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 2020-11-01 to 2024-11-01.)

Article	Citations
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	90
Clinical Trial and Postmarketing Safety of Onasemnogene Abeparvovec Therapy	75
NSAIDs and COVID-19: A Systematic Review and Meta-analysis	60
Immune Checkpoint Inhibitors and Cardiotoxicity: An Analysis of Spontaneous Reports in Eudravigilance	45
Prevalence of Use of Traditional, Complementary and Alternative Medicine by the General Population: A Systematic Review of National Studies Published from 2010 to 2019	44
Emerging Skin Toxicities in Patients with Breast Cancer Treated with New Cyclin-Dependent Kinase 4/6 Inhibitors: A Systematic Review	44
The Extent of Medication-Related Hospital Admissions in Australia: A Review from 1988 to 2021	43
Reporting of Thromboembolic Events with JAK Inhibitors: Analysis of the FAERS Database 2010–2019	43
Drug-Induced Liver Injury: Highlights and Controversies in the Recent Literature	41
21st ISoP Annual Meeting “A New Era of Pharmacovigilance: Challenges and Opportunities” 20–23 September 2022 Verona, Italy	40
Validating Claims-Based Algorithms Determining Pregnancy Outcomes and Gestational Age Using a Linked Claims-Electronic Medical Record Database	36
Description of Frequencies of Reported Adverse Events Following Immunization Among Four Different COVID-19 Vaccine Brands	34
“Artificial Intelligence” for Pharmacovigilance: Ready for Prime Time?	33
Upadacitinib in Rheumatoid Arthritis: A Benefit–Risk Assessment Across a Phase III Program	31
A Systematic Review and Meta-Analysis Considering the Risk for Congenital Heart Defects of Antidepressant Classes and Individual Antidepressants	30
Safety of N-Acetylcysteine at High Doses in Chronic Respiratory Diseases: A Review	30
Post-Marketing Surveillance of CAR-T-Cell Therapies: Analysis of the FDA Adverse Event Reporting System (FAERS) Database	28
PCSK9 Inhibitors and Neurocognitive Adverse Drug Reactions: Analysis of Individual Case Safety Reports from the Eudravigilance Database	27
Incidence Rates of Autoimmune Diseases in European Healthcare Databases: A Contribution of the ADVANCE Project	27
Cumulative Adverse Event Reporting of Anaphylaxis After mRNA COVID-19 Vaccine (Pfizer-BioNTech) Injections in Japan: The First-Month Report	26
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	25
Withdrawal Syndrome Following Discontinuation of 28 Antidepressants: Pharmacovigilance Analysis of 31,688 Reports from the WHO Spontaneous Reporting Database	24
Consensus Obtained for the Nephrotoxic Potential of 167 Drugs in Adult Critically Ill Patients Using a Modified Delphi Method	23
Factors Associated with Underreporting of Adverse Drug Reactions by Health Care Professionals: A Systematic Review Update	22
A Scoping Review of Non-Medical and Extra-Medical Use of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)	22

Artificial Intelligence Based on Machine Learning in Pharmacovigilance: A Scoping Review	22
Artificial Intelligence in Pharmacovigilance: An Introduction to Terms, Concepts, Applications, and Limitations	21
Validating Intelligent Automation Systems in Pharmacovigilance: Insights from Good Manufacturing Practices	21
Signaling COVID-19 Vaccine Adverse Events	20
Validation of Artificial Intelligence to Support the Automatic Coding of Patient Adverse Drug Reaction Reports, Using Nationwide Pharmacovigilance Data	20
Artificial Intelligence-Based Pharmacovigilance in the Setting of Limited Resources	19
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	19
Overview of Causality Assessment for Drug-Induced Liver Injury (DILI) in Clinical Trials	18
Safety of S1P Modulators in Patients with Immune-Mediated Diseases: A Systematic Review and Meta-Analysis	18
Sales of Over-the-Counter Products Containing Codeine in 31 Countries, 2013–2019: A Retrospective Observational Study	17
Colchicine Drug Interaction Errors and Misunderstandings: Recommendations for Improved Evidence-Based Management	17
The Safety Profile of Upadacitinib in Patients with Rheumatoid Arthritis in Japan	17
Maternal and Early-Life Exposure to Antibiotics and the Risk of Autism and Attention-Deficit Hyperactivity Disorder in Childhood: a Swedish Population-Based Cohort Study	17
Repeated or Continuous Medically Supervised Ketamine Administration Associated with Hepatobiliary Adverse Events: A Retrospective Case Series	16
Liver Injury Associated with Metamizole Exposure: Features of an Underestimated Adverse Event	16
High-Dose Intravenous Iron with Either Ferric Carboxymaltose or Ferric Derisomaltose: A Benefit-Risk Assessment	16
