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SCI Abstract
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Identifying Maternal Conditions Leading to Gabapentinoid Prescriptions in Pregnancy Using Electronic Health Records from Six European Countries: A Contribution from the IMI ConcePTION Project
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Reporting Adverse Drug Events: A Comparison of an Online Patient Tool Versus Telephone-Based Monitoring in Community Pharmacy Patients in the Netherlands
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Identifying New Candidate Predictors of Mortality in Japanese Patients with Severe Drug Eruptions
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Uncovering Pregnancy Exposures in Pharmacovigilance Case Report Databases: A Comprehensive Evaluation of the VigiBase Pregnancy Algorithm
Information on the safety of medicine use during pregnancy is limited at the time of marketing, making post-marketing surv...
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Sex Differences in Electrolyte Disturbances Among Diuretic Users According to Renal Function and Age
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Temporal Trends of Anticholinergic Drug Exposure Among Older Adults: A 25-Year Population-Based Study
Exposure to anticholinergic drugs is associated with adverse outcomes, particularly among older adults. Limiting the antic...
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Characteristics of Drug-RElated Hospitalizations for Nursing HOme Residents: Cross-Sectional RENHO Study
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Association of GLP1-Receptor Agonists with Risk of Hepatocellular Carcinoma: A Retrospective Cohort Study
The use of glucagon-like peptide-1 receptor agonists (GLP-1RA) has exponentially increased owing to their favorable cardio...
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Strategies and Challenges in Coding Ambiguous Information Using MedDRA: An Exploration Among Norwegian Pharmacovigilance Officers
The Medical Dictionary for Regulatory Activities (MedDRA®) is an international standardized medical terminology used ...
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Signals of Adverse Reactions to Herbal Medicines: Evidence and Document Analysis Based on a Scoping Review
To date, signals of adverse reactions to herbal medicines have not been systematically reviewed, limiting pharmacovigilanc...
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The Effect of Opioid Agonist Treatment on Injection-Related Sequelae: A Population-Based Observational Study
Opioid agonist treatment (OAT) reduces drug-related poisonings and injection-related infections among people with opioid u...
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Temporal Changes in Reporting of Neurodevelopmental Outcomes After Maternal Exposure to Valproate: A Contribution of the ConcePTION Project
Understanding changes over time in the quantity and characteristics of reports submitted to pharmacovigilance centres is c...
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The Value of Sensitivity Analyses in Assessing the Risk of Two Rare Neurological Adverse Events and Pseudoephedrine Use
In 2023, the National Agency for the Safety of Medicines and Health Products (ANSM) of France raised concerns about the sa...
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Real-World Data Insights into Antidepressant Prescription and Adherence During Pregnancy in Catalonia (Spain)
Affective disorders, particularly depression, are common among women of childbearing age, and pregnancy often exacerbates ...
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Epidemiology of Thrombotic Thrombocytopenia Syndrome 2011 to 2022: English Sentinel Network Cohort Studies
Thrombotic thrombocytopenia syndrome (TTS) is a rare condition following vaccination with adenovirus-vectored coronavirus ...
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Unveiling the Burden of Drug-Induced Impulsivity: A Network Analysis of the FDA Adverse Event Reporting System
Impulsivity induced by dopaminergic agents, like pramipexole and aripiprazole, can lead to behavioral addictions that impa...
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Emergency Department Use of Heart Failure-Exacerbating Medications in Patients with Chronic Heart Failure
Use of heart failure-exacerbating medications (HFEMs) may lead to preventable episodes of acute decompensated heart failur...
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Paracetamol Dosing Errors in People Aged 12 Years and Over: An Analysis of Over 14,000 Cases Reported to an Australian Poisons Information Centre
Paracetamol dosing errors can cause acute liver injury, with potentially toxic doses only slightly above the therapeutic r...
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Examining the Effect of Missing Data and Unmeasured Confounding on External Comparator Studies: Case Studies and Simulations
Missing data and unmeasured confounding are key challenges for external comparator studies. This work evaluates bias and o...
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A Comparison of Active Pharmacovigilance Strategies Used to Monitor Adverse Events to Antiviral Agents: A Systematic Review
The safety of antiviral agents in real-world clinical settings is crucial, as pre-marketing studies often do not capture a...
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Adverse Drug Events in Ambulatory Care: A Cross-Sectional Study
Adverse drug events (ADEs) are understudied in the ambulatory care setting. We aim to estimate the prevalence and characte...
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Prenatal Exposure to Proton Pump Inhibitors and Risk of Serious Infections in Offspring During the First Year of Life: A Nationwide Cohort Study
Proton pump inhibitor (PPI) use in children increases the risk of infections, prompting inquiry into the impact of prenata...
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Early Detection of Hearing Impairment Signals Post-mRNA COVID-19 Vaccination: A Disproportionality Analysis Study on French Pharmacovigilance Database
Improving adverse events following immunisation (AEFI) detection is vital for vaccine safety surveillance, as an early saf...
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Trends in Proton Pump Inhibitor Use in Sweden by Sex and Age: A Drug Utilisation Study
Proton pump inhibitors (PPIs) are among the most popular drugs worldwide. Yet, there are concerns on long-term safety and ...
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Call to action: Pharmaceutical residues in the environment: threats to ecosystems and human health
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Prenatal and Early Childhood Exposure to Proton Pump Inhibitors and Antibiotics and the Risk of Childhood Cancer: A Nationwide Population-Based Cohort Study
Our microbiome is established during infancy, a time important for later health and long-term effects. Proton pump inhibit...
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Use of Reporting Recommendation Intended for Pharmaceutical Risk Minimisation Evaluation Studies (RIMES) Checklist in Risk Minimisation/Mitigation Studies: A Review and Survey
The Reporting Recommendation Intended for Pharmaceutical Risk Minimisation Evaluation Studies (RIMES) checklist is endorse...
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Cardiovascular Safety of Romosozumab Compared to Commonly Used Anti-osteoporosis Medications in Postmenopausal Osteoporosis: A Systematic Review and Network Meta-analysis of Randomized Controlled Trials
The aim of this study was to investigate the cardiovascular safety of romosozumab in postmenopausal women with osteoporosi...
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Qualitative Interviews with Stakeholders in Herbal Pharmacovigilance and Recommendations for Best Practices to be Applied Worldwide
The use of herbal products globally is substantial, but varying definitions and regulatory frameworks have led to differen...
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Disproportionality Analysis and Characterisation of Medication Errors in EudraVigilance: Exploring Findings on Sexes and Age Groups
While medication errors (MEs) have been studied in the European Medicines Agency’s EudraVigilance, extensive charact...
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