Drug Safety

2012 - 2025

Current editor(s): Nitin Joshi

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Volume 45, issue 12, 2022

Gastrointestinal Bleeding on Oral Anticoagulation: What is Currently Known pp. 1449-1456

Arnar B. Ingason, Johann P. Hreinsson and Einar S. Björnsson

Prevalence, Causes and Severity of Medication Administration Errors in the Neonatal Intensive Care Unit: A Systematic Review and Meta-Analysis pp. 1457-1476

Josephine Henry Basil, Chandini Menon Premakumar, Adliah Mhd Ali, Nurul Ain Mohd Tahir and Noraida Mohamed Shah

mRNA (BNT162b2) and Inactivated (CoronaVac) COVID-19 Vaccination and Risk of Adverse Events and Acute Diabetic Complications in Patients with Type 2 Diabetes Mellitus: A Population-Based Study pp. 1477-1490

Eric Yuk Fai Wan, Celine Sze Ling Chui, Anna Hoi Ying Mok, Wanchun Xu, Vincent Ka Chun Yan, Francisco Tsz Tsun Lai, Xue Li, Carlos King Ho Wong, Esther Wai Yin Chan, David Tak Wai Lui, Kathryn Choon Beng Tan, Ivan Fan Ngai Hung, Cindy Lo Kuen Lam, Gabriel Matthew Leung and Ian Chi Kei Wong

Characterization of Serous Retinopathy Associated with Cobimetinib: Integrated Safety Analysis of Four Studies pp. 1491-1499

Giulio Barteselli, Grant R. Goodman, Yogesh Patel, Ivor Caro, Cloris Xue and Samuel McCallum

Detectability of Medication Errors With a STOPP/START-Based Medication Review in Older People Prior to a Potentially Preventable Drug-Related Hospital Admission pp. 1501-1516

Bastiaan T. G. M. Sallevelt, Toine C. G. Egberts, Corlina J. A. Huibers, Jimmy Ietswaart, A. Clara Drenth- van Maanen, Emma Jennings, Cian O’Mahony, Katharina Tabea Jungo, Martin Feller, Nicolas Rodondi, François-Xavier Sibille, Anne Spinewine, Eugène P. Puijenbroek, Ingeborg Wilting and Wilma Knol

Topiramate Utilization After Phentermine/Topiramate Approval for Obesity Management: Risk Minimization in the Era of Drug Repurposing pp. 1517-1527

Amir Sarayani, Christian Hampp, Joshua D. Brown, William Troy Donahoo and Almut G. Winterstein

Comparison of the MOdified NARanjo Causality Scale (MONARCSi) for Individual Case Safety Reports vs. a Reference Standard pp. 1529-1538

Shaun M. Comfort, Bruce Donzanti, Darren Dorrell, Sunita Dhar, Chris Eden and Francis Donaldson

Withdrawal Syndrome Following Discontinuation of 28 Antidepressants: Pharmacovigilance Analysis of 31,688 Reports from the WHO Spontaneous Reporting Database pp. 1539-1549

Chiara Gastaldon, Georgios Schoretsanitis, Elena Arzenton, Emanuel Raschi, Davide Papola, Giovanni Ostuzzi, Ugo Moretti, Erich Seifritz, John M. Kane, Gianluca Trifirò and Corrado Barbui

Comment on: "A Disproportionality Analysis of Drug–Drug Interactions of Tizanidine and CYP1A2 Inhibitors from the FDA Adverse Event Reporting System (FAERS)" pp. 1551-1552

Yoshihiro Noguchi

Authors’ Response to Yoshihiro Noguchi’s Comment on: “A Disproportionality Analysis of Drug-Drug Interactions of Tizanidine and CYP1A2 Inhibitors from the FDA Adverse Event Reporting System (FAERS)” pp. 1553-1555

Daniel C. Malone, Lorenzo Villa-Zapata, Ainhoa Gómez-Lumbreras, John Horn, Malinda S. Tan and Richard D. Boyce

Volume 45, issue 11, 2022

Therapeutic Management of Idiosyncratic Drug-Induced Liver Injury and Acetaminophen Hepatotoxicity in the Paediatric Population: A Systematic Review pp. 1329-1348

Hao Niu, Edmond Atallah, Ismael Alvarez-Alvarez, Inmaculada Medina-Caliz, Guruprasad P. Aithal, Cigdem Arikan, Raul J. Andrade and M. Isabel Lucena

Efficacy and Safety of Anticoagulants in Patients with Atrial Fibrillation and History of Falls or Risk of Falls: A Systematic Review and Multilevel Meta-Analysis pp. 1349-1362

