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

mended.

-- Treatment with venlafaxine is associated with sustained increases in

blood pressure (BP) in some patients. Postmarketing cases of elevated

BP requiring immediate treatment have been reported. Pre-existing

hypertension should be controlled. Regular BP monitoring is

recommended.

-- SSRIs and SNRIs, including EFFEXOR XR, may increase the risk of

bleeding events. Concomitant use of aspirin, NSAIDs, warfarin, and

other anticoagulants may add to this risk.

-- Mydriasis has been reported in association with venlafaxine; therefore,

patients with raised intraocular pressure or those at risk of acute

narrow-angle glaucoma (angle-closure glaucoma) should be monitored.

-- Abrupt discontinuation or dose reduction has been associated with

discontinuation symptoms. Patients should be counseled on possible

discontinuation symptoms and monitored while discontinuing the drug;

the dose should be tapered gradually.

-- The most common adverse events reported in EFFEXOR XR short-term

placebo-controlled MDD, generalized anxiety disorder (GAD), social

anxiety disorder (SAD), and/or panic disorder (PD) trials (incidence

greater than or equal to 10% and greater than or equal to 2x that of

placebo) were anorexia, asthenia, constipation, dizziness, dry mouth,

ejaculation problems, impotence, insomnia, nausea, nervousness,

somnolence, and sweating.

For full prescribing information for EFFEXOR XR, please go to http://www.EffexorXR.com.

About Wyeth Pharmaceuticals

Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products.

Wyeth is
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