The Impact of the Black Box Warning

The Impact of the Black Box Warning

In 2004, the FDA issued a black box warning regarding the use of SSRIs (selective serotonin reuptake inhibitors) in children and adolescents suffering from depression and/or anxiety. The impact of this public warning was impressive. Pediatricians and family practice doctors began to refer more young patients suffering from relatively straightforward cases of anxiety and/or depression to an already small pool of psychiatrists for additional evaluation and pharmacotherapy. Additionally, the news media encouraged public fear regarding these medications. In fact, prescriptions written for SSRIs decreased by approximately 18-20% by 2007, just three years after the FDA’s warning was issued. During the same period of time, an increase in the actual suicide rate among children and adolescents (up to the age of 19) rose approximately 18%- the first increase in suicide in over a decade.

So, what data behooved the FDA to issue such a weighty warning? Accor…