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Content
June 2019, Volume 42, Issue 6
- 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 - 981-988 Review of Case Narratives from Fatal Overdoses Associated with Injectable Naltrexone for Opioid Dependence
by Roxanne Saucier & Daniel Wolfe & Nabarun Dasgupta - 989-989 Correction to: Review of Case Narratives from Fatal Overdoses Associated with Injectable Naltrexone for Opioid Dependence
by Roxanne Saucier & Daniel Wolfe & Nabarun Dasgupta - 991-993 Comment on “Review of Case Narratives from Fatal Overdoses Associated with Injectable Naltrexone for Opioid Dependence”
by Bernard Silverman & Gary Bloomgren & Priya Jain & Kimberley Marcopul & Alexandra Silveira & James Fratantonio & Maria Sullivan & Sarah Akerman - 995-997 Authors’ Response to Silverman and Colleagues’ Comment on “Review of Case Narratives from Fatal Overdoses Associated with Injectable Naltrexone for Opioid Dependence”
by Nabarun Dasgupta & Roxanne Saucier & Daniel Wolfe
September 2018, Volume 41, Issue 9
- 829-833 Healthcare Databases for Drug Safety Research: Data Validity Assessment Remains Crucial
by Nigel S. B. Rawson & Carl D’Arcy - 835-842 Safety of Tamsulosin: A Systematic Review of Randomized Trials with a Focus on Women and Children
by Steven A. Kaplan & Bilal I. Chughtai - 843-848 Osteoporosis-Related Fractures in HIV-Infected Patients Receiving Long-Term Tenofovir Disoproxil Fumarate: An Observational Cohort Study
by Ayami Komatsu & Atsushi Ikeda & Akio Kikuchi & Chiaki Minami & Motomu Tan & Shuzo Matsushita - 849-857 Comparison of Data on Serious Adverse Events and Mortality in ClinicalTrials.gov, Corresponding Journal Articles, and FDA Medical Reviews: Cross-Sectional Analysis
by Richeek Pradhan & Sonal Singh - 859-869 Vitamin B6 in Health Supplements and Neuropathy: Case Series Assessment of Spontaneously Reported Cases
by Florence Hunsel & Sonja de Koppel & Eugène Puijenbroek & Agnes Kant - 871-880 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)
by H. Hilda Ampadu & Alexander N. O. Dodoo & Samuel Bosomprah & Samantha Akakpo & Pierre Hugo & Helga Gardarsdottir & H. G. M. Leufkens & Dan Kajungu & Kwaku Poku Asante - 881-897 Non-bleeding Adverse Events with the Use of Direct Oral Anticoagulants: A Sequence Symmetry Analysis
by Géric Maura & Cécile Billionnet & Joël Coste & Alain Weill & Anke Neumann & Antoine Pariente - 899-910 Exploring the Potential Routine Use of Electronic Healthcare Record Data to Strengthen Early Signal Assessment in UK Medicines Regulation: Proof-of-Concept Study
by Katherine Donegan & Rebecca Owen & Helena Bird & Brian Burch & Alex Smith & Phil Tregunno
August 2018, Volume 41, Issue 8
- 731-733 Active Safety Surveillance in Africa: Pragmatism and Agility
by Alexander N. O. Dodoo - 735-743 Drug-Induced Liver Injury: Why is the Roussel Uclaf Causality Assessment Method (RUCAM) Still Used 25 Years After Its Launch?
