Drug Safety

2012 - 2025

Current editor(s): Nitin Joshi

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Volume 42, issue 12, 2019

Recommendations for the Use of Social Media in Pharmacovigilance: Lessons from IMI WEB-RADR pp. 1393-1407

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 and Munir Pirmohamed

Comparative Effectiveness and Safety of Direct Oral Anticoagulants: Overview of Systematic Reviews pp. 1409-1422

Emanuel Raschi, Matteo Bianchin, Milo Gatti, Alessandro Squizzato and Fabrizio De Ponti

Prevalence and Nature of Medication Errors and Preventable Adverse Drug Events in Paediatric and Neonatal Intensive Care Settings: A Systematic Review pp. 1423-1436

Anwar A. Alghamdi, Richard N. Keers, Adam Sutherland and Darren M. Ashcroft

Effectiveness and Safety of Switching Originator and Biosimilar Epoetins in Patients with Chronic Kidney Disease in a Large-Scale Italian Cohort Study pp. 1437-1447

Valeria Belleudi, Francesco Trotta, Antonio Addis, Ylenia Ingrasciotta, Valentina Ientile, Michele Tari, Rosa Gini, Maurizio Pastorello, Salvatore Scondotto, Pasquale Cananzi, Giuseppe Traversa, Marina Davoli and Gianluca Trifirò

The Association between Metformin Therapy and Lactic Acidosis pp. 1449-1469

Isabelle H. S. Kuan, Ruth L. Savage, Stephen B. Duffull, Robert J. Walker and Daniel F. B. Wright

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 pp. 1471-1485

Janet Sultana, Andrea Fontana, Francesco Giorgianni, Silvia Tillati, Claudio Cricelli, Alessandro Pasqua, Elisabetta Patorno, Clive Ballard, Miriam Sturkenboom and Gianluca Trifirò

Data-Driven Identification of Adverse Event Reporting Patterns for Japan in VigiBase, the WHO Global Database of Individual Case Safety Reports pp. 1487-1498

Rika Wakao, Henric Taavola, Lovisa Sandberg, Eiko Iwasa, Saori Soejima, Rebecca Chandler and G. Niklas Norén

Rheumatology Common Toxicity Criteria (RCTC): An Update Reflecting Real-World Use pp. 1499-1506

Christian M. Stach, Victor S. Sloan, Thasia G. Woodworth, Brian Kilgallen and Daniel E. Furst

Psoriasis After Exposure to Angiotensin-Converting Enzyme Inhibitors: French Pharmacovigilance Data and Review of the Literature pp. 1507-1513

Brahim Azzouz, Aurore Morel, Lukshe Kanagaratnam, Emmanuelle Herlem and Thierry Trenque

Comment on: “Patient Registries: An Underused Resource for Medicines Evaluation: Operational Proposals for Increasing the Use of Patient Registries in Regulatory Assessments” pp. 1515-1516

Ravi Jandhyala

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” pp. 1517-1518

Patricia McGettigan, Carla Alonso Olmo, Kelly Plueschke, Mireia Castillon, Daniel Zondag, Priya Bahri, Xavier Kurz and Peter G. M. Mol

Volume 42, issue 11, 2019

Multimodal Analysis of FDA Drug Safety Communications: Lessons from Zolpidem pp. 1287-1295

Aaron S. Kesselheim, Michael S. Sinha, Eric G. Campbell, Sebastian Schneeweiss, Paula Rausch, Brian M. Lappin, Esther H. Zhou, Jerry Avorn and Gerald J. Dal Pan

Transparent Reporting on Research Using Unstructured Electronic Health Record Data to Generate ‘Real World’ Evidence of Comparative Effectiveness and Safety pp. 1297-1309

Shirley V. Wang, Olga V. Patterson, Joshua J. Gagne, Jeffrey S. Brown, Robert Ball, Pall Jonsson, Adam Wright, Li Zhou, Wim Goettsch and Andrew Bate

Benefit-Risk Assessment of Alogliptin for the Treatment of Type 2 Diabetes Mellitus pp. 1311-1327

Kohei Kaku, Koichi Kisanuki, Mari Shibata and Takashi Oohira

Prevalence of Medication Errors Among Paediatric Inpatients: Systematic Review and Meta-Analysis pp. 1329-1342

