Important Safety Information: Effexor XR®

Important Safety Information

This Important Safety Information has been adapted from the Prescribing Information for Effexor XR®.

What are the most important things I need to know about venlafaxine?

  • BOXED WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

SUICIDALITY AND ANTIDEPRESSANT DRUGS

Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in children, teens, and young adults under the age of 25 compared to placebo. 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 should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Venlafaxine is not approved for use in children and teens.

  • All patients taking antidepressants should be watched closely for signs that their condition is getting worse or that they are becoming suicidal, especially when they first start therapy, or when their dose is increased or decreased. Patients should also be watched for becoming agitated, irritable, hostile, aggressive, impulsive, or restless. Such symptoms should be reported to the patient's doctor right away.
  • Before taking venlafaxine, tell your doctor and pharmacist 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 a potentially life-threatening condition called serotonin syndrome.
  • Venlafaxine may raise blood pressure in some patients. Your blood pressure should be controlled before starting treatment and should be monitored regularly.
  • Taking venlafaxine with aspirin, nonsteroidal anti-inflammatory drugs, warfarin, or other blood thinners may increase the risk of bleeding events.
  • 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.
  • When people suddenly stop using or quickly lower their daily dose of venlafaxine, serious discontinuation symptoms may occur. Talk to your doctor before discontinuing or reducing your dose of venlafaxine.

Who should not take venlafaxine?

Do not take venlafaxine if you:

 

  • Have a history of suicidal thoughts or attempts, unless venlafaxine is used under the direction of a psychiatrist
  • Have a history of self-injurious behavior, unless venlafaxine is used under the direction of a psychiatrist
  • Have a history of bipolar disorder, unless venlafaxine is used under the direction of a psychiatrist
  • Have a history of manic or depressive episodes, unless venlafaxine is used under the direction of a psychiatrist
  • Have uncontrolled high blood pressure
  • Have a history of serotonin syndrome
  • Take medication for depression, bipolar disorder, or anxiety-including a TCA, SSRI, or SNRI (see the full list of potential drug interactions here in the drug interactions section)
  • Take MAOIs or who have taken MAOIs in the previous 2 weeks
  • Have a history of long QT syndrome or who are taking drugs that lengthen the QT interval
  • Have moderate-to-severe liver disease
  • Have moderate-to-severe kidney disease
  • Are pregnant, trying to become pregnant, or nursing
  • Are under the age of 18

People with bleeding disorders, or who are taking medications that increase their risks of bleeding, should discuss this with their doctor before taking venlafaxine. In most cases, an alternative treatment strategy will be used. Until you see how venlafaxine affects you, be careful doing such activities as driving a car or operating machinery. Avoid drinking alcohol while taking venlafaxine.

What are the most common side effects of venlafaxine?

In clinical studies, the most common side effects of venlafaxine (reported in at least 5% of patients and at least twice as often as with placebo) were:

  • Constipation
  • Dizziness
  • Dry mouth
  • Insomnia
  • Loss of appetite
  • Nausea
  • Nervousness
  • Sexual side effects
  • Sleepiness
  • Sweating
  • Weakness

When should I call my primary provider?

Contact your Rory-affiliated physician and your primary healthcare provider if you experience any new symptoms after beginning venlafaxine for hot flashes.

 

If you are experiencing a medical emergency, call 911 or seek immediate medical attention.

What is the FDA-approved use of venlafaxine?

Venlafaxine is a prescription medicine that is FDA approved for the treatment, in adults, of Major Depressive Disorder (MDD), Generalized Anxiety Disorder (GAD), Social Anxiety Disorder (SAD), and Panic Disorder (PD) with or without agoraphobia.

 

Venlafaxine is recommended by the North American Menopause Society (NAMS) for the treatment of hot flashes. While clinical data supports the use of venlafaxine for the treatment of hot flashes, this is not an FDA-approved use of the drug.

 

What should I tell my Rory-affiliated provider before taking venlafaxine?

Tell your Rory-affiliated provider if you have any of the following prior to taking venlafaxine:

  • Thoughts of doing harm to yourself at any point in the past
  • History of mental illness in you or your family (e.g., depression, psychosis, bipolar disorder, manic depression)
  • Glaucoma
  • Irregular heartbeats (arrhythmia)
  • High blood pressure
  • All medications taken now and within the past two weeks
  • History of illicit drug use
  • History of drug addiction
  • History of serotonin syndrome
  • A list of all your current medical problems, including, but not limited to, liver disease, kidney disease, heart disease, seizure disorder, and bleeding disorders
  • Allergy or negative reaction to venlafaxine or other serotonin norepinephrine reuptake inhibitors (SNRI) under different names or any components (e.g., Cymbalta, Effexor, Fetzima, Pristiq, venlafaxine, desvenlafaxine, duloxetine, levomilnacipran)

Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.

 

You are encouraged to report negative side effects of prescription products to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

 

Please see the full Prescribing Information, including the BOXED WARNING, for complete safety information.

 

 

 

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