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Content
March 2020, Volume 43, Issue 3
- 265-279 Brand-Specific Enhanced Safety Surveillance of GSK’s Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany and Spain for the 2018/2019 Season
by Gael Dos Santos & Bach-Yen Nguyen & Silvia Damaso & Lode Godderis & Xavier Martínez-Gómez & Tamara Eckermann & Hugo Loos & Ignacio Salamanca de la Cueva & Vishvesh Shende & Alexander C. Schmidt & Anne Yeakey - 281-290 Spontaneous Fluctuations in Liver Biochemistries in Patients with Compensated NASH Cirrhosis: Implications for Drug Hepatotoxicity Monitoring
by Hani Shamseddeen & Eduardo Vilar-Gomez & Naga Chalasani & Robert P. Myers & G. Mani Subramanian & Harold H. Shlevin & Adam E. Allgood & Eric S. Orman - 291-293 Insight into the Severity of Adverse Drug Reactions as Experienced by Patients
by Leàn Rolfes & Michelle Haaksman & Florence van Hunsel & Eugène van Puijenbroek - 295-296 Follow-Up on the Use of Machine Learning in Clinical Quality Assurance: Can We Detect Adverse Event Under-Reporting in Oncology Trials?
by Timothé Ménard & Björn Koneswarakantha & Donato Rolo & Yves Barmaz & Leszek Popko & Rich Bowling
February 2020, Volume 43, Issue 2
- 79-81 A New President’s Vision for International Pharmacovigilance
by Mira Harrison-Woolrych - 83-93 Medical Devices: Definition, Classification, and Regulatory Implications
by Jeffrey K. Aronson & Carl Heneghan & Robin E. Ferner - 95-102 Medical Devices: Classification and Analysis of Faults Leading to Harms
by Robin E. Ferner & Jeffrey K. Aronson - 103-110 The Use of Long-Acting Insulin Analogs and the Risk of Colorectal Cancer Among Patients with Type 2 Diabetes: A Population-Based Cohort Study
by Richeek Pradhan & Hui Yin & Oriana H. Y. Yu & Laurent Azoulay - 111-117 Occurrences and Outcomes of Immune Checkpoint Inhibitors-Induced Vitiligo in Cancer Patients: A Retrospective Cohort Study
by Samy Babai & Anne-Laure Voisin & Célia Bertin & Amandine Gouverneur & Hervé Le-Louet - 119-134 Development and First Use of the Patient’s Qualitative Assessment of Treatment (PQAT) Questionnaire in Type 2 Diabetes Mellitus to Explore Individualised Benefit–Harm of Drugs Received During Clinical Studies
by Adam Gater & Matthew Reaney & Amy Findley & Catherine Brun-Strang & Kate Burrows & My-Liên Nguyên-Pascal & Aude Roborel de Climens - 135-145 A Post-Authorization Safety Study of Quetiapine as Antidepressant Treatment in Sweden: Nested Case–Control Analyses of Select Outcomes
by Johan Reutfors & Philip Brenner & Bob Brody & Heather Wray & Morten Andersen & Lena Brandt - 147-161 Exposure to Infliximab During Pregnancy: Post-Marketing Experience
by Anja Geldhof & Jennifer Slater & Michael Clark & Urmila Chandran & Danielle Coppola - 163-177 Effectiveness of Risk Minimization Measures for Fentanyl Buccal Tablet (FENTORA) in Canada: A Mixed-Methods Evaluation Using Surveys, Medical Chart Records and Web Surveillance
by Sigal Kaplan & Aurore Bergamasco & Martin Sergerie & Anne-Marie Castilloux & Yola Moride - 179-187 New Discoveries and Updates on Cutaneous Adverse Drug Reactions Presented at the 24th World Congress of Dermatology, Milan, Italy, 2019
by Felix L. Chan & Neil H. Shear & Nidhi Shah & Cristina Olteanu & Rena Hashimoto & Roni P. Dodiuk-Gad - 189-191 The Role of Unit-Dose Child-Resistant Packaging in Unintentional Childhood Exposures to Buprenorphine–Naloxone Tablets
by Christian Hampp & Maribeth C. Lovegrove & Daniel S. Budnitz & Justin Mathew & Amy Ho & Jana McAninch - 193-193 Comment on “Evaluation of Potential Drug–Drug Interactions in Adults in the Intensive Care Unit: A Systematic Review and Meta-analysis”
by Nusret Uysal & Elif Keskin-Arslan & Hilal Erol & Selin Acar & Yusuf Cem Kaplan - 195-196 Authors’ Reply to Uysal and Colleagues’ Comment on: “Evaluation of Potential Drug–Drug Interactions in Adults in the Intensive Care Unit: A Systematic Review and Meta-Analysis”
by Adrian Wong & Mary Grace Fitzmaurice & Pamela L. Smithburger & Mitchell S. Buckley & Sandra L. Kane-Gill
January 2020, Volume 43, Issue 1
- 1-5 Healthcare Database Networks for Drug Regulatory Policies: International Workshop on the Canadian, US and Spanish Experience and Future Steps for Italy
by Janet Sultana & Francesco Trotta & Antonio Addis & Jeffrey S. Brown & Miguel Gil & Francesca Menniti-Ippolito & Federica Milozzi & Samy Suissa & Gianluca Trifirò - 7-16 Exploratory Study of Signals for Asthma Drugs in Children, Using the EudraVigilance Database of Spontaneous Reports
by Esmé J. Baan & Veronique A. Smet & Christina E. Hoeve & Alexandra C. Pacurariu & Miriam C. J. M. Sturkenboom & Johan C. Jongste & Hettie M. Janssens & Katia M. C. Verhamme - 17-22 Comparing Acute Kidney Injury Reports Among Antibiotics: A Pharmacovigilance Study of the FDA Adverse Event Reporting System (FAERS)
by Taylor M. Patek & Chengwen Teng & Kaitlin E. Kennedy & Carlos A. Alvarez & Christopher R. Frei - 23-33 Adverse Events Associated with Cumulative Corticosteroid Use in Patients with Castration-Resistant Prostate Cancer: An Administrative Claims Analysis
by Neil M. Schultz & David F. Penson & Samuel Wilson & Yan Song & Hongbo Yang & Krishnan Ramaswamy & Benjamin Lowentritt - 35-43 Reported Severe Hypersensitivity Reactions after Intravenous Iron Administration in the European Economic Area (EEA) Before and After Implementation of Risk Minimization Measures
by Lennart Nathell & Annegret Gohlke & Stefan Wohlfeil - 45-55 Description of the Risk Management of Medication Errors for Centrally Authorised Products in the European Union
by Christina E. Hoeve & Reynold D. C. Francisca & Inge Zomerdijk & Miriam C. J. M. Sturkenboom & Sabine M. J. M. Straus - 57-66 Application of Augmented Intelligence for Pharmacovigilance Case Seriousness Determination
by Ramani Routray & Niki Tetarenko & Claire Abu-Assal & Ruta Mockute & Bruno Assuncao & Hanqing Chen & Shenghua Bao & Karolina Danysz & Sameen Desai & Salvatore Cicirello & Van Willis & Sharon Hensley Alford & Vivek Krishnamurthy & Edward Mingle - 67-77 Complementing Observational Signals with Literature-Derived Distributed Representations for Post-Marketing Drug Surveillance