by Gaby Danan & Rolf Teschke - 745-752 Adverse Events to Food Supplements Containing Red Yeast Rice: Comparative Analysis of FAERS and CAERS Reporting Systems
by Emanuel Raschi & Anna Girardi & Elisabetta Poluzzi & Emanuele Forcesi & Francesca Menniti-Ippolito & Gabriela Mazzanti & Fabrizio De Ponti - 753-765 The Burden of Adverse Drug Reactions Due to Artemisinin-Based Antimalarial Treatment in Selected Ugandan Health Facilities: An Active Follow-Up Study
by Helen Byomire Ndagije & Victoria Nambasa & Leonard Manirakiza & Donna Kusemererwa & Dan Kajungu & Sten Olsson & Niko Speybroeck - 767-774 Central Demyelinating Diseases after Vaccination Against Hepatitis B Virus: A Disproportionality Analysis within the VAERS Database
by Julie Mouchet & Bernard Bégaud - 775-786 Benefit–Risk Monitoring of Vaccines Using an Interactive Dashboard: A Methodological Proposal from the ADVANCE Project
by Kaatje Bollaerts & Tom Smedt & Katherine Donegan & Lina Titievsky & Vincent Bauchau - 787-795 Comparative Rates of Mortality and Serious Adverse Effects Among Commonly Prescribed Opioid Analgesics
by David L. Murphy & Jacob A. Lebin & Stevan G. Severtson & Heather A. Olsen & Nabarun Dasgupta & Richard C. Dart - 797-806 Effectiveness Evaluation of Additional Risk Minimization Measures for Adolescent Use of Aripiprazole in the European Union: Results from a Post-Authorization Safety Study
by Wally Landsberg & Imad Al-Dakkak & Antonia Coppin-Renz & Uli Geis & Timothy Peters-Strickland & Emiel Heumen & Mirza Rahman - 807-816 A Programme for Risk Assessment and Minimisation of Progressive Multifocal Leukoencephalopathy Developed for Vedolizumab Clinical Trials
by 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 & David B. Clifford - 817-826 Use of Proton Pump Inhibitors and the Risk of Acute Kidney Injury Among Patients with Rheumatoid Arthritis: Cohort Study
by Henrik Svanström & Marie Lund & Mads Melbye & Björn Pasternak - 827-827 Correction to: Drug-Induced Dental Caries: A Disproportionality Analysis Using Data from VigiBase
by Emilie Patras de Campaigno & Inès Kebir & Jean-Louis Montastruc & Manuela Rueter & Delphine Maret & Maryse Lapeyre-Mestre & Brigitte Sallerin & Fabien Despas
July 2018, Volume 41, Issue 7
- 645-653 Thromboembolism with Janus Kinase (JAK) Inhibitors for Rheumatoid Arthritis: How Real is the Risk?
by Ian C. Scott & Samantha L. Hider & David L. Scott - 655-664 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 & Tom Birkenhäger & Mascha Groothedde-Kuyvenhoven & Rob Kok & Cornelis Kramers & Wim Verbeeck & Mirjam Westra & Eric Roon & Roberto Bakker & Henricus Ruhé - 665-675 EudraVigilance Medicines Safety Database: Publicly Accessible Data for Research and Public Health Protection
by Rodrigo Postigo & Sabine Brosch & Jim Slattery & Anja Haren & Jean-Michel Dogné & Xavier Kurz & Gianmario Candore & Francois Domergue & Peter Arlett - 677-683 Sex Differences in Reported Adverse Drug Reactions of Selective Serotonin Reuptake Inhibitors
by Corine Ekhart & Florence Hunsel & Joep Scholl & Sieta Vries & Eugene Puijenbroek - 685-695 Using the Symmetry Analysis Design to Screen for Adverse Effects of Non-vitamin K Antagonist Oral Anticoagulants
by Maja Hellfritzsch & Lotte Rasmussen & Jesper Hallas & Anton Pottegård - 697-712 Interest in a Mobile App for Two-Way Risk Communication: A Survey Study Among European Healthcare Professionals and Patients
by Sieta T. de Vries & Petra Denig & Carmen Lasheras Ruiz & François Houÿez & Lisa Wong & Alastair Sutcliffe & Peter G. M. Mol - 713-724 Safety Communication Tools and Healthcare Professionals’ Awareness of Specific Drug Safety Issues in Europe: A Survey Study
by Sieta T. de Vries & Maartje J. M. van der Sar & Anna Marie Coleman & Yvette Escudero & Alfonso Rodríguez Pascual & Miguel-Ángel Maciá Martínez & Amelia Cupelli & Ilaria Baldelli & Ivana Šipić & Adriana Andrić & Line Michan & Petra Denig & Peter G. M. Mol - 725-730 Glucocorticoids and the Risk of Peptic Ulcer Bleeding: Case–Control Analysis Based on Swiss Claims Data
