FDA unveils searchable adverse events system
نویسندگان
چکیده
منابع مشابه
FDA Unveils Product Development Priorities
Priorities H ealth and Human Services (HHS) Secretary Mike Leavitt and the Food and Drug Administration (FDA) released on March 16 an initial list of priority research projects aimed at advancing innovation in medical products. The Critical Path Opportunities List, part of the FDA Critical Path Initiative, outlines 76 initial projects to bridge the gap between the quick pace of new biomedical d...
متن کاملGlucagon-like peptide-1 receptor agonists are not associated with retinal adverse events in the FDA Adverse Event Reporting System
Objectives Glucagon-like peptide-1 receptor agonists (GLP-1RA) are widely used for the treatment of type 2 diabetes. In large trials, the GLP-1RAs liraglutide and semaglutide improved cardiovascular outcomes, but semaglutide was associated with an increased risk of retinopathy progression. We herein evaluated the association between GLP-1RA and retinal adverse events (AE) in the Food and Drug A...
متن کاملAdverse Events Associated with Fosfomycin Use: Review of the Literature and Analyses of the FDA Adverse Event Reporting System Database
INTRODUCTION The growing problem of antibacterial resistance resulted in an increased interest in fosfomycin, especially its parenteral formulation. We reviewed fosfomycin safety profile using the Food and Drug Administration Adverse Event (AE) Reporting System (FAERS) and published literature. METHODS We conducted a FAERS search and disproportionality analysis of all fosfomycin-associated AE...
متن کاملStatin-Associated Muscular and Renal Adverse Events: Data Mining of the Public Version of the FDA Adverse Event Reporting System
OBJECTIVE Adverse event reports (AERs) submitted to the US Food and Drug Administration (FDA) were reviewed to assess the muscular and renal adverse events induced by the administration of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins) and to attempt to determine the rank-order of the association. METHODS After a revision of arbitrary drug names and the deletio...
متن کاملEvaluation of Dabigatran- and Warfarin-Associated Hemorrhagic Events Using the FDA-Adverse Event Reporting System Database Stratified by Age
Dabigatran and warfarin are oral anticoagulant drugs widely used for the prevention of stroke in patients with atrial fibrillation. The objective of this study was to evaluate the interaction between aging and dabigatran- and warfarin-induced gastrointestinal (GI) and nervous system hemorrhage using data available in the FDA Adverse Event Reporting System (FAERS) database. We analyzed reports o...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
ژورنال
عنوان ژورنال: Nature Reviews Drug Discovery
سال: 2017
ISSN: 1474-1776,1474-1784
DOI: 10.1038/nrd.2017.224