Warnings, COLUMNS-Drugs & Supplements, October 2004

FDA Orders Black Box Warnings On Antidepressants

The U.S. Food and Drug Administration on Oct. 15 directed 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 suicide in children.

The order followed recommendations made to the FDA at a joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Pediatric Drugs Advisory Committee in September.

The risk of suicidality for these drugs was identified in a combined analysis of short-term (up to 4 …