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Content
September 2018, Volume 41, Issue 9
- 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 - 125-137 Evaluation of Electronic Healthcare Databases for Post-Marketing Drug Safety Surveillance and Pharmacoepidemiology in China
by Yu Yang & Xiaofeng Zhou & Shuangqing Gao & Hongbo Lin & Yanming Xie & Yuji Feng & Kui Huang & Siyan Zhan - 139-141 The 9th Biennial Conference on Signal Detection and Interpretation in Pharmacovigilance
by Vicki Osborne & Saad A. W. Shakir
December 2017, Volume 40, Issue 12
- 1163-1165 Is Ribavirin Teratogenic in Humans? No Evidence So Far
by Vicente Soriano & Pablo Barreiro - 1167-1170 Safety Concerns with HPV Vaccines Continue to Linger: Are Current Vaccine Pharmacovigilance Practices Sufficient?
by Rebecca E. Chandler - 1171-1198 Neurological Adverse Effects Attributable to β-Lactam Antibiotics: A Literature Review
by Samuel Deshayes & Antoine Coquerel & Renaud Verdon - 1199-1204 Commercial Online Social Network Data and Statin Side-Effect Surveillance: A Pilot Observational Study of Aggregate Mentions on Facebook
by Marco D. Huesch - 1205-1218 The Ribavirin Pregnancy Registry: An Interim Analysis of Potential Teratogenicity at the Mid-Point of Enrollment
by Susan M. Sinclair & Judith K. Jones & Richard K. Miller & Michael F. Greene & Paul Y. Kwo & Willis C. Maddrey - 1219-1229 Suspected Adverse Effects After Human Papillomavirus Vaccination: A Temporal Relationship Between Vaccine Administration and the Appearance of Symptoms in Japan
by Kazuki Ozawa & Akiyo Hineno & Tomomi Kinoshita & Sakiko Ishihara & Shu-ichi Ikeda - 1231-1240 Safety Profile of Eslicarbazepine Acetate as Add-On Therapy in Adults with Refractory Focal-Onset Seizures: From Clinical Studies to 6 Years of Post-Marketing Experience
by Helena Gama & Mariana Vieira & Raquel Costa & Joana Graça & Luís M. Magalhães & Patrício Soares-da-Silva - 1241-1248 Medication Errors: A Characterisation of Spontaneously Reported Cases in EudraVigilance
by Victoria Newbould & Steven Meur & Thomas Goedecke & Xavier Kurz - 1249-1258 Drug-Induced Dental Caries: A Disproportionality Analysis Using Data from VigiBase
by Emilie Patras Campaigno & Inès Kebir & Jean-Louis Montastruc & Manuela Rueter & Delphine Maret & Maryse Lapeyre-Mestre & Brigitte Sallerin & Fabien Despas - 1259-1277 A Pharmacoepidemiology Database System for Monitoring Risk Due to the Use of Medicines by New Zealand Primary Care Patients
by Andrew M. Tomlin & David M. Reith & David J. Woods & Hywel S. Lloyd & Alesha Smith & John S. Fountain & Murray W. Tilyard - 1279-1292 Channeling in the Use of Nonprescription Paracetamol and Ibuprofen in an Electronic Medical Records Database: Evidence and Implications
by Rachel B. Weinstein & Patrick Ryan & Jesse A. Berlin & Amy Matcho & Martijn Schuemie & Joel Swerdel & Kayur Patel & Daniel Fife - 1293-1293 Correction to: Medication Errors: A Characterisation of Spontaneously Reported Cases in EudraVigilance
by Victoria Newbould & Steven Meur & Thomas Goedecke & Xavier Kurz - 1295-1295 Correction to: Safety Concerns with HPV Vaccines Continue to Linger: Are Current Vaccine Pharmacovigilance Practices Sufficient?
