MedWatch: The FDA Safety Information and Adverse Event Reporting Program
نویسندگان
چکیده
منابع مشابه
Comparison of the adverse event profiles of conventional and liposomal formulations of doxorubicin using the FDA adverse event reporting system
Doxorubicin (DOX) is an anthracycline widely used for the treatment of solid and hematological tumors. The aim of this study was to assess the adverse event profiles of conventional DOX and liposomal DOX. This is the first study to evaluate the effect of a liposomal formulation of DOX using spontaneous reporting system (SRS) databases. The SRS used was the US Food and Drug Administration Advers...
متن کاملAntipsychotics and Torsadogenic Risk: Signals Emerging from the US FDA Adverse Event Reporting System Database
BACKGROUND Drug-induced torsades de pointes (TdP) and related clinical entities represent a current regulatory and clinical burden. OBJECTIVE As part of the FP7 ARITMO (Arrhythmogenic Potential of Drugs) project, we explored the publicly available US FDA Adverse Event Reporting System (FAERS) database to detect signals of torsadogenicity for antipsychotics (APs). METHODS Four groups of even...
متن کاملData Mining of the Public Version of the FDA Adverse Event Reporting System
The US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS, formerly AERS) is a database that contains information on adverse event and medication error reports submitted to the FDA. Besides those from manufacturers, reports can be submitted from health care professionals and the public. The original system was started in 1969, but since the last major revision in 1997, rep...
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 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...
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ژورنال
عنوان ژورنال: Journal of the Medical Library Association
سال: 2007
ISSN: 1536-5050,1558-9439
DOI: 10.3163/1536-5050.95.2.224