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Effexor (Venlafaxine Hydrochloride) - Summary

 
 



PACKAGE LABEL — PRINCIPAL DISPLAY PANEL — 100 MG LABEL

NDC 0008-0705-07

Effexor®

(venlafaxine HCl) Tablets

Equivalent to 100 mg venlafaxine

SEALED FOR YOUR PROTECTION

Note to authorized dispenser: Each time Effexor is dispensed, give the patient the attached Medication Guide.

Unit of Use 20 Tablets

Rx only

Wyeth®

Suicidality and Antidepressant Drugs

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Effexor or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. 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. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Effexor is not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use)

 

EFFEXOR SUMMARY

Effexor (venlafaxine hydrochloride) is a structurally novel antidepressant for oral administration.

Effexor (venlafaxine hydrochloride) is indicated for the treatment of major depressive disorder.

The efficacy of Effexor in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS).

A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation.

The efficacy of Effexor XR in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of Effexor in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use Effexor/Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.


See all Effexor indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Effexor (Venlafaxine)

Pfizer Recalls Effexor Antidepressant
Source: MedicineNet Product Recalls Home Page Specialty [2014.03.10]
Title: Pfizer Recalls Effexor Antidepressant
Category: Health News
Created: 3/8/2014 11:04:00 AM
Last Editorial Review: 3/10/2014 12:00:00 AM

more news >>

Published Studies Related to Effexor (Venlafaxine)

Sexual function in women on estradiol or venlafaxine for hot flushes: a randomized controlled trial. [2014]
estradiol or venlafaxine for hot flushes... CONCLUSION: Overall sexual function among nondepressed midlife women experiencing

Evaluation of the efficacy and safety of pregabalin, venlafaxine, and carbamazepine in patients with painful diabetic peripheral neuropathy. A randomized, double-blind trial. [2014]
venlafaxine in patients with painful diabetic neuropathy (PDN)... CONCLUSION: This study showed the efficacy of venlafaxine, pregabalin, and

Catechol-O-methyltransferase genotype as modifier of superior responses to venlafaxine treatment in major depressive disorder. [2013]
Responses to venlafaxine treatment in major depressive disorder were stratified by COMT genotypes (Val158Met, rs4680) in a randomized, double-blind, placebo-controlled clinical trial. Improvements in depression scores among subjects with Val/Val genotypes were larger than those in Met/Met genotypes, suggesting that venlafaxine may alter noradrenergic flux differentially according to COMT activity..

Interaction between polymorphisms in serotonin transporter (SLC6A4) and serotonin receptor 2A (HTR2A) genes predict treatment response to venlafaxine XR in generalized anxiety disorder. [2013]
Variation in genes involved in serotonergic signaling is thought to be associated with antidepressant treatment response in generalized anxiety disorder (GAD). We examined a possible interaction between the serotonin transporter gene (SLC6A4) 5-HTTLPR/rs25531 haplotype and the serotonin 2A receptor gene (HTR2A) single-nucleotide polymorphism (SNP) rs7997012 in antidepressant treatment outcome in GAD...

Benefits from antidepressants: synthesis of 6-week patient-level outcomes from double-blind placebo-controlled randomized trials of fluoxetine and venlafaxine. [2012]
CONCLUSIONS: To our knowledge, this is the first research synthesis in this area

more studies >>

Clinical Trials Related to Effexor (Venlafaxine)

Study Evaluating Effexor« (Venlafaxine) in Achieving Response and Maintaining Remission [Completed]

Repetitive Transcranial Magnetic Stimulation and Venlafaxine in Depression [Recruiting]
The purpose of this study is to assess the efficacy of add-on therapy with repetitive Transcranial Magnetic Stimulation (rTMS) and venlafaxine in the treatment of major depressive disorders compared to venlafaxine only (the optimal medication) and to rTMS only.

Comparative Efficacy of Low-Dose Estradiol and Venlafaxine XR for Treatment of Menopausal Symptoms [Recruiting]
The primary objective of this study is to determine the efficacy of both low-dose oral (by mouth) 17-▀-estradiol and the non-hormonal drug venlafaxine XR compared to placebo in reducing hot flashes. Included in this objective is the intention to compare venlafaxine XR to estradiol therapy, to provide evidence of the relative efficacy of venlafaxine to what is currently considered the most established but also a controversial therapy. 17-├č-estradiol is a type of estrogen. Venlafaxine XR is the extended release (XR) version of venlafaxine. Venlafaxine XR is an serotonin-norepinephrine reuptake inhibitor (SNRI). A placebo is a substance containing no medication.

Quality of Life Study Using Gabapentin Versus Venlafaxine in Treating Hot Flashes in Patients With Prostate Cancer [Recruiting]
The purpose of this study is to assess the change in quality of life over a 6 month period between gabapentin and venlafaxine in men with prostate cancer treated for hot flashes related to androgen deprivation therapy.

