Effexor (Venlafaxine) is a drug prescribed to treat major depressive disorder. It belongs to a class of medications called selective serotonin norepinephrine reuptake inhibitors (SNRIs) which works by increasing the amount of serotonin and norepinephrine in the brain to help maintain mental balance. It may work to improve your mood, energy level, and may help give you a zest and interest for daily life. 

Effexor is used to treat depression, and the extended-release capsule is used to treat generalized anxiety disorder, social anxiety disorder, and panic disorder. Off-label, it is used to treat migraine, diabetic neuropathy, and hot flashes that occur with menopause. 

Prescription Name and Overview

Effexor is one of the most commonly prescribed antidepressant drugs in the United States and comes as a tablet or an extended-release capsule that should be taken orally. The extended-release capsule is used to treat generalized anxiety disorder (GAD; uncontrollable excessive worrying), social anxiety disorder (extreme fear of interacting with others or performing in front of other people which results to difficulty to a difficulty to live a normal life), and panic disorder (sudden, unexpected attacks of extreme fear or worrying about having these attacks).

The prescribed dose for Effexor (venlafaxine) usually starts at 75 mg/day divided into two or three doses, taken with food. Depending on the the patient’s tolerance and severity of the illness, the dose may be increased to 150 mg/day or up to 225 mg/day. The increase in the dosage should not be more than 75 mg/day with no less than 4 days interval in every increase in dosage. 

A maximum of 375 mg/day divided in three doses can be prescribed to severely depressed patients under direct supervision. 

Generic Name and Overview

Venlafaxine is the generic name of Effexor and Effexor XR. 

In 2010, the generic version of Effexor, was approved by the FDA. Venlafaxine was formerly sold as Effexor but has been discontinued in the US. Effexor XR and the generic version of the original formula are still available. 

OTC  Name and Overview

Manufacturer

Wyeth Pharmaceuticals, Inc. made Effexor, until Pfizer bought Wyeth and began manufacturing the drug. In 1993, the US Food and Drug Administration approved the medical use and manufacture of Effexor.

Effexor has been discontinued from marketing, but Effexor XR is still available by prescription because it causes less nausea than the original formula found in Effexor. 

Labeled Indications

• Major depressive disorder
• Generalized anxiety disorder (GAD)
• Social anxiety disorder
• Panic disorder

Some doctors may prescribe Effexor “off-label” for:

• Diabetic neuropathy
• Migraine
• Hot flashes
• Adverse effects of medication for breast cancer

Active Ingredients

Venlafaxine is the active ingredient of Effexor.

What Is It Used For?

How Does it Work?

Venlafaxine works by helping restore the balance of serotonin and norepinephrine in the brain. It belongs to a class of medications called SNRIs or Serotonin-norepinephrine reuptake inhibitor. It helps block the reabsorption of both serotonin and norepinephrine. These two chemicals send and receive nerve signals. 

Scientists propose that when proper levels of serotonin are present in the brain, this prevents depression and anxiety to happen. Scientists also believe that boosting norepinephrine reduces neuropathic pain. 

What are the Approved Uses?

Effexor is approved to treat depression, and the extended-release capsule (Effexor XR) is used to treat generalized anxiety disorder, social anxiety disorder, and panic disorder. 

Production Anecdotes / History

The US Food and Drug Administration first approved Effexor in 1993 to treat major depressive disorder in adults. In 1997, the FDA approved the extended-release version of the drug called Effexor XR. Both Effexor and Effexor XR were manufactured by Wyeth Pharmaceuticals INC. until 2009 when Pfizer acquired the company. Pfizer discontinued to manufacture the original Effexor and only continued to market Effexor XR.

In 2010, FDA approved the first generic version of the original formula of Effexor. 

Precautions

This drug should be taken with precaution. If you are planning to take this drug, you must inform your doctor about:

• Your other conditions especially if you’ve had:
  • Bipolar disorder
  • Cirrhosis or other liver disease
  • Kidney disease 
  • Heart disease, high blood pressure, high cholesterol
  • Diabetes
  • Narrow-angle glaucoma
  • Any thyroid disorder
  • A history of seizures
  • Bleeding or clotting disorder
  • Low sodium
  • Have used another antidepressant before
• If you are pregnant or are planning to be pregnant
• If you are breastfeeding
• Other drugs you are using.

You should not take this drug if you experience seizures. 