by Rebecca E. Chandler
November 2017, Volume 40, Issue 11
- 1047-1048 Pharmacovigilance Using Textual Data: The Need to Go Deeper and Wider into the Con(text)
by Tavpritesh Sethi & Nigam H. Shah - 1049-1074 Clinical Relevance and Predictive Value of Damage Biomarkers of Drug-Induced Kidney Injury
by Sandra L. Kane-Gill & Pamela L. Smithburger & Kianoush Kashani & John A. Kellum & Erin Frazee - 1075-1089 Natural Language Processing for EHR-Based Pharmacovigilance: A Structured Review
by Yuan Luo & William K. Thompson & Timothy M. Herr & Zexian Zeng & Mark A. Berendsen & Siddhartha R. Jonnalagadda & Matthew B. Carson & Justin Starren - 1091-1098 Safety and Interactions of Direct Oral Anticoagulants with Antiarrhythmic Drugs
by Ipek Celikyurt & Christoph R. Meier & Michael Kühne & Beat Schaer - 1099-1107 Impact of Medicine Withdrawal on Reporting of Adverse Events Involving Therapeutic Alternatives: A Study from the French Spontaneous Reporting Database
by Cécile Pageot & Julien Bezin & Andy Smith & Mickael Arnaud & Francesco Salvo & Françoise Haramburu & Bernard Bégaud & Antoine Pariente - 1109-1118 Association of Parkinsonism or Parkinson Disease with Polypharmacy in the Year Preceding Diagnosis: A Nested Case–Control Study in South Korea
by Hae-Young Park & Ji-Won Park & Hyun Soon Sohn & Jin-Won Kwon - 1119-1129 Using Multiple Pharmacovigilance Models Improves the Timeliness of Signal Detection in Simulated Prospective Surveillance
by Rolina D. van Gaalen & Michal Abrahamowicz & David L. Buckeridge - 1131-1140 Overview of the Safety of Anti-VEGF Drugs: Analysis of the Italian Spontaneous Reporting System
by Paola Maria Cutroneo & Claudia Giardina & Valentina Ientile & Simona Potenza & Laura Sottosanti & Carmen Ferrajolo & Costantino J. Trombetta & Gianluca Trifirò - 1141-1146 Signal of Miscarriage with Aripiprazole: A Disproportionality Analysis of the Japanese Adverse Drug Event Report Database
by Takamasa Sakai & Fumiko Ohtsu & Chiyo Mori & Kouichi Tanabe & Nobuyuki Goto - 1147-1155 The Fetal Safety of Enoxaparin Use During Pregnancy: A Population-Based Retrospective Cohort Study
by Meital Shlomo & Rafael Gorodischer & Sharon Daniel & Arnon Wiznitzer & Ilan Matok & Boris Fishman & Gideon Koren & Amalia Levy
October 2017, Volume 40, Issue 10
- 841-844 The New Phase of ISoP
by Sten Olsson & Ian C. K. Wong & Jean-Christophe Delumeau & Mira Harrison-Woolrych - 845-849 A New Erice Report Considering the Safety of Medicines in the 21st Century
by Ivor Ralph Edwards - 851-853 Statin Therapy and Risk of Intracranial Hemorrhage in Patients with Ischemic Stroke
by Matilda Florentin & Moses S. Elisaf - 855-869 Promoting and Protecting Public Health: How the European Union Pharmacovigilance System Works
by Aniello Santoro & Georgy Genov & Almath Spooner & June Raine & Peter Arlett - 871-886 Frequency and Nature of Medication Errors and Adverse Drug Events in Mental Health Hospitals: a Systematic Review
by Ghadah H. Alshehri & Richard N. Keers & Darren M. Ashcroft - 887-893 Lipophilic Statins and the Risk of Intracranial Hemorrhage Following Ischemic Stroke: A Population-Based Study
by Kieran L. Quinn & Erin M. Macdonald & Muhammad M. Mamdani & Christina Diong & David N. Juurlink - 895-909 Muscular Adverse Drug Reactions Associated with Proton Pump Inhibitors: A Disproportionality Analysis Using the Italian National Network of Pharmacovigilance Database
