Drug Safety

2012 - 2025

Current editor(s): Nitin Joshi

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Volume 41, issue 12, 2018

First Conference on Big Data for Pharmacovigilance pp. 1281-1284

Jae Min, Vicki Osborne, Elizabeth Lynn and Saad A. W. Shakir

Enhancing Pharmacovigilance Capabilities in the EU Regulatory Network: The SCOPE Joint Action pp. 1285-1302

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 and June Raine

Risks of Opioids in ST-Elevation Myocardial Infarction: A Review pp. 1303-1308

Anne Henrieke Tavenier, Renicus Suffridus Hermanides, Jan Paul Ottervanger, Peter Gerrit Johannes Horst, Elvin Kedhi and Adriaan W. J. Hof

Real World Evidence: Time for a Switch? pp. 1309-1312

Rachel E. Sobel, Andrew Bate and Robert F. Reynolds

Evaluation of Switching Patterns in FDA’s Sentinel System: A New Tool to Assess Generic Drugs pp. 1313-1323

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 and Sarah K. Dutcher

Gabapentin and Pregabalin and Risk of Atrial Fibrillation in the Elderly: A Population-Based Cohort Study in an Electronic Prescription Database pp. 1325-1331

Leticia Ortiz de Landaluce, Pere Carbonell, Carmen Asensio, Núria Escoda, Pilar López and Joan-Ramon Laporte

Changes in Outpatient Use of Antibiotics by Adults in the United States, 2006–2015 pp. 1333-1342

Mallika L. Mundkur, Jessica Franklin, Krista F. Huybrechts, Michael A. Fischer, Aaron S. Kesselheim, Jeffrey A. Linder, Joan Landon and Elisabetta Patorno

Adverse Drug Reactions Among Patients Initiating Second-Line Antiretroviral Therapy in South Africa pp. 1343-1353

Dorina Onoya, Kamban Hirasen, Liudmyla Berg, Jacqui Miot, Lawrence C. Long and Matthew P. Fox

Assessment of the Utility of Social Media for Broad-Ranging Statistical Signal Detection in Pharmacovigilance: Results from the WEB-RADR Project pp. 1355-1369

Ola Caster, Juergen Dietrich, Marie-Laure Kürzinger, Magnus Lerch, Simon Maskell, G. Niklas Norén, Stéphanie Tcherny-Lessenot, Benoit Vroman, Antoni Wisniewski and John Stekelenborg

Comment on “Assessment of the Utility of Social Media for Broad-Ranging Statistical Signal Detection in Pharmacovigilance: Results from the WEB-RADR Project” pp. 1371-1373

Cedric Bousquet, Bissan Audeh, Florelle Bellet and Agnès Lillo-Le Louët

A Critical Evaluation of Safety Signal Analysis Using Algorithmic Standardised MedDRA Queries pp. 1375-1385

Carolyn Tieu and Christopher D. Breder

Proton Pump Inhibitor Use and Risk of Developing Alzheimer’s Disease or Vascular Dementia: A Case–Control Analysis pp. 1387-1396

Patrick Imfeld, Michael Bodmer, Susan S. Jick and Christoph R. Meier

Methods to Compare Adverse Events in Twitter to FAERS, Drug Information Databases, and Systematic Reviews: Proof of Concept with Adalimumab pp. 1397-1410

Karen Smith, Susan Golder, Abeed Sarker, Yoon Loke, Karen O’Connor and Graciela Gonzalez-Hernandez

Comment on “Proton Pump Inhibitor Use and Risk of Developing Alzheimer’s Disease or Vascular Dementia: A Case–Control Analysis” pp. 1411-1411

Katsuhiro Toda

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” pp. 1413-1413

Patrick Imfeld, Michael Bodmer, Susan S. Jick and Christoph R. Meier

Comment on: “Limited Evidence for Risk Factors for Proarrhythmia and Sudden Cardiac Death in Patients Using Antidepressants: Dutch Consensus on ECG Monitoring” pp. 1415-1416

Alain Braillon

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” pp. 1417-1418

Mirjam Simoons, Adrie Seldenrijk, Hans Mulder, Eric Roon, Roberto Bakker and Henricus Ruhé

Comment on: “Mixed Approach Retrospective Analyses of Suicide and Suicidal Ideation for Brand Compared with Generic Central Nervous System Drugs” pp. 1419-1421

Courtney M. Suggs, Robert L. Levin, Andrew D. Mosholder, Richard S. Swain and Liang Zhao

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” pp. 1423-1424

Richard A. Hansen, Ning Cheng, Md. Motiur Rahman, Yasser Alatawi, Jingjing Qian, Peggy L. Peissig, Richard L. Berg and C. David Page

