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Background The growing interest in using electronic healthcare record (EHR) databases for drug safety surveillance has spurred development of new methodologies for signal detection. Although several drugs have been withdrawn postmarketing by regulatory authorities after scientific evaluation of harms and benefits, there is no definitive list of confirmed signals (i.e. list of all known adverse reactions...
Background: Automated disproportionality analysis of spontaneous reporting is increasingly used routinely. It can theoretically be influenced by a competition bias for signal detection owing to the presence of reports related to well-established drug-event associations. Objective: The aim of the study was to explore the effects of competition bias on safety signals generated from a large spontaneous...
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