Drug Safety

2012 - 2025

Current editor(s): Nitin Joshi

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Volume 44, issue 12, 2021

COVID-19 Vaccination in Pregnancy, Paediatrics, Immunocompromised Patients, and Persons with History of Allergy or Prior SARS-CoV-2 Infection: Overview of Current Recommendations and Pre- and Post-Marketing Evidence for Vaccine Efficacy and Safety pp. 1247-1269

Nicoletta Luxi, Alexia Giovanazzi, Annalisa Capuano, Salvatore Crisafulli, Paola Maria Cutroneo, Maria Pia Fantini, Carmen Ferrajolo, Ugo Moretti, Elisabetta Poluzzi, Emanuel Raschi, Claudia Ravaldi, Chiara Reno, Marco Tuccori, Alfredo Vannacci, Giovanna Zanoni and Gianluca Trifirò

Mechanisms, Management and Prevention of Pemetrexed-Related Toxicity pp. 1271-1281

Nikki Rouw, Berber Piet, Hieronymus J. Derijks, Michel M. den Heuvel and Rob Heine

The Effectiveness and Value of Written Medicine Information Across Asia and Africa: Systematic Review pp. 1283-1295

Pitchaya Nualdaisri, Sarah A. Corlett and Janet Krska

Maternal Complications and Prescription Opioid Exposure During Pregnancy: Using Marginal Structural Models pp. 1297-1309

Xuerong Wen, Shuang Wang, Adam K. Lewkowitz, Kristina E. Ward, Erin Christine Brousseau and Kimford J. Meador

Renal Safety of Hydroxyethyl starch 130/0.42 After Cardiac Surgery: A Retrospective Cohort Analysis pp. 1311-1321

Benedict Morath, Andreas D. Meid, Johannes Rickmann, Jasmin Soethoff, Markus Verch, Matthias Karck and Marcin Zaradzki

Dispensing of Potentially Harmful Prescription Drugs in 1.8 Million Pregnant Women in France: A Nationwide Study Based on Two Risk Classification Systems pp. 1323-1339

Pierre-Olivier Blotière, Christine Damase-Michel, Alain Weill and Géric Maura

An Analysis of Spontaneously Reported Data of Vesicular and Bullous Cutaneous Eruptions Occurring Following Vaccination with the Adjuvanted Recombinant Zoster Vaccine pp. 1341-1353

Paola Pirrotta, Fernanda Tavares-Da-Silva, Maribel Co, Nicolas Lecrenier, Caroline Hervé and Jens-Ulrich Stegmann

Long-Term Safety and Tolerability of Fremanezumab for Migraine Preventive Treatment in Japanese Outpatients: A Multicenter, Randomized, Open-Label Study pp. 1355-1364

Fumihiko Sakai, Norihiro Suzuki, Xiaoping Ning, Miki Ishida, Chiharu Usuki, Katsuhiro Iba, Yuki Isogai and Nobuyuki Koga

Repeated or Continuous Medically Supervised Ketamine Administration Associated with Hepatobiliary Adverse Events: A Retrospective Case Series pp. 1365-1374

Samantha Cotter, Jennie Wong, Neha Gada, Rajdeep Gill, S. Christopher Jones, Grace Chai, Daniel Foster, Mark Avigan and Mallika Mundkur

Safety Profile of GSK’s Inactivated Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany and Spain: Passive Enhanced Safety Surveillance Study for the 2019/2020 Influenza Season pp. 1375-1390

Ignacio Salamanca de la Cueva, Elisa Cinconze, Tamara Eckermann, Ugo Nwoji, Lode Godderis, Emily Lu, Xavier Martínez-Gómez, Huajun Wang and Emad Yanni

Volume 44, issue 11, 2021

Inconsistent Safety Outcome Reporting in Randomized Clinical Trials of COVID-19 Vaccines Complicates Informed Medical Decisions pp. 1121-1123

Joseph E. Blais, Yue Wei, Celine S. L. Chui, Esther W. Chan and Ian C. K. Wong

Drug-Induced Liver Injury: Highlights and Controversies in the Recent Literature pp. 1125-1149

Joseph William Clinton, Sara Kiparizoska, Soorya Aggarwal, Stephanie Woo, William Davis and James H. Lewis

Validating Claims-Based Algorithms Determining Pregnancy Outcomes and Gestational Age Using a Linked Claims-Electronic Medical Record Database pp. 1151-1164

Keran Moll, Hui Lee Wong, Kathryn Fingar, Shayan Hobbi, Minya Sheng, Timothy A. Burrell, Linda O. Eckert, Flor M. Munoz, Bethany Baer, Azadeh Shoaibi and Steven Anderson

Identifying Actionability as a Key Factor for the Adoption of ‘Intelligent’ Systems for Drug Safety: Lessons Learned from a User-Centred Design Approach pp. 1165-1178

George I. Gavriilidis, Vlasios K. Dimitriadis, Marie-Christine Jaulent and Pantelis Natsiavas

Role of Drug–Gene Interactions and Pharmacogenetics in Simvastatin-Associated Pulmonary Toxicity pp. 1179-1191