Comment on “Central Demyelinating Diseases After Vaccination Against Hepatitis B Virus: A Disproportionality Analysis Within the VAERS Database” pp. 1425-1427

Carine Cohen, Annick Houdeau and Alena Khromava

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” pp. 1429-1430

Julie Mouchet and Bernard Bégaud

Correction to: Liver Safety of Fasiglifam (TAK-875) in Patients with Type 2 Diabetes: Review of the Global Clinical Trial Experience pp. 1431-1437

John F. Marcinak, Melvin S. Munsaka, Paul B. Watkins, Takashi Ohira and Neila Smith

Correction to: Medication Errors: A Characterisation of Spontaneously Reported Cases in EudraVigilance pp. 1439-1440

Victoria Newbould, Steven Meur, Thomas Goedecke and Xavier Kurz

Volume 41, issue 11, 2018

Ibuprofen and Paracetamol: Acceptably Safe for All? pp. 999-1001

Filippo Pigazzani, Isla Mackenzie and Thomas M. MacDonald

What Future Healthcare Professionals Need to Know About Pharmacovigilance: Introduction of the WHO PV Core Curriculum for University Teaching with Focus on Clinical Aspects pp. 1003-1011

Rike van Eekeren, Leàn Rolfes, Andries S. Koster, Lara Magro, Gurumurthy Parthasarathi, Hussain Al Ramimmy, Tim Schutte, Daisuke Tanaka, Eugène van Puijenbroek and Linda Härmark

Safety of Biologics, Including Biosimilars: Perspectives on Current Status and Future Direction pp. 1013-1022

Ylenia Ingrasciotta, Paola M. Cutroneo, Ilaria Marcianò, Thijs Giezen, Fabiola Atzeni and Gianluca Trifirò

Prescription Opioid Fatalities: Examining Why the Healer Could be the Culprit pp. 1023-1033

Adeleke D. Adewumi, Christine E. Staatz, Samantha A. Hollingworth, Jason P. Connor and Rosa Alati

Safety Profile of Benznidazole in the Treatment of Chronic Chagas Disease: Experience of a Referral Centre and Systematic Literature Review with Meta-Analysis pp. 1035-1048

Clara Crespillo-Andújar, Emmanuele Venanzi-Rullo, Rogelio López-Vélez, Begoña Monge-Maillo, Francesca Norman, Ana López-Polín and José A. Pérez-Molina

Coronary Events After Dispensing of Ibuprofen: A Propensity Score-Matched Cohort Study Versus Paracetamol in the French Nationwide Claims Database Sample pp. 1049-1058

Mai Duong, Abdelilah Abouelfath, Regis Lassalle, Cécile Droz, Patrick Blin and Nicholas Moore

Predicting Adverse Drug Effects from Literature- and Database-Mined Assertions pp. 1059-1072

Mary K. La, Alexander Sedykh, Denis Fourches, Eugene Muratov and Alexander Tropsha

MOdified NARanjo Causality Scale for ICSRs (MONARCSi): A Decision Support Tool for Safety Scientists pp. 1073-1085

Shaun Comfort, Darren Dorrell, Shawman Meireis and Jennifer Fine

Role of Serotonin Transporter in Antidepressant-Induced Diabetes Mellitus: A Pharmacoepidemiological–Pharmacodynamic Study in VigiBase® pp. 1087-1096

Thi Thu Ha Nguyen, Anne Roussin, Vanessa Rousseau, Jean-Louis Montastruc and François Montastruc

Comment on “Using Human ‘Experiments of Nature’ to Predict Drug Safety Issues: An Example with PCSK9 Inhibitors” pp. 1097-1099

Lucas D. Ward, Graeme J. Moffat, Jing Yuan and Paul Nioi

Reply to Ward and Colleagues’ Comment on “Using Human Experiments of Nature to Predict Drug Safety Issues: An Example with PCSK9 Inhibitors” pp. 1101-1101

Rebecca N. Jerome, Jill M. Pulley, Dan M. Roden, Jana K. Shirey-Rice, Lisa A. Bastarache, Gordon Bernard, Leeland Ekstrom, William J. Lancaster and Joshua C. Denny

Volume 41, issue 10, 2018

Challenges and Opportunities for the Traceability of (Biological) Medicinal Products pp. 911-918

Kevin Klein and Pieter Stolk

Cardiac Complications Attributed to Chloroquine and Hydroxychloroquine: A Systematic Review of the Literature pp. 919-931

Clotilde Chatre, François Roubille, Hélène Vernhet, Christian Jorgensen and Yves-Marie Pers

Inadequate harms reporting in randomized control trials of antibiotics for pediatric acute otitis media: a systematic review pp. 933-938

Stephanie W. Hum, Susan Golder and Nader Shaikh

Association of Statin Use with Increased Risk of Musculoskeletal Conditions: A Retrospective Cohort Study pp. 939-950

