FDA Approves PRISTIQ(TM) for the Treatment of Adult Patients with Major Depressiv...(IQ. Adverse Reactions -- The most ...)

Adverse Reactions

-- The most commonly observed adverse reactions in patients taking PRISTIQ

for MDD in short-term fixed-dose premarketing studies (incidence

greater than or equal to 5% and twice the rate of placebo in the 50- or

100-mg dose groups) were nausea, dizziness, insomnia, hyperhidrosis,

constipation, somnolence, decreased appetite, anxiety, and specific

male sexual function disorders.

Full prescribing information for PRISTIQ will be available at Pristiq.com.

Important Treatment Considerations for EFFEXOR XR

-- EFFEXOR XR is contraindicated in patients taking monoamine oxidase

inhibitors (MAOIs).

-- Adult and pediatric patients taking antidepressants can experience

worsening of their depression and/or the emergence of suicidality. All

patients should be monitored appropriately and observed closely for

clinical worsening and suicidality, especially at the beginning of drug

therapy, or at the time of increases or decreases in dose. Anxiety,

agitation, panic attacks, insomnia, irritability, hostility,

aggressiveness, impulsivity, akathisia, hypomania, and mania have been

reported and may represent precursors to emerging suicidality. Stopping

or modifying therapy should be considered especially when symptoms are

severe, abrupt in onset, or not part of presenting symptoms.

-- The development of potentially life-threatening serotonin syndrome may

occur when EFFEXOR XR is coadministered with other drugs that may

affect the serotonergic neurotransmitter systems. Concomitant use of

EFFEXOR XR with MAOIs is contraindicated. If concomitant use of EFFEXOR

XR with an SSRI, SNRI, or a triptan is clinically warranted, careful

observation of the patient is advised. Concomitant use of EFFEXOR XR

with tryptophan supplements is not recom
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