by Justin Mower & Trevor Cohen & Devika Subramanian
December 2019, Volume 42, Issue 12
- 1393-1407 Recommendations for the Use of Social Media in Pharmacovigilance: Lessons from IMI WEB-RADR
by John Stekelenborg & Johan Ellenius & Simon Maskell & Tomas Bergvall & Ola Caster & Nabarun Dasgupta & Juergen Dietrich & Sara Gama & David Lewis & Victoria Newbould & Sabine Brosch & Carrie E. Pierce & Gregory Powell & Alicia Ptaszyńska-Neophytou & Antoni F. Z. Wiśniewski & Phil Tregunno & G. Niklas Norén & Munir Pirmohamed - 1409-1422 Comparative Effectiveness and Safety of Direct Oral Anticoagulants: Overview of Systematic Reviews
by Emanuel Raschi & Matteo Bianchin & Milo Gatti & Alessandro Squizzato & Fabrizio De Ponti - 1423-1436 Prevalence and Nature of Medication Errors and Preventable Adverse Drug Events in Paediatric and Neonatal Intensive Care Settings: A Systematic Review
by Anwar A. Alghamdi & Richard N. Keers & Adam Sutherland & Darren M. Ashcroft - 1437-1447 Effectiveness and Safety of Switching Originator and Biosimilar Epoetins in Patients with Chronic Kidney Disease in a Large-Scale Italian Cohort Study
by Valeria Belleudi & Francesco Trotta & Antonio Addis & Ylenia Ingrasciotta & Valentina Ientile & Michele Tari & Rosa Gini & Maurizio Pastorello & Salvatore Scondotto & Pasquale Cananzi & Giuseppe Traversa & Marina Davoli & Gianluca Trifirò - 1449-1469 The Association between Metformin Therapy and Lactic Acidosis
by Isabelle H. S. Kuan & Ruth L. Savage & Stephen B. Duffull & Robert J. Walker & Daniel F. B. Wright - 1471-1485 Measuring the Effectiveness of Safety Warnings on the Risk of Stroke in Older Antipsychotic Users: A Nationwide Cohort Study in Two Large Electronic Medical Records Databases in the United Kingdom and Italy
by Janet Sultana & Andrea Fontana & Francesco Giorgianni & Silvia Tillati & Claudio Cricelli & Alessandro Pasqua & Elisabetta Patorno & Clive Ballard & Miriam Sturkenboom & Gianluca Trifirò - 1487-1498 Data-Driven Identification of Adverse Event Reporting Patterns for Japan in VigiBase, the WHO Global Database of Individual Case Safety Reports
by Rika Wakao & Henric Taavola & Lovisa Sandberg & Eiko Iwasa & Saori Soejima & Rebecca Chandler & G. Niklas Norén - 1499-1506 Rheumatology Common Toxicity Criteria (RCTC): An Update Reflecting Real-World Use
by Christian M. Stach & Victor S. Sloan & Thasia G. Woodworth & Brian Kilgallen & Daniel E. Furst - 1507-1513 Psoriasis After Exposure to Angiotensin-Converting Enzyme Inhibitors: French Pharmacovigilance Data and Review of the Literature
by Brahim Azzouz & Aurore Morel & Lukshe Kanagaratnam & Emmanuelle Herlem & Thierry Trenque - 1515-1516 Comment on: “Patient Registries: An Underused Resource for Medicines Evaluation: Operational Proposals for Increasing the Use of Patient Registries in Regulatory Assessments”
by Ravi Jandhyala - 1517-1518 Authors’ Reply to Ravi Jandhyala’s Comment on “Patient Registries: An Underused Resource for Medicines Evaluation: Operational Proposals for Increasing the Use of Patient Registries in Regulatory Assessments”
by Patricia McGettigan & Carla Alonso Olmo & Kelly Plueschke & Mireia Castillon & Daniel Zondag & Priya Bahri & Xavier Kurz & Peter G. M. Mol
November 2019, Volume 42, Issue 11
- 1287-1295 Multimodal Analysis of FDA Drug Safety Communications: Lessons from Zolpidem
by Aaron S. Kesselheim & Michael S. Sinha & Eric G. Campbell & Sebastian Schneeweiss & Paula Rausch & Brian M. Lappin & Esther H. Zhou & Jerry Avorn & Gerald J. Dal Pan - 1297-1309 Transparent Reporting on Research Using Unstructured Electronic Health Record Data to Generate ‘Real World’ Evidence of Comparative Effectiveness and Safety
by Shirley V. Wang & Olga V. Patterson & Joshua J. Gagne & Jeffrey S. Brown & Robert Ball & Pall Jonsson & Adam Wright & Li Zhou & Wim Goettsch & Andrew Bate - 1311-1327 Benefit-Risk Assessment of Alogliptin for the Treatment of Type 2 Diabetes Mellitus
by Kohei Kaku & Koichi Kisanuki & Mari Shibata & Takashi Oohira - 1329-1342 Prevalence of Medication Errors Among Paediatric Inpatients: Systematic Review and Meta-Analysis
by Peter J. Gates & Melissa T. Baysari & Madlen Gazarian & Magdalena Z. Raban & Sophie Meyerson & Johanna I. Westbrook - 1343-1351 Patient Registries: An Underused Resource for Medicines Evaluation
by Patricia McGettigan & Carla Alonso Olmo & Kelly Plueschke & Mireia Castillon & Daniel Nogueras Zondag & Priya Bahri & Xavier Kurz & Peter G. M. Mol - 1353-1353 Correction to: Patient Registries: An Underused Resource for Medicines Evaluation
by Patricia McGettigan & Carla Alonso Olmo & Kelly Plueschke & Mireia Castillon & Daniel Nogueras Zondag & Priya Bahri & Xavier Kurz & Peter G. M. Mol - 1355-1363 Non-Vitamin K Antagonist Oral Anticoagulants and Angioedema: A Cohort and Case-Crossover Study
by John G. Connolly & Sebastian Schneeweiss & Robert J. Glynn & Joshua J. Gagne - 1365-1376 A Novel Approach to Visualize Risk Minimization Effectiveness: Peeping at the 2012 UK Proton Pump Inhibitor Label Change Using a Rapid Cycle Analysis Tool
by Rachel E. Sobel & William Blackwell & David M. Fram & Andrew Bate - 1377-1386 Identifying the DEAD: Development and Validation of a Patient-Level Model to Predict Death Status in Population-Level Claims Data
by Jenna M. Reps & Peter R. Rijnbeek & Patrick B. Ryan
October 2019, Volume 42, Issue 10
- 1115-1124 Pharmacovigilance as Scientific Discovery: An Argument for Trans-Disciplinarity
by Elena Rocca & Samantha Copeland & I. Ralph Edwards - 1125-1134 Unintended Effects of Communicating About Drug Safety Issues: A Critical Review of the Literature
by Jessica T. DeFrank & Lauren McCormack & Suzanne L. West & Craig Lefebvre & Olivia Burrus - 1135-1148 Comparative Effectiveness and Safety of Direct Oral Anticoagulants in Patients with Atrial Fibrillation: A Systematic Review and Meta-Analysis of Observational Studies
