What You Should Know About FDA 'Black Box' Warning

The Food and Drug Administration (FDA) recently issued a warning that antidepressant medications, including selective serotonin reuptake inhibitors (SSRIs), may increase suicidal thoughts and behaviors in a small number of children and adolescents. The FDA report was based on studies of antidepressant medications (SSRIs and others) involving over 4,400 children and adolescents with major depressive disorder, obsessive-compulsive disorder, and other psychiatric disorders.

The FDA warning does not prohibit the use of these medications in children and adolescents. The FDA warning alerts patients and families to the risk of suicidal thoughts and behavior, but also notes that this risk must be balanced with clinical need.

Analyses of the studies showed that the average risk of suicidal thoughts or behaviors occurred in 4% of children and adolescents treated with an antidepressant, compared to 2% of patients who were treated with a placebo (sugar pill). No suicides occurred in any of the studies.

"Caregivers should be open to asking their child or adolescent if he or she is having suicidal thoughts, and to monitor for changes in behavior such as agitation, restlessness, irritability or other changes in your child's behavior or personality," said Marcia J. Slattery, MD, MHS, Director of Child and Adolescent Psychiatry at the University of Wisconsin Medical School. "Parents should contact their child's doctor if any of these or other concerns arise. The medication dose may need to be lowered, or the medication may need to be discontinued. Patients should not stop taking their medication abruptly without their doctor's supervision since this may worsen symptoms."

For more information, parents can consult Frequently Asked Questions on our website.

To read the FDA news release and the black box warning, visit the FDA website.