Una E. Makris, Carlos A. Alvarez, Eric M. Mortensen and Ishak A. Mansi

Cohort Study of Psychiatric Adverse Events Following Exposure to Levonorgestrel-Containing Intrauterine Devices in UK General Practice pp. 951-958

Jim Slattery, Daniel Morales, Luis Pinheiro and Xavier Kurz

Potentially Inappropriate Medication Prescribing and Risk of Unplanned Hospitalization among the Elderly: A Self-Matched, Case-Crossover Study pp. 959-968

Izumi Sato, Yosuke Yamamoto, Genta Kato and Koji Kawakami

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 pp. 969-978

Ingrid Oosterhuis, Henric Taavola, Philip M. Tregunno, Petar Mas, Sara Gama, Victoria Newbould, Ola Caster and Linda Härmark

Potential Risk Window for Opioid Overdose Related to Treatment with Extended-Release Injectable Naltrexone pp. 979-980

Ingrid A. Binswanger and Jason M. Glanz

Review of Case Narratives from Fatal Overdoses Associated with Injectable Naltrexone for Opioid Dependence pp. 981-988

Roxanne Saucier, Daniel Wolfe and Nabarun Dasgupta

Correction to: Review of Case Narratives from Fatal Overdoses Associated with Injectable Naltrexone for Opioid Dependence pp. 989-989

Roxanne Saucier, Daniel Wolfe and Nabarun Dasgupta

Comment on “Review of Case Narratives from Fatal Overdoses Associated with Injectable Naltrexone for Opioid Dependence” pp. 991-993

Bernard Silverman, Gary Bloomgren, Priya Jain, Kimberley Marcopul, Alexandra Silveira, James Fratantonio, Maria Sullivan and Sarah Akerman

Authors’ Response to Silverman and Colleagues’ Comment on “Review of Case Narratives from Fatal Overdoses Associated with Injectable Naltrexone for Opioid Dependence” pp. 995-997

Nabarun Dasgupta, Roxanne Saucier and Daniel Wolfe

Volume 41, issue 9, 2018

Healthcare Databases for Drug Safety Research: Data Validity Assessment Remains Crucial pp. 829-833

Nigel S. B. Rawson and Carl D’Arcy

Safety of Tamsulosin: A Systematic Review of Randomized Trials with a Focus on Women and Children pp. 835-842

Steven A. Kaplan and Bilal I. Chughtai

Osteoporosis-Related Fractures in HIV-Infected Patients Receiving Long-Term Tenofovir Disoproxil Fumarate: An Observational Cohort Study pp. 843-848

Ayami Komatsu, Atsushi Ikeda, Akio Kikuchi, Chiaki Minami, Motomu Tan and Shuzo Matsushita

Comparison of Data on Serious Adverse Events and Mortality in ClinicalTrials.gov, Corresponding Journal Articles, and FDA Medical Reviews: Cross-Sectional Analysis pp. 849-857

Richeek Pradhan and Sonal Singh

Vitamin B6 in Health Supplements and Neuropathy: Case Series Assessment of Spontaneously Reported Cases pp. 859-869

Florence Hunsel, Sonja de Koppel, Eugène Puijenbroek and Agnes Kant

Safety Experience During Real-World Use of Injectable Artesunate in Public Health Facilities in Ghana and Uganda: Outcomes of a Modified Cohort Event Monitoring Study (CEMISA) pp. 871-880

H. Hilda Ampadu, Alexander N. O. Dodoo, Samuel Bosomprah, Samantha Akakpo, Pierre Hugo, Helga Gardarsdottir, H. G. M. Leufkens, Dan Kajungu and Kwaku Poku Asante

Non-bleeding Adverse Events with the Use of Direct Oral Anticoagulants: A Sequence Symmetry Analysis pp. 881-897

Géric Maura, Cécile Billionnet, Joël Coste, Alain Weill, Anke Neumann and Antoine Pariente

Exploring the Potential Routine Use of Electronic Healthcare Record Data to Strengthen Early Signal Assessment in UK Medicines Regulation: Proof-of-Concept Study pp. 899-910

Katherine Donegan, Rebecca Owen, Helena Bird, Brian Burch, Alex Smith and Phil Tregunno

Volume 41, issue 8, 2018

Active Safety Surveillance in Africa: Pragmatism and Agility pp. 731-733

Alexander N. O. Dodoo

Drug-Induced Liver Injury: Why is the Roussel Uclaf Causality Assessment Method (RUCAM) Still Used 25 Years After Its Launch? pp. 735-743

Gaby Danan and Rolf Teschke

Adverse Events to Food Supplements Containing Red Yeast Rice: Comparative Analysis of FAERS and CAERS Reporting Systems pp. 745-752

