Important Safety Information About PRISTIQ

Important Safety Information About PRISTIQ

Suicidality and Antidepressant Drugs

Antidepressants increased the risk of suicidal thinking and behavior in children, teens, and young adults. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy or when the dose is changed should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior such as becoming agitated, irritable, hostile, aggressive, impulsive, or restless. Should these occur, report them to a doctor right away. PRISTIQ is not approved for use in children under 18.

Do not take PRISTIQ if you are allergic to desvenlafaxine, venlafaxine, or any of the ingredients in PRISTIQ. Do not take PRISTIQ if you currently take, or have taken within the last 14 days, any medicine known as an MAOI (including intravenous methylene blue or the antibiotic linezolid). Allow 7 days after stopping PRISTIQ before starting an MAOI. Taking an MAOI with PRISTIQ can cause serious or even life-threatening side effects.

Before taking PRISTIQ, tell your healthcare professional about all prescription and over-the-counter medications and supplements you take or plan to take including: those to treat migraines or psychiatric disorders (including other antidepressants or amphetamines), to avoid serotonin syndrome, a potentially life-threatening condition; aspirin, NSAID pain relievers, or blood thinners because they may increase the risk of bleeding.

PRISTIQ may cause or worsen some conditions, so tell your healthcare professional about all the medical conditions you have or had including:

  • High blood pressure, which should be controlled before starting PRISTIQ and monitored regularly
  • Heart problems, high cholesterol or triglyceride levels, a history of stroke, kidney or liver problems, or low sodium levels in your blood
  • Bleeding problems
  • Depression, suicidal thoughts or behavior
  • Mania, bipolar disorder, or seizures or convulsions
  • Nursing, pregnancy, or plans to become pregnant

Some people are at risk for visual problems such as eye pain, changes in vision, or swelling or redness around the eye. You may want to undergo an eye examination to see if you are at risk and get preventative treatment if you are.

Discontinuation symptoms may occur when stopping or reducing PRISTIQ, so talk to your healthcare professional before stopping or changing your dose.

Until you see how PRISTIQ affects you, be careful driving a car or operating machinery. Avoid drinking alcohol while taking PRISTIQ.

In clinical studies, most common side effects with PRISTIQ 50 mg were nausea, dizziness, sweating, constipation, and decreased appetite.

INDICATION

PRISTIQ® (desvenlafaxine) is a prescription medication approved for the treatment of major depressive disorder in adults.

Please see full Prescribing Information, including BOXED WARNING, and Medication Guide.

You may report an adverse event related to Pfizer products by calling 1-800-438-1985 (US only). If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. The FDA has established a reporting service known as MedWatch where healthcare professionals and consumers can report serious problems they suspect may be associated with the drugs and medical devices they prescribe, dispense, or use. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088.