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Real-World Effectiveness and Safety of Tixagevimab–Cilgavimab: A Target Trial Emulation Study
Real-World Effectiveness and Safety of Tixagevimab–Cilgavimab: A Target Trial Emulation Study
Immunocompromised individuals are at high risk of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection a...
Pharmacovigilance in Pregnancy Studies, Exposures and Outcomes Ascertainment, and Findings from Low- and Middle-Income Countries: A Scoping Review
Pharmacovigilance in Pregnancy Studies, Exposures and Outcomes Ascertainment, and Findings from Low- and Middle-Income Countries: A Scoping Review
Pharmacovigilance (PV), or the ongoing safety monitoring after a medication has been licensed, plays a crucial role in pre...
What is the Safety of COVID-19 Vaccines in Immunocompromised Patients? Results from the European “Covid Vaccine Monitor” Active Surveillance Study
What is the Safety of COVID-19 Vaccines in Immunocompromised Patients? Results from the European “Covid Vaccine Monitor” Active Surveillance Study
The safety profile of COVID-19 vaccines in immunocompromised patients has not been comprehensively evaluated. To measure t...
Identification of Pregnancy Adverse Drug Reactions in Pharmacovigilance Reporting Systems: A Novel Algorithm Developed in EudraVigilance
Identification of Pregnancy Adverse Drug Reactions in Pharmacovigilance Reporting Systems: A Novel Algorithm Developed in EudraVigilance
There is a need to strengthen the evidence base regarding medication use during pregnancy and to facilitate the early dete...
Tardive Dyskinesia with Antipsychotic Medication in Children and Adolescents: A Systematic Literature Review
Tardive Dyskinesia with Antipsychotic Medication in Children and Adolescents: A Systematic Literature Review
Tardive dyskinesia (TD) is a persisting, and potentially irreversible, movement disorder associated with treatment with do...
Key Opinion Leaders’ Interviews to Inform the Future of Benefit–Risk Planning in the Medical Total Product Life Cycle of Global Pharmaceutical and Medical Device Organizations
Key Opinion Leaders’ Interviews to Inform the Future of Benefit–Risk Planning in the Medical Total Product Life Cycle of Global Pharmaceutical and Medical Device Organizations
Key opinion leader (KOL) interviews were conducted by the Benefit–Risk Assessment Planning (BRAP) Taskforce...
Targeting CCL24 in Inflammatory and Fibrotic Diseases: Rationale and Results from Three CM-101 Phase 1 Studies
Targeting CCL24 in Inflammatory and Fibrotic Diseases: Rationale and Results from Three CM-101 Phase 1 Studies
Overexpression of C-C motif chemokine ligand 24 (CCL24) is associated with inflammatory and fibrotic diseases, including p...
Trends in Use and Evidence of Adherence to Risk Evaluation and Mitigation Strategy Pregnancy Testing Requirements for Thalidomide, Lenalidomide, and Pomalidomide in the USA, 2000–2020
Trends in Use and Evidence of Adherence to Risk Evaluation and Mitigation Strategy Pregnancy Testing Requirements for Thalidomide, Lenalidomide, and Pomalidomide in the USA, 2000–2020
Lenalidomide, pomalidomide, and thalidomide are effective treatments for multiple myeloma but are teratogenic. To mitigate...
Long-Term Safety Analysis of the BBV152 Coronavirus Vaccine in Adolescents and Adults: Findings from a 1-Year Prospective Study in North India
Long-Term Safety Analysis of the BBV152 Coronavirus Vaccine in Adolescents and Adults: Findings from a 1-Year Prospective Study in North India
Evidence on the long-term safety of COVID-19 vaccines is scarce. Here, in continuation of our previously published results...
Predictors of Adverse Drug Reaction-Related Hospitalisations Among People with Dementia: A Retrospective Case-Control Study
Predictors of Adverse Drug Reaction-Related Hospitalisations Among People with Dementia: A Retrospective Case-Control Study
Adverse drug reactions (ADRs) are common among people with dementia; however, little is known about the magnitude and pred...