Thibaut Galvain, Ruaraidh Hill, Sarah Donegan, Paulo Lisboa, Gregory Y. H. Lip and Gabriela Czanner

Lost in Translation: A Multilingual Survey of Interlinguistic Variations in Terms Used in Pharmacovigilance pp. 1363-1368

Jeffrey K. Aronson

Factors Influencing Preferences and Responses Towards Drug Safety Communications: A Conjoint Experiment Among Hospital-Based Healthcare Professionals in the Netherlands pp. 1369-1380

Esther Vries, Elisabeth Bakker, Taco B. M. Monster, Petra Denig and Peter G. M. Mol

Pediatric Drug Safety Surveillance: A 10-Year Analysis of Adverse Drug Reaction Reporting Data in Calabria, Southern Italy pp. 1381-1402

Christian Leporini, Caterina Sarro, Caterina Palleria, Iolanda Caccavo, Brunella Piro, Rita Citraro and Giovambattista Sarro

Safety of Apremilast in Patients with Psoriasis and Psoriatic Arthritis: Findings from the UK Clinical Practice Research Datalink pp. 1403-1411

Rebecca Persson, Myriam Cordey, Maria Paris and Susan Jick

Medicine-Induced Acute Kidney Injury Findings from Spontaneous Reporting Systems, Sequence Symmetry Analysis and a Case–Control Study with a Focus on Medicines Used in Primary Care pp. 1413-1421

Elizabeth E. Roughead, Mhairi Kerr, Anna Moffat, Gizat M. Kassie and Nicole Pratt

Network Analysis for Signal Detection in Spontaneous Adverse Event Reporting Database: Application of Network Weighting Normalization to Characterize Cardiovascular Drug Safety pp. 1423-1438

Mátyás Pétervári, Bettina Benczik, Olivér M. Balogh, Balázs Petrovich, Bence Ágg and Péter Ferdinandy

Correction to: Assessing Case Fatality on Cases of Thrombosis with Concurrent Thrombocytopenia Following COVID-19 Vaccine AstraZeneca (Vaxzevria) in the United Kingdom: A Review of Spontaneously Reported Data pp. 1439-1440

Samantha Lane and Saad Shakir

Volume 45, issue 10, 2022

Conundrum of Clinical QTc Monitoring pp. 1011-1014

Marek Malik

How Important is Gender in Leadership in Pharmacovigilance? Personal Reflections from the First Female President of the International Society of Pharmacovigilance pp. 1015-1018

Mira Harrison-Woolrych

High-Dose Intravenous Iron with Either Ferric Carboxymaltose or Ferric Derisomaltose: A Benefit-Risk Assessment pp. 1019-1036

Johannes M. M. Boots and Rogier A. M. Quax

Use of Electrocardiogram Monitoring in Adult Patients Taking High-Risk QT Interval Prolonging Medicines in Clinical Practice: Systematic Review and Meta-analysis pp. 1037-1048

Marijana Putnikovic, Zoe Jordan, Zachary Munn, Corey Borg and Michael Ward

Impact of Vaccine Hesitancy on Onset, Severity and Type of Self-reported Adverse Events: A French Cross-Sectional Survey pp. 1049-1056

Charles Khouri, Ayoub Larabi, Pierre Verger, Fatima Gauna, Jean-Luc Cracowski and Jeremy Ward

Analytical Approaches to Reduce Selection Bias in As-Treated Analyses with Missing In-Hospital Drug Information pp. 1057-1067

Yeon-Hee Baek, Yunha Noh, In-Sun Oh, Han Eol Jeong, Kristian B. Filion, Hyesung Lee and Ju-Young Shin

Prescribing Patterns of Codeine and Alternative Medicines in Children in Europe pp. 1069-1081

Kelly Plueschke, Robert Flynn, Karin Hedenmalm, Aikaterini-Christina Deli, Miguel-Angel Maciá-Martinez, Patricia García-Poza, David Olsen, Pierre Nguyen and Chantal Quinten

Factors Contributing to Best Practices for Patient Involvement in Pharmacovigilance in Europe: A Stakeholder Analysis pp. 1083-1098

Monica Hoof, Katherine Chinchilla, Linda Härmark, Cristiano Matos, Pedro Inácio and Florence Hunsel

A Prospective Observational Study on BBV152 Coronavirus Vaccine Use in Adolescents and Comparison with Adults: Interim Results of the First Real-World Safety Analysis pp. 1099-1109

