October 15, 2004: FDA Orders Re-Labeling on Suicidality in Child and Adolescent Antidepressant Patients
The FDA issued a public health advisory directing all antidepressant drug manufacturers to revise their product labeling to include boxed warning and expanded warning statements that alert healthcare providers to an increased risk of suicidality (suicidal thinking and behavior) in children and adolescents being treated with these medications. Symbyax-maker Eli Lilly and Company has since added a black box warning to Symbyax's prescribing information in response to the FDA advisory. Click here to read more.