FDA Approves Antidepressant Labeling, Sets 30-Day Deadline

The FDA has approved labeling revisions to antidepressants, clearing the way for drugmakers to add required "black box" warnings to their products to describe the increased risk of suicidal behavior in children and adolescents who take the drugs.

The FDA sent letters to 11 antidepressant manufacturers, informing them that their revised labeling has been approved and that standardized black box language has been developed to address potential health risks posed to children and adolescents.

The agency ordered the firms to make the revised labeling available on their websites within two weeks of the date of the letter, and on all products within 30 days. Companies must also bring their direct-to-consumer ads into compliance with the labeling requirements within 30 days, the agency said.

The standardized black box warning states, "Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with major depressive disorder and other psychiatric disorders. Anyone considering the use of [insert drug name] or any other antidepressant in a child or adolescent must balance this risk with the clinical need."

For more information about the labeling revisions, go to http://www.accessdata.fda.gov/scripts/cder/drugsatfda (http://www.accessdata.fda.gov/scripts/cder/drugsatfda).