Peter J. Gates, Melissa T. Baysari, Madlen Gazarian, Magdalena Z. Raban, Sophie Meyerson and Johanna I. Westbrook

Patient Registries: An Underused Resource for Medicines Evaluation pp. 1343-1351

Patricia McGettigan, Carla Alonso Olmo, Kelly Plueschke, Mireia Castillon, Daniel Nogueras Zondag, Priya Bahri, Xavier Kurz and Peter G. M. Mol

Correction to: Patient Registries: An Underused Resource for Medicines Evaluation pp. 1353-1353

Patricia McGettigan, Carla Alonso Olmo, Kelly Plueschke, Mireia Castillon, Daniel Nogueras Zondag, Priya Bahri, Xavier Kurz and Peter G. M. Mol

Non-Vitamin K Antagonist Oral Anticoagulants and Angioedema: A Cohort and Case-Crossover Study pp. 1355-1363

John G. Connolly, Sebastian Schneeweiss, Robert J. Glynn and Joshua J. Gagne

A Novel Approach to Visualize Risk Minimization Effectiveness: Peeping at the 2012 UK Proton Pump Inhibitor Label Change Using a Rapid Cycle Analysis Tool pp. 1365-1376

Rachel E. Sobel, William Blackwell, David M. Fram and Andrew Bate

Identifying the DEAD: Development and Validation of a Patient-Level Model to Predict Death Status in Population-Level Claims Data pp. 1377-1386

Jenna M. Reps, Peter R. Rijnbeek and Patrick B. Ryan

Volume 42, issue 10, 2019

Pharmacovigilance as Scientific Discovery: An Argument for Trans-Disciplinarity pp. 1115-1124

Elena Rocca, Samantha Copeland and I. Ralph Edwards

Unintended Effects of Communicating About Drug Safety Issues: A Critical Review of the Literature pp. 1125-1134

Jessica T. DeFrank, Lauren McCormack, Suzanne L. West, Craig Lefebvre and Olivia Burrus

Comparative Effectiveness and Safety of Direct Oral Anticoagulants in Patients with Atrial Fibrillation: A Systematic Review and Meta-Analysis of Observational Studies pp. 1135-1148

Antonios Douros, Madeleine Durand, Carla M. Doyle, Sarah Yoon, Pauline Reynier and Kristian B. Filion

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 pp. 1149-1155

Sandra L. Kane-Gill, Marlies Ostermann, Jing Shi, Emily L. Joyce and John A. Kellum

Intravenous Infusion Administration: A Comparative Study of Practices and Errors Between the United States and England and Their Implications for Patient Safety pp. 1157-1165

Ann Blandford, Patricia C. Dykes, Bryony Dean Franklin, Dominic Furniss, Galal H. Galal-Edeen, Kumiko O. Schnock and David W. Bates

Study Design and Cohort Comparability in a Study of Major Cardiovascular Events in New Users of Prucalopride Versus Polyethylene Glycol 3350 pp. 1167-1177

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 and Elizabeth B. Andrews

Cardiovascular Safety of Prucalopride in Patients with Chronic Constipation: A Multinational Population-Based Cohort Study pp. 1179-1190

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 and Elizabeth B. Andrews

Pooling Different Safety Data Sources: Impact of Combining Solicited and Spontaneous Reports on Signal Detection In Pharmacovigilance pp. 1191-1198

Jeremy D. Jokinen, Rosalind J. Walley, Michael W. Colopy, Thomas S. Hilzinger and Peter Verdru

The Impact of Litigation-Associated Reports on Signal Identification in the US FDA’s Adverse Event Reporting System pp. 1199-1201

Monica A. Muñoz and Gerald J. Dal Pan

Volume 42, issue 9, 2019

Fluoroquinolone Use and the Risk of Collagen-Associated Adverse Events: A Systematic Review and Meta-Analysis pp. 1025-1033

Xinyu Yu, Ding-sheng Jiang, Jing Wang, Rui Wang, Taiqiang Chen, Kan Wang, Shiyi Cao and Xiang Wei

Evaluation of Potential Drug–Drug Interactions in Adults in the Intensive Care Unit: A Systematic Review and Meta-Analysis pp. 1035-1044

