What is Effexor?
Effexor (venlafaxine) was the first in a new class of drugs approved for use in the United States called selective serotonin and norepinephrine reuptake inhibitors, or SNRIs. SNRIs target neurotransmitters in the brain to treat depression in adults and children.
What is Effexor used to treat?
Effexor was approved by the Food and Drug Administration to treat major depressive disorder, or MDD. Effexor is not approved for the treatment of Bipolar disorder, and patients should be screened for potential Bipolar disorder before being prescribed Effexor.
Effexor XR, an extended release version of Effexor, is indicated to treat MDD, as well as social anxiety disorder, also called social phobia.
Effexor has also been used to treat obsessive compulsive disorder (OCD), generalized anxiety disorder and panic disorder.
How does Effexor work?
Effexor’s main ingredient, venlafaxine, works by blocking certain proteins in the brain that “reuptake” the neurotransmitters serotonin and norepinephrine. Serotonin and norepinephrine play a key role in stabilizing mood. When these chemicals are “off-balance,” it can lead to conditions like depression. Effexor works by eliminating those imbalances and stabilizing mood.
What are the possible side effects of Effexor?
Effexor carries the risk of certain side effects which can range from mild to severe. According to the drug’s package insert, the most common side effects include:
- unusual dreams
- sexual problems, changes in sex drive (libido)
- loss of appetite, constipation, diarrhea, nausea or vomiting, or dry mouth
- feeling tired, low-energy, fatigued or overly sleepy
- change in sleep habits, problems sleeping
- tremor or shaking
- dizziness, blurred vision
- feeling anxious, nervous or jittery
- increase in heart rate
Other side effects have been associated with Effexor. Some of these side effects are severe enough to warrant a “black box warning” on the drug’s label. A black box warning is the FDA’s strongest warning against a drug as there is a risk of serious injury or death associated with the drug.
Effexor includes a black box warning about the potential for the drug to cause suicidal thoughts or actions in children, teens and young adults.
Other side effects, some of which can be serious or life-threatening, include:
- Serotonin syndrome
- agitation, hallucinations, coma or other changes in mental status
- coordination problems or muscle twitches
- racing heartbeat, high or low blood pressure
- sweating or fever
- nausea, vomiting or diarrhea
- muscle rigidity
- Changes in blood pressure
- Enlarged pupils (mydriasis)
- Anxiety and insomnia
- Changes in appetite or weight, including weight gain or weight loss
- Manic/hypomanic episodes
- greatly increased energy
- severe trouble sleeping
- racing thoughts
- reckless behavior
- unusually grand ideas
- excessive happiness or irritability
- talking more or faster than usual
- Low sodium levels in blood
- weakness or feeling unsteady
- confusion, problems concentrating
- Seizures or convulsions
- Abnormal bleeding – especially while taking a blood thinner such as warfarin
- Elevated cholesterol
- Lung disease and pneumonia
- Severe allergic reactions
- trouble breathing
- rash, itchy welts (hives) or blisters alone or with fever or joint pain
- swelling of face, tongue, eyes or mouth
People who stop taking Effexor too suddenly, or quit cold turkey, may experience unpleasant withdrawal symptoms (also called discontinuation syndrome), including:
- Anxiety, irritability
- Feeling tired, restless or problems sleeping
- Headache, sweating, dizziness
- Electric shock-like sensations (sometimes called “brain zaps”), shaking, confusion, nightmares
- Vomiting, nausea, diarrhea
Is it safe to take Effexor during pregnancy?
Effexor is classified as a Pregnancy Category C by the FDA. This means studies have not been conducted in humans but tests on lab animals have shown the drug can harm the fetus.
The FDA warns that the drug is especially dangerous to the fetus during the third trimester of pregnancy. In 2004, the FDA required the makers of all SSRIs and SNRIs, including Effexor, to include a warning on the drugs’ labels stating the medication could cause complications at birth similar to withdrawal symptoms.
The complications, which include respiratory distress, seizures, temperature instability, feeding difficulty, vomiting, tremor, irritability and constant crying, could require prolonged hospitalization, respiratory support, and tube feeding.
“When treating pregnant women with Effexor during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering Effexor in the third trimester,” the warning read.
The FDA said the complications may also be consistent with serotonin syndrome.