Chemobrain in Breast Cancer: Mechanisms, Clinical Manifestations, and Potential Interventions	15
Safety Profile of the Adjuvanted Recombinant Zoster Vaccine in Immunocompromised Populations: An Overview of Six Trials	15
Drug-Related Problems in Hospitalised Patients with Chronic Kidney Disease: A Systematic Review	15
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	15
Spontaneous Reporting to Regulatory Authorities of Suspected Adverse Drug Reactions to COVID-19 Vaccines Over Time: The Effect of Publicity	15
Managing Cardiovascular and Cancer Risk Associated with JAK Inhibitors	14
French Pharmacovigilance Public System and COVID-19 Pandemic	14
Signals of Adverse Drug Reactions Communicated by Pharmacovigilance Stakeholders: A Scoping Review of the Global Literature	14
Preventable Deaths Involving Medicines: A Systematic Case Series of Coroners’ Reports 2013–22	14
Prevalence, Causes and Severity of Medication Administration Errors in the Neonatal Intensive Care Unit: A Systematic Review and Meta-Analysis	14
Comparison of Medication Alerts from Two Commercial Applications in the USA	14
20th ISoP Annual Meeting “Integrated pharmacovigilance for safer patients” 8–10 November 2021 Muscat, Oman (Hybrid meeting)	13
Association Between Prenatal Opioid Exposure and Neurodevelopmental Outcomes in Early Childhood: A Retrospective Cohort Study	13
The REporting of A Disproportionality Analysis for DrUg Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Explanation and Elaboration	13
Risk of Cancer in Association with Ranitidine and Nizatidine vs Other H2 Blockers: Analysis of the Japan Medical Data Center Claims Database 2005–2018	13
Should Antidepressants be Avoided in Pregnancy?	13
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	13
Adverse Drug Reactions from Real-World Data in Inflammatory Bowel Disease Patients in the IBDREAM Registry	13
Signal Detection in EUROmediCAT: Identification and Evaluation of Medication–Congenital Anomaly Associations and Use of VigiBase as a Complementary Source of Reference	12
Global Safety Database Summary of COVID-19-Related Drug Utilization-Safety Surveillance: A Sponsor’s Perspective	12
Mechanisms, Management and Prevention of Pemetrexed-Related Toxicity	12
Leveraging Machine Learning to Facilitate Individual Case Causality Assessment of Adverse Drug Reactions	12
Safety and Efficacy of Ivermectin and Doxycycline Monotherapy and in Combination in the Treatment of COVID-19: A Scoping Review	12
Future of ChatGPT in Pharmacovigilance	12
Intelligent Telehealth in Pharmacovigilance: A Future Perspective	12
Developing Strategic Recommendations for Implementing Smart Pumps in Advanced Healthcare Systems to Improve Intravenous Medication Safety	12
Mortality in Patients with Parkinson’s Disease-Related Psychosis Treated with Pimavanserin Compared with Other Atypical Antipsychotics: A Cohort Study	12
Risk Management for the 21st Century: Current Status and Future Needs	12
Capturing Data in Rare Disease Registries to Support Regulatory Decision Making: A Survey Study Among Industry and Other Stakeholders	11
Drug–Drug Interaction of the Sodium Glucose Co-Transporter 2 Inhibitors with Statins and Myopathy: A Disproportionality Analysis Using Adverse Events Reporting Data	11
Industry Perspective on Artificial Intelligence/Machine Learning in Pharmacovigilance	11
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	11
The Effect of Metformin on Chemotherapy-Induced Toxicities in Non-diabetic Breast Cancer Patients: A Randomised Controlled Study	11
Patient-Reported Reasons for Switching or Discontinuing Statin Therapy: A Mixed Methods Study Using Social Media	11

A Review of Causal Inference for External Comparator Arm Studies	11
Kidney Damage and Stress Biomarkers for Early Identification of Drug-Induced Kidney Injury: A Systematic Review	11
Therapeutic Management of Idiosyncratic Drug-Induced Liver Injury and Acetaminophen Hepatotoxicity in the Paediatric Population: A Systematic Review	11
Impact of European Union Label Changes for Fluoroquinolone-Containing Medicinal Products for Systemic and Inhalation Use: Post-Referral Prescribing Trends	11
Provision and Need for Medicine Information in Asia and Africa: A Scoping Review of the Literature	10
Long-Term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis	10
Pregnancy, Fetal, and Infant Outcomes Following Maternal Exposure to Glatiramer Acetate During Pregnancy and Breastfeeding	10
Deliberate Self-Poisoning: Real-Time Characterization of Suicidal Habits and Toxidromes in the Food and Drug Administration Adverse Event Reporting System	10