Emanuel Raschi, Anna Girardi, Elisabetta Poluzzi, Emanuele Forcesi, Francesca Menniti-Ippolito, Gabriela Mazzanti and Fabrizio De Ponti

The Burden of Adverse Drug Reactions Due to Artemisinin-Based Antimalarial Treatment in Selected Ugandan Health Facilities: An Active Follow-Up Study pp. 753-765

Helen Byomire Ndagije, Victoria Nambasa, Leonard Manirakiza, Donna Kusemererwa, Dan Kajungu, Sten Olsson and Niko Speybroeck

Central Demyelinating Diseases after Vaccination Against Hepatitis B Virus: A Disproportionality Analysis within the VAERS Database pp. 767-774

Julie Mouchet and Bernard Bégaud

Benefit–Risk Monitoring of Vaccines Using an Interactive Dashboard: A Methodological Proposal from the ADVANCE Project pp. 775-786

Kaatje Bollaerts, Tom Smedt, Katherine Donegan, Lina Titievsky and Vincent Bauchau

Comparative Rates of Mortality and Serious Adverse Effects Among Commonly Prescribed Opioid Analgesics pp. 787-795

David L. Murphy, Jacob A. Lebin, Stevan G. Severtson, Heather A. Olsen, Nabarun Dasgupta and Richard C. Dart

Effectiveness Evaluation of Additional Risk Minimization Measures for Adolescent Use of Aripiprazole in the European Union: Results from a Post-Authorization Safety Study pp. 797-806

Wally Landsberg, Imad Al-Dakkak, Antonia Coppin-Renz, Uli Geis, Timothy Peters-Strickland, Emiel Heumen and Mirza Rahman

A Programme for Risk Assessment and Minimisation of Progressive Multifocal Leukoencephalopathy Developed for Vedolizumab Clinical Trials pp. 807-816

Asit Parikh, Kristin Stephens, Eugene Major, Irving Fox, Catherine Milch, Serap Sankoh, Michael H. Lev, James M. Provenzale, Jesse Shick, Mark Patti, Megan McAuliffe, Joseph R. Berger and David B. Clifford

Use of Proton Pump Inhibitors and the Risk of Acute Kidney Injury Among Patients with Rheumatoid Arthritis: Cohort Study pp. 817-826

Henrik Svanström, Marie Lund, Mads Melbye and Björn Pasternak

Correction to: Drug-Induced Dental Caries: A Disproportionality Analysis Using Data from VigiBase pp. 827-827

Emilie Patras de Campaigno, Inès Kebir, Jean-Louis Montastruc, Manuela Rueter, Delphine Maret, Maryse Lapeyre-Mestre, Brigitte Sallerin and Fabien Despas

Volume 41, issue 7, 2018

Thromboembolism with Janus Kinase (JAK) Inhibitors for Rheumatoid Arthritis: How Real is the Risk? pp. 645-653

Ian C. Scott, Samantha L. Hider and David L. Scott

Limited Evidence for Risk Factors for Proarrhythmia and Sudden Cardiac Death in Patients Using Antidepressants: Dutch Consensus on ECG Monitoring pp. 655-664

Mirjam Simoons, Adrie Seldenrijk, Hans Mulder, Tom Birkenhäger, Mascha Groothedde-Kuyvenhoven, Rob Kok, Cornelis Kramers, Wim Verbeeck, Mirjam Westra, Eric Roon, Roberto Bakker and Henricus Ruhé

EudraVigilance Medicines Safety Database: Publicly Accessible Data for Research and Public Health Protection pp. 665-675

Rodrigo Postigo, Sabine Brosch, Jim Slattery, Anja Haren, Jean-Michel Dogné, Xavier Kurz, Gianmario Candore, Francois Domergue and Peter Arlett

Sex Differences in Reported Adverse Drug Reactions of Selective Serotonin Reuptake Inhibitors pp. 677-683

Corine Ekhart, Florence Hunsel, Joep Scholl, Sieta Vries and Eugene Puijenbroek

Using the Symmetry Analysis Design to Screen for Adverse Effects of Non-vitamin K Antagonist Oral Anticoagulants pp. 685-695

Maja Hellfritzsch, Lotte Rasmussen, Jesper Hallas and Anton Pottegård

Interest in a Mobile App for Two-Way Risk Communication: A Survey Study Among European Healthcare Professionals and Patients pp. 697-712

Sieta T. de Vries, Petra Denig, Carmen Lasheras Ruiz, François Houÿez, Lisa Wong, Alastair Sutcliffe and Peter G. M. Mol

Safety Communication Tools and Healthcare Professionals’ Awareness of Specific Drug Safety Issues in Europe: A Survey Study pp. 713-724

