For decades, some physicians have suspected that patients' risk of suicidality (suicidal thoughts and behavior) increased when pediatric patients first began taking antidepressants, according to background information in the article. Research indicates that there is no such association in adults. In 2003, a report submitted to the Food and Drug Administration (FDA) suggested a link between the antidepressant paroxetine and suicidality in pediatric patients. The FDA then requested pediatric data from the manufacturers of eight other antidepressant drugs, the authors report.
Tarek A. Hammad, M.D., Ph.D., and colleagues at the FDA performed a meta-analysis of data from 23 short-term clinical trials received in response to the request, as well as one trial funded by the National Institute of Mental Health (NIMH). The 24 studies included 4,582 pediatric patients taking one of nine antidepressant medications for depression, anxiety or other psychiatric disorder.
No children committed suicide in any of the trials. Although the NIMH-funded trial was the only individual trial to show a significant increase in suicidality among children taking antidepressants, the analysis of all the trials together showed a higher risk of suicidal ideation and behavior for children taking the drugs compared with those who were not. "When considering 100 treated patients, we might expect one to three patients to have an increase in suicidality beyond the risk that occurs with depression itself owing to short-term treatment with an antidepressant," the authors write.
The FDA now requires warnings regarding the risk of suicidality in children on antidepressant labeling a
Contact: Susan Cruzan
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