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COVID-19 Vaccines and Heavy Menstrual Bleeding: The Impact of Media Attention on Reporting to EudraVigilance
COVID-19 Vaccines and Heavy Menstrual Bleeding: The Impact of Media Attention on Reporting to EudraVigilance
During the COVID-19 vaccination campaign, over 34,000 reports of heavy menstrual bleeding following the administration of ...
Enzalutamide: Understanding and Managing Drug Interactions to Improve Patient Safety and Drug Efficacy
Enzalutamide: Understanding and Managing Drug Interactions to Improve Patient Safety and Drug Efficacy
Enzalutamide is an oral androgen receptor signaling inhibitor utilized in the treatment of men with prostate cancer. It is...
Behavioral Science: Enhancing Our Approach to the Development of Effective Additional Risk Minimization Strategies
Behavioral Science: Enhancing Our Approach to the Development of Effective Additional Risk Minimization Strategies
Additional risk minimization strategies may be required to assure a positive benefit–risk balance for some therapeut...
Fatal Intoxications with Zopiclone—A Cause for Concern?
Fatal Intoxications with Zopiclone—A Cause for Concern?
Zopiclone, a controlled substance prescribed for insomnia, has become a common toxicological finding in forensic autopsy c...
Angiotensin Receptor Blockers and the Risk of Suspected Drug-Induced Liver Injury: A Retrospective Cohort Study Using Electronic Health Record-Based Common Data Model in South Korea
Angiotensin Receptor Blockers and the Risk of Suspected Drug-Induced Liver Injury: A Retrospective Cohort Study Using Electronic Health Record-Based Common Data Model in South Korea
Angiotensin receptor blockers are widely used antihypertensive drugs in South Korea. In 2021, the Korea Ministry of Food a...
The Role of Mitochondria in Statin-Induced Myopathy
The Role of Mitochondria in Statin-Induced Myopathy
Statins represent the primary therapy for combatting hypercholesterolemia and reducing mortality from cardiovascular event...
Drug-Gene Risk Stratification in Patients with Suspected Drug-Induced Interstitial Lung Disease
Drug-Gene Risk Stratification in Patients with Suspected Drug-Induced Interstitial Lung Disease
Pulmonary toxicity has been associated with drug use. This is often not recognized in clinical practice, and underestimate...
Drug–Drug Interactions and Actual Harm to Hospitalized Patients: A Multicentre Study Examining the Prevalence Pre- and Post-Electronic Medication System Implementation
Drug–Drug Interactions and Actual Harm to Hospitalized Patients: A Multicentre Study Examining the Prevalence Pre- and Post-Electronic Medication System Implementation
Drug–drug interactions (DDIs) have potential to cause patient harm, including lowering therapeutic efficacy. This st...
The Reporting Recommendations Intended for Pharmaceutical Risk Minimization Evaluation Studies: Standards for Reporting of Implementation Studies Extension (RIMES-SE)
The Reporting Recommendations Intended for Pharmaceutical Risk Minimization Evaluation Studies: Standards for Reporting of Implementation Studies Extension (RIMES-SE)
The Reporting recommendations Intended for pharmaceutical risk Minimization Evaluation Studies (RIMES) was developed to im...
An 8-Year Prospective, Observational, Multi-centre Post-Marketing Safety Surveillance Study Conducted in South Korea (2014–2022) Following the Introduction of GSK’s Inactivated Quadrivalent Seasonal Influenza Vaccine (Fluarix Tetra) for Subjects Aged 6 Months and Older
An 8-Year Prospective, Observational, Multi-centre Post-Marketing Safety Surveillance Study Conducted in South Korea (2014–2022) Following the Introduction of GSK’s Inactivated Quadrivalent Seasonal Influenza Vaccine (Fluarix Tetra) for Subjects Aged 6 Months and Older
Seasonal influenza is associated with substantial public health burden. The objective of this study was to assess the safe...
Using Social Media as a Source of Real-World Data for Pharmaceutical Drug Development and Regulatory Decision Making
Using Social Media as a Source of Real-World Data for Pharmaceutical Drug Development and Regulatory Decision Making
While pharmaceutical companies aim to leverage real-world data (RWD) to bridge the gap between clinical drug development a...
Risk of Systemic Inflammatory Response Syndrome Following Preoperative Glucocorticoids Administration in Patients After Percutaneous Nephrolithotomy: A Retrospective Cohort Study
Risk of Systemic Inflammatory Response Syndrome Following Preoperative Glucocorticoids Administration in Patients After Percutaneous Nephrolithotomy: A Retrospective Cohort Study
Systemic inflammatory response syndrome (SIRS) is one of the most serious complications in patients undergoing percutaneou...
In Utero Exposure to Antibiotics and Risk of Serious Infections in the First Year of Life
In Utero Exposure to Antibiotics and Risk of Serious Infections in the First Year of Life
Given the high prevalence of antibiotic prescription during pregnancy in France and previous studies suggesting an increas...
A Comparison of Signals of Designated Medical Events and Non-designated Medical Events: Results from a Scoping Review
A Comparison of Signals of Designated Medical Events and Non-designated Medical Events: Results from a Scoping Review
The European Medicines Agency (EMA) maintains a list of designated medical events (DMEs), events that are inherently serio...
