Content
August 2022, Volume 45, Issue 8
- 873-880 Short-Term Risk of Unintentional Poisoning After New Initiation of Central Nervous System Medications in Swedish Older Adults: A Register-Based Case-Crossover Study
by Yang Zhao & Yajun Liang & Lucie Laflamme & Christian Rausch & Kristina Johnell & Jette Möller - 881-889 Developing Strategic Recommendations for Implementing Smart Pumps in Advanced Healthcare Systems to Improve Intravenous Medication Safety
by Adam Sutherland & Matthew D. Jones & Moninne Howlett & Sara Arenas-Lopez & Arif Patel & Bryony Dean Franklin - 891-908 Post-Marketing Surveillance of CAR-T-Cell Therapies: Analysis of the FDA Adverse Event Reporting System (FAERS) Database
by Michele Fusaroli & Valentina Isgrò & Paola Maria Cutroneo & Carmen Ferrajolo & Valentina Cirillo & Francesca Del Bufalo & Emanuel Raschi & Elisabetta Poluzzi & Gianluca Trifirò - 909-922 Safety of Praziquantel and Albendazole Coadministration for the Control and Elimination of Schistosomiasis and Soil-Transmitted Helminths Among Children in Rwanda: An Active Surveillance Study
by Joseph Kabatende & Abbie Barry & Michael Mugisha & Lazare Ntirenganya & Ulf Bergman & Emile Bienvenu & Eleni Aklillu - 923-923 Comment on “Description of Frequencies of Reported Adverse Events Following Immunization Among Four Different COVID-19 Vaccine Brands”
by Rujittika Mungmunpuntipantip & Viroj Wiwanitkit - 925-926 Authors’ Reply to Mungmunpuntipantip et al.’s Comment on “Description of Frequencies of Reported Adverse Events Following Immunization Among Four Different COVID-19 Vaccine Brands”
by Agnes Kant & Florence Hunsel - 927-927 Correction to: Machine Learning in Causal Inference: Application in Pharmacovigilance
by Yiqing Zhao & Yue Yu & Hanyin Wang & Yikuan Li & Yu Deng & Guoqian Jiang & Yuan Luo
July 2022, Volume 45, Issue 7
- 699-702 An Update on the International Society of Pharmacovigilance China Chapter
by Yalu Wen & Tianyi Yang & Li Zhang & Brian Edwards & Honghui Wu & Jukai Huang & Xiaohui Yang - 703-712 Incidence, Pathogenesis, and Management of Proton Pump Inhibitor-Induced Nephrotoxicity
by Xiao Wei & Jun Yu & Zhengkun Xu & Chun Wang & Yonggui Wu - 713-735 Prevalence of Use of Traditional, Complementary and Alternative Medicine by the General Population: A Systematic Review of National Studies Published from 2010 to 2019
by E Lyn Lee & Noni Richards & Jeff Harrison & Joanne Barnes - 737-745 Safety-Related Drug Withdrawals in China Between 1999 and 2021: A Systematic Investigation and Analysis
by Yanrong Li & Yang Jiang & Haixue Wang & Li Zhang & Yue Yang - 747-754 Collection of Data on Adverse Events Related to Medicinal Products: A Survey Among Registries in the ENCePP Resources Database
by Kelly Plueschke & Carla Jonker & Valerie Strassmann & Xavier Kurz - 755-764 Quantitative Prediction of Adverse Event Probability Due to Pharmacokinetic Interactions
by Michel Tod & Thomas Rodier & Marine Auffret - 765-780 Signaling COVID-19 Vaccine Adverse Events
by Rave Harpaz & William DuMouchel & Robbert Manen & Alexander Nip & Steve Bright & Ana Szarfman & Joseph Tonning & Magnus Lerch - 781-790 Incidence of Acute Renal Failure in Patients Using Levetiracetam Versus Other Antiseizure Medications: A Voluntary Post-Authorization Safety Study
by Raphaelle Beau-Lejdstrom & Lai San Hong & Xabier Garcia de Albeniz & Florin Floricel & Johan Lorenzen & Francois Bonfitto & Linda Kalilani & Christian Loesch & Graham Luscombe & Susana Perez-Gutthann & Isabelle Mottet & Nadia Foskett - 791-807 Hip Fracture Risk After Treatment with Tramadol or Codeine: An Observational Study
by Erica A. Voss & Saberi Rana Ali & Arun Singh & Peter R. Rijnbeek & Martijn J. Schuemie & Daniel Fife - 809-811 Comment on: "Drug–Drug Interaction of the Sodium Glucose Co-transporter 2 Inhibitors with Statins and Myopathy: A Disproportionality Analysis Using Adverse Events Reporting Data"
by Yoshihiro Noguchi - 813-814 Authors’ Reply to Noguchi’s comment on: “Drug-Drug Interaction of the Sodium Glucose Co-transporter 2 Inhibitors with Statins and Myopathy: A Disproportionality Analysis Using Adverse Events Reporting Data.”
