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Brookings Roundtable on Active Medical Product Surveillance: Findings from a Mini-Sentinel Medical Product Assessment

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    On October 16, 2012, the Engelberg Center for Health Care Reform at Brookings held a webinar on “Findings from a Mini-Sentinel Medical Product Assessment.” Mini-Sentinel investigators have recently completed an assessment that examined a possible association between use of certain antihypertensive medications and angioedema events. This protocol-based assessment compared the incidence of angioedema with drugs that target the renin-angiotensin-aldosterone system using beta blockers as comparators. While not intended to provide a definitive conclusion on the association, the results will help to interpret the larger context of what is known about the drugs from various sources. The assessment also enabled Mini-Sentinel investigators to build general strategies to assess suspected associations of selected medical products and adverse events.


    Gregory W. Daniel PhD, MPH, RPh; Managing Director for Evidence Development & Innovation, Engelberg Center for Health Care Reform, Brookings Institution, Washington, DC


    Marsha Reichman PhD; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD

    Darren Toh ScD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA