Results 21 to 30 of about 492 (136)

Post-marketing safety signals and report-level ARIA-E stratification for lecanemab and donanemab: an integrated FAERS and WHO-VigiAccess pharmacovigilance study [PDF]

Therapeutic Advances in Drug Safety
Background: Anti-β-amyloid monoclonal antibodies provide a disease-modifying treatment approach for Alzheimer’s disease, but post-marketing safety concerns remain, particularly amyloid-related imaging abnormalities (ARIA).
Wei-Yang Xue, Xi Li, Wen-Ting Li, Bao-Zhi Qin, Cong-Zhi Wang, Tao Liu, Min Wang   +6 more
doaj   +3 more sources

Assessing the real-world safety of fenofibric acid for hyperlipidemia: results from WHO-VigiAccess and FAERS databases [PDF]

Frontiers in Medicine
BackgroundFenofibric acid is a small-molecule fibrate that functions as an agonist of peroxisome proliferator-activated receptor alpha (PPARα) and serves as an inhibitor of liver fatty acid-binding protein.
Yaxing Li, Yaxing Li, Yi Wang, Jidang Zhang, Ruonan Zhang, Zhiwen Yao, Zhiwen Yao, Xuepin Chen, Xingli Xu   +8 more
doaj   +4 more sources

Adverse events of hepatic anti-fibrotic agents in phase 3 and above clinical trials: a descriptive analysis of the WHO-VigiAccess database [PDF]

Frontiers in Pharmacology
IntroductionLiver fibrosis is a pathological condition in response to chronic liver injuries. Currently, there is no Food and Drug Administration (FDA) approved pharmacotherapy for liver fibrosis.
Yuwei Liu, Yuwei Liu, Xu Zhao, Xu Zhao, Xinrui Wang, Xinrui Wang, Qiang Zhou, Qiang Zhou   +7 more
exaly   +4 more sources

Adverse event profile of lomustine and temozolomide: a descriptive analysis from WHO-VigiAccess

Frontiers in Pharmacology
IntroductionIn gliomas, various oncogenic factors can lead to an imbalance between cell proliferation and apoptosis. Lomustine inhibits tumor cell growth by disrupting DNA replication and repair mechanisms.
Liang Lü, Liwei Zhang, Youfu He
exaly   +5 more sources

Real-world safety of ixekizumab: a disproportionality analysis using the FDA adverse event reporting system and the VigiAccess databases [PDF]

Frontiers in Medicine
IntroductionIxekizumab is a biologic agent primarily indicated for the treatment of moderate to-severe plaque psoriasis. This study aimed to evaluate the post-marketing safety profile of ixekizumab by analyzing adverse event (AE) reports retrieved from ...
Kaidi Zhao, Xuanfeng Tan, Miao Qin, Qinxiao Li, Qinqin Meng, Ying Liu, Jing Li, Jiashu Liu   +7 more
doaj   +5 more sources

Characterization of adverse reactions to four common targeted drugs for hepatocellular carcinoma in WHO-VigiAccess

Scientific Reports
Hepatocellular carcinoma (HCC) is one of the leading causes of cancer-related mortality, with limited therapeutic options available for advanced stages of the disease.
Zeyu Wang, Jiyao Sheng, Xuewen Zhang
doaj   +4 more sources

A real-world data analysis of ocular adverse events linked to anti-VEGF drugs: a WHO-VigiAccess study [PDF]

Frontiers in Pharmacology
IntroductionVascular endothelial growth factor (VEGF) is key to wet age-related macular degeneration (wAMD). Anti-VEGF drugs are the main treatment in clinics.
Chen Li, Yicheng Lu, Ziyue Song, Yueqi Liu   +3 more
doaj   +4 more sources

Pharmacovigilance analysis of cutaneous adverse drug reactions for cetuximab, panitumumab, and necitumumab based on EudraVigilance and WHO VigiAccess [PDF]

Frontiers in Pharmacology
IntroductionAnti-EGFR monoclonal antibodies (mAbs)--cetuximab, panitumumab, and necitumumab--are cornerstone therapies for selected solid tumors but are frequently associated with cutaneous adverse drug reactions (ADRs).
Natalia Sauer, Piotr Giedziun, Jacek Calik, Jacek Calik, Anna Wiela-Hojeńska   +4 more
doaj   +4 more sources

Real-world adverse event profiles of Zuranolone and Brexanolone based on FAERS and VigiAccess databases: An observational study. [PDF]

Medicine (Baltimore)
Zuranolone and Brexanolone are Food and Drug Administration-approved novel agents for postpartum depression, yet real-world post-marketing safety data for the two drugs remain insufficient. This study aimed to systematically characterize their adverse event (AE) profiles via two authoritative pharmacovigilance ...
Xie G, Weng H, Yu J, Chi L.
europepmc   +3 more sources

An Assessment of the Reporting Pattern of Adverse Events Following Immunizations in VigiAccess

Global Journal of Health Science, 2018
PURPOSE: Globally, adverse events following immunization (AEFI) reporting continues to be a challenge. It is estimated that about 95% of AEFIs never get reported after vaccinations necessitating strategies to improve it. The introduction of databases such as VigiAccess in which AEFI data from Pharmacovigilance centres around the world can be assessed ...
Peter Yamoah, Frasia Oosthuizen
core   +5 more sources