Mary Grace Fitzmaurice, Adrian Wong, Hannah Akerberg, Simona Avramovska, Pamela L. Smithburger, Mitchell S. Buckley and Sandra L. Kane-Gill

Enabling Data-Driven Clinical Quality Assurance: Predicting Adverse Event Reporting in Clinical Trials Using Machine Learning pp. 1045-1053

Timothé Ménard, Yves Barmaz, Björn Koneswarakantha, Rich Bowling and Leszek Popko

Auto-Generated Physiological Chain Data for an Ontological Framework for Pharmacology and Mechanism of Action to Determine Suspected Drugs in Cases of Dysuria pp. 1055-1069

Masayo Hayakawa, Takeshi Imai, Yoshimasa Kawazoe, Kouji Kozaki and Kazuhiko Ohe

Evaluation of Use of Technologies to Facilitate Medical Chart Review pp. 1071-1080

Loreen Straub, Joshua J. Gagne, Judith C. Maro, Michael D. Nguyen, Nicolas Beaulieu, Jeffrey S. Brown, Adee Kennedy, Margaret Johnson, Adam Wright, Li Zhou and Shirley V. Wang

Antidepressants and the Risk of Hemorrhagic Stroke in the Elderly: a Nested Case–Control Study pp. 1081-1089

Wiebke Schäfer, Christina Princk, Bianca Kollhorst and Tania Schink

Prevalence, Safety and Long-Term Retention Rates of Biologics in Hong Kong from 2001 to 2015 pp. 1091-1102

Mengqin Ge, Kenneth K. Man, Celine S. Chui, Esther W. Chan, Ian C. Wong and Xue Li

Randomized Placebo-Controlled Trial Evaluating the Ophthalmic Safety of Single-Dose Tafenoquine in Healthy Volunteers pp. 1103-1114

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 and Justin A. Green

Volume 42, issue 8, 2019

Establishing a Framework for the Use of Social Media in Pharmacovigilance in Europe pp. 921-930

Sabine Brosch, Anne-Marie Ferran, Victoria Newbould, Diane Farkas, Marina Lengsavath and Phil Tregunno

Standardising the Classification of Harm Associated with Medication Errors: The Harm Associated with Medication Error Classification (HAMEC) pp. 931-939

Peter J. Gates, Melissa T. Baysari, Virginia Mumford, Magdalena Z. Raban and Johanna I. Westbrook

Established and Emerging Immunological Complications of Biological Therapeutics in Multiple Sclerosis pp. 941-956

Babak Soleimani, Katy Murray and David Hunt

Benefit-Risk Assessment of Obesity Drugs: Focus on Glucagon-like Peptide-1 Receptor Agonists pp. 957-971

Rasmus M. Christensen, Christian R. Juhl and Signe S. Torekov

Mechanisms of Severe Cutaneous Adverse Reactions: Recent Advances pp. 973-992

Teresa Bellón

Bismuth Concentrations in Patients Treated in Real-Life Practice with a Bismuth Subcitrate-Metronidazole-Tetracycline Preparation: The SAPHARY Study pp. 993-1003

Estelle Guiard, Bénédicte Lelievre, Magali Rouyer, Frank Zerbib, Bertrand Diquet, Francis Mégraud, François Tison, Emmanuelle Bignon, Régis Lassalle, Cécile Droz-Perroteau, Nicholas Moore and Patrick Blin

Androgen Deprivation Therapy for Prostate Cancer and the Risk of Rheumatoid Arthritis: A Population-Based Cohort Study pp. 1005-1011

Adi J. Klil-Drori, Christina Santella, Koray Tascilar, Hui Yin, Armen Aprikian and Laurent Azoulay

Long-Term Safety and Tolerability of OnabotulinumtoxinA Treatment in Patients with Chronic Migraine: Results of the COMPEL Study pp. 1013-1024

Paul K. Winner, Andrew M. Blumenfeld, Eric J. Eross, Amelia C. Orejudos, Debbie L. Mirjah, Aubrey Manack Adams and Mitchell F. Brin

Volume 42, issue 7, 2019

Inflammation, Monoclonal Antibodies and Depression: Joining the Dots pp. 811-812

David Hunt

Sirolimus and mTOR Inhibitors: A Review of Side Effects and Specific Management in Solid Organ Transplantation pp. 813-825