by John-Michael Gamble & Wajd Alkabbani
June 2022, Volume 45, Issue 6
- 597-599 The International Society of Pharmacovigilance Vaccines Special Interest Group: Challenges and Opportunities
by Rebecca E. Chandler - 601-621 Chemobrain in Breast Cancer: Mechanisms, Clinical Manifestations, and Potential Interventions
by Giovana R. Onzi & Nathalia D’Agustini & Solange C. Garcia & Silvia S. Guterres & Paula R. Pohlmann & Daniela D. Rosa & Adriana R. Pohlmann - 623-638 Hydroxyzine Initiation Following Drug Safety Advisories on Cardiac Arrhythmias in the UK and Canada: A Longitudinal Cohort Study
by Richard L. Morrow & Barbara Mintzes & Patrick C. Souverein & Christine E. Hallgreen & Bilal Ahmed & Elizabeth E. Roughead & Marie L. Bruin & Sarah Brøgger Kristiansen & Joel Lexchin & Anna Kemp-Casey & Ingrid Sketris & Dee Mangin & Sallie-Anne Pearson & Lorri Puil & Ruth Lopert & Lisa Bero & Danijela Gnjidic & Ameet Sarpatwari & Colin R. Dormuth - 639-650 Drug-Induced Sexual Dysfunction: An Analysis of Reports to a National Pharmacovigilance Database
by Carolina Valeiro & Cristiano Matos & Joep Scholl & Florence Hunsel - 651-661 Analysis of Reports on Adverse Drug Reactions Related to Herbal Medicinal Products and Herbal Supplements in the Netherlands Received by the National Pharmacovigilance Centre Lareb
by Florence P. A. M. Hunsel & Djurre Kooi & Sonja Koppel & Burt H. Kroes & Herman J. Woerdenbag - 663-673 Amyotrophic Lateral Sclerosis as an Adverse Drug Reaction: A Disproportionality Analysis of the Food and Drug Administration Adverse Event Reporting System
by Anna Gaimari & Michele Fusaroli & Emanuel Raschi & Elisa Baldin & Luca Vignatelli & Francesco Nonino & Fabrizio Ponti & Jessica Mandrioli & Elisabetta Poluzzi - 675-684 Montelukast and Nightmares: Further Characterisation Using Data from VigiBase
by Sarah Watson & Elenor Kaminsky & Henric Taavola & Marian Attalla & Qun-Ying Yue - 685-698 Phenotype Algorithms for the Identification and Characterization of Vaccine-Induced Thrombotic Thrombocytopenia in Real World Data: A Multinational Network Cohort Study
by Azza Shoaibi & Gowtham A. Rao & Erica A. Voss & Anna Ostropolets & Miguel Angel Mayer & Juan Manuel Ramírez-Anguita & Filip Maljković & Biljana Carević & Scott Horban & Daniel R. Morales & Talita Duarte-Salles & Clement Fraboulet & Tanguy Carrour & Spiros Denaxas & Vaclav Papez & Luis H. John & Peter R. Rijneek & Evan Minty & Thamir M. Alshammari & Rupa Makadia & Clair Blacketer & Frank DeFalco & Anthony G. Sena & Marc A. Suchard & Daniel Prieto-Alhambra & Patrick B. Ryan
May 2022, Volume 45, Issue 5
- 403-405 Artificial Intelligence and Machine Learning for Safe Medicines
by Andrew Bate & Yuan Luo - 407-418 Artificial Intelligence in Pharmacovigilance: An Introduction to Terms, Concepts, Applications, and Limitations
by Jeffrey K. Aronson - 419-427 Black Swan Events and Intelligent Automation for Routine Safety Surveillance
by Oeystein Kjoersvik & Andrew Bate - 429-438 “Artificial Intelligence” for Pharmacovigilance: Ready for Prime Time?