by Antonios Douros & Madeleine Durand & Carla M. Doyle & Sarah Yoon & Pauline Reynier & Kristian B. Filion - 1149-1155 Evaluating Renal Stress Using Pharmacokinetic Urinary Biomarker Data in Critically Ill Patients Receiving Vancomycin and/or Piperacillin–Tazobactam: A Secondary Analysis of the Multicenter Sapphire Study
by Sandra L. Kane-Gill & Marlies Ostermann & Jing Shi & Emily L. Joyce & John A. Kellum - 1157-1165 Intravenous Infusion Administration: A Comparative Study of Practices and Errors Between the United States and England and Their Implications for Patient Safety
by Ann Blandford & Patricia C. Dykes & Bryony Dean Franklin & Dominic Furniss & Galal H. Galal-Edeen & Kumiko O. Schnock & David W. Bates - 1167-1177 Study Design and Cohort Comparability in a Study of Major Cardiovascular Events in New Users of Prucalopride Versus Polyethylene Glycol 3350
by Joan Fortuny & Alicia Gilsenan & Miguel Cainzos-Achirica & Oscar F. Cantero & Robert W. V. Flynn & Luis Garcia-Rodriguez & Bianca Kollhorst & Pär Karlsson & Love Linnér & Thomas M. MacDonald & Estel Plana & Ana Ruigómez & Tania Schink & Ryan Ziemiecki & Elizabeth B. Andrews - 1179-1190 Cardiovascular Safety of Prucalopride in Patients with Chronic Constipation: A Multinational Population-Based Cohort Study
by Alicia Gilsenan & Joan Fortuny & Miguel Cainzos-Achirica & Oscar F. Cantero & Robert W. V. Flynn & Luis Garcia-Rodriguez & Abenah Harding & Bianca Kollhorst & Pär Karlsson & Love Linnér & Thomas M. MacDonald & Ingvild Odsbu & Estel Plana & Ana Ruigómez & Tania Schink & Ryan Ziemiecki & Elizabeth B. Andrews - 1191-1198 Pooling Different Safety Data Sources: Impact of Combining Solicited and Spontaneous Reports on Signal Detection In Pharmacovigilance
by Jeremy D. Jokinen & Rosalind J. Walley & Michael W. Colopy & Thomas S. Hilzinger & Peter Verdru - 1199-1201 The Impact of Litigation-Associated Reports on Signal Identification in the US FDA’s Adverse Event Reporting System
by Monica A. Muñoz & Gerald J. Dal Pan
September 2019, Volume 42, Issue 9
- 1025-1033 Fluoroquinolone Use and the Risk of Collagen-Associated Adverse Events: A Systematic Review and Meta-Analysis
by Xinyu Yu & Ding-sheng Jiang & Jing Wang & Rui Wang & Taiqiang Chen & Kan Wang & Shiyi Cao & Xiang Wei - 1035-1044 Evaluation of Potential Drug–Drug Interactions in Adults in the Intensive Care Unit: A Systematic Review and Meta-Analysis
by Mary Grace Fitzmaurice & Adrian Wong & Hannah Akerberg & Simona Avramovska & Pamela L. Smithburger & Mitchell S. Buckley & Sandra L. Kane-Gill - 1045-1053 Enabling Data-Driven Clinical Quality Assurance: Predicting Adverse Event Reporting in Clinical Trials Using Machine Learning
by Timothé Ménard & Yves Barmaz & Björn Koneswarakantha & Rich Bowling & Leszek Popko - 1055-1069 Auto-Generated Physiological Chain Data for an Ontological Framework for Pharmacology and Mechanism of Action to Determine Suspected Drugs in Cases of Dysuria
by Masayo Hayakawa & Takeshi Imai & Yoshimasa Kawazoe & Kouji Kozaki & Kazuhiko Ohe - 1071-1080 Evaluation of Use of Technologies to Facilitate Medical Chart Review
by Loreen Straub & Joshua J. Gagne & Judith C. Maro & Michael D. Nguyen & Nicolas Beaulieu & Jeffrey S. Brown & Adee Kennedy & Margaret Johnson & Adam Wright & Li Zhou & Shirley V. Wang - 1081-1089 Antidepressants and the Risk of Hemorrhagic Stroke in the Elderly: a Nested Case–Control Study
by Wiebke Schäfer & Christina Princk & Bianca Kollhorst & Tania Schink - 1091-1102 Prevalence, Safety and Long-Term Retention Rates of Biologics in Hong Kong from 2001 to 2015
by Mengqin Ge & Kenneth K. Man & Celine S. Chui & Esther W. Chan & Ian C. Wong & Xue Li - 1103-1114 Randomized Placebo-Controlled Trial Evaluating the Ophthalmic Safety of Single-Dose Tafenoquine in Healthy Volunteers
by Jessica Ackert & Khadeeja Mohamed & Jason S. Slakter & Sherif El-Harazi & Alessandro Berni & Hakop Gevorkyan & Elizabeth Hardaker & Azra Hussaini & Siôn W. Jones & Gavin C. K. W. Koh & Jyoti Patel & Scott Rasmussen & Deborah S. Kelly & David E. Barañano & John T. Thompson & Keith A. Warren & Robert C. Sergott & John Tonkyn & Allen Wolstenholme & Hanna Coleman & Alex Yuan & Stephan Duparc & Justin A. Green
August 2019, Volume 42, Issue 8
- 921-930 Establishing a Framework for the Use of Social Media in Pharmacovigilance in Europe
by Sabine Brosch & Anne-Marie Ferran & Victoria Newbould & Diane Farkas & Marina Lengsavath & Phil Tregunno - 931-939 Standardising the Classification of Harm Associated with Medication Errors: The Harm Associated with Medication Error Classification (HAMEC)
by Peter J. Gates & Melissa T. Baysari & Virginia Mumford & Magdalena Z. Raban & Johanna I. Westbrook - 941-956 Established and Emerging Immunological Complications of Biological Therapeutics in Multiple Sclerosis
by Babak Soleimani & Katy Murray & David Hunt - 957-971 Benefit-Risk Assessment of Obesity Drugs: Focus on Glucagon-like Peptide-1 Receptor Agonists
by Rasmus M. Christensen & Christian R. Juhl & Signe S. Torekov - 973-992 Mechanisms of Severe Cutaneous Adverse Reactions: Recent Advances
by Teresa Bellón - 993-1003 Bismuth Concentrations in Patients Treated in Real-Life Practice with a Bismuth Subcitrate-Metronidazole-Tetracycline Preparation: The SAPHARY Study
by Estelle Guiard & Bénédicte Lelievre & Magali Rouyer & Frank Zerbib & Bertrand Diquet & Francis Mégraud & François Tison & Emmanuelle Bignon & Régis Lassalle & Cécile Droz-Perroteau & Nicholas Moore & Patrick Blin - 1005-1011 Androgen Deprivation Therapy for Prostate Cancer and the Risk of Rheumatoid Arthritis: A Population-Based Cohort Study
by Adi J. Klil-Drori & Christina Santella & Koray Tascilar & Hui Yin & Armen Aprikian & Laurent Azoulay - 1013-1024 Long-Term Safety and Tolerability of OnabotulinumtoxinA Treatment in Patients with Chronic Migraine: Results of the COMPEL Study
by Paul K. Winner & Andrew M. Blumenfeld & Eric J. Eross & Amelia C. Orejudos & Debbie L. Mirjah & Aubrey Manack Adams & Mitchell F. Brin