Upinder Kaur, Anju K.l, Mayank Chauhan, Aditi Joshi, Agniva Das, Sangeeta Kansal, Vaibhav Jaisawal, Kishor Patwardhan and Sankha Shubhra Chakrabarti

Volume 45, issue 9, 2022

Pancreas and Adverse Drug Reactions: A Literature Review pp. 929-939

Konrad Sosnowski, Piotr Nehring and Adam Przybyłkowski

Impact of Policy Interventions on Oxycodone Prescribing in Queensland, Australia: An Uncontrolled Interrupted Time Series Study pp. 941-949

William Tumusiime, Caitlin Hardman and Elizabeth McCourt

Anti-tumor Necrosis Factor-Alpha Therapy and Hypoglycemia: A Real-World Pharmacovigilance Analysis pp. 951-959

Yu Zhou, Wenhuo Xie, Linyao Wang, Xinyan Zhu, Jianbin Li, Libin Liu, Shuaijun Zhu and Lijing Wang

BAHAMA: A Bayesian Hierarchical Model for the Detection of MedDRA®-Coded Adverse Events in Randomized Controlled Trials pp. 961-970

Alma Revers, Michel H. Hof and Aeilko H. Zwinderman

Patient-Reported Reasons for Switching or Discontinuing Statin Therapy: A Mixed Methods Study Using Social Media pp. 971-981

Susan Golder, Davy Weissenbacher, Karen O’Connor, Sean Hennessy, Robert Gross and Graciela Gonzalez Hernandez

Cardiovascular Risks of Diclofenac Versus Other Older COX-2 Inhibitors (Meloxicam and Etodolac) and Newer COX-2 Inhibitors (Celecoxib and Etoricoxib): A Series of Nationwide Emulated Trials pp. 983-994

Morten Schmidt, Henrik Toft Sørensen and Lars Pedersen

Differences in the Recurrence Rate of Immediate Adverse Drug Reactions According to the Components of Alternative Contrast Media: Analysis of Repetitive Computed Tomography Cases in a Single Tertiary Hospital pp. 995-1002

Sung-Ryeol Kim, Nak-Hoon Son, Hye Jung Park, Kyung Hee Park, Jung-Won Park and Jae-Hyun Lee

Assessing Case Fatality on Cases of Thrombosis with Concurrent Thrombocytopenia Following COVID-19 Vaccine AstraZeneca (Vaxzevria) in the United Kingdom: A Review of Spontaneously Reported Data pp. 1003-1008

Samantha Lane and Saad Shakir

Correction to: Impact of Policy Interventions on Oxycodone Prescribing in Queensland, Australia: An Uncontrolled Interrupted Time Series Study pp. 1009-1010

William Tumusiime, Caitlin Hardman and Elizabeth McCourt

Volume 45, issue 8, 2022

A Review of Causal Inference for External Comparator Arm Studies pp. 815-837

Gerd Rippin, Nicolás Ballarini, Héctor Sanz, Joan Largent, Chantal Quinten and Francesco Pignatti

Kidney Damage and Stress Biomarkers for Early Identification of Drug-Induced Kidney Injury: A Systematic Review pp. 839-852

Ravi J. Desai, Christina L. Kazarov, Adrian Wong and Sandra L. Kane-Gill

Combining Machine Learning with a Rule-Based Algorithm to Detect and Identify Related Entities of Documented Adverse Drug Reactions on Hospital Discharge Summaries pp. 853-862

Hui Xing Tan, Chun Hwee Desmond Teo, Pei San Ang, Wei Ping Celine Loke, Mun Yee Tham, Siew Har Tan, Bee Leng Sally Soh, Pei Qin Belinda Foo, Zheng Jye Ling, Wei Luen James Yip, Yixuan Tang, Jisong Yang, Kum Hoe Anthony Tung and Sreemanee Raaj Dorajoo

A Disproportionality Analysis of Drug–Drug Interactions of Tizanidine and CYP1A2 Inhibitors from the FDA Adverse Event Reporting System (FAERS) pp. 863-871

Lorenzo Villa-Zapata, Ainhoa Gómez-Lumbreras, John Horn, Malinda S. Tan, Richard D. Boyce and Daniel C. Malone

Short-Term Risk of Unintentional Poisoning After New Initiation of Central Nervous System Medications in Swedish Older Adults: A Register-Based Case-Crossover Study pp. 873-880

Yang Zhao, Yajun Liang, Lucie Laflamme, Christian Rausch, Kristina Johnell and Jette Möller

Developing Strategic Recommendations for Implementing Smart Pumps in Advanced Healthcare Systems to Improve Intravenous Medication Safety pp. 881-889