Naomi T. Jessurun, Marjolein Drent, Petal A. Wijnen, Ankie M. Harmsze, Eugène P. Puijenbroek, Otto Bekers and Aalt Bast

Systematising Pharmacovigilance Engagement of Patients, Healthcare Professionals and Regulators: A Practical Decision Guide Derived from the International Risk Governance Framework for Engagement Events and Discourse pp. 1193-1208

Priya Bahri and Antoine Pariente

Cumulative Adverse Event Reporting of Anaphylaxis After mRNA COVID-19 Vaccine (Pfizer-BioNTech) Injections in Japan: The First-Month Report pp. 1209-1214

Toyotaka Iguchi, Hikari Umeda, Michie Kojima, Yuri Kanno, Yuta Tanaka, Natsumi Kinoshita and Daisaku Sato

Surveillance of Antidepressant Safety (SADS): Active Signal Detection of Serious Medical Events Following SSRI and SNRI Initiation Using Big Healthcare Data pp. 1215-1230

Mia Aakjær, Marie Louise Bruin, Murat Kulahci and Morten Andersen

Desloratadine Exposure and Incidence of Seizure: A Nordic Post-authorization Safety Study Using a New-User Cohort Study Design, 2001–2015 pp. 1231-1242

Annette Kjær Ersbøll, Kaushik Sengupta, Eero Pukkala, Kristian Bolin, Eline Aas, Martha Emneus, Dena Rosen Ramey, Joanne E. Brady, Daniel Mines, Kristian Aasbjerg, Christian Vestergaard, Gunnar Gislason, Alfred Peter Born and Thora Majlund Kjærulff

Volume 44, issue 10, 2021

A Multidisciplinary Approach in Pharmacovigilance Awareness: ISoP Egypt Chapter’s MedSafetyWeek Experience pp. 1017-1020

Hadir Rostom, Mohamed A. Elhawary and Islam N. Ali

Eritrean Pharmacovigilance System: Key Strategies, Success Stories, Challenges and Lessons Learned pp. 1021-1032

Mulugeta Russom, Iyassu Bahta and Merhawi Debesai

Use of Primary Care Data in Research and Pharmacovigilance: Eight Scenarios Where Prescription Data are Absent pp. 1033-1040

Grace N. Okoli, Puja Myles, Tarita Murray-Thomas, Hilary Shepherd, Ian C. K. Wong and Duncan Edwards

Drug-Related Problems in Hospitalised Patients with Chronic Kidney Disease: A Systematic Review pp. 1041-1058

Wadia S. Alruqayb, Malcolm J. Price, Vibhu Paudyal and Anthony R. Cox

Patient Global Impression of Benefit–Risk (PGI-BR): Incorporating Patients’ Views of Clinical Benefit–Risk into Assessment of New Medicines pp. 1059-1072

Daniel Eek, Katarina Halling, Emuella Flood, Matthew Blowfield, Oren Meyers, Meredith Venerus, Jean Paty and Richard Hermann

Motives to Report Adverse Drug Reactions to the National Agency: A Survey Study among Healthcare Professionals and Patients in Croatia, The Netherlands, and the UK pp. 1073-1083

Sieta T. de Vries, Petra Denig, Adriana Andrić, Marina Dimov Di Giusti, Alicia Ptaszynska-Neophytou, Linda Härmark and Peter G. M. Mol

Smart Safety Surveillance (3S): Multi-Country Experience of Implementing the 3S Concepts and Principles pp. 1085-1098

Noha Iessa, Viola Macolic Sarinic, Lilit Ghazaryan, Naira Romanova, Asnakech Alemu, Watcharee Rungapiromnan, Porntip Jiamsuchon, Pattreya Pokhagul, Jose Luis Castro, Diego Macias Saint-Gerons, Gayane Ghukasyan, Mengistab Teferi, Madhur Gupta and Shanthi Narayan Pal

Safety of Eslicarbazepine Acetate in Elderly Versus Non-Elderly Patients with Focal Seizures: From Pooled Data of Clinical Studies to 8 Years of Post-Marketing Experience pp. 1099-1107

Luís M. Magalhães, Raquel Costa, Mariana Vieira, Joana Moreira, Helena Gama and Patrício Soares-da-Silva

Clinical Trial and Postmarketing Safety of Onasemnogene Abeparvovec Therapy pp. 1109-1119

John W. Day, Jerry R. Mendell, Eugenio Mercuri, Richard S. Finkel, Kevin A. Strauss, Aaron Kleyn, Sitra Tauscher-Wisniewski, Francis Fonyuy Tukov, Sandra P. Reyna and Deepa H. Chand

Volume 44, issue 9, 2021

A Scoping Review of Non-Medical and Extra-Medical Use of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) pp. 917-928

Rebekah Brennan, Mayyada Wazaify, Haneen Shawabkeh, Ian Boardley, Jim McVeigh and Marie Claire Hout

NSAIDs and COVID-19: A Systematic Review and Meta-analysis pp. 929-938

Nicholas Moore, Pauline Bosco-Levy, Nicolas Thurin, Patrick Blin and Cécile Droz-Perroteau

Augmenting Product Defect Surveillance Through Web Crawling and Machine Learning in Singapore pp. 939-948