Lee S. Nguyen, Mathieu Vautier, Yves Allenbach, Noel Zahr, Olivier Benveniste, Christian Funck-Brentano and Joe-Elie Salem

Drug-Induced Photosensitivity—An Update: Culprit Drugs, Prevention and Management pp. 827-847

Kim M. Blakely, Aaron M. Drucker and Cheryl F. Rosen

Pharmacovigilance Systems in Arab Countries: Overview of 22 Arab Countries pp. 849-868

Thamir M. Alshammari, Neslihan Mendi, Khalidah A. Alenzi and Yazed Alsowaida

Long-Term Safety and Efficacy of Fecal Microbiota Transplant in Active Ulcerative Colitis pp. 869-880

Xiao Ding, Qianqian Li, Pan Li, Ting Zhang, Bota Cui, Guozhong Ji, Xiang Lu and Faming Zhang

Use of a Patient-Friendly Terms List in the Adverse Drug Reaction Report Form: A Database Study pp. 881-886

Sieta T. de Vries, Judy Harrison, Patrick Revelle, Alicia Ptaszynska-Neophytou, Anna Radecka, Gowthamei Ragunathan, Phil Tregunno, Petra Denig and Peter G. M. Mol

Exploring the Association between Monoclonal Antibodies and Depression and Suicidal Ideation and Behavior: A VigiBase Study pp. 887-895

Lotte A. Minnema, Thijs J. Giezen, Patrick C. Souverein, Toine C. G. Egberts, Hubert G. M. Leufkens and Helga Gardarsdottir

Use of FDA’s Sentinel System to Quantify Seizure Risk Immediately Following New Ranolazine Exposure pp. 897-906

Efe Eworuke, Emily C. Welch, Anne Tobenkin and Judith C. Maro

Summary of Torsades de Pointes (TdP) Reports Associated with Intravenous Drug Formulations Containing the Preservative Chlorobutanol pp. 907-913

R. David Woosley, Klaus Romero, Craig W. Heise, Tyler Gallo, Jared Tate and Raymond L. Woosley

A Profile of Adverse Drug Reactions of Atazanavir- and Lopinavir-Based Antiretroviral Regimens in Namibia pp. 915-917

Babafunso Aderemi Adenuga and Timothy William Rennie

Correction to: Benefit-Risk Assessment of Obesity Drugs: Focus on Glucagon-like Peptide-1 Receptor Agonists pp. 919-919

Rasmus M. Christensen, Christian R. Juhl and Signe S. Torekov

Volume 42, issue 6, 2019

Frailty and Drug Safety at Older Ages pp. 699-700

Martin Gulliford

Drug-Induced Steatosis and Steatohepatitis: The Search for Novel Serum Biomarkers Among Potential Biomarkers for Non-Alcoholic Fatty Liver Disease and Non-Alcoholic Steatohepatitis pp. 701-711

Lauren Pavlik, Arie Regev, Paul A. Ardayfio and Naga P. Chalasani

Identifying Data Elements to Measure Frailty in a Dutch Nationwide Electronic Medical Record Database for Use in Postmarketing Safety Evaluation: An Exploratory Study pp. 713-719

Janet Sultana, Ingrid Leal, Marcel Wilde, Maria Ridder, Johan Lei, Miriam Sturkenboom and Gianluca Trifiro’

A Machine-Learning Algorithm to Optimise Automated Adverse Drug Reaction Detection from Clinical Coding pp. 721-725

Christopher McMaster, David Liew, Claire Keith, Parnaz Aminian and Albert Frauman

An Implementation and Visualization of the Tree-Based Scan Statistic for Safety Event Monitoring in Longitudinal Electronic Health Data pp. 727-741

Stephen E. Schachterle, Sharon Hurley, Qing Liu, Kenneth R. Petronis and Andrew Bate

A Comparison Study of Algorithms to Detect Drug–Adverse Event Associations: Frequentist, Bayesian, and Machine-Learning Approaches pp. 743-750

Minh Pham, Feng Cheng and Kandethody Ramachandran

Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn’s Disease: An Integrated Analysis of Phase II/III Clinical Development Programs pp. 751-768