July 2019, Volume 42, Issue 7
- 811-812 Inflammation, Monoclonal Antibodies and Depression: Joining the Dots
by David Hunt - 813-825 Sirolimus and mTOR Inhibitors: A Review of Side Effects and Specific Management in Solid Organ Transplantation
by Lee S. Nguyen & Mathieu Vautier & Yves Allenbach & Noel Zahr & Olivier Benveniste & Christian Funck-Brentano & Joe-Elie Salem - 827-847 Drug-Induced Photosensitivity—An Update: Culprit Drugs, Prevention and Management
by Kim M. Blakely & Aaron M. Drucker & Cheryl F. Rosen - 849-868 Pharmacovigilance Systems in Arab Countries: Overview of 22 Arab Countries
by Thamir M. Alshammari & Neslihan Mendi & Khalidah A. Alenzi & Yazed Alsowaida - 869-880 Long-Term Safety and Efficacy of Fecal Microbiota Transplant in Active Ulcerative Colitis
by Xiao Ding & Qianqian Li & Pan Li & Ting Zhang & Bota Cui & Guozhong Ji & Xiang Lu & Faming Zhang - 881-886 Use of a Patient-Friendly Terms List in the Adverse Drug Reaction Report Form: A Database Study
by Sieta T. de Vries & Judy Harrison & Patrick Revelle & Alicia Ptaszynska-Neophytou & Anna Radecka & Gowthamei Ragunathan & Phil Tregunno & Petra Denig & Peter G. M. Mol - 887-895 Exploring the Association between Monoclonal Antibodies and Depression and Suicidal Ideation and Behavior: A VigiBase Study
by Lotte A. Minnema & Thijs J. Giezen & Patrick C. Souverein & Toine C. G. Egberts & Hubert G. M. Leufkens & Helga Gardarsdottir - 897-906 Use of FDA’s Sentinel System to Quantify Seizure Risk Immediately Following New Ranolazine Exposure
by Efe Eworuke & Emily C. Welch & Anne Tobenkin & Judith C. Maro - 907-913 Summary of Torsades de Pointes (TdP) Reports Associated with Intravenous Drug Formulations Containing the Preservative Chlorobutanol
by R. David Woosley & Klaus Romero & Craig W. Heise & Tyler Gallo & Jared Tate & Raymond L. Woosley - 915-917 A Profile of Adverse Drug Reactions of Atazanavir- and Lopinavir-Based Antiretroviral Regimens in Namibia
by Babafunso Aderemi Adenuga & Timothy William Rennie - 919-919 Correction to: Benefit-Risk Assessment of Obesity Drugs: Focus on Glucagon-like Peptide-1 Receptor Agonists
by Rasmus M. Christensen & Christian R. Juhl & Signe S. Torekov
June 2019, Volume 42, Issue 6
- 699-700 Frailty and Drug Safety at Older Ages
by Martin Gulliford - 701-711 Drug-Induced Steatosis and Steatohepatitis: The Search for Novel Serum Biomarkers Among Potential Biomarkers for Non-Alcoholic Fatty Liver Disease and Non-Alcoholic Steatohepatitis
by Lauren Pavlik & Arie Regev & Paul A. Ardayfio & Naga P. Chalasani - 713-719 Identifying Data Elements to Measure Frailty in a Dutch Nationwide Electronic Medical Record Database for Use in Postmarketing Safety Evaluation: An Exploratory Study
by Janet Sultana & Ingrid Leal & Marcel Wilde & Maria Ridder & Johan Lei & Miriam Sturkenboom & Gianluca Trifiro’ - 721-725 A Machine-Learning Algorithm to Optimise Automated Adverse Drug Reaction Detection from Clinical Coding
by Christopher McMaster & David Liew & Claire Keith & Parnaz Aminian & Albert Frauman - 727-741 An Implementation and Visualization of the Tree-Based Scan Statistic for Safety Event Monitoring in Longitudinal Electronic Health Data
by Stephen E. Schachterle & Sharon Hurley & Qing Liu & Kenneth R. Petronis & Andrew Bate - 743-750 A Comparison Study of Algorithms to Detect Drug–Adverse Event Associations: Frequentist, Bayesian, and Machine-Learning Approaches
by Minh Pham & Feng Cheng & Kandethody Ramachandran - 751-768 Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn’s Disease: An Integrated Analysis of Phase II/III Clinical Development Programs
by Subrata Ghosh & Lianne S. Gensler & Zijiang Yang & Chris Gasink & Soumya D. Chakravarty & Kamyar Farahi & Paraneedharan Ramachandran & Elyssa Ott & Bruce E. Strober - 769-784 Evaluation of Antibody Properties and Clinically Relevant Immunogenicity, Anaphylaxis, and Hypersensitivity Reactions in Two Phase III Trials of Tralokinumab in Severe, Uncontrolled Asthma
by Mats Carlsson & Martin Braddock & Yuling Li & Jihong Wang & Weichen Xu & Nicholas White & Ayman Megally & Gillian Hunter & Gene Colice - 785-796 All-Cause Mortality Associated with Tramadol Use: A Case-Crossover Study
by Sohyun Jeong & Ha Jin Tchoe & Junqing Li & Ju-Young Shin - 797-801 The 10th International Congress on Cutaneous Adverse Drug Reactions, Shimane, Japan, 2018: Focus on New Discoveries
by Cristina Olteanu & Neil H. Shear & Eishin Morita & Wen-Hung Chung & Hiroyuki Niihara & Setsuko Matsukura & Rena Hashimoto & Roni P. Dodiuk-Gad - 803-803 Advances in Diagnosis and Management of Cutaneous Adverse Drug Reactions: Current and Future Trends
by Mark Lebwohl - 805-805 Correction to: vigiGrade: A Tool to Identify Well-Documented Individual Case Reports and Highlight Systematic Data Quality Issues
by Tomas Bergvall & G. Niklas Norén & Marie Lindquist - 807-807 Correction to: A Machine-Learning Algorithm to Optimise Automated Adverse Drug Reaction Detection from Clinical Coding
by Christopher McMaster & David Liew & Claire Keith & Parnaz Aminian & Albert Frauman - 809-809 Correction to: Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn’s Disease: An Integrated Analysis of Phase II/III Clinical Development Programs
by Subrata Ghosh & Lianne S. Gensler & Zijiang Yang & Chris Gasink & Soumya D. Chakravarty & Kamyar Farahi & Paraneedharan Ramachandran & Elyssa Ott & Bruce E. Strober
May 2019, Volume 42, Issue 5
- 581-582 Building an Evidence Base on the Place of Industry-Sponsored Programs in Drug Safety Surveillance
by Peter Arlett - 583-586 From Data Silos to Standardized, Linked, and FAIR Data for Pharmacovigilance: Current Advances and Challenges with Observational Healthcare Data
by Vassilis Koutkias - 587-601 Benefit–Risk Assessment of Blinatumomab in the Treatment of Relapsed/Refractory B-Cell Precursor Acute Lymphoblastic Leukemia