by Daphne Reinau & Matthias Schwenkglenks & Mathias Früh & Andri Signorell & Eva Blozik & Christoph R. Meier
June 2018, Volume 41, Issue 6
- 545-553 Gastrointestinal Perforations with Biologics in Patients with Rheumatoid Arthritis: Implications for Clinicians
by Aprajita Jagpal & Jeffrey R. Curtis - 555-564 The Risk for Lung Cancer Incidence with Calcium Channel Blockers: A Systematic Review and Meta-Analysis of Observational Studies
by Victoria Rotshild & Laurent Azoulay & Majd Zarifeh & Reem Masarwa & Bruria Hirsh-Raccah & Amichai Perlman & Mordechai Muszkat & Ilan Matok - 565-577 Time Series Disturbance Detection for Hypothesis-Free Signal Detection in Longitudinal Observational Databases
by Ed Whalen & Manfred Hauben & Andrew Bate - 579-590 Sorting Through the Safety Data Haystack: Using Machine Learning to Identify Individual Case Safety Reports in Social-Digital Media
by Shaun Comfort & Sujan Perera & Zoe Hudson & Darren Dorrell & Shawman Meireis & Meenakshi Nagarajan & Cartic Ramakrishnan & Jennifer Fine - 591-602 A Multi-hospital Before–After Observational Study Using a Point-Prevalence Approach with an Infusion Safety Intervention Bundle to Reduce Intravenous Medication Administration Errors
by 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 & David W. Bates - 603-613 Evidence-Based Recommendations to Improve the Safe Use of Drugs in Patients with Liver Cirrhosis
by 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 & Sander D. Borgsteede - 615-624 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
by Sun-Kyeong Park & Yeon-Hee Baek & Nicole Pratt & Lisa Kalisch Ellett & Ju-Young Shin - 625-640 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 - 641-642 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”
by Tomoyuki Kawada - 643-644 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’’
by Alyssa M. Peckham & Kathleen A. Fairman & David A. Sclar
May 2018, Volume 41, Issue 5
- 441-449 Long-Acting β2-Agonists in Asthma: Enantioselective Safety Studies are Needed
by Glenn A. Jacobson & Sharanne Raidal & Morten Hostrup & Luigino Calzetta & Richard Wood-Baker & Mark O. Farber & Clive P. Page & E. Haydn Walters - 451-464 Drug-Induced Ototoxicity: Diagnosis and Monitoring
by Kathleen C. M. Campbell & Colleen G. Prell - 465-471 A Review of Methods for Monitoring Adverse Events in Pediatric Psychopharmacology Clinical Trials
by Margaret Coates & Marina Spanos & Pooja Parmar & Tara Chandrasekhar & Linmarie Sikich - 473-488 The Impact of Biologics and Tofacitinib on Cardiovascular Risk Factors and Outcomes in Patients with Rheumatic Disease: A Systematic Literature Review
by Michael Nurmohamed & Ernest Choy & Sadiq Lula & Blerina Kola & Ryan DeMasi & Paola Accossato - 489-509 Potential Risks Related to Modulating Interleukin-13 and Interleukin-4 Signalling: A Systematic Review
by Martin Braddock & Nicola A. Hanania & Amir Sharafkhaneh & Gene Colice & Mats Carlsson - 511-514 Adverse Drug Reaction Reports Received Through the Mobile App, VigiBIP®: A Comparison with Classical Methods of Reporting
by François Montastruc & Haleh Bagheri & Isabelle Lacroix & Christine Damase-Michel & Leila Chebane & Vanessa Rousseau & Emilie Jouanjus & Maryse Lapeyre-Mestre & Geneviève Durrieu & Jean-Louis Montastruc - 515-521 Case Series Analysis of New Zealand Reports of Rapid Intense Potentiation of Warfarin by Roxithromycin
by Ruth L. Savage & Michael V. Tatley - 523-536 Signal Detection for Recently Approved Products: Adapting and Evaluating Self-Controlled Case Series Method Using a US Claims and UK Electronic Medical Records Database
by Xiaofeng Zhou & Ian. J. Douglas & Rongjun. Shen & Andrew. Bate - 537-538 Comment on “Safety of Human Papillomavirus Vaccines: An Updated Review”
by Rebecca Ellen Chandler & I. Ralph Edwards & Marie Lindquist - 539-540 Comment on: “Safety of Human Papillomavirus Vaccines: An Updated Review”
by Manuel Martínez-Lavín - 541-543 Authors’ reply: Safety of Human Papillomavirus Vaccines
by Kristine Macartney & Anastasia Phillips & Cyra Patel & Alexis Pillsbury & Julia Brotherton
April 2018, Volume 41, Issue 4
