In 2003, the U.S. FDA, MHRA in the U.K., and European union released public health advisories for a possible causal link between antidepressant treatment and suicide in children and adolescents ages 18 and under. This led the U.S. FDA to issue a black box warning for antidepressant treatment of childhood depression in 2004, which was later extended to include young adults (18-24) in 2006. Following these warnings, rather than observing the anticipated decrease in youth suicide rates, record increases in youth suicide rates were observed in both the U.S. and Europe. In this presentation, we review the data and statistical methodology that led to the public health advisories and black box warning, and the data that led to the record increases in youth suicide rates and discuss their possible relationship. New approaches to drug adverse-event surveillance are developed and discussed.