PRS1 Assessing the Association of Omalizumab Use and Arteriothrombotic Events Through Spontaneous Adverse Event Reporting
نویسندگان
چکیده
منابع مشابه
Assessing the association between omalizumab and arteriothrombotic events through spontaneous adverse event reporting
BACKGROUND Omalizumab is a monoclonal antibody, indicated for the treatment of severe allergic asthma. In Europe, there have been concerns about the cardiovascular safety of omalizumab. The objective of this study was to analyze the association between omalizumab and arterial thrombotic events in a spontaneous adverse drug reaction reporting database in the US. METHODS AND MATERIALS Reports o...
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OBJECTIVE To analyze the association between pioglitazone use and bladder cancer through a spontaneous adverse event reporting system for medications. RESEARCH DESIGN AND METHODS Case/noncase bladder cancer reports associated with antidiabetic drug use were retrieved from the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (AERS) between 2004 and 2009 and analyzed by th...
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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 کاملSimulating adverse event spontaneous reporting systems as preferential attachment networks: application to the Vaccine Adverse Event Reporting System.
BACKGROUND Spontaneous Reporting Systems [SRS] are critical tools in the post-licensure evaluation of medical product safety. Regulatory authorities use a variety of data mining techniques to detect potential safety signals in SRS databases. Assessing the performance of such signal detection procedures requires simulated SRS databases, but simulation strategies proposed to date each have limita...
متن کاملReporting of adverse events.
From the Harvard School of Public Health, Boston. HEN the Institute of Medicine (IOM) issued To Err Is Human,1 the recommendation to expand reporting of serious adverse events and medical errors, particularly mandatory reporting, received the most attention and sparked controversy.2 The American Medical Association and the American Hospital Association raised strong objections, claiming that ma...
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ژورنال
عنوان ژورنال: Value in Health
سال: 2012
ISSN: 1098-3015
DOI: 10.1016/j.jval.2012.03.285