- 325-328 The Safety of Generic Prescription Drugs in the United States
by Sonal Singh - 329-346 Safety of Human Papillomavirus Vaccines: An Updated Review
by Anastasia Phillips & Cyra Patel & Alexis Pillsbury & Julia Brotherton & Kristine Macartney - 347-356 Management Strategies to Facilitate Optimal Outcomes for Patients Treated with Delayed-release Dimethyl Fumarate
by Lori Mayer & Mary Kay Fink & Carrie Sammarco & Lisa Laing - 357-361 Analysis of Spontaneous Postmarket Case Reports Submitted to the FDA Regarding Thromboembolic Adverse Events and JAK Inhibitors
by Abril Verden & Mo Dimbil & Robert Kyle & Brian Overstreet & Keith B. Hoffman - 363-376 Mixed Approach Retrospective Analyses of Suicide and Suicidal Ideation for Brand Compared with Generic Central Nervous System Drugs
by Ning Cheng & Md. Motiur Rahman & Yasser Alatawi & Jingjing Qian & Peggy L. Peissig & Richard L. Berg & C. David Page & Richard A. Hansen - 377-387 An Automated System Combining Safety Signal Detection and Prioritization from Healthcare Databases: A Pilot Study
by Mickael Arnaud & Bernard Bégaud & Frantz Thiessard & Quentin Jarrion & Julien Bezin & Antoine Pariente & Francesco Salvo - 389-401 The RIMES Statement: A Checklist to Assess the Quality of Studies Evaluating Risk Minimization Programs for Medicinal Products
by Meredith Y. Smith & Andrea Russell & Priya Bahri & Peter G. M. Mol & Sarah Frise & Emily Freeman & Elaine H. Morrato - 403-413 Amyotrophic Lateral Sclerosis Associated with Statin Use: A Disproportionality Analysis of the FDA’s Adverse Event Reporting System
by Beatrice A. Golomb & Abril Verden & Alexis K. Messner & Hayley J. Koslik & Keith B. Hoffman - 415-427 Beta-Blocker Use in Pregnancy and Risk of Specific Congenital Anomalies: A European Case-Malformed Control Study
by 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 & Marian K. Bakker - 429-440 Cardiovascular Profile of Valbenazine: Analysis of Pooled Data from Three Randomized, Double-Blind, Placebo-Controlled Trials
by Dao Thai-Cuarto & Christopher F. O’Brien & Roland Jimenez & Grace S. Liang & Joshua Burke
March 2018, Volume 41, Issue 3
- 239-252 Can SGLT2 Inhibitors Cause Acute Renal Failure? Plausible Role for Altered Glomerular Hemodynamics and Medullary Hypoxia
by Auryan Szalat & Amichai Perlman & Mordechai Muszkat & Mogher Khamaisi & Zaid Abassi & Samuel N. Heyman - 253-265 Neuropsychiatric Events Associated with Leukotriene-Modifying Agents: A Systematic Review
by Sharon W. Y. Law & Angel Y. S. Wong & Shweta Anand & Ian C. K. Wong & Esther W. Chan - 267-275 Utilisation and Safety of Deferasirox: Results from an Observational Cohort Study in England
by Vicki Osborne & Miranda Davies & Deborah Layton & Saad A. W. Shakir - 277-284 Severe Physical Complications among Survivors of Stevens–Johnson Syndrome and Toxic Epidermal Necrolysis
by 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 & Roni P. Dodiuk-Gad - 285-295 Risk of Psoriasis Following Terbinafine or Itraconazole Treatment for Onychomycosis: A Population-Based Case-Control Comparative Study
by Hsien-Yi Chiu & Wei-Lun Chang & Tsen-Fang Tsai & Yi-Wen Tsai & Ming-Neng Shiu - 297-302 Evaluation of ‘Definite’ Anaphylaxis Drug Allergy Alert Overrides in Inpatient and Outpatient Settings
by Adrian Wong & Diane L. Seger & Sarah P. Slight & Mary G. Amato & Patrick E. Beeler & Julie M. Fiskio & David W. Bates - 303-311 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 - 313-320 Reported Adverse Events with Painkillers: Data Mining of the US Food and Drug Administration Adverse Events Reporting System
by Jae Min & Vicki Osborne & Allison Kowalski & Mattia Prosperi - 321-322 Comment on: “Adverse Drug Reaction-Related Hospitalizations in Elderly Australians: A Prospective Cross-Sectional Study in Two Tasmanian Hospitals”
by Mona Kargar & Alireza Ahmadvand & Kheirollah Gholami - 323-324 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”
by Nibu Parameswaran Nair & Leanne Chalmers & Bonnie J. Bereznicki & Colin Curtain & Gregory M. Peterson & Michael Connolly & Luke R. Bereznicki
February 2018, Volume 41, Issue 2
