Title : Singulair: Safety signal detection based on AERS data

November '09

Singulair has been brought under the scanner of the United States Food and Drug Administration (US FDA) in the context of adverse events related to suicide and mood and behavioral changes. In this paper we explore this association using retrospective data that is publicly available (US FDA Adverse Events database) and using quantitative methods of safety signal detection. Different measures of signal detection are discussed, along with a qualitative comparison of the methods.