Results 1 to 10 of about 3,513 (158)

Global patterns and trends in spontaneous reporting systems: VigiBase, FAERS, VAERS, and JADER [PDF]

Frontiers in Drug Safety and Regulation
IntroductionSpontaneous reporting systems (SRSs) gather millions of reports of adverse events occurring to patients worldwide. For its volume and breadth of data, they are often regarded as the cornerstone of pharmacovigilance.
Nikola Panajotovikj, Nikola Panajotovikj, Jordi Mestres, Jordi Mestres   +3 more
doaj   +2 more sources

A Systematic Review and a VigiBase Study of Accidental Clozapine Intoxications in Children and Adolescents [PDF]

Hum Psychopharmacol
ABSTRACT Objectives This study aimed to: (1) systematically review published cases of accidental clozapine poisoning in children and adolescents, and (2) study accidental pediatric clozapine intoxications reported to VigiBase, the global pharmacovigilance database.
Jiménez‐Fernández S, De las Cuevas C, Sanz E, de Leon J.   +3 more
europepmc   +2 more sources

Maternal and Neonatal Complications Associated with Breast Cancer Systemic Treatments-A VigiBase Disproportionality Analysis Study. [PDF]

Clin Pharmacol Ther
Pregnancy‐associated breast cancer (PrBC) presents therapeutic challenges. Understanding maternal–fetal safety of systemic anticancer therapies is critical. We performed a case/non‐case disproportionality analysis using the WHO global pharmacovigilance database up to January 2024, to evaluate maternal–fetal outcomes associated with breast cancer (BC ...
Kabirian R, Jochum F, Dumas E, Coussy F, Bihan K, Lebrun-Vignes B, Pistilli B, Benderra MA, Selleret L, Chouchana L, Reyal F, Hamy AS, Gougis P.   +12 more
europepmc   +2 more sources

Comparative potential for generating spontaneous signals for abuse and dependence among drugs used for attention deficit hyperactivity disorder: A disproportionality analysis in VigiBase®. [PDF]

Gen Psychiatr
ABSTRACT Background The comparative liability for abuse and dependence of drugs used for attention deficit hyperactivity disorder (ADHD) has been poorly explored so far. Aims To evaluate the relative potential of medications used for ADHD for generating spontaneous reports of abuse and dependence in international pharmacovigilance data.
Jouanjus E, Grime T, Bordet C, Lapeyre-Mestre M, Rolland B.   +4 more
europepmc   +2 more sources

Potential association of cluster headache with certain COVID-19 vaccines: An assessment from the pharmacovigilance databases. [PDF]

Headache
Abstract Objectives/Background The main objective of our study was to assess the potential association between coronavirus disease 2019 (COVID‐19) vaccination and cluster headache (CH) using a pharmacovigilance approach. A secondary objective was to determine whether COVID‐19 vaccines predominantly triggered onset or worsening of the disease.
Van Obberghen EK, Parigny L, Ben-Othman N, Ewig E, Drici MD, Gérard AO, Gautier S, Lanteri-Minet M.   +7 more
europepmc   +2 more sources

A ‘One Health’ cross-sectional analysis of reports of potential antibiotic resistance cases in international pharmacovigilance databases [PDF]

Frontiers in Public Health
IntroductionAntibiotic resistance is a global health problem that requires ‘One Health’ interventions encompassing human, animal, and environmental health.
Joseph Mitchell, Joseph Mitchell, Pinelopi Lundquist, Camilla Westerberg, Manju Purohit, Manju Purohit, Cecilia Stålsby Lundborg   +6 more
doaj   +2 more sources

Characterization of ocular adverse events associated with crizotinib: real-world insights from the two global pharmacovigilance databases of FAERS and VigiBase [PDF]

Frontiers in Oncology
To evaluate the risk of ocular adverse events (AEs) associated with crizotinib using real-world data from FAERS and VigiBase, and to characterize signal patterns through disproportionality and time-to-onset (TTO) analyses. Reports from FAERS and VigiBase
Shuai Dong, Zhi-chao Jiang, Li Gao, Rong Zhang, Yan Liu   +4 more
doaj   +2 more sources

From signal to significance: characterizing anthracycline-related hypercoagulable adverse events via pharmacovigilance, animal models, and clinical observation [PDF]

Frontiers in Pharmacology
BackgroundAnthracyclines are widely used antineoplastic agents with well-recognized cardiotoxicity; however, reports of hypercoagulable adverse events (HC-AEs) remain scattered and incompletely described.
Wen Huang, Junyi Shen, Jian Zhang
doaj   +2 more sources

Identification of immunomodulators associated with atrial fibrillation reporting to better understand AF immunologic mechanisms: a Vigibase retrospective disproportionality analysis and a literature review [PDF]

BMJ Open
Objectives Growing evidence exists about the pivotal role of immune mechanisms in the physiopathology of atrial fibrillation (AF). Drugs that modulate the immune system (immunomodulators) may contribute to the development of AF.
Charles Dolladille, Joachim Alexandre, Hubert de Boysson, Paul Milliez, Jonaz Font, Laure Champ-Rigot, Basile Chrétien, Jordane Divoux, Damien Legallois, Pierre Ollitrault, Virginie Ferchaud, Arnaud Pellissier   +11 more
doaj   +2 more sources

Metoclopramide and Risk of Pheochromocytoma Crisis: A Causality Assessment Using Literature and VigiBase Data [PDF]

Drug, Healthcare and Patient Safety
Merhawi Bahta,1 Abraham Dawit,2 Million Okubazghi,1 Mulugeta Russom1 1Eritrean Pharmacovigilance Center, National Medicines and Food Administration, Ministry of Health, Asmara, Eritrea; 2Godaif Community Hospital, Ministry of Health, Asmara ...
Bahta M, Dawit A, Okubazghi M, Russom M
doaj   +2 more sources