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Public Health Advisory: Suicidality in Children and Adolescents Being Treated with Anti-depressant Medications

Audience: Neuropsychiatric healthcare professionals and consumers

The Food and Drug Administration issued a Public Health Advisory, asking manufacturers of all antidepressant drugs to revise the labeling for their products to include a boxed warning and expanded warning statements that alert health care providers to an increased risk of suicidality (suicidal thinking and behavior) in children and adolescents being treated with these agents, and additional information about the results of pediatric studies. FDA also informed these manufacturers that it has determined that a Patient Medication Guide (MedGuide), which will be given to patients receiving the drugs to advise them of the risk and precautions that can be taken, is appropriate for these drug products.

[October 15, 2004 - Public Health Advisory - FDA]
[October 15, 2004 - Drug Information Page - FDA]