Studies link Effexor to Birth Defects
Several studies have also linked Effexor to numerous birth defects, including studies published as recently as July 2016.
Studies have linked Effexor to the following birth defects:
- Persistent Pulmonary Hypertension, or PPHN
- Neural tube defects
- Septal heart defects, including atrial septal defect (ASD) and ventricular septal defect (VSD)
- Enlarged heart
- Spina bifida
- Club foot
- Cleft lip and/or palate
- Skull malformations, including craniosynostosis
- Abdominal defects, including gastroschisis
- Anal atresia
Who makes Effexor?
Effexor was first manufactured by Wyeth Pharmaceuticals Inc., a Philadelphia-based company known for producing the over-the-counter medications Robitussin and Advil.
Wyeth was purchased by pharmaceutical giant Pfizer Inc. in 2009, which purchased the rights to market Effexor and Effexor XR (extended release). Today, Pfizer only manufactures Effexor XR.
When was Effexor approved for use in the US?
Effexor was approved by the Food and Drug Administration (FDA) for use in the United States on December 28, 1993.
Are there generic versions of Effexor?
Today, Effexor is only available as a generic. It is manufactured by several different pharmaceutical companies under its generic name, venlafaxine hydrochloride.
How do you take Effexor?
Effexor is taken by mouth usually two or three times per day. Effexor should be taken with food and around the same times each day.
Effexor is available in several different doses, including 25 mg, 37.5 mg, 50 mg, 75 mg and 100 mg tablets. The initial starting dose is usually 37.5 mg taken twice per day or 25 mg taken three times per day.
If you miss a dose, take it as soon as you remember but do not take two doses at one time. If it is almost time for the next dose, skip the missed dose.
The maximum dosage for severely depressed patients is 375 mg and 225 mg for moderately depressed patients.
It is possible to overdose on Effexor. If you take too much, seek emergency medical help or call the Poison Help line at 1-800-222-1222.
How much does Effexor cost?
Effexor is now available only as a generic, which tend to cost less than their brand-name counterparts. The price of Effexor also depends on the dosage. The lowest dose of Effexor available, for example, costs about $0.50 per pill with a discount coupon on GoodRx.
Has Effexor been recalled?
Effexor has not been pulled from the market due to its potential side effects. Pfizer’s Effexor XR was the subject of a large recall in 2014 because a single capsule of the drug Tikosyn was found in one bottle of the antidepressant. Generic Effexor XR was also recalled in 2008 by Advantage Dose LLC and again by Aidapak Services LLC in 2013 due to manufacturing problems.
Which drugs might interact with Effexor?
There are several drugs which might interact with Effexor, including:
- MAOIs (monoamine oxidase inhibitor)
- Medicines used to treat migraines, like triptans
- Medicines used to treat mood, anxiety, psychotic or thought disorders
- Tricyclic antidepressants
- SSRIs, like Paxil, Zoloft and Lexapro
- Antipsychotic drugs,
- Medicines used to treat pain, such as tramadol
- Medicines used to thin blood, like warfarin
- Medicines used to treat heartburn, like cimetidine
- Over-the-counter medicines or supplements
- Aspirin, other NSAIDs
- John’s Wart
- Alcohol – may increase side effects of Effexor
What other drugs are in the same class as Effexor?
Effexor is an SNRI, or selective serotonin and norepinephrine inhibitor. There are several other SNRIs currently available on the US market; however, they are not necessarily indicated to treat the same disorders as Effexor. Other SNRIs include:
- Pristiq (desvenlafaxine)
- Cymbalta (duloxetine)
- Fetzima (levomilnacipran)
- Strattera (atomoxetine)
Are there lawsuits against the maker of Effexor?
The families of children born with birth defects after being exposed to Effexor in the womb may be entitled to financial compensation for medical bills and other damages. The Effexor lawyers at Hood National Law Group are currently investigating a possible class-action lawsuit against the maker of Effexor, Wyeth Pharmaceuticals and Pfizer Inc.
If your child was harmed because of this antidepressant medication, contact Hood National Law Group today to speak with a member of our legal team. We can help you determine if your case qualifies for a possible Effexor class-action lawsuit. Call 1-800-214-1010 today for a free initial consultation or use the form on the right-hand side of your screen.