Antidepressants and Suicide Fact Sheet

The FDA has taken action regarding antidepressant use in pediatric populations. On October, 15, 2004 the FDA announced that it was implementing new regulations regarding the use of antidepressant medication, based on the recommendations of an advisory panel which held hearings on September 13 and 14, 2004. The hearings were held in response to a number of reports suggesting that there was an increased rate of suicidality (thoughts or acts of self harm) associated with the use of antidepressants in children and adolescents. It is important to note that there were no deaths in any of the 24 trials that were reviewed, which involved 4,555 adolescents. Of this total, 33 or 0.72 percent of the subjects engaged in suicidal behavior and 45 additional subjects experienced suicidal ideation, bringing the total affected to 1.7 percent. However, the subjects who did experience suicidality were about twice as likely to be taking an antidepressant as a placebo. Based on these data, and the recommendations of the advisory panel, the FDA will require the following: • A “black-box ” warning related to an increased risk for suicidality in pediatric patients for all antidepressant drugs (advisory committee recommended this action by a split decision; 15-yes, 8-no). • A patient information sheet for this class of drugs to be provided to the patient or their caregiver with every prescription