Adam Sutherland, Matthew D. Jones, Moninne Howlett, Sara Arenas-Lopez, Arif Patel and Bryony Dean Franklin

Post-Marketing Surveillance of CAR-T-Cell Therapies: Analysis of the FDA Adverse Event Reporting System (FAERS) Database pp. 891-908

Michele Fusaroli, Valentina Isgrò, Paola Maria Cutroneo, Carmen Ferrajolo, Valentina Cirillo, Francesca Del Bufalo, Emanuel Raschi, Elisabetta Poluzzi and Gianluca Trifirò

Safety of Praziquantel and Albendazole Coadministration for the Control and Elimination of Schistosomiasis and Soil-Transmitted Helminths Among Children in Rwanda: An Active Surveillance Study pp. 909-922

Joseph Kabatende, Abbie Barry, Michael Mugisha, Lazare Ntirenganya, Ulf Bergman, Emile Bienvenu and Eleni Aklillu

Comment on “Description of Frequencies of Reported Adverse Events Following Immunization Among Four Different COVID-19 Vaccine Brands” pp. 923-923

Rujittika Mungmunpuntipantip and Viroj Wiwanitkit

Authors’ Reply to Mungmunpuntipantip et al.’s Comment on “Description of Frequencies of Reported Adverse Events Following Immunization Among Four Different COVID-19 Vaccine Brands” pp. 925-926

Agnes Kant and Florence Hunsel

Correction to: Machine Learning in Causal Inference: Application in Pharmacovigilance pp. 927-927

Yiqing Zhao, Yue Yu, Hanyin Wang, Yikuan Li, Yu Deng, Guoqian Jiang and Yuan Luo

Volume 45, issue 7, 2022

An Update on the International Society of Pharmacovigilance China Chapter pp. 699-702

Yalu Wen, Tianyi Yang, Li Zhang, Brian Edwards, Honghui Wu, Jukai Huang and Xiaohui Yang

Incidence, Pathogenesis, and Management of Proton Pump Inhibitor-Induced Nephrotoxicity pp. 703-712

Xiao Wei, Jun Yu, Zhengkun Xu, Chun Wang and Yonggui Wu

Prevalence of Use of Traditional, Complementary and Alternative Medicine by the General Population: A Systematic Review of National Studies Published from 2010 to 2019 pp. 713-735

E Lyn Lee, Noni Richards, Jeff Harrison and Joanne Barnes

Safety-Related Drug Withdrawals in China Between 1999 and 2021: A Systematic Investigation and Analysis pp. 737-745

Yanrong Li, Yang Jiang, Haixue Wang, Li Zhang and Yue Yang

Collection of Data on Adverse Events Related to Medicinal Products: A Survey Among Registries in the ENCePP Resources Database pp. 747-754

Kelly Plueschke, Carla Jonker, Valerie Strassmann and Xavier Kurz

Quantitative Prediction of Adverse Event Probability Due to Pharmacokinetic Interactions pp. 755-764

Michel Tod, Thomas Rodier and Marine Auffret

Signaling COVID-19 Vaccine Adverse Events pp. 765-780

Rave Harpaz, William DuMouchel, Robbert Manen, Alexander Nip, Steve Bright, Ana Szarfman, Joseph Tonning and Magnus Lerch

Incidence of Acute Renal Failure in Patients Using Levetiracetam Versus Other Antiseizure Medications: A Voluntary Post-Authorization Safety Study pp. 781-790

Raphaelle Beau-Lejdstrom, Lai San Hong, Xabier Garcia de Albeniz, Florin Floricel, Johan Lorenzen, Francois Bonfitto, Linda Kalilani, Christian Loesch, Graham Luscombe, Susana Perez-Gutthann, Isabelle Mottet and Nadia Foskett

Hip Fracture Risk After Treatment with Tramadol or Codeine: An Observational Study pp. 791-807

Erica A. Voss, Saberi Rana Ali, Arun Singh, Peter R. Rijnbeek, Martijn J. Schuemie and Daniel Fife

Comment on: "Drug–Drug Interaction of the Sodium Glucose Co-transporter 2 Inhibitors with Statins and Myopathy: A Disproportionality Analysis Using Adverse Events Reporting Data" pp. 809-811

Yoshihiro Noguchi

Authors’ Reply to Noguchi’s comment on: “Drug-Drug Interaction of the Sodium Glucose Co-transporter 2 Inhibitors with Statins and Myopathy: A Disproportionality Analysis Using Adverse Events Reporting Data.” pp. 813-814