by Anthony Stein & Janet L. Franklin & Victoria M. Chia & Deborah Arrindell & William Kormany & Jacqueline Wright & Mandy Parson & Hamid R. Amouzadeh & Jessica Choudhry & Guiandre Joseph - 603-615 Benefit–Risk Assessment of Plecanatide in the Treatment of Chronic Idiopathic Constipation
by Philip B. Miner - 617-632 Benefit–Risk Assessment of Vedolizumab in the Treatment of Crohn’s Disease and Ulcerative Colitis
by Robert Battat & Christopher Ma & Vipul Jairath & Reena Khanna & Brian G. Feagan - 633-647 Managing Risks with Immune Therapies in Multiple Sclerosis
by Moritz Förster & Patrick Küry & Orhan Aktas & Clemens Warnke & Joachim Havla & Reinhard Hohlfeld & Jan Mares & Hans-Peter Hartung & David Kremer - 649-655 Evaluation of Postmarketing Reports from Industry-Sponsored Programs in Drug Safety Surveillance
by Lisa Harinstein & Dipti Kalra & Cindy M. Kortepeter & Monica A. Muñoz & Eileen Wu & Gerald J. Dal Pan - 657-670 Development of a Controlled Vocabulary-Based Adverse Drug Reaction Signal Dictionary for Multicenter Electronic Health Record-Based Pharmacovigilance
by Suehyun Lee & Jongsoo Han & Rae Woong Park & Grace Juyun Kim & John Hoon Rim & Jooyoung Cho & Kye Hwa Lee & Jisan Lee & Sujeong Kim & Ju Han Kim - 671-682 Drug-Induced Anaphylaxis in a Vietnamese Pharmacovigilance Database: Trends and Specific Signals from a Disproportionality Analysis
by Khac-Dung Nguyen & Hoang-Anh Nguyen & Dinh-Hoa Vu & Thi Thuy-Linh Le & Hoang-Anh Nguyen & Bich-Viet Dang & Trung-Nguyen Nguyen & Dang-Hoa Nguyen & Thanh-Binh Nguyen & Jean-Louis Montastruc & Haleh Bagheri - 683-687 Workshop on the Italian Pharmacovigilance System in the International Context: Critical Issues and Perspectives
by Janet Sultana & Ugo Moretti & Antonio Addis & Pia Caduff & Annalisa Capuano & Agnes Kant & Joan-Ramon Laporte & Marie Lindquist & June Raine & Daniele Sartori & Gianluca Trifirò & Marco Tuccori & Mauro Venegoni & Eugene Puijenbroek & Roberto Leone - 689-691 Comment on ‘Evaluation of the Reported Rates of Severe Hypersensitivity Reactions Associated with Ferric Carboxymaltose and Iron(III) Isomaltoside 1000 in Europe Based on Data from EudraVigilance and VigiBase™ Between 2014 and 2017’
by Philip Schaffalitzky de Muckadell & Claes Christian Strom - 693-696 Authors’ reply to Schaffalitzky de Muckadell and colleague’s Comment on “Evaluation of the Reported Rates of Severe Hypersensitivity Reactions Associated with Ferric Carboxymaltose and Iron (III) Isomaltoside 1000 in Europe Based on Data from EudraVigilance and VigiBase™ between 2014 and 2017”
by Birgit Ehlken & Lennart Nathell & Annegret Gohlke & Derya Bocuk & Massoud Toussi & Stefan Wohlfeil - 697-697 Correction to: Antipsychotic Prescribing to Patients Diagnosed with Dementia Without a Diagnosis of Psychosis in the Context of National Guidance and Drug Safety Warnings: Longitudinal Study in UK General Practice
by S. Jill Stocks & Evangelos Kontopantelis & Roger T. Webb & Anthony J. Avery & Alistair Burns & Darren M. Ashcroft
April 2019, Volume 42, Issue 4
- 477-489 Recommendations on the Use of Mobile Applications for the Collection and Communication of Pharmaceutical Product Safety Information: Lessons from IMI WEB-RADR
by Carrie E. Pierce & Sieta T. Vries & Stephanie Bodin-Parssinen & Linda Härmark & Phil Tregunno & David J. Lewis & Simon Maskell & Raphael Eemeren & Alicia Ptaszynska-Neophytou & Victoria Newbould & Nabarun Dasgupta & Antoni F. Z. Wisniewski & Sara Gama & Peter G. M. Mol - 491-497 Artificial Intelligence and the Future of the Drug Safety Professional
by Karolina Danysz & Salvatore Cicirello & Edward Mingle & Bruno Assuncao & Niki Tetarenko & Ruta Mockute & Danielle Abatemarco & Mark Widdowson & Sameen Desai - 499-513 Advances in Epidemiological Methods and Utilisation of Large Databases: A Methodological Review of Observational Studies on Central Nervous System Drug Use in Pregnancy and Central Nervous System Outcomes in Children
by Zixuan Wang & Phoebe W. H. Ho & Michael T. H. Choy & Ian C. K. Wong & Ruth Brauer & Kenneth K. C. Man - 515-527 Diagnostic Algorithms for Cardiovascular Death in Administrative Claims Databases: A Systematic Review
by Sonal Singh & Hassan Fouayzi & Kathryn Anzuoni & Leah Goldman & Jea Young Min & Marie Griffin & Carlos G. Grijalva & James A. Morrow & Christine C. Whitmore & Charles E. Leonard & Mano Selvan & Vinit Nair & Yunping Zhou & Sengwee Toh & Andrew Petrone & James Williams & Elnara Fazio-Eynullayeva & Richard Swain & D. Tyler Coyle & Susan Andrade - 529-538 Fluoroquinolones and Cardiovascular Risk: A Systematic Review, Meta-analysis and Network Meta-analysis
by Einat Gorelik & Reem Masarwa & Amichai Perlman & Victoria Rotshild & Momen Abbasi & Mordechai Muszkat & Ilan Matok - 539-546 Prevalence of Drug Prescriptions and Potential Safety in Patients with Cirrhosis: A Retrospective Real-World Study
by Rianne A. Weersink & Katja Taxis & Joost P. H. Drenth & Eline Houben & Herold J. Metselaar & Sander D. Borgsteede - 547-557 The Role of European Patient Organizations in Pharmacovigilance
by Cristiano Matos & Gerda Weits & Florence Hunsel - 559-572 Previous Drug Exposure in Patients Hospitalised for Acute Liver Injury: A Case-Population Study in the French National Healthcare Data System
by Nicholas Moore & Stéphanie Duret & Adeline Grolleau & Régis Lassalle & Vanessa Barbet & Mai Duong & Nicolas Thurin & Cécile Droz-Perroteau & Sinem Ezgi Gulmez - 573-579 Evaluation of Harm Associated with High Dose-Range Clinical Decision Support Overrides in the Intensive Care Unit
by Adrian Wong & Christine Rehr & Diane L. Seger & Mary G. Amato & Patrick E. Beeler & Sarah P. Slight & Adam Wright & David W. Bates
March 2019, Volume 42, Issue 3
- 335-337 Correcting QT for Heart Rate When Both are Affected by a Drug
by Georg Ferber - 339-346 Pharmacovigilance in India: Present Scenario and Future Challenges
by V. Kalaiselvan & Sushma Srivastava & Abhishank Singh & SK Gupta - 347-363 The Role of European Healthcare Databases for Post-Marketing Drug Effectiveness, Safety and Value Evaluation: Where Does Italy Stand?
