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Home » A new study is consistent with FDA’s black box requirements for antidepressants.

A new study is consistent with FDA’s black box requirements for antidepressants.

May 1, 2008
From The Carlat Psychiatry Report
Issue Links: Learning Objectives | Editorial Information | PDF of Issue
Dilip Jeste, MD

The FDA now requires antidepres- sant drug makers to carry black box warnings about an increased risk of sui- cidality in children and young adults. As covered in the April TCPR, the FDA data indicated that antidepressants were most dangerous for children, and that the suicidogenic effects waned consis- tently with increasing age of patients. These warnings continue to incite con- troversy among psychiatrists. The March issue of Journal of Clinical Psychiatry carries a new study with a different data set in apparent support of the FDA’s action. Researchers searched a national Medicaid database for all patients aged 6 to 64 who made a suicide attempt after receiving treatment for depression (with or without antidepressants; rates of completed suicides were not report- ed) during 1999 and 2000. They identi- fied 236 cases, and they then compared them with a control group of similar patients (matched for diagnosis and demographics) who had not made sui- cide attempts. The research question: were suicide attempters more likely to have been started on antidepressants than suicide non-attempters? They found that, indeed, antidepressant treatment was associated with a higher risk of suicide attempts, but only in children and adoles- cents (ages 6 to 18). For patients 19 to 64, antidepressants had no effect on suicidali- ty, and for adult males specifically, antide- pressants had a protective effect (Olfson M and Marcus SC, J Clin Psychiatry 2008;69:425-432).

TCPR’s Take: While one always has to be cautious when interpreting this type of observational research, given how in sync these findings are with the FDA analysis, we find the results quite convincing.

General Psychiatry
KEYWORDS bipolar_disorder
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    Issue Date: May 1, 2008
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