by Robert Ball & Gerald Dal Pan - 439-448 Industry Perspective on Artificial Intelligence/Machine Learning in Pharmacovigilance
by Raymond Kassekert & Neal Grabowski & Denny Lorenz & Claudia Schaffer & Dieter Kempf & Promit Roy & Oeystein Kjoersvik & Griselda Saldana & Sarah ElShal - 449-458 Intelligent Telehealth in Pharmacovigilance: A Future Perspective
by Heba Edrees & Wenyu Song & Ania Syrowatka & Aurélien Simona & Mary G. Amato & David W. Bates - 459-476 Machine Learning in Causal Inference: Application in Pharmacovigilance
by Yiqing Zhao & Yue Yu & Hanyin Wang & Yikuan Li & Yu Deng & Guoqian Jiang & Yuan Luo - 477-491 Artificial Intelligence Based on Machine Learning in Pharmacovigilance: A Scoping Review
by Benjamin Kompa & Joe B. Hakim & Anil Palepu & Kathryn Grace Kompa & Michael Smith & Paul A. Bain & Stephen Woloszynek & Jeffery L. Painter & Andrew Bate & Andrew L. Beam - 493-510 Applying Machine Learning in Distributed Data Networks for Pharmacoepidemiologic and Pharmacovigilance Studies: Opportunities, Challenges, and Considerations
by Jenna Wong & Daniel Prieto-Alhambra & Peter R. Rijnbeek & Rishi J. Desai & Jenna M. Reps & Sengwee Toh - 511-519 Artificial Intelligence-Based Pharmacovigilance in the Setting of Limited Resources
by Likeng Liang & Jifa Hu & Gang Sun & Na Hong & Ge Wu & Yuejun He & Yong Li & Tianyong Hao & Li Liu & Mengchun Gong - 521-533 Identifying and Mitigating Potential Biases in Predicting Drug Approvals
by Qingyang Xu & Elaheh Ahmadi & Alexander Amini & Daniela Rus & Andrew W. Lo - 535-548 Validation of Artificial Intelligence to Support the Automatic Coding of Patient Adverse Drug Reaction Reports, Using Nationwide Pharmacovigilance Data
by Guillaume L. Martin & Julien Jouganous & Romain Savidan & Axel Bellec & Clément Goehrs & Mehdi Benkebil & Ghada Miremont & Joëlle Micallef & Francesco Salvo & Antoine Pariente & Louis Létinier - 549-561 Automated Drug Coding Using Artificial Intelligence: An Evaluation of WHODrug Koda on Adverse Event Reports
by Eva-Lisa Meldau & Shachi Bista & Emma Rofors & Lucie M. Gattepaille - 563-570 Using Iterative Pairwise External Validation to Contextualize Prediction Model Performance: A Use Case Predicting 1-Year Heart Failure Risk in Patients with Diabetes Across Five Data Sources
by Ross D. Williams & Jenna M. Reps & Jan A. Kors & Patrick B. Ryan & Ewout Steyerberg & Katia M. Verhamme & Peter R. Rijnbeek - 571-582 Leveraging Machine Learning to Facilitate Individual Case Causality Assessment of Adverse Drug Reactions
by Yauheniya Cherkas & Joshua Ide & John Stekelenborg - 583-596 Supervised Machine Learning-Based Decision Support for Signal Validation Classification
by Muhammad Imran & Aasia Bhatti & David M. King & Magnus Lerch & Jürgen Dietrich & Guy Doron & Katrin Manlik
April 2022, Volume 45, Issue 4
- 305-318 New Drug Postmarketing Requirements and Commitments in the US: A Systematic Review of the Evidence
by Osman Moneer & Beatrice L. Brown & Jerry Avorn & Jonathan J. Darrow & Mayookha Mitra-Majumdar & Krysten W. Joyce & Murray Ross & Catherine Pham & Aaron S. Kesselheim - 319-331 Description of Frequencies of Reported Adverse Events Following Immunization Among Four Different COVID-19 Vaccine Brands
by Agnes Kant & Jurriaan Jansen & Leontine Balveren & Florence Hunsel - 333-344 A Landscape Analysis of Post-Marketing Studies Registered in the EU PAS Register and ClinicalTrials.gov Focusing on Pregnancy Outcomes or Breastfeeding Effects: A Contribution from the ConcePTION Project
by Leonardo Roque Pereira & Carlos E. Durán & Deborah Layton & Georgios Poulentzas & Panagiotis-Nikolaos Lalagkas & Christos Kontogiorgis & Miriam Sturkenboom - 345-357 Pregnancy, Fetal, and Infant Outcomes Following Maternal Exposure to Glatiramer Acetate During Pregnancy and Breastfeeding