Pei San Ang, Desmond Chun Hwee Teo, Sreemanee Raaj Dorajoo, Mukundaram Prem Kumar, Yi Hao Chan, Chih Tzer Choong, Doris Sock Tin Phuah, Dorothy Hooi Myn Tan, Filina Meixuan Tan, Huilin Huang, Maggie Siok Hwee Tan, Michelle Sau Yuen Ng and Jalene Wang Woon Poh

Bayesian Modeling for the Detection of Adverse Events Underreporting in Clinical Trials pp. 949-955

Yves Barmaz and Timothé Ménard

Immune Checkpoint Inhibitors and Cardiotoxicity: An Analysis of Spontaneous Reports in Eudravigilance pp. 957-971

Annamaria Mascolo, Cristina Scavone, Carmen Ferrajolo, Concetta Rafaniello, Romano Danesi, Marzia Re, Antonio Russo, Enrico Coscioni, Francesco Rossi, Roberto Alfano and Annalisa Capuano

Is There an Increased Risk of Hepatotoxicity with Metamizole? A Comparative Cohort Study in Incident Users pp. 973-985

Karin Hedenmalm, Alexandra Pacurariu, Jim Slattery, Xavier Kurz, Gianmario Candore and Rob Flynn

Remdesivir in the COVID-19 Pandemic: An Analysis of Spontaneous Reports in VigiBase During 2020 pp. 987-998

Elena Rocca, Oskar Gauffin, Ruth Savage, Sara Hedfors Vidlin and Birgitta Grundmark

Study of Natural Products Adverse Reactions (SONAR) in Adults with Mental Health Conditions: A Cross-Sectional Study pp. 999-1006

Liliane Zorzela, Baljit Khamba, Emma Sparks, Candace Necyk, Liana Urichuk, Martin A. Katzman, David Koczerginski, Pierre Chue, Joanne Barnes and Sunita Vohra

Comment on: "Proposals for Engaging Patients and Healthcare Professionals in Risk Minimisation from an Analysis of Stakeholder Input to the EU Valproate Assessment Using the Novel Analysing Stakeholder Safety Engagement Tool (ASSET)" pp. 1007-1009

Alain Braillon and Marine Martin

Authors’ Reply to Braillon and Martin’s Comment on “Proposals for Engaging Patients and Healthcare Professionals in Risk Minimisation from an Analysis of Stakeholder Input to the EU Valproate Assessment using the Novel Analysing Stakeholder Safety Engagement Tool (ASSET)” pp. 1011-1013

Priya Bahri, Daniel R. Morales, Adrien Inoubli, Jean-Michel Dogné and Sabine M. J. M. Straus

Correction to: Provision and Need for Medicine Information in Asia and Africa: A Scoping Review of the Literature pp. 1015-1015

Pitchaya Nualdaisri, Sarah A. Corlett and Janet Krska

Volume 44, issue 8, 2021

Monitoring and Managing Lorlatinib Adverse Events in the Portuguese Clinical Setting: A Position Paper pp. 825-834

Fernando Barata, Carlos Aguiar, Tiago Reis Marques, José Bravo Marques and Venceslau Hespanhol

The Role of the Contextual Cohort to Resolve Some Challenges and Limitations of Comparisons in Pharmacoepidemiology pp. 835-841

Vicki Osborne, Samantha Lane and Saad A. W. Shakir

Enhancing Pharmacovigilance from the US Experience: Current Practices and Future Opportunities pp. 843-852

Veronique F. Kugener, Eric S. Freedland, Kenneth I. Maynard, Omar Aimer, Peggy S. Webster, Maribel Salas and Maxine Gossell-Williams

Capturing Data in Rare Disease Registries to Support Regulatory Decision Making: A Survey Study Among Industry and Other Stakeholders pp. 853-861

Carla J. Jonker, Sieta T. Vries, H. Marijke Berg, Patricia McGettigan, Arno W. Hoes and Peter G. M. Mol

Association Between Prenatal Opioid Exposure and Neurodevelopmental Outcomes in Early Childhood: A Retrospective Cohort Study pp. 863-875

Xuerong Wen, Oluwadolapo D. Lawal, Nicholas Belviso, Kelly L. Matson, Shuang Wang, Brian J. Quilliam and Kimford J. Meador

Prevalence, Nature, Severity and Preventability of Adverse Drug Events in Mental Health Settings: Findings from the MedicAtion relateD harm in mEntal health hospitals (MADE) Study pp. 877-888

Ghadah H. Alshehri, Darren M. Ashcroft, Joanne Nguyen, Mark Hann, Richard Jones, Kristof Seaton, Graham Newton and Richard N. Keers

Reporting of Thromboembolic Events with JAK Inhibitors: Analysis of the FAERS Database 2010–2019 pp. 889-897

Juliana Setyawan, Nassir Azimi, Vibeke Strand, Andres Yarur and Moshe Fridman

Cardiovascular Risk in Users of Mirabegron Compared with Users of Antimuscarinic Treatments for Overactive Bladder: Findings from a Non-Interventional, Multinational, Cohort Study pp. 899-915