Post-Conceptional Exposure to Clomiphene Citrate and Congenital Malformations: A Cohort Study
Post-Conceptional Exposure to Clomiphene Citrate and Congenital Malformations: A Cohort Study
Clomiphene citrate is an ovulation inductor for which inadvertent post-conceptional exposures may occur in early pregnancy...
Risk of Mortality Associated with Potentially Inappropriate Medication Use Including Opioids in Older Adults
Risk of Mortality Associated with Potentially Inappropriate Medication Use Including Opioids in Older Adults
As the population ages, understanding the potential risks associated with inappropriate medication use becomes increasingl...
Use of Sotrovimab in Pregnancy: Experiences from the COVID-19 International Drug Pregnancy Registry
Use of Sotrovimab in Pregnancy: Experiences from the COVID-19 International Drug Pregnancy Registry
Available data regarding the safety and efficacy of sotrovimab in pregnant patients remain limited due to their exclusion ...
Comparators in Pharmacovigilance: A Quasi-Quantification Bias Analysis
Comparators in Pharmacovigilance: A Quasi-Quantification Bias Analysis
It is unclear which comparator is the most appropriate for bias reduction in disproportionality analyses based on spontane...
Can We Ask ChatGPT About Drug Safety? Appropriateness of ChatGPT Responses to Questions About Drug Use and Adverse Reactions Received by Pharmacovigilance Centers
Can We Ask ChatGPT About Drug Safety? Appropriateness of ChatGPT Responses to Questions About Drug Use and Adverse Reactions Received by Pharmacovigilance Centers
Funding No funding was received to assist in the preparation of thi...
Dipeptidyl Peptidase-4 Inhibitors and the Risk of Gallbladder and Bile Duct Disease Among Patients with Type 2 Diabetes: A Population-Based Cohort Study
Dipeptidyl Peptidase-4 Inhibitors and the Risk of Gallbladder and Bile Duct Disease Among Patients with Type 2 Diabetes: A Population-Based Cohort Study
The use of dipeptidyl peptidase-4 (DPP-4) inhibitors may be associated with an increased risk of gallbladder and bile duct...
Antipsychotic-Related DRESS Syndrome: Analysis of Individual Case Safety Reports of the WHO Pharmacovigilance Database
Antipsychotic-Related DRESS Syndrome: Analysis of Individual Case Safety Reports of the WHO Pharmacovigilance Database
Drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome is gaining attention in pharmacovigilance, but its ...
The Safety of Ixekizumab in Chinese Adults with Moderate-to-Severe Plaque Psoriasis: Analyses from a Prospective, Single-Arm, Multicenter, 12-Week Observational Study
The Safety of Ixekizumab in Chinese Adults with Moderate-to-Severe Plaque Psoriasis: Analyses from a Prospective, Single-Arm, Multicenter, 12-Week Observational Study
Ixekizumab, a monoclonal antibody against interleukin-17A, is efficacious and well tolerated for the treatment of moderate...
Timing Matters: A Machine Learning Method for the Prioritization of Drug–Drug Interactions Through Signal Detection in the FDA Adverse Event Reporting System and Their Relationship with Time of Co-exposure
Timing Matters: A Machine Learning Method for the Prioritization of Drug–Drug Interactions Through Signal Detection in the FDA Adverse Event Reporting System and Their Relationship with Time of Co-exposure
Current drug–drug interaction (DDI) detection methods often miss the aspect of temporal plausibility, leading to fal...
Competing Benefits and Competing Hazards: The Benefit to Harm Balance in Individual Patients in Rational Therapeutics
Competing Benefits and Competing Hazards: The Benefit to Harm Balance in Individual Patients in Rational Therapeutics
For any therapeutic intervention in an individual, there is a balance between the potential benefits and the possible harm...
Composite Plot for Visualizing Aminotransferase and Bilirubin Changes in Clinical Trials of Subjects with Abnormal Baseline Values
Composite Plot for Visualizing Aminotransferase and Bilirubin Changes in Clinical Trials of Subjects with Abnormal Baseline Values
On-treatment excursions of liver laboratory test values in clinical trials involving subjects with underlying liver diseas...
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...
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