by Sigal Kaplan & Mikhail Zeygarnik & Tal Stern - 359-367 Postoperative Respiratory Events in Surgical Patients Exposed to Opioid Analgesic Shortages Compared to Fully Matched Patients Non-exposed to Shortages
by Rosa Rodriguez-Monguio & Zhixin Lun & Tasce Bongiovanni & Catherine L. Chen & Enrique Seoane-Vazquez - 369-378 Handling of New Drug Safety Information in the Dutch Hospital Setting: A Mixed Methods Approach
by Esther Vries & Elisabeth Bakker & Remy D. C. Francisca & Stijn Croonen & Petra Denig & Peter G. M. Mol - 379-388 Intracranial Hemorrhage Following Anticoagulant Treatment in Denmark: Spontaneous Adverse Drug Reaction Reports Versus Real-World Data
by Benedikte Irene Osmanski & Astrid Blicher Schelde & Espen Jimenez-Solem & Martin Erik Nyeland & Henrik Horwitz - 389-398 Consensus Obtained for the Nephrotoxic Potential of 167 Drugs in Adult Critically Ill Patients Using a Modified Delphi Method
by Matthew P. Gray & Erin F. Barreto & Diana J. Schreier & John A. Kellum & Kangho Suh & Kianoush B. Kashani & Andrew D. Rule & Sandra L. Kane-Gill - 399-399 Correction to: A Landscape Analysis of Post-Marketing Studies Registered in the EU PAS Register and ClinicalTrials.gov Focusing on Pregnancy Outcomes or Breastfeeding Effects: A Contribution from the ConcePTION Project
by Leonardo Roque Pereira & Carlos E. Durán & Deborah Layton & Georgios Poulentzas & Panagiotis-Nikolaos Lalagkas & Christos Kontogiorgis & Miriam Sturkenboom - 401-401 Correction to: Review of Over 15 Years Postmarketing Safety Surveillance Spontaneous Data for the Human Rotavirus Vaccine (Rotarix) on Intussusception
by Tina Singh & Frédérique Delannois & François Haguinet & Lifeter Yenwo Molo
March 2022, Volume 45, Issue 3
- 193-213 A Review on Application of DNA Barcoding Technology for Rapid Molecular Diagnostics of Adulterants in Herbal Medicine
by Alok Senapati & Supriyo Basak & Latha Rangan - 215-235 Cannabinoid-Related Acute Pancreatitis: An Update from International Literature and Individual Case Safety Reports
by Camille Azam & Louis Buscail & Adrian Culetto & Maryse Lapeyre-Mestre - 237-247 Sales of Over-the-Counter Products Containing Codeine in 31 Countries, 2013–2019: A Retrospective Observational Study
by Georgia C. Richards & Jeffrey K. Aronson & Brian MacKenna & Ben Goldacre & F. D. Richard Hobbs & Carl Heneghan - 249-257 The Extent of Medication-Related Hospital Admissions in Australia: A Review from 1988 to 2021
by Renly Lim & Lisa M. Kalisch Ellett & Susan Semple & Elizabeth E. Roughead - 259-274 Improving the Safety of Medicines via Digital Technology: An Assessment of the Scope and Quality of Risk Minimization Websites in the United States and United Kingdom
by Meredith Y. Smith & Sarah Frise & Jane Feron & Ryan Marshall - 275-285 High-Dimensional Propensity Score-Adjusted Case-Crossover for Discovering Adverse Drug Reactions from Computerized Administrative Healthcare Databases
by Etienne Volatier & Francesco Salvo & Antoine Pariente & Émeline Courtois & Sylvie Escolano & Pascale Tubert-Bitter & Ismaïl Ahmed - 287-295 Drug–Drug Interaction of the Sodium Glucose Co-Transporter 2 Inhibitors with Statins and Myopathy: A Disproportionality Analysis Using Adverse Events Reporting Data
by Wajd Alkabbani & Ryan Pelletier & Michael A. Beazely & Youssef Labib & Breanna Quan & John-Michael Gamble - 297-304 Impact of Preventive Strategies on Gastrointestinal Complications in Elderly Patients on Concomitant Use of Oral Anticoagulants and Nonsteroidal Anti-Inflammatory Drugs: A Nationwide Cohort Study
by Suhyun Lee & Kyu-Nam Heo & Mee Yeon Lee & Woo‑Youn Kim & Young-Mi Ah & Jaekyu Shin & Ju‑Yeun Lee