Veena Hoffman, Jesper Hallas, Marie Linder, Andrea V. Margulis, Brandon T. Suehs, Alejandro Arana, Kelesitse Phiri, Cheryl Enger, Libby Horter, Ingvild Odsbu, Morten Olesen, Susana Perez-Gutthann, Yihua Xu, Nina Sahlertz Kristiansen, Kwame Appenteng, Stefan de Vogel and John D. Seeger

Volume 44, issue 7, 2021

Emerging Skin Toxicities in Patients with Breast Cancer Treated with New Cyclin-Dependent Kinase 4/6 Inhibitors: A Systematic Review pp. 725-732

Martina Silvestri, Antonio Cristaudo, Aldo Morrone, Claudia Messina, Luigi Bennardo, Steven Paul Nisticò, Maria Mariano and Norma Cameli

Risk Minimization of Antibody–Drug Conjugates in Oncology: A Review pp. 733-742

Fabio A. Lievano, Linda J. Scarazzini, Jerzy E. Tyczynski, Charles M. Schubert and Cheryl L. Renz

A Multi-modal Approach to Evaluate the Impact of Risk Evaluation and Mitigation Strategy (REMS) Programs pp. 743-751

Ameet Sarpatwari, Mayookha Mitra-Majumdar, Katsiaryna Bykov, Jerry Avorn, Steven Woloshin, Gita A. Toyserkani, Cynthia LaCivita, Claudia Manzo, Esther H. Zhou, Ellen Pinnow, Gerald J. Dal Pan, Joshua J. Gagne, Krista F. Huybrechts, William B. Feldman, Kristyn Chin and Aaron S. Kesselheim

Risk of Severe Abnormal Uterine Bleeding Associated with Rivaroxaban Compared with Apixaban, Dabigatran and Warfarin pp. 753-763

Efe Eworuke, Laura Hou, Rongmei Zhang, Hui-Lee Wong, Peter Waldron, Abby Anderson, Audrey Gassman, David Moeny and Ting-Ying Huang

Signal Detection in EUROmediCAT: Identification and Evaluation of Medication–Congenital Anomaly Associations and Use of VigiBase as a Complementary Source of Reference pp. 765-785

Alana Cavadino, Lovisa Sandberg, Inger Öhman, Tomas Bergvall, Kristina Star, Helen Dolk, Maria Loane, Marie-Claude Addor, Ingeborg Barisic, Clara Cavero-Carbonell, Ester Garne, Miriam Gatt, Babak Khoshnood, Kari Klungsøyr, Anna Latos-Bielenska, Nathalie Lelong, Reneé Lutke, Anna Materna-Kiryluk, Vera Nelen, Amanda Nevill, Mary O’Mahony, Olatz Mokoroa, Anna Pierini, Hanitra Randrianaivo, Anke Rissmann, David Tucker, Awi Wiesel, Lyubov Yevtushok and Joan K Morris

Risk of Pregnancy Termination and Congenital Anomalies After Domperidone Exposure: A Study in the EFEMERIS Database pp. 787-796

Mélanie Araujo, Clémentine Vabre, Justine Benevent, Agnès Sommet, Christine Damase-Michel, Caroline Hurault-Delarue and Isabelle Lacroix

Comparison of Longitudinal and Cross-Sectional Approaches in Studies About Knowledge, Attitude, and Practices Related to Antibiotic Misuse pp. 797-809

Narmeen Mallah, Adolfo Figueiras and Bahi Takkouche

Safety Profile of the Adjuvanted Recombinant Zoster Vaccine in Immunocompromised Populations: An Overview of Six Trials pp. 811-823

Marta López-Fauqued, Maribel Co- van der Mee, Adriana Bastidas, Pierre Beukelaers, Alemnew F. Dagnew, Juan Jose Fernandez Garcia, Anne Schuind and Fernanda Tavares-da-Silva

Volume 44, issue 6, 2021

The International Society of Pharmacovigilance (ISoP) Pharmacogenomic Special Interest Group: Pharmacogenomics in Pharmacovigilance pp. 615-617

Qun-Ying Yue

Overview of Causality Assessment for Drug-Induced Liver Injury (DILI) in Clinical Trials pp. 619-634

Juliana Hey-Hadavi, Daniel Seekins, Melissa Palmer, Denise Coffey, John Caminis, Sandzhar Abdullaev, Meenal Patwardhan, Haifa Tyler, Ritu Raheja, Ann Marie Stanley, Liliam Pineda-Salgado, David L. Bourdet, Raul J. Andrade, Paul H. Hayashi, Lara Dimick-Santos, Don C. Rockey and Alvin Estilo

Safety and Efficacy of Ivermectin and Doxycycline Monotherapy and in Combination in the Treatment of COVID-19: A Scoping Review pp. 635-644

Subhrojyoti Bhowmick, Amit Dang, B. N. Vallish and Sumit Dang

Safety of S1P Modulators in Patients with Immune-Mediated Diseases: A Systematic Review and Meta-Analysis pp. 645-660

Juan S. Lasa, Pablo A. Olivera, Stefanos Bonovas, Silvio Danese and Laurent Peyrin-Biroulet

