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U.S. Department of Health and Human Services

Safety

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Pristiq (desvenlafaxine) extended-release tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- August 2009, December 2010 and April 2011

 

April 2011

Summary View

 

MEDICATION GUIDE

  • vertigo information..."feeling that your surroundings are moving"...

 

December 2010

Summary View

 

WARNINGS AND PRECAUTIONS

Clinical Worsening and Suicide Risk
  • provides for changes to correctly bold a mandatory class-labeling statement

 

August 2009

Summary View

 

WARNINGS and PRECAUTIONS

Elevated Blood Pressure
  • Has occurred with Pristiq.  hypertension should be controlled before initiating treatment. Monitor blood pressure regularly during treatment.

Renal Impairment

  • Reduces the clearance of Pristiq. Dosage adjustment is necessary in severe and ESRD. In moderate renal impairment, the dose should not exceed 50 mg/day.

ADVERSE REACTIONS

Clinical Studies Experience
  • Adverse reactions in patients in short-term fixed-dose studies (incidence ≥ 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

USE IN SPECIFIC POPULATIONS

  • Dosage adjustment is recommended in patients with severe renal impairment and end-stage renal disease The dose should not be escalated in moderate to severe impairment or in ESRD
  • For elderly patients, the possibility of reduced renal clearance of desvenlafaxine should be considered when determining dose.