- 143-149 From Big Data to Smart Data for Pharmacovigilance: The Role of Healthcare Databases and Other Emerging Sources
by Gianluca Trifirò & Janet Sultana & Andrew Bate - 151-159 Overview of Pharmacovigilance System in Vietnam: Lessons Learned in a Resource-Restricted Country
by Khac-Dung Nguyen & Phuong-Thuy Nguyen & Hoang-Anh Nguyen & Anne Roussin & Jean-Louis Montastruc & Haleh Bagheri & Sten Olsson - 161-169 Use of Antihypertensive Drugs and Risk of Malignant Melanoma: A Meta-analysis of Observational Studies
by Huilin Tang & Shuangshuang Fu & Suodi Zhai & Yiqing Song & Jiali Han - 171-177 Safety of Russian-Backbone Trivalent, Live Attenuated Seasonal Influenza Vaccine in Healthy Subjects: Open-Label, Non-randomized Phase 4 Study
by Prashant V. Nigwekar & Anuj Kumar & Vikram V. Padbidri & Amlan Choudhury & Amol B. Chaudhari & Prasad S. Kulkarni - 179-189 Preferences of Patients and Pharmacists with Regard to the Management of Drug–Drug Interactions: A Choice-Based Conjoint Analysis
by Mette Heringa & Annemieke Floor-Schreudering & Hans Wouters & Peter A. G. M. De Smet & Marcel L. Bouvy - 191-202 Study Design and Evaluation of Risk Minimization Measures: A Review of Studies Submitted to the European Medicines Agency for Cardiovascular, Endocrinology, and Metabolic Drugs
by Giampiero Mazzaglia & Sabine M. J. Straus & Peter Arlett & Daniela Silva & Heidi Janssen & June Raine & Enrica Alteri - 203-212 Safety Concerns Reported by Patients Identified in a Collaborative Signal Detection Workshop using VigiBase: Results and Reflections from Lareb and Uppsala Monitoring Centre
by Sarah Watson & Rebecca E. Chandler & Henric Taavola & Linda Härmark & Birgitta Grundmark & Alem Zekarias & Kristina Star & Florence Hunsel - 213-228 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
by Alyssa M. Peckham & Kathleen A. Fairman & David A. Sclar - 229-237 Erlotinib Plus Bevacizumab Phase ll Study in Patients with Advanced Non-small-Cell Lung Cancer (JO25567): Updated Safety Results
by Terufumi Kato & Takashi Seto & Makoto Nishio & Koichi Goto & Noboru Yamamoto & Isamu Okamoto & Liang Tao & Wei Yu & Tarik Khaznadar & Kosei Tajima & Masahiko Shibata & Akihiro Seki & Nobuyuki Yamamoto
January 2018, Volume 41, Issue 1
- 1-6 An Update on ISoP Special Interest Groups (SIGs)
by Deirdre McCarthy & Priya Bahri & Joanne Barnes & Jean-Christophe Delumeau & Brian Edwards & Mira Harrison-Woolrych - 7-9 Setting Standards for Pregnancy Registries
by Lewis B. Holmes - 11-17 Drug-Induced QT Prolongation and Torsades de Pointes: An All-Exclusive Relationship or Time for an Amicable Separation?
by Luc M. Hondeghem - 19-75 Dopamine Agonists and Impulse Control Disorders: A Complex Association
by Marie Grall-Bronnec & Caroline Victorri-Vigneau & Yann Donnio & Juliette Leboucher & Morgane Rousselet & Elsa Thiabaud & Nicolas Zreika & Pascal Derkinderen & Gaëlle Challet-Bouju - 77-86 Cardiac Harms of Sofosbuvir: Systematic Review and Meta-Analysis
by Daniel Caldeira & Filipe B. Rodrigues & Marta M. Duarte & Carmelo Sterrantino & Márcio Barra & Nilza Gonçalves & Fausto J. Pinto & Joaquim J. Ferreira & João Costa - 87-94 Enrollment and Retention in 34 United States Pregnancy Registries Contrasted with the Manufacturer’s Capture of Spontaneous Reports for Exposed Pregnancies
by Steven T. Bird & Kate Gelperin & Lockwood Taylor & Leyla Sahin & Hoda Hammad & Susan E. Andrade & Mohamed A. Mohamoud & Sengwee Toh & Christian Hampp - 95-102 Antidepressant-Induced Acute Liver Injury: A Case–Control Study in an Italian Inpatient Population
by Carmen Ferrajolo & Cristina Scavone & Monia Donati & Oscar Bortolami & Giovanna Stoppa & Domenico Motola & Alfredo Vannacci & Alessandro Mugelli & Roberto Leone & Annalisa Capuano - 103-110 Deaths from Medicines: A Systematic Analysis of Coroners’ Reports to Prevent Future Deaths
by Robin E. Ferner & Craig Easton & Anthony R. Cox - 111-123 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
by Giacomo Oteri & Gianluca Trifirò & Matteo Peditto & Loredana Lo Presti & Ilaria Marcianò & Francesco Giorgianni & Janet Sultana & Antonia Marcianò