February 2022, Volume 45, Issue 2
- 97-99 Medication Errors Special Interest Group of the International Society of Pharmacovigilance and the Trends in International Collaboration for Patient Safety
by Mohamed A. Elhawary & Hadir Rostom & Brian Edwards & Angela Caro - 101-126 Cancer Chemotherapy-Induced Sinus Bradycardia: A Narrative Review of a Forgotten Adverse Effect of Cardiotoxicity
by Juan Tamargo & Ricardo Caballero & Eva Delpón - 127-136 Use of Identical INN “Imiglucerase” for Different Drug Products: Impact Analysis of Adverse Events in a Proprietary Global Safety Database
by So-Fai Tsang & Shirali Pandya & Kristina Barakov & Joan Keutzer & Grace Lewis & Leorah Ross & Selena Freisens - 137-144 Spontaneous Reporting to Regulatory Authorities of Suspected Adverse Drug Reactions to COVID-19 Vaccines Over Time: The Effect of Publicity
by Robin E. Ferner & Richard J. Stevens & Christopher Anton & Jeffrey K. Aronson - 145-153 Post-Marketing Safety Profile of Vortioxetine Using a Cluster Analysis and a Disproportionality Analysis of Global Adverse Event Reports
by Corine Ekhart & Florence Hunsel & Eugène Puijenbroek & Rebecca Chandler & Eva-Lisa Meldau & Henric Taavola & G. Niklas Norén - 155-168 Review of Over 15 Years Postmarketing Safety Surveillance Spontaneous Data for the Human Rotavirus Vaccine (Rotarix) on Intussusception
by Tina Singh & Frédérique Delannois & François Haguinet & Lifeter Yenwo Molo - 169-180 Sources of Evidence Triggering and Supporting Safety-Related Labeling Changes: A 10-Year Longitudinal Assessment of 22 New Molecular Entities Approved in 2008 by the US Food and Drug Administration
by David Croteau & Ellen Pinnow & Eileen Wu & Monica Muñoz & Ilynn Bulatao & Gerald Dal Pan - 181-189 β-Blockers and the Risk of Depression: A Matched Case–Control Study
by Delia Bornand & Daphne Reinau & Susan S. Jick & Christoph R. Meier - 191-192 Correction to: Clinical Trial and Postmarketing Safety of Onasemnogene Abeparvovec Therapy
by John W. Day & Jerry R. Mendell & Eugenio Mercuri & Richard S. Finkel & Kevin A. Strauss & Aaron Kleyn & Sitra Tauscher-Wisniewski & Francis Fonyuy Tukov & Sandra P. Reyna & Deepa H. Chand
January 2022, Volume 45, Issue 1
- 1-18 Patient Safety Incidents Related to the Use of Parenteral Nutrition in All Patient Groups: A Systematic Scoping Review
by Priya Mistry & Rebecca Heather Smith & Andy Fox - 19-26 Safety of Intravenous Push Levetiracetam Compared to Intravenous Piggyback at a Tertiary Academic Medical Center: A Retrospective Analysis
by Afrah Alkazemi & Kevin C. McLaughlin & Michael G. Chan & Michael J. Schontz & Kevin E. Anger & Paul M. Szumita - 27-35 Hybrid Method Incorporating a Rule-Based Approach and Deep Learning for Prescription Error Prediction
by Seunghee Lee & Jeongwon Shin & Hyeon Seong Kim & Min Je Lee & Jung Min Yoon & Sohee Lee & Yongsuk Kim & Jong-Yeup Kim & Suehyun Lee - 37-44 A 13-Year National Monitoring Study to Assess Narcotic Prescriptions and Indications (2007–2019)
by Joelle Perri-Plandé & Ghada Miremont-Salamé & Joëlle Micallef & Cameron Herman & Marie Baumevieille & Frédéric Abriat & Maryse Lapeyre-Mestre & Françoise Haramburu & Amélie Daveluy - 45-64 RELAY, Ramucirumab Plus Erlotinib Versus Placebo Plus Erlotinib in Patients with Untreated, Epidermal Growth Factor Receptor Mutation-Positive, Metastatic Non-Small-Cell Lung Cancer: Safety Profile and Manageability
by Ernest Nadal & Hidehito Horinouchi & Jin-Yuan Shih & Kazuhiko Nakagawa & Martin Reck & Edward B. Garon & Yu-Feng Wei & Jens Kollmeier & Bente Frimodt-Moller & Emily Barrett & Olga Lipkovich & Carla Visseren-Grul & Silvia Novello - 65-74 Renin–Angiotensin–Aldosterone System Inhibitors and Risk of Acute Pancreatitis: A Population-Based Cohort Study