Inform your doctor if you are taking other herbal products, especially St. John’s wort and tryptophan.

Inform your doctor if you have ever used illegal drugs or overused prescription medications. Also, tell your doctor if you’ve had a heart attack or if you’ve had high blood pressure, high blood cholesterol seizures, or heart, kidney, liver, or thyroid disease. 

Don’t take Effexor if you have recently been using antidepressants such as Monoamine Oxidase Inhibitor (MAOI) like Parnate or Nardil. You need to wait at least 14 days before you take Effexor. 

If you are allergic to any of the ingredients in Effexor (venlafaxine hydrochloride, gelatin, titanium dioxide, hypromellose,iron exide, ethylcellulose and cellulose), don’t take this drug.

If you have a history of glaucoma, let your doctor know about this fact first. 

Canadian Medical Association Journal (CMAJ) published their study that a pregnant woman taking Effexor (venlafaxine) has a higher risk of miscarriage. Studies have also shown that those who take the drug during pregnancy have a higher risk of giving birth to a baby with birth defects. If you become pregnant while taking Effexor, call your doctor immediately. Effexor can also pass through a mother’s breast milk. Inform your doctor if you are breastfeeding.

Alcohol should not be taken with Effexor as it adds to the drowsiness that is caused by the drug. 

This drug is not approved for use of patients below 18 years of age. Effexor has been found to cause weight gain and increase suicidal thinking in younger patients. 

Long-Term Use Considerations

Adverse effect of Effexor may be the worsening of the symptoms of depression, nausea, vomiting, and increase in suicidal thinking. 

Venlafaxine can increase the pressure in the eyes. Those with glaucoma may need regular eye check-ups. 

Changes in weight and appetite are common side-effects of SNRIs and SSNRIs, the class of medications where Effexor belongs. It may cause weight gain. 

Drug Interactions

Drug interactions happen when a substance that you are taking changes or disrupts a drug’s intended function. Interactions may be harmful to you, increase your risk for serious side effects, or inhibit a drug from functioning properly. Always consult your doctor if you are going to start a medication with a new drug. 

Can Interact with the Following

• Effexor can interact with other prescription and non-prescription drugs, supplements, and medicines that may hinder or bring serious side-effects. In July 2006, the FDA issued an alert about serotonin syndrome, a life-threatening condition that occurs when Effexor is taken together with other migraine medicines such as 5-hydroxytryptamine receptor agonists (triptans). 
• Effexor can interact with alcohol. Alcohol will augment the sleepiness effect of the drug.
• Effexor interacts with the following drugs and should not be taken with Effexor. They may be taken only with close medical supervision:
  • Monoamine oxidase inhibitors (MAOIs)  such as Nardil, Parnate, Marplen, Azilect, Eldepryl, Emsam, etc.
  • Antidepressants such as Elavil, Celexa, Prozac, Paxil, Zoloft, Luvox
  • Triptans (Imitrex, Imigran, Migriptan)
  • Linezolid (Zyvos)
  • Cimetidine (Tagamet, Tagamet HB)
  • Ketoconazole (Nizoral)
  • Ibuprofen (Advil, Motrin)
  • Naproxen (Aleve, Naprosyn)
  • Warfarin (Coumadin)
  • Aspirin (Bayer)
  • Lithium (Eskalith, LithoBid)
  • Tramadol (Ultram, Ultracet)
  • Tryptophan
  • St. John’s Wort

• Inform your doctor if you are taking or ar planning to take other drugs. There are 1169 drugs that are known to interact with effexor. The complete list is found here. 
  • 270 major drug interactions
  • 890 moderate drug interactions
  • 9 minor drug interactions

Can’t Interact with the Following

Some over the counter medicines, dietary supplements, herbal medicines and vitamins may interact with Effexor. Ask your doctor if you can safely use the other drugs, vitamins, or supplements along with Effexor.

When To Stop Taking

It’s not clear how long patients who suffer from depression, generalized anxiety disorder, social phobia, or panic disorder need to take Effexor. Studies have shown that the same dose of the drug is effective up to 52 weeks without having to adjust the dosage. However, if the risks outweigh the benefits, it is advised to stop taking Effexor.

Effexor can only be stopped upon the advice of the doctor. Those who stop taking this drug have to do so gradually and not abruptly, under direct medical supervision. Stopping can cause withdrawal symptoms to occur. Never stop taking Effexor without a doctor’s direction.

