What is a Black Box Drug?

An FDA Black Box Drug is a drug that the Food and Drug Administration has deemed as a significant danger due to dangerous or troubling side effects. The FDA mandates that the manufacturer of the drug place the dangerous side effects in a “black box” in all literature and labeling associated with the drug. The dangerous side effects are supposed to appear on the manufacturer’s web site – again, in a “black box” (many drug manufacturers are slow to post this information).

The FDA Black Box information for Celexa is an appropriate example of how FDA Black Box information should appear on the web site and on packaging. This information can be located at www.celexa.com. [The information below appears in a bold, black framed box to emphasize its importance.]

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Celexa or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Celexa is not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use.)