by Julie Rouette & Hui Yin & Emily G. McDonald & Alan Barkun & Laurent Azoulay - 75-82 The Risk of Preoperative Central Nervous System-Acting Medications on Delirium Following Hip or Knee Surgery: A Matched Case-Control Study
by Gizat M. Kassie & Elizabeth E. Roughead & Tuan A. Nguyen & Nicole L. Pratt & Lisa M. Kalisch Ellett - 83-95 The Impact of Mandatory Reporting of Non-Serious Safety Reports to EudraVigilance on the Detection of Adverse Reactions
by Gianmario Candore & Sebastian Monzon & Jim Slattery & Loris Piccolo & Rodrigo Postigo & Xavier Xurz & Sabine Strauss & Peter Arlett
December 2021, Volume 44, Issue 12
- 1247-1269 COVID-19 Vaccination in Pregnancy, Paediatrics, Immunocompromised Patients, and Persons with History of Allergy or Prior SARS-CoV-2 Infection: Overview of Current Recommendations and Pre- and Post-Marketing Evidence for Vaccine Efficacy and Safety
by Nicoletta Luxi & Alexia Giovanazzi & Annalisa Capuano & Salvatore Crisafulli & Paola Maria Cutroneo & Maria Pia Fantini & Carmen Ferrajolo & Ugo Moretti & Elisabetta Poluzzi & Emanuel Raschi & Claudia Ravaldi & Chiara Reno & Marco Tuccori & Alfredo Vannacci & Giovanna Zanoni & Gianluca Trifirò - 1271-1281 Mechanisms, Management and Prevention of Pemetrexed-Related Toxicity
by Nikki Rouw & Berber Piet & Hieronymus J. Derijks & Michel M. den Heuvel & Rob Heine - 1283-1295 The Effectiveness and Value of Written Medicine Information Across Asia and Africa: Systematic Review
by Pitchaya Nualdaisri & Sarah A. Corlett & Janet Krska - 1297-1309 Maternal Complications and Prescription Opioid Exposure During Pregnancy: Using Marginal Structural Models
by Xuerong Wen & Shuang Wang & Adam K. Lewkowitz & Kristina E. Ward & Erin Christine Brousseau & Kimford J. Meador - 1311-1321 Renal Safety of Hydroxyethyl starch 130/0.42 After Cardiac Surgery: A Retrospective Cohort Analysis
by Benedict Morath & Andreas D. Meid & Johannes Rickmann & Jasmin Soethoff & Markus Verch & Matthias Karck & Marcin Zaradzki - 1323-1339 Dispensing of Potentially Harmful Prescription Drugs in 1.8 Million Pregnant Women in France: A Nationwide Study Based on Two Risk Classification Systems
by Pierre-Olivier Blotière & Christine Damase-Michel & Alain Weill & Géric Maura - 1341-1353 An Analysis of Spontaneously Reported Data of Vesicular and Bullous Cutaneous Eruptions Occurring Following Vaccination with the Adjuvanted Recombinant Zoster Vaccine
by Paola Pirrotta & Fernanda Tavares-Da-Silva & Maribel Co & Nicolas Lecrenier & Caroline Hervé & Jens-Ulrich Stegmann - 1355-1364 Long-Term Safety and Tolerability of Fremanezumab for Migraine Preventive Treatment in Japanese Outpatients: A Multicenter, Randomized, Open-Label Study
by Fumihiko Sakai & Norihiro Suzuki & Xiaoping Ning & Miki Ishida & Chiharu Usuki & Katsuhiro Iba & Yuki Isogai & Nobuyuki Koga - 1365-1374 Repeated or Continuous Medically Supervised Ketamine Administration Associated with Hepatobiliary Adverse Events: A Retrospective Case Series
by Samantha Cotter & Jennie Wong & Neha Gada & Rajdeep Gill & S. Christopher Jones & Grace Chai & Daniel Foster & Mark Avigan & Mallika Mundkur - 1375-1390 Safety Profile of GSK’s Inactivated Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany and Spain: Passive Enhanced Safety Surveillance Study for the 2019/2020 Influenza Season
by Ignacio Salamanca de la Cueva & Elisa Cinconze & Tamara Eckermann & Ugo Nwoji & Lode Godderis & Emily Lu & Xavier Martínez-Gómez & Huajun Wang & Emad Yanni
November 2021, Volume 44, Issue 11
- 1121-1123 Inconsistent Safety Outcome Reporting in Randomized Clinical Trials of COVID-19 Vaccines Complicates Informed Medical Decisions
