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

ISTIQ is contraindicated in patients with a known hypersensitivity to

PRISTIQ or venlafaxine.

-- PRISTIQ must not be used concomitantly with an MAOI or within 14 days

of stopping an MAOI. Allow 7 days after stopping PRISTIQ before

starting an MAOI.

Warnings and Precautions

-- All patients treated with antidepressants should be monitored

appropriately and observed closely for clinical worsening, suicidality,

and unusual changes in behavior, especially during the first few months

of treatment and when changing the dose. Consider changing the

therapeutic regimen, including possibly discontinuing the medication,

in patients whose depression is persistently worse or includes symptoms

of anxiety, agitation, panic attacks, insomnia, irritability,

hostility, aggressiveness, impulsivity, akathisia, hypomania, mania, or

suicidality that are severe, abrupt in onset, or were not part of the

patient's presenting symptoms. Families and caregivers of patients

being treated with antidepressants should be alerted about the need to

monitor patients.

-- Development of a potentially life-threatening serotonin syndrome may

occur with SNRIs and SSRIs, including PRISTIQ, particularly with

concomitant use of serotonergic drugs, including triptans. If

concomitant use is clinically warranted, careful observation of the

patient is advised, particularly during treatment initiation and dose

increases. Concomitant use of PRISTIQ with serotonin precursors is not

recommended.

-- Patients receiving PRISTIQ should have regular monitoring of blood

pressure since sustained increases in blood pressure were observed in

clinical studies. Pre-existing hypertension should be controlled before

starting PRISTIQ. Caution should be exercised in treating patients with


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SOURCE Wyeth Pharmaceuticals
Copyright©2008 PR Newswire.
All rights reserved

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