Long-Term Safety Analysis of the ChAdOx1-nCoV-19 Corona Virus Vaccine: Results from a Prospective Observational Study in Priority Vaccinated Groups in North India	10
Challenges and Opportunities in Accessing and Analysing FAERS Data: A Call Towards a Collaborative Approach	10
Cancer Chemotherapy-Induced Sinus Bradycardia: A Narrative Review of a Forgotten Adverse Effect of Cardiotoxicity	10
Artificial Intelligence and Machine Learning for Safe Medicines	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
Factors Contributing to Best Practices for Patient Involvement in Pharmacovigilance in Europe: A Stakeholder Analysis	10
Enhancing Pharmacovigilance from the US Experience: Current Practices and Future Opportunities	10
Post-Marketing Safety Profile of Vortioxetine Using a Cluster Analysis and a Disproportionality Analysis of Global Adverse Event Reports	10
New Drug Postmarketing Requirements and Commitments in the US: A Systematic Review of the Evidence	9
The Impact of Mandatory Reporting of Non-Serious Safety Reports to EudraVigilance on the Detection of Adverse Reactions	9
Machine Learning in Causal Inference: Application in Pharmacovigilance	9
Dispensing of Potentially Harmful Prescription Drugs in 1.8 Million Pregnant Women in France: A Nationwide Study Based on Two Risk Classification Systems	9
Development and Validation of ICD-10-CM-based Algorithms for Date of Last Menstrual Period, Pregnancy Outcomes, and Infant Outcomes	9
Public Perspectives of Using Social Media Data to Improve Adverse Drug Reaction Reporting: A Mixed-Methods Study	9
Cardiovascular Toxicity of Immune Checkpoint Inhibitors: A Guide for Clinicians	9
Cohort Event Monitoring of Adverse Reactions to COVID-19 Vaccines in Seven European Countries: Pooled Results on First Dose	9
Use of Electronic Health Record Data for Drug Safety Signal Identification: A Scoping Review	9
Montelukast and Nightmares: Further Characterisation Using Data from VigiBase	9
Core Data Elements for Pregnancy Pharmacovigilance Studies Using Primary Source Data Collection Methods: Recommendations from the IMI ConcePTION Project	9
Effective Pharmacovigilance System Development: EFPIA-IPVG Consensus Recommendations	9
The Reporting of a Disproportionality Analysis for Drug Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Development and Statement	9
Safety of As-Needed Budesonide-Formoterol in Mild Asthma: Data from the Two Phase III SYGMA Studies	9
Amyotrophic Lateral Sclerosis as an Adverse Drug Reaction: A Disproportionality Analysis of the Food and Drug Administration Adverse Event Reporting System	9
Incidence, Pathogenesis, and Management of Proton Pump Inhibitor-Induced Nephrotoxicity	9
Systematising Pharmacovigilance Engagement of Patients, Healthcare Professionals and Regulators: A Practical Decision Guide Derived from the International Risk Governance Framework for Engagement Even	9
A Multi-modal Approach to Evaluate the Impact of Risk Evaluation and Mitigation Strategy (REMS) Programs	9
Implications of Non-Specific Effects for Testing, Approving, and Regulating Vaccines	9
Optimizing Safety Surveillance for COVID-19 Vaccines at the National Pharmacovigilance Centre Lareb: One Year of COVID-19 Vaccine Experience	8
Applying Machine Learning in Distributed Data Networks for Pharmacoepidemiologic and Pharmacovigilance Studies: Opportunities, Challenges, and Considerations	8
Drug-Induced Sexual Dysfunction: An Analysis of Reports to a National Pharmacovigilance Database	8
Black Swan Events and Intelligent Automation for Routine Safety Surveillance	8
Supervised Machine Learning-Based Decision Support for Signal Validation Classification	8
Remdesivir in the COVID-19 Pandemic: An Analysis of Spontaneous Reports in VigiBase During 2020	8
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	8
Cardiovascular Risk in Users of Mirabegron Compared with Users of Antimuscarinic Treatments for Overactive Bladder: Findings from a Non-Interventional, Multinational, Cohort Study	8
Risk Minimization of Antibody–Drug Conjugates in Oncology: A Review	8
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	8
Developing Crowdsourced Training Data Sets for Pharmacovigilance Intelligent Automation	8
Long-Term Safety and Tolerability of Fremanezumab for Migraine Preventive Treatment in Japanese Outpatients: A Multicenter, Randomized, Open-Label Study	8
A Prospective Observational Study on BBV152 Coronavirus Vaccine Use in Adolescents and Comparison with Adults: Interim Results of the First Real-World Safety Analysis	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
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	8