by Joseph E. Blais & Yue Wei & Celine S. L. Chui & Esther W. Chan & Ian C. K. Wong - 1125-1149 Drug-Induced Liver Injury: Highlights and Controversies in the Recent Literature
by Joseph William Clinton & Sara Kiparizoska & Soorya Aggarwal & Stephanie Woo & William Davis & James H. Lewis - 1151-1164 Validating Claims-Based Algorithms Determining Pregnancy Outcomes and Gestational Age Using a Linked Claims-Electronic Medical Record Database
by Keran Moll & Hui Lee Wong & Kathryn Fingar & Shayan Hobbi & Minya Sheng & Timothy A. Burrell & Linda O. Eckert & Flor M. Munoz & Bethany Baer & Azadeh Shoaibi & Steven Anderson - 1165-1178 Identifying Actionability as a Key Factor for the Adoption of ‘Intelligent’ Systems for Drug Safety: Lessons Learned from a User-Centred Design Approach
by George I. Gavriilidis & Vlasios K. Dimitriadis & Marie-Christine Jaulent & Pantelis Natsiavas - 1179-1191 Role of Drug–Gene Interactions and Pharmacogenetics in Simvastatin-Associated Pulmonary Toxicity
by Naomi T. Jessurun & Marjolein Drent & Petal A. Wijnen & Ankie M. Harmsze & Eugène P. Puijenbroek & Otto Bekers & Aalt Bast - 1193-1208 Systematising Pharmacovigilance Engagement of Patients, Healthcare Professionals and Regulators: A Practical Decision Guide Derived from the International Risk Governance Framework for Engagement Events and Discourse
by Priya Bahri & Antoine Pariente - 1209-1214 Cumulative Adverse Event Reporting of Anaphylaxis After mRNA COVID-19 Vaccine (Pfizer-BioNTech) Injections in Japan: The First-Month Report
by Toyotaka Iguchi & Hikari Umeda & Michie Kojima & Yuri Kanno & Yuta Tanaka & Natsumi Kinoshita & Daisaku Sato - 1215-1230 Surveillance of Antidepressant Safety (SADS): Active Signal Detection of Serious Medical Events Following SSRI and SNRI Initiation Using Big Healthcare Data
by Mia Aakjær & Marie Louise Bruin & Murat Kulahci & Morten Andersen - 1231-1242 Desloratadine Exposure and Incidence of Seizure: A Nordic Post-authorization Safety Study Using a New-User Cohort Study Design, 2001–2015
by Annette Kjær Ersbøll & Kaushik Sengupta & Eero Pukkala & Kristian Bolin & Eline Aas & Martha Emneus & Dena Rosen Ramey & Joanne E. Brady & Daniel Mines & Kristian Aasbjerg & Christian Vestergaard & Gunnar Gislason & Alfred Peter Born & Thora Majlund Kjærulff
October 2021, Volume 44, Issue 10
- 1017-1020 A Multidisciplinary Approach in Pharmacovigilance Awareness: ISoP Egypt Chapter’s MedSafetyWeek Experience
by Hadir Rostom & Mohamed A. Elhawary & Islam N. Ali - 1021-1032 Eritrean Pharmacovigilance System: Key Strategies, Success Stories, Challenges and Lessons Learned
by Mulugeta Russom & Iyassu Bahta & Merhawi Debesai - 1033-1040 Use of Primary Care Data in Research and Pharmacovigilance: Eight Scenarios Where Prescription Data are Absent
by Grace N. Okoli & Puja Myles & Tarita Murray-Thomas & Hilary Shepherd & Ian C. K. Wong & Duncan Edwards - 1041-1058 Drug-Related Problems in Hospitalised Patients with Chronic Kidney Disease: A Systematic Review
by Wadia S. Alruqayb & Malcolm J. Price & Vibhu Paudyal & Anthony R. Cox - 1059-1072 Patient Global Impression of Benefit–Risk (PGI-BR): Incorporating Patients’ Views of Clinical Benefit–Risk into Assessment of New Medicines
by Daniel Eek & Katarina Halling & Emuella Flood & Matthew Blowfield & Oren Meyers & Meredith Venerus & Jean Paty & Richard Hermann - 1073-1083 Motives to Report Adverse Drug Reactions to the National Agency: A Survey Study among Healthcare Professionals and Patients in Croatia, The Netherlands, and the UK
by Sieta T. de Vries & Petra Denig & Adriana Andrić & Marina Dimov Di Giusti & Alicia Ptaszynska-Neophytou & Linda Härmark & Peter G. M. Mol - 1085-1098 Smart Safety Surveillance (3S): Multi-Country Experience of Implementing the 3S Concepts and Principles
