The Food and Drug Administration is actively searching more than 100 million health insurance records to uncover possible adverse events, rather than relying on doctors and patients to report them, according to Michael Nguyen, M.D., Acting Director of the Division of Epidemiology in FDAs Center for Biologics Evaluation and Research.
The surveillance system, called Sentinel, is the result of a partnership between FDA and the Harvard Pilgrim Healthcare Institute, who are using the system to determine whether a certain type of immune therapy is associated with heart attacks or strokes, and to better define the true rate of acute lung injury after transfusions of certain blood components.
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