by Alice Capogrosso Sansone & Irma Convertino & Maria Teresa Galiulo & Stefano Salvadori & Stefania Pieroni & Tamara Knezevic & Stefania Mantarro & Alessandra Marino & Manfred Hauben & Corrado Blandizzi & Marco Tuccori - 911-921 Patients’ Perspectives on Adverse Drug Reaction Reporting in a Developing Country: A Case Study from Ghana
by George Tsey Sabblah & Delese Mimi Darko & Hudu Mogtari & Linda Härmark & Eugène Puijenbroek - 923-932 Updating the Evidence of the Interaction Between Clopidogrel and CYP2C19-Inhibiting Selective Serotonin Reuptake Inhibitors: A Cohort Study and Meta-Analysis
by Katsiaryna Bykov & Sebastian Schneeweiss & Robert J. Glynn & Murray A. Mittleman & David W. Bates & Joshua J. Gagne - 933-934 Brian A. Baldo, Safety of Biologics Therapy: Monoclonal Antibodies, Cytokines, Fusion Proteins, Hormones, Enzymes, Coagulation Proteins, Vaccines, Botulinum Toxins, 1st Edition, Springer, 2016, Print Book ISBN: 978-3-319-30470-0, e-Book ISBN 978-3-319-30472-4
by Kevin Broady - 935-936 Comment on “Patient Reporting in the EU: Analysis of EudraVigilance Data”
by Farid Kheloufi & Anne Default & Frank Rouby & Olivier Blin & Joelle Micallef
September 2017, Volume 40, Issue 9
- 757-760 Using Simulated Data to Assess Case-Crossover Designs for Studying Less Transient Effects of Drugs
by Malcolm Maclure - 761-769 Potential Teratogenic Effects of Clomiphene Citrate
by Alessandra Scaparrotta & Francesco Chiarelli & Alberto Verrotti - 771-781 Second-Generation Antipsychotics and Metabolic Side Effects: A Systematic Review of Population-Based Studies
by Lauren Hirsch & Jaeun Yang & Lauren Bresee & Nathalie Jette & Scott Patten & Tamara Pringsheim - 783-787 The Incidence of Drug- and Herbal and Dietary Supplement-Induced Liver Injury: Preliminary Findings from Gastroenterologist-Based Surveillance in the Population of the State of Delaware
by Maricruz Vega & Manisha Verma & David Beswick & Stephanie Bey & Jared Hossack & Nathan Merriman & Ashish Shah & Victor Navarro - 789-798 Evaluation of the Case–Crossover (CCO) Study Design for Adverse Drug Event Detection
by Zachary Burningham & Tao He & Chia-Chen Teng & Xi Zhou & Jonathan Nebeker & Brian C. Sauer - 799-808 An Algorithm to Identify Generic Drugs in the FDA Adverse Event Reporting System
by Geetha Iyer & Sathiya Priya Marimuthu & Jodi B. Segal & Sonal Singh - 809-821 Role of Medicines of Unknown Identity in Adverse Drug Reaction-Related Hospitalizations in Developing Countries: Evidence from a Cross-Sectional Study in a Teaching Hospital in the Lao People’s Democratic Republic
by Céline Caillet & Chanvilay Sichanh & Gaëtan Assemat & Myriam Malet-Martino & Agnès Sommet & Haleh Bagheri & Noudy Sengxeu & Niphonh Mongkhonmath & Mayfong Mayxay & Lamphone Syhakhang & Maryse Lapeyre-Mestre & Paul N. Newton & Anne Roussin - 823-834 Occurrence of Multiple Sclerosis After Drug Exposure: Insights From Evidence Mapping
by Ippazio Cosimo Antonazzo & Emanuel Raschi & Luca Vignatelli & Elisa Baldin & Trond Riise & Roberto D’Alessandro & Fabrizio De Ponti & Elisabetta Poluzzi - 835-840 Macrolides, Digoxin Toxicity and the Risk of Sudden Death: A Population-Based Study
by Kieran L. Quinn & Erin M. Macdonald & Tara Gomes & Muhammad M. Mamdani & Anjie Huang & David N. Juurlink
August 2017, Volume 40, Issue 8
- 647-649 Good Intentions, But What About Unintended Consequences?
