 565-579 Anticholinergic Activity of Psychotropic Drugs and Cognitive Impairment Among Participants Aged 45 and Over: The CONSTANCES Study
by Abdelkrim Ziad & Claudine Berr & Fabrice Ruiz & Bernard Bégaud & Cédric Lemogne & Marcel Goldberg & Marie Zins & Thibault Mura - 581-588 Adverse Drug Reactions from Real-World Data in Inflammatory Bowel Disease Patients in the IBDREAM Registry
by Eline L. Giraud & Pepijn W. A. Thomas & Jette A. Lint & Eugene P. Puijenbroek & Tessa E. H. Römkens & Rachel L. West & Maurice G. V. M. Russel & Jeroen M. Jansen & Naomi T. Jessurun & Frank Hoentjen - 589-600 Assessing the Impact on Health of Pharmacovigilance Activities: Example of Four Safety Signals
by Florence Hunsel & Laura Peters & Helga Gardarsdottir & Agnes Kant - 601-607 Clinical Utility of Pharmacogenomic Data Collected by a Health-System Biobank to Predict and Prevent Adverse Drug Events
by Sonam N. Shah & Roseann S. Gammal & Mary G. Amato & Maryam Alobaidly & Dariel Delos Reyes & Sarah Hasan & Diane L. Seger & Joel B. Krier & David W. Bates - 609-610 Comment on: 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 Michael Auerbach - 611-613 Authors’ Reply to Michael Auerbach’s Comment on: “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
April 2021, Volume 44, Issue 4
- 399-402 Safety Consequences of Off-Label Drugs Used for COVID-19
by Nabarun Dasgupta - 403-404 ISoP Fellowships: Recognising and Promoting Leaders in Pharmacovigilance
by Deirdre McCarthy - 405-408 French Pharmacovigilance Public System and COVID-19 Pandemic
by Aurélie Grandvuillemin & Milou-Daniel Drici & Annie Pierre Jonville-Bera & Joelle Micallef & Jean Louis Montastruc - 409-419 Risk Management for the 21st Century: Current Status and Future Needs
by Rania Mouchantaf & Doris Auth & Yola Moride & June Raine & Soon Young Han & Meredith Y. Smith - 421-437 Provision and Need for Medicine Information in Asia and Africa: A Scoping Review of the Literature
by Pitchaya Nualdaisri & Sarah A. Corlett & Janet Krska - 439-446 The DIANA Study: Continued Access to Darunavir/Ritonavir (DRV/r) and Long-Term Safety Follow-Up in HIV-1-Infected Pediatric Patients Aged 3 to
by Avy Violari & Maysseb Masenya & Stephane Blanche & Simon Vanveggel & Veerle Hufkens & Polan Chetty & Magda Opsomer - 447-454 Real-World Fetal Exposure to Acne Treatments in the United States: A Retrospective Analysis from 2006 to 2015
by Yasser Albogami & Amir Sarayani & Juan M. Hincapie-Castillo & Almut G. Winterstein - 455-466 Evaluation of the Risk of Inflammatory Bowel Disease after the HPV Vaccination in Primary Care in Spain: A Time-Varying Cohort Analysis of Around 390,000 Girls
by Elisa Martín-Merino & Belén Castillo-Cano & Mar Martín-Pérez & Ana Llorente-García & Dolores Montero-Corominas - 467-478 Safety of As-Needed Budesonide-Formoterol in Mild Asthma: Data from the Two Phase III SYGMA Studies
by J. Mark FitzGerald & Paul M. O’Byrne & Eric D. Bateman & Peter J. Barnes & Jinping Zheng & Stefan Ivanov & Rosa Lamarca & Ulrika Larsdotter & Ulrika Emerath & Gerreke Jansen & Margareta Puu & Vijay K. T. Alagappan & Filip Surmont & Helen K. Reddel - 479-497 Comparative Risk Assessment of Severe Uterine Bleeding Following Exposure to Direct Oral Anticoagulants: A Network Study Across Four Observational Databases in the USA
by James Weaver & Azza Shoaibi & Huy Q. Truong & Leila Larbi & Shujian Wu & Peter Wildgoose & Gowtham Rao & Amy Freedman & Lu Wang & Zhong Yuan & Elliot Barnathan - 499-501 Communicating About Risks and Safe Use of Medicines