Subrata Ghosh, Lianne S. Gensler, Zijiang Yang, Chris Gasink, Soumya D. Chakravarty, Kamyar Farahi, Paraneedharan Ramachandran, Elyssa Ott and Bruce E. Strober

Evaluation of Antibody Properties and Clinically Relevant Immunogenicity, Anaphylaxis, and Hypersensitivity Reactions in Two Phase III Trials of Tralokinumab in Severe, Uncontrolled Asthma pp. 769-784

Mats Carlsson, Martin Braddock, Yuling Li, Jihong Wang, Weichen Xu, Nicholas White, Ayman Megally, Gillian Hunter and Gene Colice

All-Cause Mortality Associated with Tramadol Use: A Case-Crossover Study pp. 785-796

Sohyun Jeong, Ha Jin Tchoe, Junqing Li and Ju-Young Shin

The 10th International Congress on Cutaneous Adverse Drug Reactions, Shimane, Japan, 2018: Focus on New Discoveries pp. 797-801

Cristina Olteanu, Neil H. Shear, Eishin Morita, Wen-Hung Chung, Hiroyuki Niihara, Setsuko Matsukura, Rena Hashimoto and Roni P. Dodiuk-Gad

Advances in Diagnosis and Management of Cutaneous Adverse Drug Reactions: Current and Future Trends pp. 803-803

Mark Lebwohl

Correction to: vigiGrade: A Tool to Identify Well-Documented Individual Case Reports and Highlight Systematic Data Quality Issues pp. 805-805

Tomas Bergvall, G. Niklas Norén and Marie Lindquist

Correction to: A Machine-Learning Algorithm to Optimise Automated Adverse Drug Reaction Detection from Clinical Coding pp. 807-807

Christopher McMaster, David Liew, Claire Keith, Parnaz Aminian and Albert Frauman

Correction to: Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn’s Disease: An Integrated Analysis of Phase II/III Clinical Development Programs pp. 809-809

Subrata Ghosh, Lianne S. Gensler, Zijiang Yang, Chris Gasink, Soumya D. Chakravarty, Kamyar Farahi, Paraneedharan Ramachandran, Elyssa Ott and Bruce E. Strober

Volume 42, issue 5, 2019

Building an Evidence Base on the Place of Industry-Sponsored Programs in Drug Safety Surveillance pp. 581-582

Peter Arlett

From Data Silos to Standardized, Linked, and FAIR Data for Pharmacovigilance: Current Advances and Challenges with Observational Healthcare Data pp. 583-586

Vassilis Koutkias

Benefit–Risk Assessment of Blinatumomab in the Treatment of Relapsed/Refractory B-Cell Precursor Acute Lymphoblastic Leukemia pp. 587-601

Anthony Stein, Janet L. Franklin, Victoria M. Chia, Deborah Arrindell, William Kormany, Jacqueline Wright, Mandy Parson, Hamid R. Amouzadeh, Jessica Choudhry and Guiandre Joseph

Benefit–Risk Assessment of Plecanatide in the Treatment of Chronic Idiopathic Constipation pp. 603-615

Philip B. Miner

Benefit–Risk Assessment of Vedolizumab in the Treatment of Crohn’s Disease and Ulcerative Colitis pp. 617-632

Robert Battat, Christopher Ma, Vipul Jairath, Reena Khanna and Brian G. Feagan

Managing Risks with Immune Therapies in Multiple Sclerosis pp. 633-647

Moritz Förster, Patrick Küry, Orhan Aktas, Clemens Warnke, Joachim Havla, Reinhard Hohlfeld, Jan Mares, Hans-Peter Hartung and David Kremer

Evaluation of Postmarketing Reports from Industry-Sponsored Programs in Drug Safety Surveillance pp. 649-655

Lisa Harinstein, Dipti Kalra, Cindy M. Kortepeter, Monica A. Muñoz, Eileen Wu and Gerald J. Dal Pan

Development of a Controlled Vocabulary-Based Adverse Drug Reaction Signal Dictionary for Multicenter Electronic Health Record-Based Pharmacovigilance pp. 657-670

