OOIR: Observatory of International Research

Papers

(The TQCC of Drug Safety is 8. The table below lists those papers that are above that threshold based on CrossRef citation counts [max. 250 papers]. The publications cover those that have been published in the past four years, i.e., from 2020-04-01 to 2024-04-01.)

Article	Citations
Azithromycin in COVID-19 Patients: Pharmacological Mechanism, Clinical Evidence and Prescribing Guidelines	98
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-Mar	81
Drug-Induced Liver Injury and COVID-19 Infection: The Rules Remain the Same	71
Clinical Trial and Postmarketing Safety of Onasemnogene Abeparvovec Therapy	62
Does Ibuprofen Worsen COVID-19?	57
NSAIDs and COVID-19: A Systematic Review and Meta-analysis	52
The Impact of the COVID-19 “Infodemic” on Drug-Utilization Behaviors: Implications for Pharmacovigilance	52
Current Evidence on Abuse and Misuse of Gabapentinoids	49
Remdesivir in Treatment of COVID-19: A Systematic Benefit–Risk Assessment	47
Safety of Eosinophil-Depleting Therapy for Severe, Eosinophilic Asthma: Focus on Benralizumab	46
Renin–Angiotensin–Aldosterone System Inhibitors and Risk of Death in Patients Hospitalised with COVID-19: A Retrospective Italian Cohort Study of 43,000 Patients	44
Emerging Skin Toxicities in Patients with Breast Cancer Treated with New Cyclin-Dependent Kinase 4/6 Inhibitors: A Systematic Review	40
Lopinavir-Ritonavir in the Treatment of COVID-19: A Dynamic Systematic Benefit-Risk Assessment	39
Immune Checkpoint Inhibitors and Cardiotoxicity: An Analysis of Spontaneous Reports in Eudravigilance	38
Chloroquine for COVID-19 Infection	37
21st ISoP Annual Meeting “A New Era of Pharmacovigilance: Challenges and Opportunities” 20–23 September 2022 Verona, Italy	37
Critical Assessment of Pharmacokinetic Drug–Drug Interaction Potential of Tofacitinib, Baricitinib and Upadacitinib, the Three Approved Janus Kinase Inhibitors for Rheumatoid Arthritis Treatment	36
Effect of Bempedoic Acid on Serum Uric Acid and Related Outcomes: A Systematic Review and Meta-analysis of the available Phase 2 and Phase 3 Clinical Studies	35
Reporting of Thromboembolic Events with JAK Inhibitors: Analysis of the FAERS Database 2010–2019	34
Drug-Induced Liver Injury: Highlights and Controversies in the Recent Literature	34
The Extent of Medication-Related Hospital Admissions in Australia: A Review from 1988 to 2021	32
Psychiatric Disorders and Hydroxychloroquine for Coronavirus Disease 2019 (COVID-19): A VigiBase Study	31
Prevalence of Use of Traditional, Complementary and Alternative Medicine by the General Population: A Systematic Review of National Studies Published from 2010 to 2019	30
Thromboembolic Safety Reporting of Tofacitinib and Baricitinib: An Analysis of the WHO VigiBase	30
Assessing the Safety of COVID-19 Vaccines: A Primer	30

Description of Frequencies of Reported Adverse Events Following Immunization Among Four Different COVID-19 Vaccine Brands	29
Risk Factor Considerations in Statistical Signal Detection: Using Subgroup Disproportionality to Uncover Risk Groups for Adverse Drug Reactions in VigiBase	28
A Systematic Review and Meta-Analysis Considering the Risk for Congenital Heart Defects of Antidepressant Classes and Individual Antidepressants	27
Sex Differences in Reported Adverse Drug Reactions to COVID-19 Drugs in a Global Database of Individual Case Safety Reports	27
Upadacitinib in Rheumatoid Arthritis: A Benefit–Risk Assessment Across a Phase III Program	27
PCSK9 Inhibitors and Neurocognitive Adverse Drug Reactions: Analysis of Individual Case Safety Reports from the Eudravigilance Database	26
Artificial Intelligence, Real-World Automation and the Safety of Medicines	26
Use of Hydrochlorothiazide and Risk of Melanoma and Nonmelanoma Skin Cancer	26
Incidence Rates of Autoimmune Diseases in European Healthcare Databases: A Contribution of the ADVANCE Project	26
