The United States Food and Drug Administration issued a Black Box warning in 
October 2004 after placebo-controlled trials of antidepressant medications found 
an increased risk of suicidal thoughts and behaviors among children and 
adolescents taking antidepressant medications relative to placebo. Subsequently, 
some researchers have concluded that the Black Box warning caused severe 
unintended consequences; specifically, they have argued that the warning led to 
reduced use of antidepressants among youth, which led to more suicides. In this 
paper, we critically examine research regarding the Black Box warning's alleged 
deleterious consequences. One study claimed that controlled trials did not 
actually find an increased risk of suicidality among youth taking fluoxetine 
relative to those taking placebo, but its measure of suicidality is likely 
invalid. We found that ecological time series studies claiming that decreasing 
antidepressant prescriptions are linked to higher rates of suicide attempts or 
actual suicides among youth were methodologically weak. These studies exhibited 
shortcomings including: selective use of time points, use of only a short-term 
time series, lack of performing statistical analysis, not examining level of 
severity/impairment among participants, inability to control confounding 
variables, and/or use of questionable measures of suicide attempts. Further, 
while some time-series studies claim that increased antidepressant prescriptions 
are related to fewer youth suicides, more recent data suggests that increasing 
antidepressant prescriptions are related to more youth suicide attempts and more 
completed suicides among American children and adolescents. We also note that 
case-control studies show increased risk of suicide attempts and suicide among 
youth taking antidepressants, even after controlling for some relevant 
confounds. As clinical trials have the greatest ability to control relevant 
confounds, it is important to remember such trials demonstrated increased risk 
of suicidality adverse events among youth taking antidepressants. The Black Box 
warning is firmly rooted in solid data whereas attempts to claim the warning has 
caused harm are based on quite weak evidence.