by Gianluca Trifirò & Rosa Gini & Francesco Barone-Adesi & Ettore Beghi & Anna Cantarutti & Annalisa Capuano & Carla Carnovale & Antonio Clavenna & Mirosa Dellagiovanna & Carmen Ferrajolo & Matteo Franchi & Ylenia Ingrasciotta & Ursula Kirchmayer & Francesco Lapi & Roberto Leone & Olivia Leoni & Ersilia Lucenteforte & Ugo Moretti & Alessandro Mugelli & Luigi Naldi & Elisabetta Poluzzi & Concita Rafaniello & Federico Rea & Janet Sultana & Mauro Tettamanti & Giuseppe Traversa & Alfredo Vannacci & Lorenzo Mantovani & Giovanni Corrao - 365-387 Drug-Induced Liver Injury: Highlights of the Recent Literature
by Mark Real & Michele S. Barnhill & Cory Higley & Jessica Rosenberg & James H. Lewis - 389-400 Pharmacoepidemiologic Evaluation of Birth Defects from Health-Related Postings in Social Media During Pregnancy
by Su Golder & Stephanie Chiuve & Davy Weissenbacher & Ari Klein & Karen O’Connor & Martin Bland & Murray Malin & Mondira Bhattacharya & Linda J. Scarazzini & Graciela Gonzalez-Hernandez - 401-414 Implications of Individual QT/RR Profiles—Part 1: Inaccuracies and Problems of Population-Specific QT/Heart Rate Corrections
by Marek Malik & Christine Garnett & Katerina Hnatkova & Jose Vicente & Lars Johannesen & Norman Stockbridge - 415-426 Implications of Individual QT/RR Profiles—Part 2: Zero QTc/RR Correlations Do Not Prove QTc Correction Accuracy in Studies of QTc Changes
by Marek Malik & Christine Garnett & Katerina Hnatkova & Jose Vicente & Lars Johannesen & Norman Stockbridge - 427-444 Potential Direct Costs of Adverse Drug Events and Possible Cost Savings Achievable by their Prevention in Tuscany, Italy: A Model-Based Analysis
by Irma Convertino & Stefano Salvadori & Alessandro Pecori & Maria Teresa Galiulo & Sara Ferraro & Maria Parrilli & Tiberio Corona & Giuseppe Turchetti & Corrado Blandizzi & Marco Tuccori - 445-451 Preventing Future Deaths from Medicines: Responses to Coroners’ Concerns in England and Wales
by Robin E. Ferner & Tohfa Ahmad & Zainab Babatunde & Anthony R. Cox - 453-461 Safety of Follitropin Alfa/Lutropin Alfa for Stimulation of Follicular Development
by Nadezda Abramova & Julie Hubbard & Joan Schertz & Emilia Richter - 463-471 Evaluation of the Reported Rates of Severe Hypersensitivity Reactions Associated with Ferric Carboxymaltose and Iron (III) Isomaltoside 1000 in Europe Based on Data from EudraVigilance and VigiBase™ between 2014 and 2017
by Birgit Ehlken & Lennart Nathell & Annegret Gohlke & Derya Bocuk & Massoud Toussi & Stefan Wohlfeil - 473-473 Correction to: Implications of Individual QT/RR Profiles—Part 1: Inaccuracies and Problems of Population-Specific QT/Heart Rate Corrections
by Marek Malik & Christine Garnett & Katerina Hnatkova & Jose Vicente & Lars Johannesen & Norman Stockbridge - 475-475 Correction to: Implications of Individual QT/RR Profiles—Part 2: Zero QTc/RR Correlations Do Not Prove QTc Correction Accuracy in Studies of QTc Changes
by Marek Malik & Christine Garnett & Katerina Hnatkova & Jose Vicente & Lars Johannesen & Norman Stockbridge
February 2019, Volume 42, Issue 2
- 157-158 Safety of Novel Targeted Therapies in Oncology
by Rashmi R. Shah & Giuseppe Curigliano - 159-179 Safety and Tolerability of Anti-Angiogenic Protein Kinase Inhibitors and Vascular-Disrupting Agents in Cancer: Focus on Gastrointestinal Malignancies
by Letizia Procaccio & Vera Damuzzo & Francesca Sarra & Alberto Russi & Federica Todino & Vincenzo Dadduzio & Francesca Bergamo & Alessandra Anna Prete & Sara Lonardi & Hans Prenen & Angelo Claudio Palozzo & Fotios Loupakis - 181-198 Safety and Tolerability of Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitors in Oncology
by Rashmi R. Shah & Devron R. Shah - 199-209 Safety and Tolerability of Anaplastic Lymphoma Kinase Inhibitors in Non-Small-Cell Lung Cancer
by Danilo Rocco & Ciro Battiloro & Luigi Della Gravara & Cesare Gridelli - 211-233 Safety and Tolerability of c-MET Inhibitors in Cancer
by Alberto Puccini & Nagore I. Marín-Ramos & Francesca Bergamo & Marta Schirripa & Sara Lonardi & Heinz-Josef Lenz & Fotios Loupakis & Francesca Battaglin - 235-245 Safety and Tolerability of Histone Deacetylase (HDAC) Inhibitors in Oncology
by Rashmi R. Shah - 247-262 Safety and Tolerability of Phosphatidylinositol-3-Kinase (PI3K) Inhibitors in Oncology
by Giuseppe Curigliano & Rashmi R. Shah - 263-279 Safety and Tolerability of Sonic Hedgehog Pathway Inhibitors in Cancer
by Richard L. Carpenter & Haimanti Ray - 281-294 Safety and Tolerability of Immune Checkpoint Inhibitors (PD-1 and PD-L1) in Cancer
by Iosune Baraibar & Ignacio Melero & Mariano Ponz-Sarvise & Eduardo Castanon - 295-314 Safety and Tolerability of Antibody-Drug Conjugates in Cancer
by Anna Wolska-Washer & Tadeusz Robak - 315-334 Safety and Tolerability of Adoptive Cell Therapy in Cancer
by Benita Wolf & Stefan Zimmermann & Caroline Arber & Melita Irving & Lionel Trueb & George Coukos
January 2019, Volume 42, Issue 1
- 1-12 Aim and Design of pREGnant, the Dutch Pregnancy Drug Register
by Saskia Vorstenbosch & Bernke Winkel & Marleen M. H. J Gelder & Agnes Kant & Nel Roeleveld & Eugène Puijenbroek - 13-25 The Prevalence of Dose Errors Among Paediatric Patients in Hospital Wards with and without Health Information Technology: A Systematic Review and Meta-Analysis
by Peter J. Gates & Sophie A. Meyerson & Melissa T. Baysari & Johanna I. Westbrook - 27-34 The Social Impact of Suspected Adverse Drug Reactions: An analysis of the Canada Vigilance Spontaneous Reporting Database
by Genaro Castillon & Francesco Salvo & Yola Moride - 35-43 Surveillance of Drug Safety During Pregnancy: Insight in Current International Activities, Future Intentions and Need for Support of National Pharmacovigilance Centres
by Agnes Kant & Loes Vries & Leàn Rolfes - 45-54 POMME: The New Cohort to Evaluate Long-Term Effects After Prenatal Medicine Exposure
by Justine Benevent & Caroline Hurault-Delarue & Mélanie Araujo & Jean-Louis Montastruc & Isabelle Lacroix & Christine Damase-Michel - 55-66 Stevens–Johnson Syndrome and Toxic Epidermal Necrolysis in Association with Commonly Prescribed Drugs in Outpatient Care Other than Anti-Epileptic Drugs and Antibiotics: A Population-Based Case–Control Study
