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FDA Approves PRISTIQ(TM) for the Treatment of Adult Patients with Major Depressive Disorder

pre-existing hypertension or other underlying conditions that might be

compromised by increases in blood pressure. Cases of elevated blood

pressure requiring immediate treatment have been reported.

-- SSRIs and SNRIs, including PRISTIQ, 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 PRISTIQ; therefore,

patients with raised intraocular pressure or those at risk of acute

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

-- As with all antidepressants, PRISTIQ should be used cautiously in

patients with a history or family history of mania or hypomania.

-- Caution is advised in administering PRISTIQ to patients with

cardiovascular, cerebrovascular, or lipid metabolism disorders.

Increases in blood pressure and small increases in heart rate were

observed in clinical studies with PRISTIQ.

-- Dose-related elevations in fasting serum total cholesterol, LDL (low

density lipoprotein) cholesterol, and triglycerides were observed in

clinical studies. Measurement of serum lipids should be considered

during PRISTIQ treatment.

-- Symptoms associated with discontinuation of PRISTIQ have been reported.

Patients should be monitored for symptoms when discontinuing treatment.

A gradual reduction in dose rather than abrupt cessation is recommended

whenever possible.

-- Dosage adjustment (50 mg every other day) is necessary in patients with

severe renal impairment or end-stage renal disease (ESRD). The dose

should not be escalated in patients with moderate or severe renal

impairment or ESRD.

-- Products containing desvenlafaxine and products containing venlafaxine

should not be used concomitantly with PRIST

SOURCE Wyeth Pharmaceuticals
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