Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Celexa or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be 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 approvedfor use in pediatric patients.

On October 15, 2004, the FDA ordered that all antidepressants, such as Celexa, must carry the government’s “black box” safety alert to warn that the drugs are linked to increased suicidal thoughts and behavior among children and teens. The warning came after two days of public hearings of the FDA’s Psychopharmacologic Drugs and Pediatric Advisory Committees (PDAC), where testimony by victims, parents and experts, in combination with previous testimony from the PDAC’s hearing in February was
presented. The committee voted 15-to-8 for a “Black Box” warning for children and adolescents after reviewing clinical-trial data that showed the drugs are twice as likely as a placebo to cause suicidal thoughts or behavior.