Comparison of Medication Alerts from Two Commercial Applications in the USA pp. 661-668

Sonam N. Shah, Diane L. Seger, Julie M. Fiskio, John R. Horn and David W. Bates

Liver Injury Associated with Metamizole Exposure: Features of an Underestimated Adverse Event pp. 669-680

Sabine Weber, Andreas Benesic, Jens Neumann and Alexander L. Gerbes

The Use of Subgroup Disproportionality Analyses to Explore the Sensitivity of a Global Database of Individual Case Safety Reports to Known Pharmacogenomic Risk Variants Common in Japan pp. 681-697

Rika Wakao, Ingrid M. Lönnstedt, Yasunori Aoki and Rebecca E. Chandler

Signal Detection and Methodological Limitations in a Real-World Registry: Learnings from the Evaluation of Long-Term Safety Analyses in PSOLAR pp. 699-709

Robert Bissonnette, Alice B. Gottlieb, Richard G. Langley, Craig L. Leonardi, Kim A. Papp, David M. Pariser, Jonathan Uy, Kim Parnell Lafferty, Wayne Langholff, Steven Fakharzadeh, Jesse A. Berlin, Emily S. Brouwer, Andrew J. Greenspan and Bruce E. Strober

The Safety Profile of Upadacitinib in Patients with Rheumatoid Arthritis in Japan pp. 711-722

Kunihiro Yamaoka, Yoshiya Tanaka, Hideto Kameda, Nasser Khan, Nobuhito Sasaki, Masayoshi Harigai, Yanna Song, Ying Zhang and Tsutomu Takeuchi

Correction to: Enhancing Pharmacovigilance in Sub-Saharan Africa Through Training and Mentoring: A GSK Pilot Initiative in Malawi pp. 723-723

Viviane Jusot, Frider Chimimba, Nettie Dzabala, Olga Menang, Joy Cole, Gregory Gardiner, Opokua Ofori-Anyinam, Olakunle Oladehin, Cecilia Sambakunsi, Mphatso Kawaye, Jens-Ulrich Stegmann and Yolanda Guerra Mendoza

Volume 44, issue 5, 2021

An Update of the North American Chapter of the International Society of Pharmacovigilance (NASoP) pp. 511-513

Maxine Gossell-Williams, Veronique F. Kugener, Maribel Salas, Kenneth I. Maynard and Abimbola Cole

Upadacitinib in Rheumatoid Arthritis: A Benefit–Risk Assessment Across a Phase III Program pp. 515-530

Philip G. Conaghan, Eduardo Mysler, Yoshiya Tanaka, Barbara Silva-Tillmann, Tim Shaw, John Liu, Ryan Ferguson, Jeffrey V. Enejosa, Stanley Cohen, Peter Nash, William Rigby and Gerd Burmester

Population-Based Observational Study of Adverse Drug Event-Related Mortality in the Super-Aged Society of Japan pp. 531-539

Tomoko Funahashi, Toshihiro Koyama, Hideharu Hagiya, Ko Harada, Syunya Iinuma, Soichiro Ushio, Yoshito Zamami, Takahiro Niimura, Kazuaki Shinomiya, Keisuke Ishizawa, Toshiaki Sendo, Shiro Hinotsu and Mitsunobu R. Kano

Identification and Validation of Major Cardiovascular Events in the United Kingdom Data Sources Included in a Multi-database Post-authorization Safety Study of Prucalopride pp. 541-551

Ana Ruigómez, Estel Plana, Alicia Gilsenan, Joan Fortuny, Miguel Cainzos-Achirica, Robert W. V. Flynn, Thomas M. MacDonald, Luis Garcia-Rodriguez, Ryan Ziemiecki and Elizabeth B. Andrews

Public Perspectives of Using Social Media Data to Improve Adverse Drug Reaction Reporting: A Mixed-Methods Study pp. 553-564

Alexander Bulcock, Lamiece Hassan, Sally Giles, Caroline Sanders, Goran Nenadic, Stephen Campbell and Will Dixon

Anticholinergic Activity of Psychotropic Drugs and Cognitive Impairment Among Participants Aged 45 and Over: The CONSTANCES Study pp. 565-579

Abdelkrim Ziad, Claudine Berr, Fabrice Ruiz, Bernard Bégaud, Cédric Lemogne, Marcel Goldberg, Marie Zins and Thibault Mura

Adverse Drug Reactions from Real-World Data in Inflammatory Bowel Disease Patients in the IBDREAM Registry pp. 581-588

Eline L. Giraud, Pepijn W. A. Thomas, Jette A. Lint, Eugene P. Puijenbroek, Tessa E. H. Römkens, Rachel L. West, Maurice G. V. M. Russel, Jeroen M. Jansen, Naomi T. Jessurun and Frank Hoentjen

Assessing the Impact on Health of Pharmacovigilance Activities: Example of Four Safety Signals pp. 589-600

Florence Hunsel, Laura Peters, Helga Gardarsdottir and Agnes Kant

Clinical Utility of Pharmacogenomic Data Collected by a Health-System Biobank to Predict and Prevent Adverse Drug Events pp. 601-607

