A real-world pharmacovigilance study of adverse drug reactions associated with lecanemab and aducanumab based on WHO-VigiAccess and FAERS databases [PDF]
Frontiers in PharmacologyBackgroundLecanemab and Aducanumab are two novel anti-amyloid beta (Aβ) therapies for Alzheimer’s disease (AD) that have shown promise in slowing cognitive decline. However, their safety profiles remain unclear due to limited real-world evidence.
Yunhan Zhao, Haoxiang Hu, Jianghai He
exaly +8 more sources
Real-world safety of tirofiban: a disproportionality analysis using data from FAERS and WHO-VigiAccess [PDF]
Frontiers in PharmacologyObjectiveThis study aimed to detect tirofiban-related adverse event (AE) signals using the FAERS and WHO-VigiAccess databases to support safer clinical use.MethodsAll tirofiban-related AE reports were retrieved from FAERS (2004Q1 to 2024Q4) and WHO ...
Jia Li +7 more
exaly +6 more sources
Characteristic analysis of adverse reactions of finerenone: an in-depth analysis from WHO-VigiAccess [PDF]
Frontiers in PharmacologyIntroductionFinerenone is a novel non-steroidal mineralocorticoid receptor antagonist that has shown promise in the treatment of chronic kidney disease and heart failure.
Boda Zhou, Hongxuan Fan, Zhuolin Huang
exaly +6 more sources
Human Vaccines and Immunotherapeutics, 2022 This study assessed adverse events following immunizations (AEFIs) reported on COVID-19 vaccines in VigiAccess and determined the reporting trends across all continents of the world. The study was cross-sectional quantitative in design.
Joseph Attakorah +2 more
exaly +3 more sources
Association between ranitidine use and thyroid cancer based on FAERS and VigiAccess databases [PDF]
Discover OncologyPurpose The potential carcinogenic risk of ranitidine has sparked widespread controversy, and its relationship with thyroid cancer remains unclear. This study aimed to evaluate the disproportionality signal for thyroid cancer reporting associated with ...
Qingli Shen +4 more
doaj +3 more sources
Adverse event profile of five anti head and neck squamous cell carcinoma drugs: a descriptive analysis from WHO-VigiAccess [PDF]
Frontiers in PharmacologyBackgroundHead and neck squamous cell carcinoma (HNSCC) remains a significant global health concern, with treatment outcomes for advanced or metastatic stages being suboptimal despite the availability of various targeted therapies and immunotherapies ...
Weimin Gao +3 more
exaly +4 more sources
Pharmacovigilance evaluation of somatrogon-associated adverse events in real-world databases [PDF]
Endocrine ConnectionsBackground: Somatrogon, a long-acting recombinant human growth hormone, is used in children with growth hormone deficiency. While clinical trials have shown its safety, real-world post-marketing data are limited, and uncommon or delayed adverse events ...
Mengyuan Cai +5 more
doaj +2 more sources
Real-world pharmacovigilance of drug-related bone metabolism disorders: integrating FAERS and VigiAccess with a Bradford Hill-based causal plausibility assessment [PDF]
Frontiers in PharmacologyBackgroundMetabolic bone diseases (MBDs) are a group of conditions characterized by imbalanced bone remodeling, including osteoporosis, osteomalacia, and rickets.
Pei Liu +6 more
doaj +2 more sources
Post-marketing safety signals of Wilson’s disease therapies: evidence from FAERS and VigiBase [PDF]
Orphanet Journal of Rare DiseasesIntroduction Wilson’s disease is a rare autosomal copper metabolism recessive disorder that requires lifelong pharmacological treatment. D-penicillamine and trientine are the most commonly used copper chelators.
Hülya Tezel-Yalçın +3 more
doaj +2 more sources
Real-world pharmacovigilance analysis and cross-database consistency assessment of resmetirom-related adverse events using FAERS and VigiAccess [PDF]
Frontiers in PharmacologyObjectiveThis study aimed to characterize the post-marketing safety profile and potential adverse event signals of resmetirom using the FAERS and VigiAccess databases.MethodsFAERS reports from the quarter of initial United States approval through 2026Q1 ...
Yali Zhong +3 more
doaj +2 more sources