The Role of the European Medicines Agency in the Safety Monitoring of COVID-19 Vaccines and Future Directions in Enhancing Vaccine Safety Globally
The Role of the European Medicines Agency in the Safety Monitoring of COVID-19 Vaccines and Future Directions in Enhancing Vaccine Safety Globally
The European Union (EU) regulatory network was at the forefront of the safety monitoring of COVID-19 vaccines during the p...
Detection Algorithms for Simple Two-Group Comparisons Using Spontaneous Reporting Systems
Detection Algorithms for Simple Two-Group Comparisons Using Spontaneous Reporting Systems
Medical science has often used adult males as the standard to establish pathological conditions, their transitions, diagno...
Sociodemographic Characteristics of Adverse Event Reporting in the USA: An Ecologic Study
Sociodemographic Characteristics of Adverse Event Reporting in the USA: An Ecologic Study
The Food and Drug Administration Adverse Event Reporting System (FAERS) is a vital source of new drug safety information, ...
Exploring the Role of Guidelines in Contributing to Medication Errors: A Descriptive Analysis of National Patient Safety Incident Data
Exploring the Role of Guidelines in Contributing to Medication Errors: A Descriptive Analysis of National Patient Safety Incident Data
Clinical guidelines can contribute to medication errors but there is no overall understanding of how and where these occur...
Drug-Drug Interactions Between Glucagon-Like Peptide 1 Receptor Agonists and Oral Medications: A Systematic Review
Drug-Drug Interactions Between Glucagon-Like Peptide 1 Receptor Agonists and Oral Medications: A Systematic Review
Glucagon-like peptide 1 receptor agonists (GLP1RAs) are used in the treatment of diabetes and obesity. Their slowing effec...
Correction to: Patient-Reported Reasons for Antihypertensive Medication Change: A Quantitative Study Using Social Media
Correction to: Patient-Reported Reasons for Antihypertensive Medication Change: A Quantitative Study Using Social Media
Author notesCristina MicalePresent address: Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA, ...
Drug-Induced Liver Injury in the Elderly: Consensus Statements and Recommendations from the IQ-DILI Initiative
Drug-Induced Liver Injury in the Elderly: Consensus Statements and Recommendations from the IQ-DILI Initiative
The elderly demographic is the fastest-growing segment of the world’s population and is projected to exceed 1.5 bill...
Enhancing Transparency in Defining Studied Drugs: The Open-Source Living DiAna Dictionary for Standardizing Drug Names in the FAERS
Enhancing Transparency in Defining Studied Drugs: The Open-Source Living DiAna Dictionary for Standardizing Drug Names in the FAERS
In refining drug safety signals, defining the object of study is crucial. While research has explored the effect of differ...
Industry Review of Best Practices for Risk Management of Drug-Induced Liver Injury from Development to Real-World Use
Industry Review of Best Practices for Risk Management of Drug-Induced Liver Injury from Development to Real-World Use
The relative treatment benefit of a drug for patients during development, marketing authorization review, or after approva...
Validation of a Novel Method to Assess the Clinical Quality of Information in Pregnancy-Related Pharmacovigilance Case Reports: A ConcePTION Project
Validation of a Novel Method to Assess the Clinical Quality of Information in Pregnancy-Related Pharmacovigilance Case Reports: A ConcePTION Project
To assess the causal relationship between a medicinal product and a reported event, relevant information needs to be prese...
Risk of Major Bleeding Associated with Concomitant Direct-Acting Oral Anticoagulant and Clopidogrel Use: A Retrospective Cohort Study
Risk of Major Bleeding Associated with Concomitant Direct-Acting Oral Anticoagulant and Clopidogrel Use: A Retrospective Cohort Study
Combined anticoagulant-antiplatelet therapy is often indicated in adults with cardiovascular disease and atrial fibrillati...
International Trends in Adverse Drug Event-Related Mortality from 2001 to 2019: An Analysis of the World Health Organization Mortality Database from 54 Countries
International Trends in Adverse Drug Event-Related Mortality from 2001 to 2019: An Analysis of the World Health Organization Mortality Database from 54 Countries
Adverse drug events (ADEs) are becoming a significant public health issue. However, reports on ADE-related mortality are l...
Appeal for Increasing the Impact of Pharmacovigilance
Appeal for Increasing the Impact of Pharmacovigilance
Pharmacovigilance (PV) is defined as the science and activities related to detecting, assessing, understanding and prevent...
The Critical Intersect of Regulations, Health Technology Assessment, and Drug Safety Assessments
The Critical Intersect of Regulations, Health Technology Assessment, and Drug Safety Assessments
Health technology assessment (HTA) is a multidisciplinary process that determines the value of health technology at differ...
Improving Data Collection in Pregnancy Safety Studies: Towards Standardisation of Data Elements in Pregnancy Reports from Public and Private Partners, A Contribution from the ConcePTION Project
Improving Data Collection in Pregnancy Safety Studies: Towards Standardisation of Data Elements in Pregnancy Reports from Public and Private Partners, A Contribution from the ConcePTION Project
The ConcePTION project aims to improve the way medication use during pregnancy is studied. This includes exploring the pos...
Implementation of a Taxonomy-Based Framework for the Selection of Appropriate Drugs and Outcomes for Real-World Data Signal Detection Studies
Implementation of a Taxonomy-Based Framework for the Selection of Appropriate Drugs and Outcomes for Real-World Data Signal Detection Studies
For signal detection studies investigating either drug safety or method evaluation, the choice of drug-outcome pairs needs...
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