Healthy Skepticism Library item: 8665

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Publication type: Journal Article

Kuehn BM.
FDA panel seeks to balance risks in warnings for antidepressants.
JAMA 2007 Feb 14; 297:(6):573-4
http://jama.ama-assn.org/cgi/content/full/297/6/573

Abstract:

Newer generation antidepressants should carry a broader warning of an increased risk of suicidal thoughts and behaviors in not only children and adolescents, but also young adults, recommended a US Food and Drug Administration (FDA) advisory committee after considering new data from the agency. But in an unprecedented step, the panel also recommended that the warnings include information on the benefits of treating depression and the risk of suicide associated with untreated depression, based on emerging data that warnings about potential adverse effects of medications may lead to undertreatment and subsequent suicides.

The committee met December 13 and voted 6 to 2 in favor of extending the existing black box warnings, although members also agreed that the warning should address the benefits of treatment and the risks associated with declining treatment, said Daniel S. Pine, MD, acting chair of the committee and chief of child and adolescent . . .

Keywords:
Publication Types: News MeSH Terms: Adolescent Adult Antidepressive Agents*/adverse effects Child Depressive Disorder/drug therapy* Drug Labeling* Humans Risk Suicide United States United States Food and Drug Administration Substances: Antidepressive Agents