Sieta T. de Vries, Maartje J. M. van der Sar, Anna Marie Coleman, Yvette Escudero, Alfonso Rodríguez Pascual, Miguel-Ángel Maciá Martínez, Amelia Cupelli, Ilaria Baldelli, Ivana Šipić, Adriana Andrić, Line Michan, Petra Denig and Peter G. M. Mol

Glucocorticoids and the Risk of Peptic Ulcer Bleeding: Case–Control Analysis Based on Swiss Claims Data pp. 725-730

Daphne Reinau, Matthias Schwenkglenks, Mathias Früh, Andri Signorell, Eva Blozik and Christoph R. Meier

Volume 41, issue 6, 2018

Gastrointestinal Perforations with Biologics in Patients with Rheumatoid Arthritis: Implications for Clinicians pp. 545-553

Aprajita Jagpal and Jeffrey R. Curtis

The Risk for Lung Cancer Incidence with Calcium Channel Blockers: A Systematic Review and Meta-Analysis of Observational Studies pp. 555-564

Victoria Rotshild, Laurent Azoulay, Majd Zarifeh, Reem Masarwa, Bruria Hirsh-Raccah, Amichai Perlman, Mordechai Muszkat and Ilan Matok

Time Series Disturbance Detection for Hypothesis-Free Signal Detection in Longitudinal Observational Databases pp. 565-577

Ed Whalen, Manfred Hauben and Andrew Bate

Sorting Through the Safety Data Haystack: Using Machine Learning to Identify Individual Case Safety Reports in Social-Digital Media pp. 579-590

Shaun Comfort, Sujan Perera, Zoe Hudson, Darren Dorrell, Shawman Meireis, Meenakshi Nagarajan, Cartic Ramakrishnan and Jennifer Fine

A Multi-hospital Before–After Observational Study Using a Point-Prevalence Approach with an Infusion Safety Intervention Bundle to Reduce Intravenous Medication Administration Errors pp. 591-602

Kumiko O. Schnock, Patricia C. Dykes, Jennifer Albert, Deborah Ariosto, Caitlin Cameron, Diane L. Carroll, Moreen Donahue, Adrienne G. Drucker, Rosemary Duncan, Linda Fang, Marla Husch, Nicole McDonald, Ray R. Maddox, Julie McGuire, Sally Rafie, Emilee Robertson, Melinda Sawyer, Elizabeth Wade, Catherine S. Yoon, Stuart Lipsitz and David W. Bates

Evidence-Based Recommendations to Improve the Safe Use of Drugs in Patients with Liver Cirrhosis pp. 603-613

Rianne A. Weersink, Margriet Bouma, David M. Burger, Joost P. H. Drenth, S. Froukje Harkes-Idzinga, Nicole G. M. Hunfeld, Herold J. Metselaar, Margje H. Monster-Simons, Katja Taxis and Sander D. Borgsteede

The Uncertainty of the Association Between Proton Pump Inhibitor Use and the Risk of Dementia: Prescription Sequence Symmetry Analysis Using a Korean Healthcare Database Between 2002 and 2013 pp. 615-624

Sun-Kyeong Park, Yeon-Hee Baek, Nicole Pratt, Lisa Kalisch Ellett and Ju-Young Shin

Liver Safety of Fasiglifam (TAK-875) in Patients with Type 2 Diabetes: Review of the Global Clinical Trial Experience pp. 625-640

John F. Marcinak, Melvin S. Munsaka, Paul B. Watkins, Takashi Ohira and Neila Smith

Comment on: “All-Cause and Drug-Related Medical Events Associated with Overuse of Gabapentin and/or Opioid Medications: A Retrospective Cohort Analysis of a Commercially Insured US Population” pp. 641-642

Tomoyuki Kawada

Authors’ Reply to: Tomoyuki Kawada’s Comment on: “All-Cause and Drug-Related Medical Events Associated with Overuse of Gabapentin and/or Opioid Medications: A Retrospective Cohort Analysis of a Commercially Insured US Population’’ pp. 643-644

Alyssa M. Peckham, Kathleen A. Fairman and David A. Sclar

Volume 41, issue 5, 2018

Long-Acting β2-Agonists in Asthma: Enantioselective Safety Studies are Needed pp. 441-449

Glenn A. Jacobson, Sharanne Raidal, Morten Hostrup, Luigino Calzetta, Richard Wood-Baker, Mark O. Farber, Clive P. Page and E. Haydn Walters

Drug-Induced Ototoxicity: Diagnosis and Monitoring pp. 451-464

Kathleen C. M. Campbell and Colleen G. Prell

A Review of Methods for Monitoring Adverse Events in Pediatric Psychopharmacology Clinical Trials pp. 465-471