John-Michael Gamble and Wajd Alkabbani

Volume 45, issue 6, 2022

The International Society of Pharmacovigilance Vaccines Special Interest Group: Challenges and Opportunities pp. 597-599

Rebecca E. Chandler

Chemobrain in Breast Cancer: Mechanisms, Clinical Manifestations, and Potential Interventions pp. 601-621

Giovana R. Onzi, Nathalia D’Agustini, Solange C. Garcia, Silvia S. Guterres, Paula R. Pohlmann, Daniela D. Rosa and Adriana R. Pohlmann

Hydroxyzine Initiation Following Drug Safety Advisories on Cardiac Arrhythmias in the UK and Canada: A Longitudinal Cohort Study pp. 623-638

Richard L. Morrow, Barbara Mintzes, Patrick C. Souverein, Christine E. Hallgreen, Bilal Ahmed, Elizabeth E. Roughead, Marie L. Bruin, Sarah Brøgger Kristiansen, Joel Lexchin, Anna Kemp-Casey, Ingrid Sketris, Dee Mangin, Sallie-Anne Pearson, Lorri Puil, Ruth Lopert, Lisa Bero, Danijela Gnjidic, Ameet Sarpatwari and Colin R. Dormuth

Drug-Induced Sexual Dysfunction: An Analysis of Reports to a National Pharmacovigilance Database pp. 639-650

Carolina Valeiro, Cristiano Matos, Joep Scholl and Florence Hunsel

Analysis of Reports on Adverse Drug Reactions Related to Herbal Medicinal Products and Herbal Supplements in the Netherlands Received by the National Pharmacovigilance Centre Lareb pp. 651-661

Florence P. A. M. Hunsel, Djurre Kooi, Sonja Koppel, Burt H. Kroes and Herman J. Woerdenbag

Amyotrophic Lateral Sclerosis as an Adverse Drug Reaction: A Disproportionality Analysis of the Food and Drug Administration Adverse Event Reporting System pp. 663-673

Anna Gaimari, Michele Fusaroli, Emanuel Raschi, Elisa Baldin, Luca Vignatelli, Francesco Nonino, Fabrizio Ponti, Jessica Mandrioli and Elisabetta Poluzzi

Montelukast and Nightmares: Further Characterisation Using Data from VigiBase pp. 675-684

Sarah Watson, Elenor Kaminsky, Henric Taavola, Marian Attalla and Qun-Ying Yue

Phenotype Algorithms for the Identification and Characterization of Vaccine-Induced Thrombotic Thrombocytopenia in Real World Data: A Multinational Network Cohort Study pp. 685-698

Azza Shoaibi, Gowtham A. Rao, Erica A. Voss, Anna Ostropolets, Miguel Angel Mayer, Juan Manuel Ramírez-Anguita, Filip Maljković, Biljana Carević, Scott Horban, Daniel R. Morales, Talita Duarte-Salles, Clement Fraboulet, Tanguy Carrour, Spiros Denaxas, Vaclav Papez, Luis H. John, Peter R. Rijneek, Evan Minty, Thamir M. Alshammari, Rupa Makadia, Clair Blacketer, Frank DeFalco, Anthony G. Sena, Marc A. Suchard, Daniel Prieto-Alhambra and Patrick B. Ryan

Volume 45, issue 5, 2022

Artificial Intelligence and Machine Learning for Safe Medicines pp. 403-405

Andrew Bate and Yuan Luo

Artificial Intelligence in Pharmacovigilance: An Introduction to Terms, Concepts, Applications, and Limitations pp. 407-418

Jeffrey K. Aronson

Black Swan Events and Intelligent Automation for Routine Safety Surveillance pp. 419-427

Oeystein Kjoersvik and Andrew Bate

“Artificial Intelligence” for Pharmacovigilance: Ready for Prime Time? pp. 429-438

Robert Ball and Gerald Dal Pan

Industry Perspective on Artificial Intelligence/Machine Learning in Pharmacovigilance pp. 439-448

Raymond Kassekert, Neal Grabowski, Denny Lorenz, Claudia Schaffer, Dieter Kempf, Promit Roy, Oeystein Kjoersvik, Griselda Saldana and Sarah ElShal

Intelligent Telehealth in Pharmacovigilance: A Future Perspective pp. 449-458

Heba Edrees, Wenyu Song, Ania Syrowatka, Aurélien Simona, Mary G. Amato and David W. Bates

Machine Learning in Causal Inference: Application in Pharmacovigilance pp. 459-476

