FDA requiring antidepressant warnings

FDA announced that it is requiring manufacturers to include a black box warning on antidepressants regarding the increased risk of suicidal thoughts and behavior in children and adolescents. Although Prozac fluoxetine from Eli Lilly (LLY) is the only antidepressant approved for use by children, FDA is requiring labels on all antidepressants due to widespread off-label use.

According to FDA, the warning should describe "the increased risk of suicidality in children and adolescents given antidepressant medications and notes what uses the drugs have been approved or not approved for in these patients." It also requires the inclusion of data about pediatric studies. ...