A Black-Box Warning for Antidepressants in Children?

On September 14, 2004, a Food and Drug Administration (FDA) joint advisory committee voted 15 to 8 to recommend that a “black-box” warning label be required for antidepressant drugs, indicating that they increase the risk of suicidal thinking and behavior (“suicidality”) in pediatric patients. Although, as an epidemiologist and general pediatrician, I do not have clinical experience caring for depressed patients, after reviewing the evidence, I strongly favored the black-box warning.During consideration of the proposed labeling change, the committee heard a number of presentations summarizing evidence that suicidality in children and adolescents may be increased by the newer antidepressant . . .