Yiqing Zhao, Yue Yu, Hanyin Wang, Yikuan Li, Yu Deng, Guoqian Jiang and Yuan Luo

Artificial Intelligence Based on Machine Learning in Pharmacovigilance: A Scoping Review pp. 477-491

Benjamin Kompa, Joe B. Hakim, Anil Palepu, Kathryn Grace Kompa, Michael Smith, Paul A. Bain, Stephen Woloszynek, Jeffery L. Painter, Andrew Bate and Andrew L. Beam

Applying Machine Learning in Distributed Data Networks for Pharmacoepidemiologic and Pharmacovigilance Studies: Opportunities, Challenges, and Considerations pp. 493-510

Jenna Wong, Daniel Prieto-Alhambra, Peter R. Rijnbeek, Rishi J. Desai, Jenna M. Reps and Sengwee Toh

Artificial Intelligence-Based Pharmacovigilance in the Setting of Limited Resources pp. 511-519

Likeng Liang, Jifa Hu, Gang Sun, Na Hong, Ge Wu, Yuejun He, Yong Li, Tianyong Hao, Li Liu and Mengchun Gong

Identifying and Mitigating Potential Biases in Predicting Drug Approvals pp. 521-533

Qingyang Xu, Elaheh Ahmadi, Alexander Amini, Daniela Rus and Andrew Lo

Validation of Artificial Intelligence to Support the Automatic Coding of Patient Adverse Drug Reaction Reports, Using Nationwide Pharmacovigilance Data pp. 535-548

Guillaume L. Martin, Julien Jouganous, Romain Savidan, Axel Bellec, Clément Goehrs, Mehdi Benkebil, Ghada Miremont, Joëlle Micallef, Francesco Salvo, Antoine Pariente and Louis Létinier

Automated Drug Coding Using Artificial Intelligence: An Evaluation of WHODrug Koda on Adverse Event Reports pp. 549-561

Eva-Lisa Meldau, Shachi Bista, Emma Rofors and Lucie M. Gattepaille

Using Iterative Pairwise External Validation to Contextualize Prediction Model Performance: A Use Case Predicting 1-Year Heart Failure Risk in Patients with Diabetes Across Five Data Sources pp. 563-570

Ross D. Williams, Jenna M. Reps, Jan A. Kors, Patrick B. Ryan, Ewout Steyerberg, Katia M. Verhamme and Peter R. Rijnbeek

Leveraging Machine Learning to Facilitate Individual Case Causality Assessment of Adverse Drug Reactions pp. 571-582

Yauheniya Cherkas, Joshua Ide and John Stekelenborg

Supervised Machine Learning-Based Decision Support for Signal Validation Classification pp. 583-596

Muhammad Imran, Aasia Bhatti, David M. King, Magnus Lerch, Jürgen Dietrich, Guy Doron and Katrin Manlik

Volume 45, issue 4, 2022

New Drug Postmarketing Requirements and Commitments in the US: A Systematic Review of the Evidence pp. 305-318

Osman Moneer, Beatrice L. Brown, Jerry Avorn, Jonathan J. Darrow, Mayookha Mitra-Majumdar, Krysten W. Joyce, Murray Ross, Catherine Pham and Aaron S. Kesselheim

Description of Frequencies of Reported Adverse Events Following Immunization Among Four Different COVID-19 Vaccine Brands pp. 319-331

Agnes Kant, Jurriaan Jansen, Leontine Balveren and Florence Hunsel

A Landscape Analysis of Post-Marketing Studies Registered in the EU PAS Register and ClinicalTrials.gov Focusing on Pregnancy Outcomes or Breastfeeding Effects: A Contribution from the ConcePTION Project pp. 333-344

Leonardo Roque Pereira, Carlos E. Durán, Deborah Layton, Georgios Poulentzas, Panagiotis-Nikolaos Lalagkas, Christos Kontogiorgis and Miriam Sturkenboom

Pregnancy, Fetal, and Infant Outcomes Following Maternal Exposure to Glatiramer Acetate During Pregnancy and Breastfeeding pp. 345-357

Sigal Kaplan, Mikhail Zeygarnik and Tal Stern

Postoperative Respiratory Events in Surgical Patients Exposed to Opioid Analgesic Shortages Compared to Fully Matched Patients Non-exposed to Shortages pp. 359-367

Rosa Rodriguez-Monguio, Zhixin Lun, Tasce Bongiovanni, Catherine L. Chen and Enrique Seoane-Vazquez

Handling of New Drug Safety Information in the Dutch Hospital Setting: A Mixed Methods Approach pp. 369-378