by Helen C. Kales & Donovan T. Maust - 651-661 Species Adulteration in the Herbal Trade: Causes, Consequences and Mitigation
by Ramanujam Srirama & J. U. Santhosh Kumar & G. S. Seethapathy & Steven G. Newmaster & S. Ragupathy & K. N. Ganeshaiah & R. Uma Shaanker & Gudasalamani Ravikanth - 663-677 Managing Cardiovascular Risk of Macrolides: Systematic Review and Meta-Analysis
by Angel Y. S. Wong & Esther W. Chan & Shweta Anand & Alan J. Worsley & Ian C. K. Wong - 679-692 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 - 693-702 Adjuvanted (AS03) A/H1N1 2009 Pandemic Influenza Vaccines and Solid Organ Transplant Rejection: Systematic Signal Evaluation and Lessons Learnt
by Gaël Dos Santos & Harry A. Seifert & Vincent Bauchau & Vivek Shinde & Dominique M. Barbeau & Catherine Cohet - 703-713 Detecting Signals of Disproportionate Reporting from Singapore’s Spontaneous Adverse Event Reporting System: An Application of the Sequential Probability Ratio Test
by Cheng Leng Chan & Sowmya Rudrappa & Pei San Ang & Shu Chuen Li & Stephen J. W. Evans - 715-727 Preliminary Results of a Novel Algorithmic Method Aiming to Support Initial Causality Assessment of Routine Pharmacovigilance Case Reports for Medication-Induced Liver Injury: The PV-RUCAM
by Erik Scalfaro & Henk Johan Streefkerk & Michael Merz & Christoph Meier & David Lewis - 729-742 Communication on Safety of Medicines in Europe: Current Practices and General Practitioners’ Awareness and Preferences
by Sieta T. Vries & Maartje J. M. Sar & Amelia Cupelli & Ilaria Baldelli & Anna Marie Coleman & Dolores Montero & Ivana Šipić & Adriana Andrić & Annika Wennberg & Jane Ahlqvist-Rastad & Petra Denig & Peter G. M. Mol - 743-754 People’s Understanding of Verbal Risk Descriptors in Patient Information Leaflets: A Cross-Sectional National Survey of 18- to 65-Year-Olds in England
by Rebecca K. Webster & John Weinman & G James Rubin - 755-755 Comment on: “Evaluation of Facebook and Twitter Monitoring to Detect Safety Signals for Medical Products: An Analysis of Recent FDA Safety Alerts”
by Viroj Wiwanitkit
July 2017, Volume 40, Issue 7
- 543-546 The Power of the Case Narrative - Can it be Brought to Bear on Duplicate Detection?
by G. Niklas Norén - 547-558 Summarising the Evidence for Drug Safety: A Methodological Discussion of Different Meta-Analysis Approaches
by Guillermo Prada-Ramallal & Bahi Takkouche & Adolfo Figueiras - 559-570 Targeting Interleukin-5 or Interleukin-5Rα: Safety Considerations
by Diego Bagnasco & Matteo Ferrando & Marco Caminati & Alice Bragantini & Francesca Puggioni & Gilda Varricchi & Giovanni Passalacqua & Giorgio Walter Canonica - 571-582 Using Probabilistic Record Linkage of Structured and Unstructured Data to Identify Duplicate Cases in Spontaneous Adverse Event Reporting Systems
by Kory Kreimeyer & David Menschik & Scott Winiecki & Wendy Paul & Faith Barash & Emily Jane Woo & Meghna Alimchandani & Deepa Arya & Craig Zinderman & Richard Forshee & Taxiarchis Botsis - 583-596 Drospirenone-Containing Oral Contraceptive Pills and the Risk of Venous Thromboembolism: An Assessment of Risk in First-Time Users and Restarters
