FDA pediatric advisory committee calls for "black box" warning on antidepressant drugs

October 1, 2004

The Food and Drug Administration's Psychopharmacologic Drugs Committee and the newly-formed Pediatric Advisory Committee have called for a "black box" warning that selective serotonin reuptake inhibitor antidepressant drugs carry a risk of suicidal behavior in children.

In a joint action after a contentious and emotional public hearing last month, the Food and Drug Administration's Psychopharmacologic Drugs Committee and the newly-formed Pediatric Advisory Committee have called for a "black box" warning that selective serotonin reuptake inhibitor antidepressant drugs carry a risk of suicidal behavior in children. The vote was 15 to eight. Speaking for the majority, Chairman Wayne Goodman, MD, said the warning is worthwhile because it "raise[s] the threshold" for prescribing these drugs for children and adolescents. Opponents fear the warning will impede access to needed treatment for those who are at risk of suicide because of underlying depressive illness. The FDA is not required to follow the recommendations of advisory committees, but it usually does. The agency is expected to announce its decision within a few months. For background on this long-simmering controversy, see "Updates" in the July 2004 issue, available at http://www.contemporarypediatrics.com/