by Noha Iessa & Viola Macolic Sarinic & Lilit Ghazaryan & Naira Romanova & Asnakech Alemu & Watcharee Rungapiromnan & Porntip Jiamsuchon & Pattreya Pokhagul & Jose Luis Castro & Diego Macias Saint-Gerons & Gayane Ghukasyan & Mengistab Teferi & Madhur Gupta & Shanthi Narayan Pal - 1099-1107 Safety of Eslicarbazepine Acetate in Elderly Versus Non-Elderly Patients with Focal Seizures: From Pooled Data of Clinical Studies to 8 Years of Post-Marketing Experience
by Luís M. Magalhães & Raquel Costa & Mariana Vieira & Joana Moreira & Helena Gama & Patrício Soares-da-Silva - 1109-1119 Clinical Trial and Postmarketing Safety of Onasemnogene Abeparvovec Therapy
by John W. Day & Jerry R. Mendell & Eugenio Mercuri & Richard S. Finkel & Kevin A. Strauss & Aaron Kleyn & Sitra Tauscher-Wisniewski & Francis Fonyuy Tukov & Sandra P. Reyna & Deepa H. Chand
September 2021, Volume 44, Issue 9
- 917-928 A Scoping Review of Non-Medical and Extra-Medical Use of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
by Rebekah Brennan & Mayyada Wazaify & Haneen Shawabkeh & Ian Boardley & Jim McVeigh & Marie Claire Hout - 929-938 NSAIDs and COVID-19: A Systematic Review and Meta-analysis
by Nicholas Moore & Pauline Bosco-Levy & Nicolas Thurin & Patrick Blin & Cécile Droz-Perroteau - 939-948 Augmenting Product Defect Surveillance Through Web Crawling and Machine Learning in Singapore
by Pei San Ang & Desmond Chun Hwee Teo & Sreemanee Raaj Dorajoo & Mukundaram Prem Kumar & Yi Hao Chan & Chih Tzer Choong & Doris Sock Tin Phuah & Dorothy Hooi Myn Tan & Filina Meixuan Tan & Huilin Huang & Maggie Siok Hwee Tan & Michelle Sau Yuen Ng & Jalene Wang Woon Poh - 949-955 Bayesian Modeling for the Detection of Adverse Events Underreporting in Clinical Trials
by Yves Barmaz & Timothé Ménard - 957-971 Immune Checkpoint Inhibitors and Cardiotoxicity: An Analysis of Spontaneous Reports in Eudravigilance
by Annamaria Mascolo & Cristina Scavone & Carmen Ferrajolo & Concetta Rafaniello & Romano Danesi & Marzia Re & Antonio Russo & Enrico Coscioni & Francesco Rossi & Roberto Alfano & Annalisa Capuano - 973-985 Is There an Increased Risk of Hepatotoxicity with Metamizole? A Comparative Cohort Study in Incident Users
by Karin Hedenmalm & Alexandra Pacurariu & Jim Slattery & Xavier Kurz & Gianmario Candore & Rob Flynn - 987-998 Remdesivir in the COVID-19 Pandemic: An Analysis of Spontaneous Reports in VigiBase During 2020
by Elena Rocca & Oskar Gauffin & Ruth Savage & Sara Hedfors Vidlin & Birgitta Grundmark - 999-1006 Study of Natural Products Adverse Reactions (SONAR) in Adults with Mental Health Conditions: A Cross-Sectional Study
by Liliane Zorzela & Baljit Khamba & Emma Sparks & Candace Necyk & Liana Urichuk & Martin A. Katzman & David Koczerginski & Pierre Chue & Joanne Barnes & Sunita Vohra - 1007-1009 Comment on: "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 Alain Braillon & Marine Martin - 1011-1013 Authors’ Reply to Braillon and Martin’s Comment on “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 - 1015-1015 Correction to: Provision and Need for Medicine Information in Asia and Africa: A Scoping Review of the Literature
by Pitchaya Nualdaisri & Sarah A. Corlett & Janet Krska
August 2021, Volume 44, Issue 8
- 825-834 Monitoring and Managing Lorlatinib Adverse Events in the Portuguese Clinical Setting: A Position Paper
by Fernando Barata & Carlos Aguiar & Tiago Reis Marques & José Bravo Marques & Venceslau Hespanhol - 835-841 The Role of the Contextual Cohort to Resolve Some Challenges and Limitations of Comparisons in Pharmacoepidemiology
by Vicki Osborne & Samantha Lane & Saad A. W. Shakir - 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