A Framework for Methodological Choice and Evidence Assessment for Studies Using External Comparators from Real-World Data	25
Liver Injury with Ulipristal Acetate: Exploring the Underlying Pharmacological Basis	25
Validating Claims-Based Algorithms Determining Pregnancy Outcomes and Gestational Age Using a Linked Claims-Electronic Medical Record Database	24
Potential Safety Issues with Use of Sodium-Glucose Cotransporter 2 Inhibitors, Particularly in People with Type 2 Diabetes and Chronic Kidney Disease	24
Safety of N-Acetylcysteine at High Doses in Chronic Respiratory Diseases: A Review	24
Cumulative Adverse Event Reporting of Anaphylaxis After mRNA COVID-19 Vaccine (Pfizer-BioNTech) Injections in Japan: The First-Month Report	24
“Artificial Intelligence” for Pharmacovigilance: Ready for Prime Time?	22
Post-Marketing Surveillance of CAR-T-Cell Therapies: Analysis of the FDA Adverse Event Reporting System (FAERS) Database	20
Pregnancy Outcomes During the Clinical Development Program of Cladribine in Multiple Sclerosis: An Integrated Analysis of Safety	20
Patient-Reported Burden of Adverse Drug Reactions Attributed to Biologics Used for Immune-Mediated Inflammatory Diseases	20
Should Patients Receiving ACE Inhibitors or Angiotensin Receptor Blockers be Switched to Other Antihypertensive Drugs to Prevent or Improve Prognosis of Novel Coronavirus Disease 2019 (COVID-19)?	19
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	19
Consensus Obtained for the Nephrotoxic Potential of 167 Drugs in Adult Critically Ill Patients Using a Modified Delphi Method	19
Combining Social Media and FDA Adverse Event Reporting System to Detect Adverse Drug Reactions	19
Validating Intelligent Automation Systems in Pharmacovigilance: Insights from Good Manufacturing Practices	18
Artificial Intelligence in Pharmacovigilance: An Introduction to Terms, Concepts, Applications, and Limitations	17
Withdrawal Syndrome Following Discontinuation of 28 Antidepressants: Pharmacovigilance Analysis of 31,688 Reports from the WHO Spontaneous Reporting Database	17
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	16
Signaling COVID-19 Vaccine Adverse Events	16
Patterns of Benzodiazepine Use and Excess Risk of All-Cause Mortality in the Elderly: A Nationwide Cohort Study	15
Overview of Causality Assessment for Drug-Induced Liver Injury (DILI) in Clinical Trials	15
Human-Based Errors Involving Smart Infusion Pumps: A Catalog of Error Types and Prevention Strategies	15
Artificial Intelligence Based on Machine Learning in Pharmacovigilance: A Scoping Review	15
Spontaneous Reporting to Regulatory Authorities of Suspected Adverse Drug Reactions to COVID-19 Vaccines Over Time: The Effect of Publicity	15
Liver Injury Associated with Metamizole Exposure: Features of an Underestimated Adverse Event	15
Prospective Evaluation of Adverse Event Recognition Systems in Twitter: Results from the Web-RADR Project	15
The Safety Profile of Upadacitinib in Patients with Rheumatoid Arthritis in Japan	15
Safety of S1P Modulators in Patients with Immune-Mediated Diseases: A Systematic Review and Meta-Analysis	14
Benefit–Risk Assessment of Vaccines. Part I: A Systematic Review to Identify and Describe Studies About Quantitative Benefit–Risk Models Applied to Vaccines	14
Sales of Over-the-Counter Products Containing Codeine in 31 Countries, 2013–2019: A Retrospective Observational Study	14
The Role of Pharmacovigilance and ISoP During the Global COVID-19 Pandemic	14
Interstitial Lung Disease as an Adverse Drug Reaction in Japan: Exploration of Regulatory Actions as a Basis for High Reporting	14
French Pharmacovigilance Public System and COVID-19 Pandemic	14
20th ISoP Annual Meeting “Integrated pharmacovigilance for safer patients” 8–10 November 2021 Muscat, Oman (Hybrid meeting)	13
