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.
Brookings Roundtable on Active Medical Product Surveillance: Findings from a Mini-Sentinel Medical Product Assessment
Marsha E. ReichmanSenior Advisor and Scientific Lead for Surveillance Programs - Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administraion