by Natasha Larivée & Samy Suissa & Janie Coulombe & Vicky Tagalakis & Kristian B. Filion - 597-606 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 - 607-614 The Quality of Clinical Information in Adverse Drug Reaction Reports by Patients and Healthcare Professionals: A Retrospective Comparative Analysis
by Leàn Rolfes & Florence Hunsel & Laura Linden & Katja Taxis & Eugène Puijenbroek - 615-627 Impact of Safety-Related Regulations on Codeine Use in Children: A Quasi-Experimental Study Using Taiwan’s National Health Insurance Research Database
by Chih-Wan Lin & Ching-Huan Wang & Wei-I Huang & Wei-Ming Ke & Pi-Hui Chao & Wen-Wen Chen & Fei-Yuan Hsiao - 629-645 Patient Reporting in the EU: Analysis of EudraVigilance Data
by Marin Banovac & Gianmario Candore & Jim Slattery & Francois Houÿez & David Haerry & Georgy Genov & Peter Arlett
June 2017, Volume 40, Issue 6
- 457-459 Medicines Save, Medicines Kill
by Joel Lexchin - 461-464 Drug-Induced Arrhythmia: Bridging the Gap Between Pathophysiological Knowledge and Clinical Practice
by Elisabetta Poluzzi & Emanuel Raschi & Igor Diemberger & Fabrizio De Ponti - 465-474 Adverse Drug Event Causality Analysis (ADECA): A Process for Evaluating Evidence and Assigning Drugs to Risk Categories for Sudden Death
by Raymond L. Woosley & Klaus Romero & Craig W. Heise & Tyler Gallo & Jared Tate & Raymond David Woosley & Sophie Ward - 475-482 Pharmacovigilance of Regenerative Medicine Under the Amended Pharmaceutical Affairs Act in Japan
by Yasuko Inokuma - 483-495 Evaluation of ‘SAEFVIC’, A Pharmacovigilance Surveillance Scheme for the Spontaneous Reporting of Adverse Events Following Immunisation in Victoria, Australia
by Hazel J. Clothier & Nigel W. Crawford & Melissa Russell & Heath Kelly & Jim P. Buttery - 497-503 Evaluation of Pre-marketing Factors to Predict Post-marketing Boxed Warnings and Safety Withdrawals
by Andreas Schick & Kathleen L. Miller & Michael Lanthier & Gerald Dal Pan & Clark Nardinelli - 505-515 The Risk of Ischemic Cardio- and Cerebrovascular Events Associated with Oxycodone–Naloxone and Other Extended-Release High-Potency Opioids: A Nested Case–Control Study
by Kathrin Jobski & Bianca Kollhorst & Edeltraut Garbe & Tania Schink - 517-530 A Survey on Pharmacovigilance Activities in ASEAN and Selected Non-ASEAN Countries, and the Use of Quantitative Signal Detection Algorithms
by Cheng Leng Chan & Pei San Ang & Shu Chuen Li - 531-542 Patient and Physician Perceptions of Drug Safety Information for Sleep Aids: A Qualitative Study
by Aaron S. Kesselheim & Sarah A. McGraw & Sara Z. Dejene & Paula Rausch & Gerald J. Dal Pan & Brian M. Lappin & Esther H. Zhou & Jerry Avorn & Eric G. Campbell
May 2017, Volume 40, Issue 5
- 363-364 Antenatal Exposure and Diseases in the Offspring: The Role of Big Data
by Christoph R. Meier & Susan S. Jick - 365-372 Causality Assessment in Pharmacovigilance: Still a Challenge
by I. Ralph Edwards - 373-386 Anti-Angiogenic Tyrosine Kinase Inhibitors and Reversible Posterior Leukoencephalopathy Syndrome: Could Hypomagnesaemia Be the Trigger?
by Rashmi R. Shah - 387-397 Sensitivity of the UK Clinical Practice Research Datalink to Detect Neurodevelopmental Effects of Medicine Exposure in Utero: Comparative Analysis of an Antiepileptic Drug-Exposed Cohort
by R. A. Charlton & A. McGrogan & J. Snowball & L. M. Yates & A. Wood & J. Clayton-Smith & W. H. Smithson & J. L. Richardson & N. McHugh & S. H. L. Thomas & G. A. Baker & R. Bromley - 399-408 Validation of New Signal Detection Methods for Web Query Log Data Compared to Signal Detection Algorithms Used With FAERS
by Susan Colilla & Elad Yom Tov & Ling Zhang & Marie-Laure Kurzinger & Stephanie Tcherny-Lessenot & Catherine Penfornis & Shang Jen & Danny S. Gonzalez & Patrick Caubel & Susan Welsh & Juhaeri Juhaeri - 409-418 Feasibility and Educational Value of a Student-Run Pharmacovigilance Programme: A Prospective Cohort Study
by Tim Schutte & Jelle Tichelaar & Michael O. Reumerman & Rike Eekeren & Leàn Rolfes & Eugène P. Puijenbroek & Milan C. Richir & Michiel A. Agtmael - 419-430 Evaluation of Potentially Drug-Related Patient-Reported Common Symptoms Assessed During Clinical Medication Reviews: A Cross-Sectional Observational Study
by Tim W. A. Schoenmakers & Martina Teichert & Michel Wensing & Peter A. G. M. Smet - 431-441 Post-Marketing Regulation of Medicines Withdrawn from the Market Because of Drug-Attributed Deaths: An Analysis of Justification
by Igho J. Onakpoya & Carl J. Heneghan & Jeffrey K. Aronson - 443-455 Factors Influencing the Use of a Mobile App for Reporting Adverse Drug Reactions and Receiving Safety Information: A Qualitative Study
by Sieta T. Vries & Lisa Wong & Alastair Sutcliffe & François Houÿez & Carmen Lasheras Ruiz & Peter G. M. Mol
April 2017, Volume 40, Issue 4
- 273-283 Pre-Exposure Prophylaxis for HIV Prevention: Safety Concerns
by Raymond A. Tetteh & Barbara A. Yankey & Edmund T. Nartey & Margaret Lartey & Hubert G. M. Leufkens & Alexander N. O. Dodoo - 285-292 Digitalis Use and the Risk of Breast Cancer: A Systematic Review and Meta-Analysis
by Chen Zhang & Shao-Hua Xie & Bingfei Xu & Shi Lu & Pian Liu - 293-303 Identification of Substandard Medicines via Disproportionality Analysis of Individual Case Safety Reports
by Zahra Anita Trippe & Bruno Brendani & Christoph Meier & David Lewis - 305-315 Antibiotic-Induced Liver Injury in Paediatric Outpatients: A Case-Control Study in Primary Care Databases
by Carmen Ferrajolo & Katia M. C. Verhamme & Gianluca Trifirò & Geert W. ‘t Jong & Gino Picelli & Carlo Giaquinto & Giampiero Mazzaglia & Bruno H. Stricker & Francesco Rossi & Annalisa Capuano & Miriam C. J. M. Sturkenboom - 317-331 Evaluation of Facebook and Twitter Monitoring to Detect Safety Signals for Medical Products: An Analysis of Recent FDA Safety Alerts
by Carrie E. Pierce & Khaled Bouri & Carol Pamer & Scott Proestel & Harold W. Rodriguez & Hoa Le & Clark C. Freifeld & John S. Brownstein & Mark Walderhaug & I. Ralph Edwards & Nabarun Dasgupta - 333-341 Effectiveness of Risk Evaluation and Mitigation Strategies (REMS) for Lenalidomide and Thalidomide: Patient Comprehension and Knowledge Retention
by Nancy A. Brandenburg & Robert Bwire & John Freeman & Florence Houn & Paul Sheehan & Jerome B. Zeldis - 343-350 Signal Detection Based on Time to Onset Algorithm in Spontaneous Reporting System of China
by Tianyi Zhang & Xiaofei Ye & Xiaojing Guo & Guizhi Wu & Yongfang Hou & Jinfang Xu & Wentao Shi & Tiantian Zhu & Yuan Zhang & Xinji Zhang & Jiaqi Song & Jia He - 351-358 Diverging Conclusions from the Same Meta-Analysis in Drug Safety: Source of Data (Primary Versus Secondary) Takes a Toll
