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Effexor (venlafaxine) is a prescription antidepressant drug. Effexor XR (venlafaxine hydrochloride; extended release capsules) is used to treat depression, generalized anxiety disorder (GAD), and social anxiety disorder (SAD). Wyeth Pharmaceuticals, Inc. made Effexor, until Pfizer bought Wyeth and began producing the medication. Effexor was approved by the U.S. Food and Drug Administration (FDA) in 1993.

Effexor FDA Safety Alerts

The FDA issued a drug safety alert in 2006 stating that a life-threatening condition called serotonin syndrome can occur when medicines called serotonin and norepinephrine reuptake inhibitors (SNRIs), including Effexor, and medicines used to treat migraines known as 5-hydroxytryptamine receptor agonists (triptans), are used at the same time. Signs and symptoms of serotonin syndrome include:

  • Restlessness
  • Hallucinations
  • Loss of coordination
  • Fast heartbeat
  • Increased body temperature
  • Fast changes in blood pressure
  • Overactive reflexes
  • Diarrhea
  • Coma
  • Nausea
  • Vomiting

Serotonin syndrome may be more likely to occur when starting or increasing the dose of an SNRI or a triptan. If you take migraine headache medicines, ask your doctor or pharmacist f your medicine is a triptan.

Effexor and Increased Risk of Suicidality

In October 2004, the FDA issued a public health advisory directing all antidepressant drug manufacturers to revise their products' labeling to include boxed warning and expanded warning statements that alert healthcare providers to an increased risk of suicidality (suicidal thinking and behavior) in children and adolescents being treated with these medications. In response to the FDA advisory, Effexor maker Wyeth then added a black box warning to the drug’s prescribing information.

In June 2005, the FDA announced that several recent scientific studies suggested the possibility of an increased risk for suicidal behavior in adults being treated with antidepressant medications, including Effexor. The FDA advised that adults taking antidepressants, particularly those being treated for depression, should be watched closely for worsening depression and increased suicidality. Monitoring these patients is especially important when treatment begins, and when doses are increased or decreased. The FDA is working closely with antidepressant manufacturers to fully evaluate the risk of suicidality in adults treated with these medications.

Since 2006, the FDA and antidepressant manufacturers have evaluated the risk of suicidality in children, teens, and adults treated with antidepressants. Effexor now has a warning label describing the increased risk of suicidal thoughts and behavior in children and adolescents taking antidepressants. Seek help immediately if you or a loved one make comments about suicide, whether this was after recently starting a new antidepressant or for any other reason. The National Suicide Prevention Lifeline is available all day, every day at 1-800-273-TALK or 1-800-273-8255.

Other Health Risks of Taking Effexor

Never take Effexor if you are taking another drug used to treat depression called a Monoamine Oxidase Inhibitor (MAOI) or have taken an MAOI in the last 14 days. Taking both an MAOI and Effexor within a close period of time can lead to serious medical conditions, such as high body temperature, coma, and seizures, which can be fatal.

MAOI drugs include, among other brands:

  • Nardil (phenelzine sulfate)
  • Parnate (tranylcypromine sulfate)
  • Marplan (isocarboxazid)

Don't stop taking Effexor suddenly. Doing so may result in harmful side effects. You should talk to your doctor about how to slowly decrease your dose. Also, talk to your healthcare professional if you are pregnant, breastfeed, or plan to breastfeed your baby and are using Effexor or another antidepressant. For more information, see our article on Antidepressants and Pregnancy.

Getting Legal Help

Prescription drug manufacturers have a duty to make their products as reasonably safe as possible, even if some side effects are unavoidable, and to inform the medical community and the public of known risks associated with their drugs. If a medication manufacturer fails to do so, it can be held legally responsible for any patient injuries that result from inadequate warnings or the unreasonably dangerous nature of the drug, under a legal theory called "product liability."

Get Legal Help with Your Effexor Claim

If you or a loved one has experienced any serious symptoms or unusual side effects related to Effexor use, you should first contact your doctor. It may also be in your best interests to consult with a local drug and medical device attorney to discuss filing a birth defect lawsuit.

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