Esther Vries, Elisabeth Bakker, Remy D. C. Francisca, Stijn Croonen, Petra Denig and Peter G. M. Mol

Intracranial Hemorrhage Following Anticoagulant Treatment in Denmark: Spontaneous Adverse Drug Reaction Reports Versus Real-World Data pp. 379-388

Benedikte Irene Osmanski, Astrid Blicher Schelde, Espen Jimenez-Solem, Martin Erik Nyeland and Henrik Horwitz

Consensus Obtained for the Nephrotoxic Potential of 167 Drugs in Adult Critically Ill Patients Using a Modified Delphi Method pp. 389-398

Matthew P. Gray, Erin F. Barreto, Diana J. Schreier, John A. Kellum, Kangho Suh, Kianoush B. Kashani, Andrew D. Rule and Sandra L. Kane-Gill

Correction to: A Landscape Analysis of Post-Marketing Studies Registered in the EU PAS Register and ClinicalTrials.gov Focusing on Pregnancy Outcomes or Breastfeeding Effects: A Contribution from the ConcePTION Project pp. 399-399

Leonardo Roque Pereira, Carlos E. Durán, Deborah Layton, Georgios Poulentzas, Panagiotis-Nikolaos Lalagkas, Christos Kontogiorgis and Miriam Sturkenboom

Correction to: Review of Over 15 Years Postmarketing Safety Surveillance Spontaneous Data for the Human Rotavirus Vaccine (Rotarix) on Intussusception pp. 401-401

Tina Singh, Frédérique Delannois, François Haguinet and Lifeter Yenwo Molo

Volume 45, issue 3, 2022

A Review on Application of DNA Barcoding Technology for Rapid Molecular Diagnostics of Adulterants in Herbal Medicine pp. 193-213

Alok Senapati, Supriyo Basak and Latha Rangan

Cannabinoid-Related Acute Pancreatitis: An Update from International Literature and Individual Case Safety Reports pp. 215-235

Camille Azam, Louis Buscail, Adrian Culetto and Maryse Lapeyre-Mestre

Sales of Over-the-Counter Products Containing Codeine in 31 Countries, 2013–2019: A Retrospective Observational Study pp. 237-247

Georgia C. Richards, Jeffrey K. Aronson, Brian MacKenna, Ben Goldacre, F. D. Richard Hobbs and Carl Heneghan

The Extent of Medication-Related Hospital Admissions in Australia: A Review from 1988 to 2021 pp. 249-257

Renly Lim, Lisa M. Kalisch Ellett, Susan Semple and Elizabeth E. Roughead

Improving the Safety of Medicines via Digital Technology: An Assessment of the Scope and Quality of Risk Minimization Websites in the United States and United Kingdom pp. 259-274

Meredith Y. Smith, Sarah Frise, Jane Feron and Ryan Marshall

High-Dimensional Propensity Score-Adjusted Case-Crossover for Discovering Adverse Drug Reactions from Computerized Administrative Healthcare Databases pp. 275-285

Etienne Volatier, Francesco Salvo, Antoine Pariente, Émeline Courtois, Sylvie Escolano, Pascale Tubert-Bitter and Ismaïl Ahmed

Drug–Drug Interaction of the Sodium Glucose Co-Transporter 2 Inhibitors with Statins and Myopathy: A Disproportionality Analysis Using Adverse Events Reporting Data pp. 287-295

Wajd Alkabbani, Ryan Pelletier, Michael A. Beazely, Youssef Labib, Breanna Quan and John-Michael Gamble

Impact of Preventive Strategies on Gastrointestinal Complications in Elderly Patients on Concomitant Use of Oral Anticoagulants and Nonsteroidal Anti-Inflammatory Drugs: A Nationwide Cohort Study pp. 297-304

Suhyun Lee, Kyu-Nam Heo, Mee Yeon Lee, Woo‑Youn Kim, Young-Mi Ah, Jaekyu Shin and Ju‑Yeun Lee

Volume 45, issue 2, 2022

Medication Errors Special Interest Group of the International Society of Pharmacovigilance and the Trends in International Collaboration for Patient Safety pp. 97-99

Mohamed A. Elhawary, Hadir Rostom, Brian Edwards and Angela Caro

Cancer Chemotherapy-Induced Sinus Bradycardia: A Narrative Review of a Forgotten Adverse Effect of Cardiotoxicity pp. 101-126

Juan Tamargo, Ricardo Caballero and Eva Delpón

Use of Identical INN “Imiglucerase” for Different Drug Products: Impact Analysis of Adverse Events in a Proprietary Global Safety Database pp. 127-136