by Guillermo Prada-Ramallal & Bahi Takkouche & Adolfo Figueiras - 359-360 Comment on: “Proactive Regional Pharmacovigilance System Versus National Spontaneous Reporting for Collecting Safety Data on Concerning Off-Label Prescribing Practices: An Example with Baclofen and Alcohol Dependence in France”
by Alain Braillon - 361-362 Authors’ Reply to Alain Braillon’s Comment on “Proactive regional pharmacovigilance system versus national spontaneous reporting for collecting safety data on concerning off-label prescribing practices: An example with baclofen and alcohol dependence in France’’
by Marine Auffret & Julien Labreuche & Alain Duhamel & Sylvie Deheul & Olivier Cottencin & Régis Bordet & Sophie Gautier & Benjamin Rolland
March 2017, Volume 40, Issue 3
- 191-199 Developing a Crowdsourcing Approach and Tool for Pharmacovigilance Education Material Delivery
by Andrew Bate & Jürgen Beckmann & Alexander Dodoo & Linda Härmark & Kenneth Hartigan-Go & Anna Hegerius & Marie Lindquist & Eugène Puijenbroek & Marco Tuccori & Ulrich Hagemann - 201-210 Benefits and Risks of Long-Term Asthma Management in Children: Where Are We Heading?
by Hengameh H. Raissy & H. William Kelly - 211-228 Hyperglycaemia Induced by Novel Anticancer Agents: An Undesirable Complication or a Potential Therapeutic Opportunity?
by Rashmi R. Shah - 229-240 Cancer Event Rate and Mortality with Thienopyridines: A Systematic Review and Meta-Analysis
by Rafail Angelos Kotronias & Chun Shing Kwok & Chun Wai Wong & Tim Kinnaird & Azfar Zaman & Mamas A. Mamas - 241-248 Effect of Medications for Gastric Acid-Related Symptoms on Total Motile Sperm Count and Concentration: A Case–Control Study in Men of Subfertile Couples from the Netherlands
by Nicole A. Huijgen & Hedwig J. Goijen & John M. Twigt & Annemarie G. M. G. J. Mulders & Jan Lindemans & Gert R. Dohle & Joop S. E. Laven & Régine P. M. Steegers-Theunissen - 249-255 Melanoma and Non-Melanoma Skin Cancer Associated with Angiotensin-Converting-Enzyme Inhibitors, Angiotensin-Receptor Blockers and Thiazides: A Matched Cohort Study
by Beatrice Nardone & Sara Majewski & Ashley S. Kim & Tina Kiguradze & Estela M. Martinez-Escala & Rivka Friedland & Ahmad Amin & Anne E. Laumann & Beatrice J. Edwards & Alfred W. Rademaker & Mary C. Martini & Dennis P. West - 257-262 Proactive Regional Pharmacovigilance System Versus National Spontaneous Reporting for Collecting Safety Data on Concerning Off-Label Prescribing Practices: An Example with Baclofen and Alcohol Dependence in France
by Marine Auffret & Julien Labreuche & Alain Duhamel & Sylvie Deheul & Olivier Cottencin & Régis Bordet & Sophie Gautier & Benjamin Rolland - 263-272 The Impact of Provider Networks on the Co-Prescriptions of Interacting Drugs: A Claims-Based Analysis
by Mei-Sing Ong & Karen L. Olson & Laura Chadwick & Chunfu Liu & Kenneth D. Mandl
February 2017, Volume 40, Issue 2
- 101-103 Generating Evidence of Clinical Outcomes of Drug–Drug Interactions
by Katsiaryna Bykov & Joshua J. Gagne - 105-108 Active Surveillance of Follow-on Biologics: A Prescription for Uptake
by Ameet Sarpatwari & Joshua J. Gagne & Nicole L. Levidow & Aaron S. Kesselheim - 109-113 Should Domperidone be Used as a Galactagogue? Possible Safety Implications for Mother and Child
by Luc M. Hondeghem & Noël H. Logghe - 115-119 Bone Fractures with Sodium-Glucose Co-transporter-2 Inhibitors: How Real is the Risk?