by Noel Frey & Michael Bodmer & Andreas Bircher & Susan S. Jick & Christoph R. Meier & Julia Spoendlin - 67-75 Nonsteroidal Anti-Inflammatory Drugs and Risk of First Hospitalization for Heart Failure in Patients with No History of Heart Failure: A Population-Based Case-Crossover Study
by Sung-Po Huang & Yao-Chun Wen & Shih-Tsung Huang & Chih-Wan Lin & Tzung-Dau Wang & Fei-Yuan Hsiao - 77-83 Assessment of Self-Administration of Romiplostim in Patients with Immune Thrombocytopenic Purpura after Receipt of Home Administration Training Materials: a Cross-Sectional Study
by Martin Schipperus & Georgia Kaiafa & Louise Taylor & Sally Wetten & Georg Kreuzbauer & Andy Boshier & Anouchka Seesaghur - 85-93 Effect of Lawyer-Submitted Reports on Signals of Disproportional Reporting in the Food and Drug Administration’s Adverse Event Reporting System
by James R. Rogers & Ameet Sarpatwari & Rishi J. Desai & Justin M. Bohn & Nazleen F. Khan & Aaron S. Kesselheim & Michael A. Fischer & Joshua J. Gagne & John G. Connolly - 95-97 Towards Drug Safety Surveillance and Pharmacovigilance: Current Progress in Detecting Medication and Adverse Drug Events from Electronic Health Records
by Feifan Liu & Abhyuday Jagannatha & Hong Yu - 99-111 Overview of the First Natural Language Processing Challenge for Extracting Medication, Indication, and Adverse Drug Events from Electronic Health Record Notes (MADE 1.0)
by Abhyuday Jagannatha & Feifan Liu & Weisong Liu & Hong Yu - 113-122 Adverse Drug Event Detection from Electronic Health Records Using Hierarchical Recurrent Neural Networks with Dual-Level Embedding
by Susmitha Wunnava & Xiao Qin & Tabassum Kakar & Cansu Sen & Elke A. Rundensteiner & Xiangnan Kong - 123-133 MADEx: A System for Detecting Medications, Adverse Drug Events, and Their Relations from Clinical Notes
by Xi Yang & Jiang Bian & Yan Gong & William R. Hogan & Yonghui Wu - 135-146 Adverse Drug Events Detection in Clinical Notes by Jointly Modeling Entities and Relations Using Neural Networks
by Bharath Dandala & Venkata Joopudi & Murthy Devarakonda - 147-156 Detecting Adverse Drug Events with Rapidly Trained Classification Models
by Alec B. Chapman & Kelly S. Peterson & Patrick R. Alba & Scott L. DuVall & Olga V. Patterson
December 2018, Volume 41, Issue 12
- 1281-1284 First Conference on Big Data for Pharmacovigilance
by Jae Min & Vicki Osborne & Elizabeth Lynn & Saad A. W. Shakir - 1285-1302 Enhancing Pharmacovigilance Capabilities in the EU Regulatory Network: The SCOPE Joint Action
by Anna Radecka & Louise Loughlin & Mick Foy & Margarida Viana de Ferraz Guimaraes & Viola Macolic Sarinic & Marina Dimov Giusti & Marina Lesicar & Sabine Straus & Dolores Montero & Julia Pallos & Jelena Ivanovic & June Raine - 1303-1308 Risks of Opioids in ST-Elevation Myocardial Infarction: A Review
by Anne Henrieke Tavenier & Renicus Suffridus Hermanides & Jan Paul Ottervanger & Peter Gerrit Johannes Horst & Elvin Kedhi & Adriaan W. J. Hof - 1309-1312 Real World Evidence: Time for a Switch?
by Rachel E. Sobel & Andrew Bate & Robert F. Reynolds - 1313-1323 Evaluation of Switching Patterns in FDA’s Sentinel System: A New Tool to Assess Generic Drugs
by Joshua J. Gagne & Jennifer R. Popovic & Michael Nguyen & Sukhminder K. Sandhu & Patty Greene & Rima Izem & Wenlei Jiang & Zhong Wang & Yueqin Zhao & Andrew B. Petrone & Anita K. Wagner & Sarah K. Dutcher - 1325-1331 Gabapentin and Pregabalin and Risk of Atrial Fibrillation in the Elderly: A Population-Based Cohort Study in an Electronic Prescription Database
by Leticia Ortiz de Landaluce & Pere Carbonell & Carmen Asensio & Núria Escoda & Pilar López & Joan-Ramon Laporte - 1333-1342 Changes in Outpatient Use of Antibiotics by Adults in the United States, 2006–2015
by Mallika L. Mundkur & Jessica Franklin & Krista F. Huybrechts & Michael A. Fischer & Aaron S. Kesselheim & Jeffrey A. Linder & Joan Landon & Elisabetta Patorno - 1343-1353 Adverse Drug Reactions Among Patients Initiating Second-Line Antiretroviral Therapy in South Africa
by Dorina Onoya & Kamban Hirasen & Liudmyla Berg & Jacqui Miot & Lawrence C. Long & Matthew P. Fox - 1355-1369 Assessment of the Utility of Social Media for Broad-Ranging Statistical Signal Detection in Pharmacovigilance: Results from the WEB-RADR Project
by Ola Caster & Juergen Dietrich & Marie-Laure Kürzinger & Magnus Lerch & Simon Maskell & G. Niklas Norén & Stéphanie Tcherny-Lessenot & Benoit Vroman & Antoni Wisniewski & John Stekelenborg - 1371-1373 Comment on “Assessment of the Utility of Social Media for Broad-Ranging Statistical Signal Detection in Pharmacovigilance: Results from the WEB-RADR Project”
by Cedric Bousquet & Bissan Audeh & Florelle Bellet & Agnès Lillo-Le Louët - 1375-1385 A Critical Evaluation of Safety Signal Analysis Using Algorithmic Standardised MedDRA Queries
by Carolyn Tieu & Christopher D. Breder - 1387-1396 Proton Pump Inhibitor Use and Risk of Developing Alzheimer’s Disease or Vascular Dementia: A Case–Control Analysis
by Patrick Imfeld & Michael Bodmer & Susan S. Jick & Christoph R. Meier - 1397-1410 Methods to Compare Adverse Events in Twitter to FAERS, Drug Information Databases, and Systematic Reviews: Proof of Concept with Adalimumab
by Karen Smith & Su Golder & Abeed Sarker & Yoon Loke & Karen O’Connor & Graciela Gonzalez-Hernandez - 1411-1411 Comment on “Proton Pump Inhibitor Use and Risk of Developing Alzheimer’s Disease or Vascular Dementia: A Case–Control Analysis”
by Katsuhiro Toda - 1413-1413 Authors’ Reply to Katsuhiro Toda’s Comment on “Proton Pump Inhibitor Use and Risk of Developing Alzheimer’s Disease or Vascular Dementia: A Case-Control Analysis”
by Patrick Imfeld & Michael Bodmer & Susan S. Jick & Christoph R. Meier - 1415-1416 Comment on: “Limited Evidence for Risk Factors for Proarrhythmia and Sudden Cardiac Death in Patients Using Antidepressants: Dutch Consensus on ECG Monitoring”
