Abstract
Purpose: To determine the value of data mining in early identification of drug safety signals from spontaneous reporting databases. Methods: A single data mining algorithm was applied to the 2001–2003 public release of Food and Drug Administration Adverse Event Reporting System (AERS) data for all therapeutic new molecular entities (NMEs) approved in 2001. The list of detected signals was compared with the list of safety-related regulatory actions for those drugs through February 2006. Results: For the 21 NMEs, 73 signals of interest were detected by data mining. In 39 cases, that signal preceded regulatory action.
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