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Healthy Skepticism Library item: 10570

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: Journal Article

Friedman RA, Leon AC.
Expanding the black box - depression, antidepressants, and the risk of suicide.
N Engl J Med 2007 Jun 7; 356:(23):2343-6
http://content.nejm.org/cgi/content/full/356/23/2343


Abstract:

On May 2, 2007, the Food and Drug Administration (FDA) ordered that all antidepressant medications carry an expanded black-box warning incorporating information about an increased risk of suicidal symptoms in young adults 18 to 24 years of age. Since October 2004, antidepressants have been required to have a black-box warning indicating that they are associated with an increased risk of suicidal thinking, feeling, and behavior in children and adolescents.

The new warning also states that there is no evidence of an increased risk for adults older than 24 years of age and that the risk is actually decreased for adults . . .

Keywords:
MeSH Terms: Adolescent Adult Antidepressive Agents/adverse effects* Antidepressive Agents/therapeutic use Depressive Disorder/drug therapy* Depressive Disorder/psychology Drug Labeling/legislation & jurisprudence* Government Regulation Humans Odds Ratio Risk Suicide*/prevention & control Suicide*/psychology United States United States Food and Drug Administration Substances: Antidepressive Agents


Notes:

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