by Edoardo Mannucci & Matteo Monami - 121-132 The Risk of Adverse Pregnancy Outcome After First Trimester Exposure to H1 Antihistamines: A Systematic Review and Meta-Analysis
by Fatma Etwel & Lauren H. Faught & Michael J. Rieder & Gideon Koren - 133-144 Investigating the Additive Interaction of QT-Prolonging Drugs in Older People Using Claims Data
by Andreas D. Meid & Anna Medem & Dirk Heider & Jürgen-Bernhard Adler & Christian Günster & Hanna M. Seidling & Renate Quinzler & Hans-Helmut König & Walter E. Haefeli - 145-152 Surveillance of Adverse Events After Seasonal Influenza Vaccination in Pregnant Women and Their Infants in the Vaccine Adverse Event Reporting System, July 2010–May 2016
by Pedro Moro & Jane Baumblatt & Paige Lewis & Janet Cragan & Naomi Tepper & Maria Cano - 153-167 Hepatic Cyst Infection During Use of the Somatostatin Analog Lanreotide in Autosomal Dominant Polycystic Kidney Disease: An Interim Analysis of the Randomized Open-Label Multicenter DIPAK-1 Study
by Marten A. Lantinga & Hedwig M. A. D’Agnolo & Niek F. Casteleijn & Johan W. Fijter & Esther Meijer & Annemarie L. Messchendorp & Dorien J. M. Peters & Mahdi Salih & Edwin M. Spithoven & Darius Soonawala & Folkert W. Visser & Jack F. M. Wetzels & Robert Zietse & Joost P. H. Drenth & Ron T. Gansevoort - 169-181 Propensity Score Weighting Compared to Matching in a Study of Dabigatran and Warfarin
by John D. Seeger & Katsiaryna Bykov & Dorothee B. Bartels & Krista Huybrechts & Sebastian Schneeweiss - 183-185 Comment on: "Social Media Mining for Toxicovigilance: Automatic Monitoring of Prescription Medication Abuse from Twitter"
by Emilie Jouanjus & Michel Mallaret & Joëlle Micallef & Camille Ponté & Anne Roussin & Maryse Lapeyre-Mestre - 187-188 Authors’ Reply to Jouanjus and Colleagues’ Comment on “Social Media Mining for Toxicovigilance: Automatic Monitoring of Prescription Medication Abuse from Twitter”
by Abeed Sarker & Dan Malone & Graciela Gonzalez - 189-189 Erratum to: Association Between Statin Use and Bell’s Palsy: A Population-Based Study
by Shih-Han Hung & Li-Hsuan Wang & Herng-Ching Lin & Shiu-Dong Chung
January 2017, Volume 40, Issue 1
- 1-2 On the Potential of Preemptive Genotyping Towards Preventing Medication-Related Adverse Events: Results from the South Korean National Health Insurance Database
by Jonathan S. Schildcrout & Joshua C. Denny & Dan M. Roden - 3-14 The Harms of Antipsychotic Drugs: Evidence from Key Studies
by Thomas J. Moore & Curt D. Furberg - 15-36 Pharmaceutical Benefit–Risk Communication Tools: A Review of the Literature
by Dominic Way & Hortense Blazsin & Ragnar Löfstedt & Frederic Bouder - 37-47 Evaluating the Safety Profile of Non-Active Implantable Medical Devices Compared with Medicines
by Josep Pane & Preciosa M. Coloma & Katia M. C. Verhamme & Miriam C. J. M. Sturkenboom & Irene Rebollo - 49-59 Vancomycin-Induced Thrombocytopenia: A Narrative Review
by Mehdi Mohammadi & Zahra Jahangard-Rafsanjani & Amir Sarayani & Molouk Hadjibabaei & Maryam Taghizadeh-Ghehi - 61-64 Proton Pump Inhibitors and Risk of Rhabdomyolysis
by Scott J. Duncan & Colin W. Howden