TITLE

FDA's first active medical product surveillance eyes antidiabetic-MI link

AUTHOR(S)
Thompson, Cheryl A.
PUB. DATE
April 2011
SOURCE
American Journal of Health-System Pharmacy;4/1/2011, Vol. 68 Issue 7, p550
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
The article reports that Food and Drug Administration's (FDA's) first electronic active surveillance system will be used to gauge the risk of myocardial infarction (MI) in type 2 diabetes patients using saxagliptin. The analysis will be conducted ahead of a Phase IV study sponsored by Bristol-Myers Squibb, and will conclude in June 2013. The article mentions that the surveillance system was developed as part of FDA's Mini-Sentinel program to identify and evaluate safety issues in medical products.
ACCESSION #
59967711

 

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