Evidence of Clinically Meaningful Drug–Drug Interaction With Concomitant Use of Colchicine and Clarithromycin	13
Adverse Drug Reactions from Real-World Data in Inflammatory Bowel Disease Patients in the IBDREAM Registry	13
Anticoagulant Use and Bleeding Risk in Central European Patients with Idiopathic Pulmonary Fibrosis (IPF) Treated with Antifibrotic Therapy: Real-World Data from EMPIRE	13
Neuroprotective Cationic Arginine-Rich Peptides (CARPs): An Assessment of Their Clinical Safety	13
A Feasibility Study of Drug–Drug Interaction Signal Detection in Regular Pharmacovigilance	13
Artificial Intelligence-Based Pharmacovigilance in the Setting of Limited Resources	13
Validation of Artificial Intelligence to Support the Automatic Coding of Patient Adverse Drug Reaction Reports, Using Nationwide Pharmacovigilance Data	13

An Evaluation of Postmarketing Reports of Serious Idiosyncratic Liver Injury Associated with Ulipristal Acetate for the Treatment of Uterine Fibroids	13
The International Society of Pharmacovigilance (ISoP) Special Interest Group on Herbal and Traditional Medicines: Towards Progress in Pharmacovigilance for Herbal and Traditional Medicines and Other “	12
Factors Associated with Underreporting of Adverse Drug Reactions by Health Care Professionals: A Systematic Review Update	12
Pathophysiology of Drug-Induced Hypomagnesaemia	12
Preventable Deaths Involving Medicines: A Systematic Case Series of Coroners’ Reports 2013–22	12
Comparison of Medication Alerts from Two Commercial Applications in the USA	12
A Comparative View of Reported Adverse Effects of Statins in Social Media, Regulatory Data, Drug Information Databases and Systematic Reviews	12
ADE Eval: An Evaluation of Text Processing Systems for Adverse Event Extraction from Drug Labels for Pharmacovigilance	12
Temelimab, an IgG4 Anti-Human Endogenous Retrovirus Monoclonal Antibody: An Early Development Safety Review	12
Chemobrain in Breast Cancer: Mechanisms, Clinical Manifestations, and Potential Interventions	11
Repeated or Continuous Medically Supervised Ketamine Administration Associated with Hepatobiliary Adverse Events: A Retrospective Case Series	11
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	11
A Scoping Review of Non-Medical and Extra-Medical Use of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)	11
Drug-Related Problems in Hospitalised Patients with Chronic Kidney Disease: A Systematic Review	11
E-Learning in Pharmacovigilance: An Evaluation of Microlearning-Based Modules Developed by Uppsala Monitoring Centre	11
Risk of Cancer in Association with Ranitidine and Nizatidine vs Other H2 Blockers: Analysis of the Japan Medical Data Center Claims Database 2005–2018	11
Onapristone Extended Release: Safety Evaluation from Phase I–II Studies with an Emphasis on Hepatotoxicity	11
Enhancing Pharmacovigilance in Sub-Saharan Africa Through Training and Mentoring: A GSK Pilot Initiative in Malawi	11
Safety Profile of Ceftazidime–Avibactam: Pooled Data from the Adult Phase II and Phase III Clinical Trial Programme	11
Leveraging Machine Learning to Facilitate Individual Case Causality Assessment of Adverse Drug Reactions	11
Prevalence, Causes and Severity of Medication Administration Errors in the Neonatal Intensive Care Unit: A Systematic Review and Meta-Analysis	10
Signal Detection in EUROmediCAT: Identification and Evaluation of Medication–Congenital Anomaly Associations and Use of VigiBase as a Complementary Source of Reference	10
High-Dose Intravenous Iron with Either Ferric Carboxymaltose or Ferric Derisomaltose: A Benefit-Risk Assessment	10
Industry Perspective on Artificial Intelligence/Machine Learning in Pharmacovigilance	10
Patient Organizations’ Barriers in Pharmacovigilance and Strategies to Stimulate Their Participation	10
Provision and Need for Medicine Information in Asia and Africa: A Scoping Review of the Literature	10
