TY  - JOUR
PY  - 2007//
TI  - Counterproductive FDA advisories
JO  - Primary psychiatry
A1  - Sussman, N.
SP  - 15
EP  - 16
VL  - 14
IS  - 2
N2  - In the December New England Journal of Medicine, Gregory E. Simon, MD, MPH, an investigator in the Center for Health Studies at Group Health Cooperative in Seattle, and chair of the Scientific Advisory Board of the Depression and Bipolar Support Alliance, addresses the widely publicized findings from the ongoing Food and Drug Administration meta-analysis of antidepressant-associated suicidal thoughts and behavior in clinical trials. In his commentary, Simon emphasizes the importance of careful monitoring of all depressed children and adolescents for increased risk of suicidal behavior after initiation of therapy. This is consistent with an FDA advisory that is has been added to the product information of all antidepressants and some mood stabilizers, even though the studies in question involved only some of the newer agents such as bupropion, citalopram, escitalopram, fluoxetine, fluvoxamine, mirtazapine, nefazodone, paroxetine, sertraline, and venlafaxine. An additional label change, based on a more recent analysis of the data, will extend this warning to those <25 years of age.<p /> <p>Language: en</p>
LA  - en
SN  - 1082-6319
UR  - http://dx.doi.org/
ID  - ref1
ER  -