So-Fai Tsang, Shirali Pandya, Kristina Barakov, Joan Keutzer, Grace Lewis, Leorah Ross and Selena Freisens

Spontaneous Reporting to Regulatory Authorities of Suspected Adverse Drug Reactions to COVID-19 Vaccines Over Time: The Effect of Publicity pp. 137-144

Robin E. Ferner, Richard J. Stevens, Christopher Anton and Jeffrey K. Aronson

Post-Marketing Safety Profile of Vortioxetine Using a Cluster Analysis and a Disproportionality Analysis of Global Adverse Event Reports pp. 145-153

Corine Ekhart, Florence Hunsel, Eugène Puijenbroek, Rebecca Chandler, Eva-Lisa Meldau, Henric Taavola and G. Niklas Norén

Review of Over 15 Years Postmarketing Safety Surveillance Spontaneous Data for the Human Rotavirus Vaccine (Rotarix) on Intussusception pp. 155-168

Tina Singh, Frédérique Delannois, François Haguinet and Lifeter Yenwo Molo

Sources of Evidence Triggering and Supporting Safety-Related Labeling Changes: A 10-Year Longitudinal Assessment of 22 New Molecular Entities Approved in 2008 by the US Food and Drug Administration pp. 169-180

David Croteau, Ellen Pinnow, Eileen Wu, Monica Muñoz, Ilynn Bulatao and Gerald Dal Pan

β-Blockers and the Risk of Depression: A Matched Case–Control Study pp. 181-189

Delia Bornand, Daphne Reinau, Susan S. Jick and Christoph R. Meier

Correction to: Clinical Trial and Postmarketing Safety of Onasemnogene Abeparvovec Therapy pp. 191-192

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 45, issue 1, 2022

Patient Safety Incidents Related to the Use of Parenteral Nutrition in All Patient Groups: A Systematic Scoping Review pp. 1-18

Priya Mistry, Rebecca Heather Smith and Andy Fox

Safety of Intravenous Push Levetiracetam Compared to Intravenous Piggyback at a Tertiary Academic Medical Center: A Retrospective Analysis pp. 19-26

Afrah Alkazemi, Kevin C. McLaughlin, Michael G. Chan, Michael J. Schontz, Kevin E. Anger and Paul M. Szumita

Hybrid Method Incorporating a Rule-Based Approach and Deep Learning for Prescription Error Prediction pp. 27-35

Seunghee Lee, Jeongwon Shin, Hyeon Seong Kim, Min Je Lee, Jung Min Yoon, Sohee Lee, Yongsuk Kim, Jong-Yeup Kim and Suehyun Lee

A 13-Year National Monitoring Study to Assess Narcotic Prescriptions and Indications (2007–2019) pp. 37-44

Joelle Perri-Plandé, Ghada Miremont-Salamé, Joëlle Micallef, Cameron Herman, Marie Baumevieille, Frédéric Abriat, Maryse Lapeyre-Mestre, Françoise Haramburu and Amélie Daveluy

RELAY, Ramucirumab Plus Erlotinib Versus Placebo Plus Erlotinib in Patients with Untreated, Epidermal Growth Factor Receptor Mutation-Positive, Metastatic Non-Small-Cell Lung Cancer: Safety Profile and Manageability pp. 45-64

Ernest Nadal, Hidehito Horinouchi, Jin-Yuan Shih, Kazuhiko Nakagawa, Martin Reck, Edward B. Garon, Yu-Feng Wei, Jens Kollmeier, Bente Frimodt-Moller, Emily Barrett, Olga Lipkovich, Carla Visseren-Grul and Silvia Novello

Renin–Angiotensin–Aldosterone System Inhibitors and Risk of Acute Pancreatitis: A Population-Based Cohort Study pp. 65-74

Julie Rouette, Hui Yin, Emily G. McDonald, Alan Barkun and Laurent Azoulay

The Risk of Preoperative Central Nervous System-Acting Medications on Delirium Following Hip or Knee Surgery: A Matched Case-Control Study pp. 75-82

Gizat M. Kassie, Elizabeth E. Roughead, Tuan A. Nguyen, Nicole L. Pratt and Lisa M. Kalisch Ellett

The Impact of Mandatory Reporting of Non-Serious Safety Reports to EudraVigilance on the Detection of Adverse Reactions pp. 83-95

Gianmario Candore, Sebastian Monzon, Jim Slattery, Loris Piccolo, Rodrigo Postigo, Xavier Xurz, Sabine Strauss and Peter Arlett