Suehyun Lee, Jongsoo Han, Rae Woong Park, Grace Juyun Kim, John Hoon Rim, Jooyoung Cho, Kye Hwa Lee, Jisan Lee, Sujeong Kim and Ju Han Kim

Drug-Induced Anaphylaxis in a Vietnamese Pharmacovigilance Database: Trends and Specific Signals from a Disproportionality Analysis pp. 671-682

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 and Haleh Bagheri

Workshop on the Italian Pharmacovigilance System in the International Context: Critical Issues and Perspectives pp. 683-687

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 and Roberto Leone

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’ pp. 689-691

Philip Schaffalitzky de Muckadell and Claes Christian Strom

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” pp. 693-696

Birgit Ehlken, Lennart Nathell, Annegret Gohlke, Derya Bocuk, Massoud Toussi and Stefan Wohlfeil

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 pp. 697-697

S. Jill Stocks, Evangelos Kontopantelis, Roger T. Webb, Anthony J. Avery, Alistair Burns and Darren M. Ashcroft

Volume 42, issue 4, 2019

Recommendations on the Use of Mobile Applications for the Collection and Communication of Pharmaceutical Product Safety Information: Lessons from IMI WEB-RADR pp. 477-489

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 and Peter G. M. Mol

Artificial Intelligence and the Future of the Drug Safety Professional pp. 491-497

Karolina Danysz, Salvatore Cicirello, Edward Mingle, Bruno Assuncao, Niki Tetarenko, Ruta Mockute, Danielle Abatemarco, Mark Widdowson and Sameen Desai

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 pp. 499-513

Zixuan Wang, Phoebe W. H. Ho, Michael T. H. Choy, Ian C. K. Wong, Ruth Brauer and Kenneth K. C. Man

Diagnostic Algorithms for Cardiovascular Death in Administrative Claims Databases: A Systematic Review pp. 515-527

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 and Susan Andrade

Fluoroquinolones and Cardiovascular Risk: A Systematic Review, Meta-analysis and Network Meta-analysis pp. 529-538

Einat Gorelik, Reem Masarwa, Amichai Perlman, Victoria Rotshild, Momen Abbasi, Mordechai Muszkat and Ilan Matok

Prevalence of Drug Prescriptions and Potential Safety in Patients with Cirrhosis: A Retrospective Real-World Study pp. 539-546

Rianne A. Weersink, Katja Taxis, Joost P. H. Drenth, Eline Houben, Herold J. Metselaar and Sander D. Borgsteede

The Role of European Patient Organizations in Pharmacovigilance pp. 547-557

Cristiano Matos, Gerda Weits and Florence Hunsel

Previous Drug Exposure in Patients Hospitalised for Acute Liver Injury: A Case-Population Study in the French National Healthcare Data System pp. 559-572

Nicholas Moore, Stéphanie Duret, Adeline Grolleau, Régis Lassalle, Vanessa Barbet, Mai Duong, Nicolas Thurin, Cécile Droz-Perroteau and Sinem Ezgi Gulmez

Evaluation of Harm Associated with High Dose-Range Clinical Decision Support Overrides in the Intensive Care Unit pp. 573-579

Adrian Wong, Christine Rehr, Diane L. Seger, Mary G. Amato, Patrick E. Beeler, Sarah P. Slight, Adam Wright and David W. Bates

Volume 42, issue 3, 2019

Correcting QT for Heart Rate When Both are Affected by a Drug pp. 335-337

Georg Ferber

Pharmacovigilance in India: Present Scenario and Future Challenges pp. 339-346

V. Kalaiselvan, Sushma Srivastava, Abhishank Singh and Gupta Sk

The Role of European Healthcare Databases for Post-Marketing Drug Effectiveness, Safety and Value Evaluation: Where Does Italy Stand? pp. 347-363

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 and Giovanni Corrao

Drug-Induced Liver Injury: Highlights of the Recent Literature pp. 365-387

Mark Real, Michele S. Barnhill, Cory Higley, Jessica Rosenberg and James H. Lewis

Pharmacoepidemiologic Evaluation of Birth Defects from Health-Related Postings in Social Media During Pregnancy pp. 389-400

Susan Golder, Stephanie Chiuve, Davy Weissenbacher, Ari Klein, Karen O’Connor, Martin Bland, Murray Malin, Mondira Bhattacharya, Linda J. Scarazzini and Graciela Gonzalez-Hernandez