Margaret Coates, Marina Spanos, Pooja Parmar, Tara Chandrasekhar and Linmarie Sikich

The Impact of Biologics and Tofacitinib on Cardiovascular Risk Factors and Outcomes in Patients with Rheumatic Disease: A Systematic Literature Review pp. 473-488

Michael Nurmohamed, Ernest Choy, Sadiq Lula, Blerina Kola, Ryan DeMasi and Paola Accossato

Potential Risks Related to Modulating Interleukin-13 and Interleukin-4 Signalling: A Systematic Review pp. 489-509

Martin Braddock, Nicola A. Hanania, Amir Sharafkhaneh, Gene Colice and Mats Carlsson

Adverse Drug Reaction Reports Received Through the Mobile App, VigiBIP®: A Comparison with Classical Methods of Reporting pp. 511-514

François Montastruc, Haleh Bagheri, Isabelle Lacroix, Christine Damase-Michel, Leila Chebane, Vanessa Rousseau, Emilie Jouanjus, Maryse Lapeyre-Mestre, Geneviève Durrieu and Jean-Louis Montastruc

Case Series Analysis of New Zealand Reports of Rapid Intense Potentiation of Warfarin by Roxithromycin pp. 515-521

Ruth L. Savage and Michael V. Tatley

Signal Detection for Recently Approved Products: Adapting and Evaluating Self-Controlled Case Series Method Using a US Claims and UK Electronic Medical Records Database pp. 523-536

Xiaofeng Zhou, Ian. J. Douglas, Rongjun. Shen and Andrew. Bate

Comment on “Safety of Human Papillomavirus Vaccines: An Updated Review” pp. 537-538

Rebecca Ellen Chandler, I. Ralph Edwards and Marie Lindquist

Comment on: “Safety of Human Papillomavirus Vaccines: An Updated Review” pp. 539-540

Manuel Martínez-Lavín

Authors’ reply: Safety of Human Papillomavirus Vaccines pp. 541-543

Kristine Macartney, Anastasia Phillips, Cyra Patel, Alexis Pillsbury and Julia Brotherton

Volume 41, issue 4, 2018

The Safety of Generic Prescription Drugs in the United States pp. 325-328

Sonal Singh

Safety of Human Papillomavirus Vaccines: An Updated Review pp. 329-346

Anastasia Phillips, Cyra Patel, Alexis Pillsbury, Julia Brotherton and Kristine Macartney

Management Strategies to Facilitate Optimal Outcomes for Patients Treated with Delayed-release Dimethyl Fumarate pp. 347-356

Lori Mayer, Mary Kay Fink, Carrie Sammarco and Lisa Laing

Analysis of Spontaneous Postmarket Case Reports Submitted to the FDA Regarding Thromboembolic Adverse Events and JAK Inhibitors pp. 357-361

Abril Verden, Mo Dimbil, Robert Kyle, Brian Overstreet and Keith B. Hoffman

Mixed Approach Retrospective Analyses of Suicide and Suicidal Ideation for Brand Compared with Generic Central Nervous System Drugs pp. 363-376

Ning Cheng, Md. Motiur Rahman, Yasser Alatawi, Jingjing Qian, Peggy L. Peissig, Richard L. Berg, C. David Page and Richard A. Hansen

An Automated System Combining Safety Signal Detection and Prioritization from Healthcare Databases: A Pilot Study pp. 377-387

Mickael Arnaud, Bernard Bégaud, Frantz Thiessard, Quentin Jarrion, Julien Bezin, Antoine Pariente and Francesco Salvo

The RIMES Statement: A Checklist to Assess the Quality of Studies Evaluating Risk Minimization Programs for Medicinal Products pp. 389-401

Meredith Y. Smith, Andrea Russell, Priya Bahri, Peter G. M. Mol, Sarah Frise, Emily Freeman and Elaine H. Morrato

Amyotrophic Lateral Sclerosis Associated with Statin Use: A Disproportionality Analysis of the FDA’s Adverse Event Reporting System pp. 403-413

Beatrice A. Golomb, Abril Verden, Alexis K. Messner, Hayley J. Koslik and Keith B. Hoffman

Beta-Blocker Use in Pregnancy and Risk of Specific Congenital Anomalies: A European Case-Malformed Control Study pp. 415-427

Jorieke E. H. Bergman, L. Renée Lutke, Rijk O. B. Gans, Marie-Claude Addor, Ingeborg Barisic, Clara Cavero-Carbonell, Ester Garne, Miriam Gatt, Kari Klungsoyr, Nathalie Lelong, Catherine Lynch, Olatz Mokoroa, Vera Nelen, Amanda J. Neville, Anna Pierini, Hanitra Randrianaivo, Anke Rissmann, David Tucker, Awi Wiesel, Helen Dolk, Maria Loane and Marian K. Bakker