People who stop using Effexor must attend all follow up medical appointments for the doctor to check blood pressure and other vital signs. 

Long-Term Side Effects

Effexor can cause serious side effects including:

• Dangerous elevations in serotonin levels (Serotonin Syndrome)
• Abnormal Bleeding
• Seizures
• Low Sodium Levels
• Angle Closure Glaucoma
• Sustained Hypertension
• Weight and height changes in pediatric patients
• Decreased appetite and anorexia in pediatric patients
• Weight Loss
• Interstitial lung disease and eosinophilic pneumonia
• Discontinuation syndrome (withdrawal symptoms)

FDA Warnings (History Of)

In 2004, FDA has released the strongest warning on Effexor: a black box warning on clinical worsening and suicide risk.

• A small number of children, teenagers, and young adults (up to 24 years of age) who took antidepressants like Effexor during short-term clinical studies increased their risk of suicidal thinking and behavior. 
• Anyone considering the use of Effexor or any antidepressant in young children or adolescents must balance the risk with the clinical need. 
• Those who have started therapy with Effexor should be closely monitored for clinical worsening, suicidality, or unusual changes in behavior. 
• The family members and caregivers of those who are taking this drug are advised for close monitoring, observation, and communication with the doctor who prescribed this drug. 
• Effexor is not approved for use in pediatric patients.

In 2006, the FDA issued another drug safety alert stating that the drug may cause a higher risk of a patient getting a life-threatening condition called serotonin syndrome. This occurs when medicines called SNRIs (Serotonin and Norepinephrine Reuptake Inhibitors) such as Effexor, and medicines used to treat migraines (known as triptans or 5-hydroxytryptamine receptor antagonists) are used together. Symptoms are:

• Hallucinations
• Restlessness
• Loss of coordination 
• Increased heart rate
• Increased body temperature
• Diarrhea
• Nausea
• Vomiting
• Overactive reflex
• Coma

Other Common Side Effects

• Headache
• Nausea
• Insomnia
• Weakness or Tiredness
• Dizziness
• Ejaculation Disorder
• Drowsiness
• Dry mouth
• Sweating
• Loss of Appetite
• Nightmares and unusual dreams
• Vomiting
• Stomach pain
• Constipation
• Diarrhea
• Gas
• Heartburn
• Burping
• Change in the ability to taste food
• Weight loss
• Uncontrollable shaking of a part of the body
• Pain, burning, numbness, or tingling in any part of the body
• Muscle tightness
• Twitching
• Excessive and frequent yawning
• Hot flashes or flushing
• Frequent urination
• Difficulty in urinating
• Sore throat, chills, or other signs of infection
• Ringing in the ears
• Change in sexual appetite or ability
• Enlarged pupils, black circles in the middle of the eyes

Lawsuits

Many of the lawsuits filed against Effexor and its manufacturer were because of the issues that the drug increases the chance of miscarriage and birth defects.

Allegations have emerged that Wyeth marketed Effexor as safe for pregnant women despite the knowledge that the drug increases the risk of miscarriage and certain birth defects. 

In February 2012, the first Effexor lawsuit was filed. The plaintiff’s daughter was born with severe heart defects in 2012 where the baby suffered a malformed mitral valve and aorta, eventually leading to the baby’s death hours after she was born. 

In September of that same year, another couple claimed that Effexor caused their daughter to be born with hypoplastic left heart syndrome in 2004. The baby had severely underdeveloped left heart ventricle. The couple alleges that Wyeth did not clearly warn that Effexor increases the risk of birth defects.

Other birth defects associated with Effexor include:

• Holes in the heart (atrial or ventricular septal defects)
• Narrowing of the aortic valve opening
• Craniosynostosis
• Heart murmurs
• Gastroschisis (intestines sticks outside of the baby’s body)
• Spina bifida
• Club foot
• Obstruction to blood flow from the right ventricle of the heart’s pulmonary artery (pulmonary stenosis)

These birth defects incited a dozens of lawsuits against Wyeth, many of which were resolved in multidistrict litigation (MDL), a procedure used to consolidate similar cases into one federal court.

No trials or settlements have occurred in yet, and Federal Judge Cynthia Rufe has closed all cases in 2016. There are no news or update about the lawsuits and/or settlement as of the writing of this article.