Sonam N. Shah, Roseann S. Gammal, Mary G. Amato, Maryam Alobaidly, Dariel Delos Reyes, Sarah Hasan, Diane L. Seger, Joel B. Krier and David W. Bates

Comment on: Frequency and Associated Costs of Anaphylaxis- and Hypersensitivity-Related Adverse Events for Intravenous Iron Products in the USA: An Analysis Using the US Food and Drug Administration Adverse Event Reporting System pp. 609-610

Michael Auerbach

Authors’ Reply to Michael Auerbach’s Comment on: “Frequency and Associated Costs of Anaphylaxis- and Hypersensitivity-Related Adverse Events for Intravenous Iron Products in the USA: An Analysis Using the US Food and Drug Administration Adverse Event Reporting System” pp. 611-613

Henry Trumbo, Karolina Kaluza, Syed Numan and Lawrence T. Goodnough

Volume 44, issue 4, 2021

Safety Consequences of Off-Label Drugs Used for COVID-19 pp. 399-402

Nabarun Dasgupta

ISoP Fellowships: Recognising and Promoting Leaders in Pharmacovigilance pp. 403-404

Deirdre McCarthy

French Pharmacovigilance Public System and COVID-19 Pandemic pp. 405-408

Aurélie Grandvuillemin, Milou-Daniel Drici, Annie Pierre Jonville-Bera, Joelle Micallef and Jean Louis Montastruc

Risk Management for the 21st Century: Current Status and Future Needs pp. 409-419

Rania Mouchantaf, Doris Auth, Yola Moride, June Raine, Soon Young Han and Meredith Y. Smith

Provision and Need for Medicine Information in Asia and Africa: A Scoping Review of the Literature pp. 421-437

Pitchaya Nualdaisri, Sarah A. Corlett and Janet Krska

The DIANA Study: Continued Access to Darunavir/Ritonavir (DRV/r) and Long-Term Safety Follow-Up in HIV-1-Infected Pediatric Patients Aged 3 to pp. 439-446

Avy Violari, Maysseb Masenya, Stephane Blanche, Simon Vanveggel, Veerle Hufkens, Polan Chetty and Magda Opsomer

Real-World Fetal Exposure to Acne Treatments in the United States: A Retrospective Analysis from 2006 to 2015 pp. 447-454

Yasser Albogami, Amir Sarayani, Juan M. Hincapie-Castillo and Almut G. Winterstein

Evaluation of the Risk of Inflammatory Bowel Disease after the HPV Vaccination in Primary Care in Spain: A Time-Varying Cohort Analysis of Around 390,000 Girls pp. 455-466

Elisa Martín-Merino, Belén Castillo-Cano, Mar Martín-Pérez, Ana Llorente-García and Dolores Montero-Corominas

Safety of As-Needed Budesonide-Formoterol in Mild Asthma: Data from the Two Phase III SYGMA Studies pp. 467-478

J. Mark FitzGerald, Paul M. O’Byrne, Eric D. Bateman, Peter J. Barnes, Jinping Zheng, Stefan Ivanov, Rosa Lamarca, Ulrika Larsdotter, Ulrika Emerath, Gerreke Jansen, Margareta Puu, Vijay K. T. Alagappan, Filip Surmont and Helen K. Reddel

Comparative Risk Assessment of Severe Uterine Bleeding Following Exposure to Direct Oral Anticoagulants: A Network Study Across Four Observational Databases in the USA pp. 479-497

James Weaver, Azza Shoaibi, Huy Q. Truong, Leila Larbi, Shujian Wu, Peter Wildgoose, Gowtham Rao, Amy Freedman, Lu Wang, Zhong Yuan and Elliot Barnathan

Communicating About Risks and Safe Use of Medicines pp. 499-501

I. Ralph Edwards

Comment on: “Direct Oral Anticoagulants and Interstitial Lung Disease: Emerging Clues from Pharmacovigilance” pp. 503-504

Robert P. Giugliano, Raffaele De Caterina and Takeshi Yamashita

Authors’ Reply to Robert P. Giugliano and Colleagues’ Comment on: “Direct Oral Anticoagulants and Interstitial Lung Disease: Emerging Clues from Pharmacovigilance” pp. 505-506

Emanuel Raschi, Michele Fusaroli, Igor Diemberger and Elisabetta Poluzzi

Correction to: Assessing the Safety of COVID-19 Vaccines: A Primer pp. 507-507

Helen Petousis-Harris

Volume 44, issue 3, 2021

Validating Intelligent Automation Systems in Pharmacovigilance: Insights from Good Manufacturing Practices pp. 261-272

Kristof Huysentruyt, Oeystein Kjoersvik, Pawel Dobracki, Elizabeth Savage, Ellen Mishalov, Mark Cherry, Eileen Leonard, Robert Taylor, Bhavin Patel and Danielle Abatemarco

Safety of N-Acetylcysteine at High Doses in Chronic Respiratory Diseases: A Review pp. 273-290

Peter Calverley, Paola Rogliani and Alberto Papi

A Systematic Review and Meta-Analysis Considering the Risk for Congenital Heart Defects of Antidepressant Classes and Individual Antidepressants pp. 291-312