Cardiovascular Profile of Valbenazine: Analysis of Pooled Data from Three Randomized, Double-Blind, Placebo-Controlled Trials pp. 429-440

Dao Thai-Cuarto, Christopher F. O’Brien, Roland Jimenez, Grace S. Liang and Joshua Burke

Volume 41, issue 3, 2018

Can SGLT2 Inhibitors Cause Acute Renal Failure? Plausible Role for Altered Glomerular Hemodynamics and Medullary Hypoxia pp. 239-252

Auryan Szalat, Amichai Perlman, Mordechai Muszkat, Mogher Khamaisi, Zaid Abassi and Samuel N. Heyman

Neuropsychiatric Events Associated with Leukotriene-Modifying Agents: A Systematic Review pp. 253-265

Sharon W. Y. Law, Angel Y. S. Wong, Shweta Anand, Ian C. K. Wong and Esther W. Chan

Utilisation and Safety of Deferasirox: Results from an Observational Cohort Study in England pp. 267-275

Vicki Osborne, Miranda Davies, Deborah Layton and Saad A. W. Shakir

Severe Physical Complications among Survivors of Stevens–Johnson Syndrome and Toxic Epidermal Necrolysis pp. 277-284

Cristina Olteanu, Neil H. Shear, Hall F. Chew, Rena Hashimoto, Raed Alhusayen, Sonia Whyte-Croasdaile, Yaron Finkelstein, Marjorie Burnett, Michael Ziv, Shachar Sade, Marc G. Jeschke and Roni P. Dodiuk-Gad

Risk of Psoriasis Following Terbinafine or Itraconazole Treatment for Onychomycosis: A Population-Based Case-Control Comparative Study pp. 285-295

Hsien-Yi Chiu, Wei-Lun Chang, Tsen-Fang Tsai, Yi-Wen Tsai and Ming-Neng Shiu

Evaluation of ‘Definite’ Anaphylaxis Drug Allergy Alert Overrides in Inpatient and Outpatient Settings pp. 297-302

Adrian Wong, Diane L. Seger, Sarah P. Slight, Mary G. Amato, Patrick E. Beeler, Julie M. Fiskio and David W. Bates

Using Human ‘Experiments of Nature’ to Predict Drug Safety Issues: An Example with PCSK9 Inhibitors pp. 303-311

Rebecca N. Jerome, Jill M. Pulley, Dan M. Roden, Jana K. Shirey-Rice, Lisa A. Bastarache, Gordon Bernard, Leeland Ekstrom, William J. Lancaster and Joshua C. Denny

Reported Adverse Events with Painkillers: Data Mining of the US Food and Drug Administration Adverse Events Reporting System pp. 313-320

Jae Min, Vicki Osborne, Allison Kowalski and Mattia Prosperi

Comment on: “Adverse Drug Reaction-Related Hospitalizations in Elderly Australians: A Prospective Cross-Sectional Study in Two Tasmanian Hospitals” pp. 321-322

Mona Kargar, Alireza Ahmadvand and Kheirollah Gholami

Authors’ Reply to Mona Kargar and Colleagues’ Comment on “Adverse Drug Reaction-Related Hospitalizations in Elderly Australians: A Prospective Cross-Sectional Study in Two Tasmanian Hospitals” pp. 323-324

Nibu Parameswaran Nair, Leanne Chalmers, Bonnie J. Bereznicki, Colin Curtain, Gregory M. Peterson, Michael Connolly and Luke R. Bereznicki

Volume 41, issue 2, 2018

From Big Data to Smart Data for Pharmacovigilance: The Role of Healthcare Databases and Other Emerging Sources pp. 143-149

Gianluca Trifirò, Janet Sultana and Andrew Bate

Overview of Pharmacovigilance System in Vietnam: Lessons Learned in a Resource-Restricted Country pp. 151-159

Khac-Dung Nguyen, Phuong-Thuy Nguyen, Hoang-Anh Nguyen, Anne Roussin, Jean-Louis Montastruc, Haleh Bagheri and Sten Olsson

Use of Antihypertensive Drugs and Risk of Malignant Melanoma: A Meta-analysis of Observational Studies pp. 161-169

Huilin Tang, Shuangshuang Fu, Suodi Zhai, Yiqing Song and Jiali Han

Safety of Russian-Backbone Trivalent, Live Attenuated Seasonal Influenza Vaccine in Healthy Subjects: Open-Label, Non-randomized Phase 4 Study pp. 171-177

Prashant V. Nigwekar, Anuj Kumar, Vikram V. Padbidri, Amlan Choudhury, Amol B. Chaudhari and Prasad S. Kulkarni