Global Safety Database Summary of COVID-19-Related Drug Utilization-Safety Surveillance: A Sponsor’s Perspective	10
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	10
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 Proj	10
Mechanisms, Management and Prevention of Pemetrexed-Related Toxicity	10
Safety of the Geneva Cocktail, a Cytochrome P450 and P-Glycoprotein Phenotyping Cocktail, in Healthy Volunteers from Three Different Geographic Origins	9
Direct Oral Anticoagulants and Interstitial Lung Disease: Emerging Clues from Pharmacovigilance	9
A Review of Causal Inference for External Comparator Arm Studies	9
Safety Profile of the Adjuvanted Recombinant Zoster Vaccine in Immunocompromised Populations: An Overview of Six Trials	9
Developing Strategic Recommendations for Implementing Smart Pumps in Advanced Healthcare Systems to Improve Intravenous Medication Safety	9
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	9
Therapeutic Management of Idiosyncratic Drug-Induced Liver Injury and Acetaminophen Hepatotoxicity in the Paediatric Population: A Systematic Review	9
Montelukast and Nightmares: Further Characterisation Using Data from VigiBase	9
Post-Marketing Safety Profile of Vortioxetine Using a Cluster Analysis and a Disproportionality Analysis of Global Adverse Event Reports	9
Association Between Prenatal Opioid Exposure and Neurodevelopmental Outcomes in Early Childhood: A Retrospective Cohort Study	9
Capturing Data in Rare Disease Registries to Support Regulatory Decision Making: A Survey Study Among Industry and Other Stakeholders	9
Safety and Efficacy of Ivermectin and Doxycycline Monotherapy and in Combination in the Treatment of COVID-19: A Scoping Review	9
A New Drug–Drug Interaction Between Hydroxychloroquine and Metformin? A Signal Detection Study	9
Risk Management for the 21st Century: Current Status and Future Needs	9
Channeling Bias in the Analysis of Risk of Myocardial Infarction, Stroke, Gastrointestinal Bleeding, and Acute Renal Failure with the Use of Paracetamol Compared with Ibuprofen	8
Colchicine Drug Interaction Errors and Misunderstandings: Recommendations for Improved Evidence-Based Management	8
Public Perspectives of Using Social Media Data to Improve Adverse Drug Reaction Reporting: A Mixed-Methods Study	8
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 Enga	8
Detecting Medicine Safety Signals Using Prescription Sequence Symmetry Analysis of a National Prescribing Data Set	8
Intelligent Telehealth in Pharmacovigilance: A Future Perspective	8
Remdesivir in the COVID-19 Pandemic: An Analysis of Spontaneous Reports in VigiBase During 2020	8
Kidney Damage and Stress Biomarkers for Early Identification of Drug-Induced Kidney Injury: A Systematic Review	8
Assessment of the Frequency, Phenotypes, and Outcomes of Acute Liver Injury Associated with Amoxicillin/Clavulanate in 1.4 Million Patients in the Veterans Health Administration	8
The Effect of Positively Framing Side-Effect Risk in Two Different Formats on Side-Effect Expectations, Informed Consent and Credibility: A Randomised Trial of 16- to 75-Year-Olds in England	8
Patient-Reported Reasons for Switching or Discontinuing Statin Therapy: A Mixed Methods Study Using Social Media	8
Comparative Outcomes Between Direct Oral Anticoagulants, Warfarin, and Antiplatelet Monotherapy Among Chinese Patients with Atrial Fibrillation: A Population-Based Cohort Study	8
Developing Crowdsourced Training Data Sets for Pharmacovigilance Intelligent Automation	8
Black Swan Events and Intelligent Automation for Routine Safety Surveillance	8
Safety of As-Needed Budesonide-Formoterol in Mild Asthma: Data from the Two Phase III SYGMA Studies	8
Should Antidepressants be Avoided in Pregnancy?	8
Enhancing Pharmacovigilance from the US Experience: Current Practices and Future Opportunities	8