Implications of Individual QT/RR Profiles—Part 1: Inaccuracies and Problems of Population-Specific QT/Heart Rate Corrections pp. 401-414

Marek Malik, Christine Garnett, Katerina Hnatkova, Jose Vicente, Lars Johannesen and Norman Stockbridge

Implications of Individual QT/RR Profiles—Part 2: Zero QTc/RR Correlations Do Not Prove QTc Correction Accuracy in Studies of QTc Changes pp. 415-426

Marek Malik, Christine Garnett, Katerina Hnatkova, Jose Vicente, Lars Johannesen and Norman Stockbridge

Potential Direct Costs of Adverse Drug Events and Possible Cost Savings Achievable by their Prevention in Tuscany, Italy: A Model-Based Analysis pp. 427-444

Irma Convertino, Stefano Salvadori, Alessandro Pecori, Maria Teresa Galiulo, Sara Ferraro, Maria Parrilli, Tiberio Corona, Giuseppe Turchetti, Corrado Blandizzi and Marco Tuccori

Preventing Future Deaths from Medicines: Responses to Coroners’ Concerns in England and Wales pp. 445-451

Robin E. Ferner, Tohfa Ahmad, Zainab Babatunde and Anthony R. Cox

Safety of Follitropin Alfa/Lutropin Alfa for Stimulation of Follicular Development pp. 453-461

Nadezda Abramova, Julie Hubbard, Joan Schertz and Emilia Richter

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 pp. 463-471

Birgit Ehlken, Lennart Nathell, Annegret Gohlke, Derya Bocuk, Massoud Toussi and Stefan Wohlfeil

Correction to: Implications of Individual QT/RR Profiles—Part 1: Inaccuracies and Problems of Population-Specific QT/Heart Rate Corrections pp. 473-473

Marek Malik, Christine Garnett, Katerina Hnatkova, Jose Vicente, Lars Johannesen and Norman Stockbridge

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 pp. 475-475

Marek Malik, Christine Garnett, Katerina Hnatkova, Jose Vicente, Lars Johannesen and Norman Stockbridge

Volume 42, issue 2, 2019

Safety of Novel Targeted Therapies in Oncology pp. 157-158

Rashmi R. Shah and Giuseppe Curigliano

Safety and Tolerability of Anti-Angiogenic Protein Kinase Inhibitors and Vascular-Disrupting Agents in Cancer: Focus on Gastrointestinal Malignancies pp. 159-179

Letizia Procaccio, Vera Damuzzo, Francesca Sarra, Alberto Russi, Federica Todino, Vincenzo Dadduzio, Francesca Bergamo, Alessandra Anna Prete, Sara Lonardi, Hans Prenen, Angelo Claudio Palozzo and Fotios Loupakis

Safety and Tolerability of Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitors in Oncology pp. 181-198

Rashmi R. Shah and Devron R. Shah

Safety and Tolerability of Anaplastic Lymphoma Kinase Inhibitors in Non-Small-Cell Lung Cancer pp. 199-209

Danilo Rocco, Ciro Battiloro, Luigi Della Gravara and Cesare Gridelli

Safety and Tolerability of c-MET Inhibitors in Cancer pp. 211-233

Alberto Puccini, Nagore I. Marín-Ramos, Francesca Bergamo, Marta Schirripa, Sara Lonardi, Heinz-Josef Lenz, Fotios Loupakis and Francesca Battaglin

Safety and Tolerability of Histone Deacetylase (HDAC) Inhibitors in Oncology pp. 235-245

Rashmi R. Shah

Safety and Tolerability of Phosphatidylinositol-3-Kinase (PI3K) Inhibitors in Oncology pp. 247-262

Giuseppe Curigliano and Rashmi R. Shah

Safety and Tolerability of Sonic Hedgehog Pathway Inhibitors in Cancer pp. 263-279

Richard L. Carpenter and Haimanti Ray

Safety and Tolerability of Immune Checkpoint Inhibitors (PD-1 and PD-L1) in Cancer pp. 281-294