Preferences of Patients and Pharmacists with Regard to the Management of Drug–Drug Interactions: A Choice-Based Conjoint Analysis pp. 179-189

Mette Heringa, Annemieke Floor-Schreudering, Hans Wouters, Peter A. G. M. De Smet and Marcel L. Bouvy

Study Design and Evaluation of Risk Minimization Measures: A Review of Studies Submitted to the European Medicines Agency for Cardiovascular, Endocrinology, and Metabolic Drugs pp. 191-202

Giampiero Mazzaglia, Sabine M. J. Straus, Peter Arlett, Daniela Silva, Heidi Janssen, June Raine and Enrica Alteri

Safety Concerns Reported by Patients Identified in a Collaborative Signal Detection Workshop using VigiBase: Results and Reflections from Lareb and Uppsala Monitoring Centre pp. 203-212

Sarah Watson, Rebecca E. Chandler, Henric Taavola, Linda Härmark, Birgitta Grundmark, Alem Zekarias, Kristina Star and Florence Hunsel

All-Cause and Drug-Related Medical Events Associated with Overuse of Gabapentin and/or Opioid Medications: A Retrospective Cohort Analysis of a Commercially Insured US Population pp. 213-228

Alyssa M. Peckham, Kathleen A. Fairman and David A. Sclar

Erlotinib Plus Bevacizumab Phase ll Study in Patients with Advanced Non-small-Cell Lung Cancer (JO25567): Updated Safety Results pp. 229-237

Terufumi Kato, Takashi Seto, Makoto Nishio, Koichi Goto, Noboru Yamamoto, Isamu Okamoto, Liang Tao, Wei Yu, Tarik Khaznadar, Kosei Tajima, Masahiko Shibata, Akihiro Seki and Nobuyuki Yamamoto

Volume 41, issue 1, 2018

An Update on ISoP Special Interest Groups (SIGs) pp. 1-6

Deirdre McCarthy, Priya Bahri, Joanne Barnes, Jean-Christophe Delumeau, Brian Edwards and Mira Harrison-Woolrych

Setting Standards for Pregnancy Registries pp. 7-9

Lewis B. Holmes

Drug-Induced QT Prolongation and Torsades de Pointes: An All-Exclusive Relationship or Time for an Amicable Separation? pp. 11-17

Luc M. Hondeghem

Dopamine Agonists and Impulse Control Disorders: A Complex Association pp. 19-75

Marie Grall-Bronnec, Caroline Victorri-Vigneau, Yann Donnio, Juliette Leboucher, Morgane Rousselet, Elsa Thiabaud, Nicolas Zreika, Pascal Derkinderen and Gaëlle Challet-Bouju

Cardiac Harms of Sofosbuvir: Systematic Review and Meta-Analysis pp. 77-86

Daniel Caldeira, Filipe B. Rodrigues, Marta M. Duarte, Carmelo Sterrantino, Márcio Barra, Nilza Gonçalves, Fausto J. Pinto, Joaquim J. Ferreira and João Costa

Enrollment and Retention in 34 United States Pregnancy Registries Contrasted with the Manufacturer’s Capture of Spontaneous Reports for Exposed Pregnancies pp. 87-94

Steven T. Bird, Kate Gelperin, Lockwood Taylor, Leyla Sahin, Hoda Hammad, Susan E. Andrade, Mohamed A. Mohamoud, Sengwee Toh and Christian Hampp

Antidepressant-Induced Acute Liver Injury: A Case–Control Study in an Italian Inpatient Population pp. 95-102

Carmen Ferrajolo, Cristina Scavone, Monia Donati, Oscar Bortolami, Giovanna Stoppa, Domenico Motola, Alfredo Vannacci, Alessandro Mugelli, Roberto Leone and Annalisa Capuano

Deaths from Medicines: A Systematic Analysis of Coroners’ Reports to Prevent Future Deaths pp. 103-110

Robin E. Ferner, Craig Easton and Anthony R. Cox

Treatment of Medication-Related Osteonecrosis of the Jaw and its Impact on a Patient’s Quality of Life: A Single-Center, 10-Year Experience from Southern Italy pp. 111-123

Giacomo Oteri, Gianluca Trifirò, Matteo Peditto, Loredana Lo Presti, Ilaria Marcianò, Francesco Giorgianni, Janet Sultana and Antonia Marcianò

Evaluation of Electronic Healthcare Databases for Post-Marketing Drug Safety Surveillance and Pharmacoepidemiology in China pp. 125-137

Yu Yang, Xiaofeng Zhou, Shuangqing Gao, Hongbo Lin, Yanming Xie, Yuji Feng, Kui Huang and Siyan Zhan

The 9th Biennial Conference on Signal Detection and Interpretation in Pharmacovigilance pp. 139-141

Vicki Osborne and Saad A. W. Shakir