by Alain Braillon - 1417-1418 Authors’ Response to Braillon’s Comment on: “Limited Evidence for Risk Factors for Proarrhythmia and Sudden Cardiac Death in Patients Using Antidepressants: Dutch Consensus on ECG Monitoring”
by Mirjam Simoons & Adrie Seldenrijk & Hans Mulder & Eric Roon & Roberto Bakker & Henricus Ruhé - 1419-1421 Comment on: “Mixed Approach Retrospective Analyses of Suicide and Suicidal Ideation for Brand Compared with Generic Central Nervous System Drugs”
by Courtney M. Suggs & Robert L. Levin & Andrew D. Mosholder & Richard S. Swain & Liang Zhao - 1423-1424 Authors' Reply to Courtney Suggs and Colleagues’ Comment on: “Mixed Approach Retrospective Analyses of Suicide and Suicidal Ideation for Brand Compared with Generic Central Nervous System Drugs”
by Richard A. Hansen & Ning Cheng & Md. Motiur Rahman & Yasser Alatawi & Jingjing Qian & Peggy L. Peissig & Richard L. Berg & C. David Page - 1425-1427 Comment on “Central Demyelinating Diseases After Vaccination Against Hepatitis B Virus: A Disproportionality Analysis Within the VAERS Database”
by Carine Cohen & Annick Houdeau & Alena Khromava - 1429-1430 Authors’ Reply to Cohen et al.’s Comment on “Central Demyelinating Diseases after Vaccination Against Hepatitis B Virus: A Disproportionality Analysis within the VAERS Database”
by Julie Mouchet & Bernard Bégaud - 1431-1437 Correction to: Liver Safety of Fasiglifam (TAK-875) in Patients with Type 2 Diabetes: Review of the Global Clinical Trial Experience
by John F. Marcinak & Melvin S. Munsaka & Paul B. Watkins & Takashi Ohira & Neila Smith - 1439-1440 Correction to: Medication Errors: A Characterisation of Spontaneously Reported Cases in EudraVigilance
by Victoria Newbould & Steven Meur & Thomas Goedecke & Xavier Kurz
November 2018, Volume 41, Issue 11
- 999-1001 Ibuprofen and Paracetamol: Acceptably Safe for All?
by Filippo Pigazzani & Isla Mackenzie & Thomas M. MacDonald - 1003-1011 What Future Healthcare Professionals Need to Know About Pharmacovigilance: Introduction of the WHO PV Core Curriculum for University Teaching with Focus on Clinical Aspects
by Rike van Eekeren & Leàn Rolfes & Andries S. Koster & Lara Magro & Gurumurthy Parthasarathi & Hussain Al Ramimmy & Tim Schutte & Daisuke Tanaka & Eugène van Puijenbroek & Linda Härmark - 1013-1022 Safety of Biologics, Including Biosimilars: Perspectives on Current Status and Future Direction
by Ylenia Ingrasciotta & Paola M. Cutroneo & Ilaria Marcianò & Thijs Giezen & Fabiola Atzeni & Gianluca Trifirò - 1023-1033 Prescription Opioid Fatalities: Examining Why the Healer Could be the Culprit
by Adeleke D. Adewumi & Christine E. Staatz & Samantha A. Hollingworth & Jason P. Connor & Rosa Alati - 1035-1048 Safety Profile of Benznidazole in the Treatment of Chronic Chagas Disease: Experience of a Referral Centre and Systematic Literature Review with Meta-Analysis
by Clara Crespillo-Andújar & Emmanuele Venanzi-Rullo & Rogelio López-Vélez & Begoña Monge-Maillo & Francesca Norman & Ana López-Polín & José A. Pérez-Molina - 1049-1058 Coronary Events After Dispensing of Ibuprofen: A Propensity Score-Matched Cohort Study Versus Paracetamol in the French Nationwide Claims Database Sample
by Mai Duong & Abdelilah Abouelfath & Regis Lassalle & Cécile Droz & Patrick Blin & Nicholas Moore - 1059-1072 Predicting Adverse Drug Effects from Literature- and Database-Mined Assertions
by Mary K. La & Alexander Sedykh & Denis Fourches & Eugene Muratov & Alexander Tropsha - 1073-1085 MOdified NARanjo Causality Scale for ICSRs (MONARCSi): A Decision Support Tool for Safety Scientists
by Shaun Comfort & Darren Dorrell & Shawman Meireis & Jennifer Fine - 1087-1096 Role of Serotonin Transporter in Antidepressant-Induced Diabetes Mellitus: A Pharmacoepidemiological–Pharmacodynamic Study in VigiBase®
by Thi Thu Ha Nguyen & Anne Roussin & Vanessa Rousseau & Jean-Louis Montastruc & François Montastruc - 1097-1099 Comment on “Using Human ‘Experiments of Nature’ to Predict Drug Safety Issues: An Example with PCSK9 Inhibitors”
by Lucas D. Ward & Graeme J. Moffat & Jing Yuan & Paul Nioi - 1101-1101 Reply to Ward and Colleagues’ Comment on “Using Human Experiments of Nature to Predict Drug Safety Issues: An Example with PCSK9 Inhibitors”
by Rebecca N. Jerome & Jill M. Pulley & Dan M. Roden & Jana K. Shirey-Rice & Lisa A. Bastarache & Gordon Bernard & Leeland Ekstrom & William J. Lancaster & Joshua C. Denny
October 2018, Volume 41, Issue 10
- 911-918 Challenges and Opportunities for the Traceability of (Biological) Medicinal Products
by Kevin Klein & Pieter Stolk - 919-931 Cardiac Complications Attributed to Chloroquine and Hydroxychloroquine: A Systematic Review of the Literature
by Clotilde Chatre & François Roubille & Hélène Vernhet & Christian Jorgensen & Yves-Marie Pers - 933-938 Inadequate harms reporting in randomized control trials of antibiotics for pediatric acute otitis media: a systematic review
by Stephanie W. Hum & Su Golder & Nader Shaikh - 939-950 Association of Statin Use with Increased Risk of Musculoskeletal Conditions: A Retrospective Cohort Study
by Una E. Makris & Carlos A. Alvarez & Eric M. Mortensen & Ishak A. Mansi - 951-958 Cohort Study of Psychiatric Adverse Events Following Exposure to Levonorgestrel-Containing Intrauterine Devices in UK General Practice
by Jim Slattery & Daniel Morales & Luis Pinheiro & Xavier Kurz - 959-968 Potentially Inappropriate Medication Prescribing and Risk of Unplanned Hospitalization among the Elderly: A Self-Matched, Case-Crossover Study
by Izumi Sato & Yosuke Yamamoto & Genta Kato & Koji Kawakami - 969-978 Characteristics, Quality and Contribution to Signal Detection of Spontaneous Reports of Adverse Drug Reactions Via the WEB-RADR Mobile Application: A Descriptive Cross-Sectional Study
by Ingrid Oosterhuis & Henric Taavola & Philip M. Tregunno & Petar Mas & Sara Gama & Victoria Newbould & Ola Caster & Linda Härmark - 979-980 Potential Risk Window for Opioid Overdose Related to Treatment with Extended-Release Injectable Naltrexone
by Ingrid A. Binswanger & Jason M. Glanz