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On Sept 14, 2004, an FDA panel voted 18 to 5 to require manufacturers of all antidepressants to add black box warnings to their product labeling. A month later, the FDA adopted the panel's recommendations. The warning reads in part:
"Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of [Drug Name] or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior."
The warning specifically links antidepressant use to suicidal behavior in four percent of kids on these drugs compared to two percent for kids on placebos.
A "black box" warning is the most serious warning placed on the labeling of a prescription medication, but does not ban physicians from prescribing the drug to children and adolescents.
Originally posted by Sara1
I got thinking that in these situations it would be difficult to determine if it was the condition or the medication that caused such a horrible outcome (suicide/violence).
Originally posted by OhZone
In the pre-drug days there were no such things as the shootings that we are having today.
There has always been suicide, but I wonder if it was as prevalent.
Are there any stats for such incidents from before these drugs came into popular use?