What is the US Food and Drug Administration (FDA) black box warning for pediatric use of selective serotonin reuptake inhibitors (SSRIs)?

Updated: Sep 27, 2019
  • Author: Mohamed K Badawy, MD, FAAP; Chief Editor: Stephen L Thornton, MD  more...
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The US Food and Drug Administration (FDA) has issued a public health advisory that directed manufacturers of all antidepressant drugs, including SSRIs, to revise the labeling for their products to include a boxed warning and expanded warning statements alerting health care providers to an increased risk of suicidality (suicidal thinking and behavior) in children and adolescents being treated with these agents. [4]

The risk of suicidality associated with these drugs was identified based on a combined analysis of short-term (up to 4mo), placebo-controlled trials of 9 antidepressant drugs, including SSRIs, in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders. A total of 24 trials involving over 4400 patients were included. The analysis showed a greater risk of suicidality during the first few months of treatment in those receiving antidepressants. The average risk of such events drug therapy was 4%, twice the placebo risk of 2%. No suicides occurred in these trials. [4]

Based on these data, FDA has determined that the following points are appropriate for inclusion in the boxed warning [4] :

  • Antidepressants increase the risk of suicidal thinking and behavior (suicidality) in children and adolescents with MDD and other psychiatric disorders.
  • Anyone considering the use of an antidepressant in a child or adolescent for any clinical use must balance the risk of increased suicidality 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 to closely observe the patient and to communicate with the prescriber.
  • A statement regarding whether the particular drug is approved for any pediatric indication(s) and, if so, which one(s).

Only fluoxetine is FDA approved for use in treating major depressive disorder (MDD) in pediatric patients. Fluoxetine, and sertraline are approved for OCD in pediatric patients. None of those drugs is approved for other psychiatric indications in children. [4]

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