by I. Ralph Edwards - 503-504 Comment on: “Direct Oral Anticoagulants and Interstitial Lung Disease: Emerging Clues from Pharmacovigilance”
by Robert P. Giugliano & Raffaele De Caterina & Takeshi Yamashita - 505-506 Authors’ Reply to Robert P. Giugliano and Colleagues’ Comment on: “Direct Oral Anticoagulants and Interstitial Lung Disease: Emerging Clues from Pharmacovigilance”
by Emanuel Raschi & Michele Fusaroli & Igor Diemberger & Elisabetta Poluzzi - 507-507 Correction to: Assessing the Safety of COVID-19 Vaccines: A Primer
by Helen Petousis-Harris
March 2021, Volume 44, Issue 3
- 261-272 Validating Intelligent Automation Systems in Pharmacovigilance: Insights from Good Manufacturing Practices
by Kristof Huysentruyt & Oeystein Kjoersvik & Pawel Dobracki & Elizabeth Savage & Ellen Mishalov & Mark Cherry & Eileen Leonard & Robert Taylor & Bhavin Patel & Danielle Abatemarco - 273-290 Safety of N-Acetylcysteine at High Doses in Chronic Respiratory Diseases: A Review
by Peter Calverley & Paola Rogliani & Alberto Papi - 291-312 A Systematic Review and Meta-Analysis Considering the Risk for Congenital Heart Defects of Antidepressant Classes and Individual Antidepressants
by Courtney De Vries & Svetla Gadzhanova & Matthew J. Sykes & Michael Ward & Elizabeth Roughead - 313-325 An Algorithm for Comprehensive Medication Management in Nursing Homes: Results of the AMBER Project
by Susanne Erzkamp & Juliane Köberlein-Neu & Olaf Rose - 327-335 Changes in Erythropoiesis Stimulating Agent Use Under a Risk Evaluation and Mitigation Strategy (REMS) Program
by Ameet Sarpatwari & Mengdong He & Frazer A. Tessema & Joshua J. Gagne & Aaron S. Kesselheim - 337-349 PCSK9 Inhibitors and Neurocognitive Adverse Drug Reactions: Analysis of Individual Case Safety Reports from the Eudravigilance Database
by Gabriella di Mauro & Alessia Zinzi & Cristina Scavone & Annamaria Mascolo & Mario Gaio & Liberata Sportiello & Carmen Ferrajolo & Concetta Rafaniello & Francesco Rossi & Annalisa Capuano - 351-359 Evaluation of Opioid Overdose Reports in Patients Treated with Extended-Release Naltrexone: Postmarketing Data from 2006 to 2018
by Priya Jain & Kimberley McKinnell & Rose Marino & Prashanthi Vunnava & Marie A. Liles-Burden & Avani Desai & Madé Wenten & James Fratantonio & Sarah C. Akerman & Maria A. Sullivan & Gary Bloomgren - 361-371 Risk of Cancer in Association with Ranitidine and Nizatidine vs Other H2 Blockers: Analysis of the Japan Medical Data Center Claims Database 2005–2018
by Masao Iwagami & Ryosuke Kumazawa & Yoshihisa Miyamoto & Yuri Ito & Miho Ishimaru & Kojiro Morita & Shota Hamada & Nanako Tamiya & Hideo Yasunaga - 373-382 Developing Crowdsourced Training Data Sets for Pharmacovigilance Intelligent Automation
by Alex Gartland & Andrew Bate & Jeffery L. Painter & Tim A. Casperson & Gregory Eugene Powell - 383-395 Incidence Rates of Autoimmune Diseases in European Healthcare Databases: A Contribution of the ADVANCE Project
by Corinne Willame & Caitlin Dodd & Lieke van der Aa & Gino Picelli & Hanne-Dorthe Emborg & Johnny Kahlert & Rosa Gini & Consuelo Huerta & Elisa Martín-Merino & Chris McGee & Simon Lusignan & Giuseppe Roberto & Marco Villa & Daniel Weibel & Lina Titievsky & Miriam C. J. M. Sturkenboom - 397-397 Correction to: DNA Barcoding and Pharmacovigilance of Herbal Medicines
by Hugo J. Boer & Mihael C. Ichim & Steven G. Newmaster
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