Courtney De Vries, Svetla Gadzhanova, Matthew J. Sykes, Michael Ward and Elizabeth Roughead

An Algorithm for Comprehensive Medication Management in Nursing Homes: Results of the AMBER Project pp. 313-325

Susanne Erzkamp, Juliane Köberlein-Neu and Olaf Rose

Changes in Erythropoiesis Stimulating Agent Use Under a Risk Evaluation and Mitigation Strategy (REMS) Program pp. 327-335

Ameet Sarpatwari, Mengdong He, Frazer A. Tessema, Joshua J. Gagne and Aaron S. Kesselheim

PCSK9 Inhibitors and Neurocognitive Adverse Drug Reactions: Analysis of Individual Case Safety Reports from the Eudravigilance Database pp. 337-349

Gabriella di Mauro, Alessia Zinzi, Cristina Scavone, Annamaria Mascolo, Mario Gaio, Liberata Sportiello, Carmen Ferrajolo, Concetta Rafaniello, Francesco Rossi and Annalisa Capuano

Evaluation of Opioid Overdose Reports in Patients Treated with Extended-Release Naltrexone: Postmarketing Data from 2006 to 2018 pp. 351-359

Priya Jain, Kimberley McKinnell, Rose Marino, Prashanthi Vunnava, Marie A. Liles-Burden, Avani Desai, Madé Wenten, James Fratantonio, Sarah C. Akerman, Maria A. Sullivan and Gary Bloomgren

Risk of Cancer in Association with Ranitidine and Nizatidine vs Other H2 Blockers: Analysis of the Japan Medical Data Center Claims Database 2005–2018 pp. 361-371

Masao Iwagami, Ryosuke Kumazawa, Yoshihisa Miyamoto, Yuri Ito, Miho Ishimaru, Kojiro Morita, Shota Hamada, Nanako Tamiya and Hideo Yasunaga

Developing Crowdsourced Training Data Sets for Pharmacovigilance Intelligent Automation pp. 373-382

Alex Gartland, Andrew Bate, Jeffery L. Painter, Tim A. Casperson and Gregory Eugene Powell

Incidence Rates of Autoimmune Diseases in European Healthcare Databases: A Contribution of the ADVANCE Project pp. 383-395

Corinne Willame, Caitlin Dodd, Lieke van der Aa, Gino Picelli, Hanne-Dorthe Emborg, Johnny Kahlert, Rosa Gini, Consuelo Huerta, Elisa Martín-Merino, Chris McGee, Simon Lusignan, Giuseppe Roberto, Marco Villa, Daniel Weibel, Lina Titievsky and Miriam C. J. M. Sturkenboom

Correction to: DNA Barcoding and Pharmacovigilance of Herbal Medicines pp. 397-397

Hugo J. Boer, Mihael C. Ichim and Steven G. Newmaster

Volume 44, issue 2, 2021

Artificial Intelligence, Real-World Automation and the Safety of Medicines pp. 125-132

Andrew Bate and Steve F. Hobbiger

Consensus Guidelines: Best Practices for Detection, Assessment and Management of Suspected Acute Drug-Induced Liver Injury During Clinical Trials in Adults with Chronic Viral Hepatitis and Adults with Cirrhosis Secondary to Hepatitis B, C and Nonalcoholic Steatohepatitis pp. 133-165

William R. Treem, Melissa Palmer, Isabelle Lonjon-Domanec, Daniel Seekins, Lara Dimick-Santos, Mark I. Avigan, John F. Marcinak, Ajit Dash, Arie Regev, Eric Maller, Meenal Patwardhan, James H. Lewis, Don C. Rockey, Adrian M. Bisceglie, James W. Freston, Raul J. Andrade and Naga Chalasani

A Comparative View of Reported Adverse Effects of Statins in Social Media, Regulatory Data, Drug Information Databases and Systematic Reviews pp. 167-179

Susan Golder, Karen Smith, Karen O’Connor, Robert Gross, Sean Hennessy and Graciela Gonzalez-Hernandez

Patient Organizations’ Barriers in Pharmacovigilance and Strategies to Stimulate Their Participation pp. 181-191

Katherine Chinchilla, Cristiano Matos, Victoria Hall and Florence Hunsel

Proposals for Engaging Patients and Healthcare Professionals in Risk Minimisation from an Analysis of Stakeholder Input to the EU Valproate Assessment Using the Novel Analysing Stakeholder Safety Engagement Tool (ASSET) pp. 193-209

Priya Bahri, Daniel R. Morales, Adrien Inoubli, Jean-Michel Dogné and Sabine M. J. M. Straus

Patient-Reported Adverse Events of Radiopharmaceuticals: A Prospective Study of 1002 Patients pp. 211-222

Nanno Schreuder, Niels A. Jacobs, Pieter L. Jager, Jos G. W. Kosterink and Eugène P. Puijenbroek

Adverse Drug Reaction Reporting Using a Mobile Device Application by Persons with Multiple Sclerosis: A Cluster Randomized Controlled Trial pp. 223-233

Gilles Defer, Sophie Fedrizzi, Damien Chevanne, François Montastruc, Anais R. Briant, Jean-Jacques Parienti and Laure Peyro-Saint-Paul

