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).
A "black box" warning is the most serious warning placed on the labeling of a prescription medication.
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