Antidepressants and Suicide: The FDA Weighs In
Following a thorough and comprehensive review of all the available published and unpublished controlled clinical trials of
antidepressants in children and adolescents, the U.S. Food and Drug Administration (FDA) has warned the public about an increased risk of suicidal thoughts or behavior (known as "suicidality") in children, adolescents, and young adults treated with
antidepressant medications.
In the FDA review of various studies involving more than 77,000 people, it appears that antidepressants increase the risk of suicidality in children, adolescents, and young adults (age 18 to 24 years old). However, antidepressants do not appear to increase the risk in adults over age 24, and they actually seem to lower the risk in older adults (age 65 and older).
Suicide and Antidepressants: Black Box Warning
The FDA adopted a "black box" warning that antidepressants were found to increase the risk of suicidal thinking and behavior in children, adolescents, and young adults with major depressive disorder.
A black-box warning is the most serious type of warning found on a prescription drug's labeling.
The warning also emphasizes that children and adolescents who begin treatment with antidepressant medications should be closely monitored for:
- Worsening depression
- Emergence of suicidal thinking or behavior
- Unusual changes in behavior (sleeplessness, agitation, and withdrawal from normal social situations).
This monitoring is especially important during the first four weeks of treatment.