Real-World Data on Nonmedical Use of Tramadol from Patients Evaluated for Substance Abuse Treatment in the NAVIPPRO Addiction Severity Index—Multimedia Version (ASI-MV®) Network pp. 235-244

Jody L. Green, Taryn Dailey-Govoni and Stephen F. Butler

Use of Hydrochlorothiazide and Risk of Melanoma and Nonmelanoma Skin Cancer pp. 245-254

Julie Rouette, Hui Yin, Anton Pottegård, Krishnarajah Nirantharakumar and Laurent Azoulay

Sex Differences in Lopinavir Concentrations and Occurrence of Marked QTc Prolongation Episodes in Patients with COVID-19 pp. 255-257

Catia Marzolini, Felix Stader, Anne Leuppi-Taegtmeyer, Marcel Stoeckle, Manuel Battegay and Parham Sendi

Correction to: A Comparative View of Reported Adverse Effects of Statins in Social Media, Regulatory Data, Drug Information Databases and Systematic Reviews pp. 259-259

Susan Golder, Karen Smith, Karen O’Connor, Robert Gross, Sean Hennessy and Graciela Gonzalez-Hernandez

Volume 44, issue 1, 2021

How to Investigate a Serious Adverse Event Reported During a Clinical Trial for a COVID-19 Vaccine pp. 1-5

Saad Shakir, Samantha Lane and Miranda Davies

Chances and Challenges of Registry-Based Pharmacovigilance in Multiple Sclerosis: Lessons Learnt from the Implementation of the Multicenter REGIMS Registry pp. 7-15

Alexandra Simbrich, Jasmine Thibaut, Laura Khil, Stanislav Maximov, Heinz Wiendl and Klaus Berger

Effective Pharmacovigilance System Development: EFPIA-IPVG Consensus Recommendations pp. 17-28

Tanja Peters, Nigel Soanes, Maya Abbas, Jabeen Ahmad, Jean-Christophe Delumeau, Esteban Herrero-Martinez, Mélanie Paramananda, Johanna Piper, Fairouz Smail-Aoudia, Willemijn Spuij, Tina Veizovic and Gillian Winstanley

Efficacy and Safety of Bevacizumab Plus Oxaliplatin- or Irinotecan-Based Doublet Backbone Chemotherapy as the First-Line Treatment of Metastatic Colorectal Cancer: A Systematic Review and Meta-analysis pp. 29-40

Tianshu Ren, Shu Wang, Zexu Shen, Chang Xu, Yingshi Zhang, Fuhai Hui, Xingshun Qi and Qingchun Zhao

Understanding and Responding to Prescribing Patterns of Sodium Valproate-Containing Medicines in Pregnant Women and Women of Childbearing Age in Western Cape, South Africa pp. 41-51

Ushma Mehta, Mariette Smith, Emma Kalk, Helen Hayes, Annoesjka Swart, Lawrence Tucker, Renier Coetzee, Andrew Boulle and Marc Blockman

Patterns of Benzodiazepine Use and Excess Risk of All-Cause Mortality in the Elderly: A Nationwide Cohort Study pp. 53-62

Clément Mathieu, Pierre Joly, Hélène Jacqmin-Gadda, Mathilde Wanneveich, Bernard Bégaud and Antoine Pariente

Introduction or Discontinuation of Additional Risk Minimisation Measures During the Life Cycle of Medicines in Europe pp. 63-72

Reynold D. C. Francisca, Emna Baba, Christina E. Hoeve, Inge M. Zomerdijk, Miriam C. J. M. Sturkenboom and Sabine M. J. M. Straus

Dissemination of Direct Healthcare Professional Communications on Medication Errors for Medicinal Products in the EU: An Explorative Study on Relevant Factors pp. 73-82

Christina E. Hoeve, Esther Vries, Peter G. M. Mol, Miriam C. J. M. Sturkenboom and Sabine M. J. M. Straus

ADE Eval: An Evaluation of Text Processing Systems for Adverse Event Extraction from Drug Labels for Pharmacovigilance pp. 83-94

Samuel Bayer, Cheryl Clark, Oanh Dang, John Aberdeen, Sonja Brajovic, Kimberley Swank, Lynette Hirschman and Robert Ball

Global Safety Database Summary of COVID-19-Related Drug Utilization-Safety Surveillance: A Sponsor’s Perspective pp. 95-105

Elena Beyzarov, Yan Chen, Rob Julg, Karen Naim, Jigna Shah, William W. Gregory, Ayman Ayoub and Patrick Caubel

Frequency and Associated Costs of Anaphylaxis- and Hypersensitivity-Related Adverse Events for Intravenous Iron Products in the USA: An Analysis Using the US Food and Drug Administration Adverse Event Reporting System pp. 107-119

Henry Trumbo, Karolina Kaluza, Syed Numan and Lawrence T. Goodnough

Follow-up on the Use of Advanced Analytics for Clinical Quality Assurance: Bootstrap Resampling to Enhance Detection of Adverse Event Under-Reporting pp. 121-123

Björn Koneswarakantha, Yves Barmaz, Timothé Ménard and Donato Rolo