Iosune Baraibar, Ignacio Melero, Mariano Ponz-Sarvise and Eduardo Castanon

Safety and Tolerability of Antibody-Drug Conjugates in Cancer pp. 295-314

Anna Wolska-Washer and Tadeusz Robak

Safety and Tolerability of Adoptive Cell Therapy in Cancer pp. 315-334

Benita Wolf, Stefan Zimmermann, Caroline Arber, Melita Irving, Lionel Trueb and George Coukos

Volume 42, issue 1, 2019

Aim and Design of pREGnant, the Dutch Pregnancy Drug Register pp. 1-12

Saskia Vorstenbosch, Bernke Winkel, Marleen M. H. J Gelder, Agnes Kant, Nel Roeleveld and Eugène Puijenbroek

The Prevalence of Dose Errors Among Paediatric Patients in Hospital Wards with and without Health Information Technology: A Systematic Review and Meta-Analysis pp. 13-25

Peter J. Gates, Sophie A. Meyerson, Melissa T. Baysari and Johanna I. Westbrook

The Social Impact of Suspected Adverse Drug Reactions: An analysis of the Canada Vigilance Spontaneous Reporting Database pp. 27-34

Genaro Castillon, Francesco Salvo and Yola Moride

Surveillance of Drug Safety During Pregnancy: Insight in Current International Activities, Future Intentions and Need for Support of National Pharmacovigilance Centres pp. 35-43

Agnes Kant, Loes Vries and Leàn Rolfes

POMME: The New Cohort to Evaluate Long-Term Effects After Prenatal Medicine Exposure pp. 45-54

Justine Benevent, Caroline Hurault-Delarue, Mélanie Araujo, Jean-Louis Montastruc, Isabelle Lacroix and Christine Damase-Michel

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 pp. 55-66

Noel Frey, Michael Bodmer, Andreas Bircher, Susan S. Jick, Christoph R. Meier and Julia Spoendlin

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 pp. 67-75

Sung-Po Huang, Yao-Chun Wen, Shih-Tsung Huang, Chih-Wan Lin, Tzung-Dau Wang and Fei-Yuan Hsiao

Assessment of Self-Administration of Romiplostim in Patients with Immune Thrombocytopenic Purpura after Receipt of Home Administration Training Materials: a Cross-Sectional Study pp. 77-83

Martin Schipperus, Georgia Kaiafa, Louise Taylor, Sally Wetten, Georg Kreuzbauer, Andy Boshier and Anouchka Seesaghur

Effect of Lawyer-Submitted Reports on Signals of Disproportional Reporting in the Food and Drug Administration’s Adverse Event Reporting System pp. 85-93

James R. Rogers, Ameet Sarpatwari, Rishi J. Desai, Justin M. Bohn, Nazleen F. Khan, Aaron S. Kesselheim, Michael A. Fischer, Joshua J. Gagne and John G. Connolly

Towards Drug Safety Surveillance and Pharmacovigilance: Current Progress in Detecting Medication and Adverse Drug Events from Electronic Health Records pp. 95-97

Feifan Liu, Abhyuday Jagannatha and Hong Yu

Overview of the First Natural Language Processing Challenge for Extracting Medication, Indication, and Adverse Drug Events from Electronic Health Record Notes (MADE 1.0) pp. 99-111

Abhyuday Jagannatha, Feifan Liu, Weisong Liu and Hong Yu

Adverse Drug Event Detection from Electronic Health Records Using Hierarchical Recurrent Neural Networks with Dual-Level Embedding pp. 113-122

Susmitha Wunnava, Xiao Qin, Tabassum Kakar, Cansu Sen, Elke A. Rundensteiner and Xiangnan Kong

MADEx: A System for Detecting Medications, Adverse Drug Events, and Their Relations from Clinical Notes pp. 123-133

Xi Yang, Jiang Bian, Yan Gong, William R. Hogan and Yonghui Wu

Adverse Drug Events Detection in Clinical Notes by Jointly Modeling Entities and Relations Using Neural Networks pp. 135-146

Bharath Dandala, Venkata Joopudi and Murthy Devarakonda

Detecting Adverse Drug Events with Rapidly Trained Classification Models pp. 147-156

Alec B. Chapman, Kelly S. Peterson, Patrick R. Alba, Scott L. DuVall and Olga V. Patterson