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FDA Approves PRISTIQ(TM) for the Treatment of Adult Patients with Major Depressive Disorder
Date:2/29/2008

a research study estimated that the total economic burden of depression was $83.1 billion in 2000, including direct treatment costs and suicide- and work-related costs.

MDD is a serious medical condition that is different from "feeling blue" and is not something that people just "get over." Criteria for MDD include five or more of the following symptoms that have been present for at least two weeks, and at least one of the symptoms must be either depressed mood or loss of interest or pleasure: depressed mood; loss of interest or pleasure; changes in appetite or weight; changes in sleeping patterns; psychomotor agitation or retardation; fatigue or low energy; feeling worthless or guilty for no reason; difficulty thinking or concentrating; or thoughts of death or suicide. Further, people with MDD must experience clinically significant distress or impairment in social, occupational or other important areas of functioning.

Important Treatment Considerations for Antidepressants

Suicidality and Antidepressant Drugs

-- Antidepressants increased the risk compared to placebo of suicidal

thinking and behavior (suicidality) in children, adolescents, and young

adults in short-term studies of major depressive disorder (MDD) and

other psychiatric disorders.

-- Depression and certain other psychiatric disorders are themselves

associated with increases in the risk of suicide.

-- Patients of all ages who are started on antidepressant therapy should

be monitored appropriately and observed closely for clinical worsening,

suicidality, or unusual changes in behavior, especially when starting

therapy or at times of dose changes.

-- PRISTIQ is not approved for use in pediatric patients.

Important Treatment Considerations for PRISTIQ

-- PRISTIQ is indicated for the treatment of major depressive disorder in

adults.

Contraindications

-- PR
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SOURCE Wyeth Pharmaceuticals
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