Venlafaxine for Hot Flashes After Breast Cancer [Completed]
The purpose of this study is to evaluate Venlafaxine as a treatment option for hot flashes in breast cancer survivors. The goals of this study are to assess the effectiveness and toxicity of venlafaxine hydrochloride and identify the psychological, behavioral, and physical outcomes associated with relief of hot flashes in women following treatment for breast cancer.

more trials >>

Reports of Suspected Effexor (Venlafaxine) Side Effects

Drug Ineffective (90)Depression (75)Nausea (66)Withdrawal Syndrome (66)Headache (63)Feeling Abnormal (60)Malaise (58)Dizziness (53)Atrial Septal Defect (52)Anxiety (51)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 46 ratings/reviews, Effexor has an overall score of 6.52. The effectiveness score is 7.35 and the side effect score is 6.39. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Effexor review by 56 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   recurrent depression
Dosage & duration:   2 75 mg twice daily taken daily for the period of ongoing
Other conditions:   adhd
Other drugs taken:   concerta
  
Reported Results
Benefits:   This drug turned my severe recurrent depression around.
Side effects:   None.
Comments:   This drug changed my life. I have taken every antidepressant in the book. I received some benefit from most of them but my depression always returned and many of them had unpleasant side effects, including weight gain and constipation. This drug helped me enjoy life again. I still have occasional bouts of depression due to life cirsumstances but they are much briefer and less severe. I feel much more outgoing and enjoy being around people more. I no longer want to withdraw from the world and now face the world with much more confidence. For people worried that this drug produces an "artificial" feeling of happiness--this is not the case. This is the way people are supposed to feel. you will still have a normal range of moods. I only wish this drug had existed sooner--my whole life would have been differnt.

 

Effexor review by 47 year old female patient

  Rating
Overall rating:  
Effectiveness:   Moderately Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   depression
Dosage & duration:   150mg daily taken 75mg twice daily for the period of 7 years
Other conditions:   IBS, chronic tiredness, joint pain
Other drugs taken:   none
  
Reported Results
Benefits:   helped the depression initially, was far more positive during the years I took it, but the efficacy of the drug began to deteriate, and the onset of new side effects led me to try to live without the treatment
Side effects:   initially, not many, some loss of concentration when driving longer than half hour periods, eyes felt very heavy, and it felt like part of my brain had shut down, struggled not to fall to sleep. after some time, about six years, I started to get night sweats, very uncomfortable, and mood swings. I thought it might be hormaonal, but after taking away the drug , the symptoms alleviated.
Comments:   I now feel that I have suffered fibromyalgia for a long time, and part of the reason I was depressd was I found it hard to deal with the pain i was feeling at the time, I had two very young children , and was not diagnosed with a condition . If I had understood my condition better, I may have managed the fibromyalgia better. I was pushing my body too hard, as I felt frustrated t not managing everything better, and the cycle of depression continued. I have come off the venlafaxine, and the symptoms of pain, particularly in the morning have returned, but I can manage them better, knowing it is not symptomatic of a seriously damaging condition, and that it is 'normal' for me. I pace myself better, and no longer have the demands of very young children , so can do that easier. I like being 'drug' free, although I do supplement with fish oils and 5 HTP

 

Effexor review by 35 year old female patient

  Rating
Overall rating:  
Effectiveness:   Moderately Effective
Side effects:   Extremely Severe Side Effects
  
Treatment Info
Condition / reason:   GAD
Dosage & duration:   75 mg taken daily for the period of 3 days
Other conditions:   none
Other drugs taken:   antihistamine
  
Reported Results
Benefits:   This drug did work at alleviating the anxiety for which it was prescribed.
Side effects:   My God, I'm amazed that this drug is still on the market. I'm actually an MD, and was prescribed this drug for anxiety and panic attacks. I know to give a drug about a month to work, but I lasted all of 3 days on this!! Started with a 75 mg dose, immediately fell asleep for 4 hours, woke up feeling so out of it that I could barely string a sentence together, spent the next day feeling nauseous, hot, sweaty, jittery and weak. Got leg spasms that night and woke up 12 hours post-ingestion having a rebound panic attack. When morning finally arrived, I had the kind of hangover headache that you get when you're in college and have spent the night parting and binge drinking, but without any of the fun. The next day, upon advice from my psychiatrist, I dropped the dose right down to 25 mg, with no change in side effects. 3rd day I tried only 6.25 mg (quarter of a 25 mg pill), and still felt nauseous, hot, dizzy and weak...and fell asleep for two hours. This is now day 6 and I'm finally recovering from my 3 day trip to hell with Effexor. Left a 5 min message on my psychiatrist's machine - will not be taking this crap anymore!! Will not EVER be prescribing this to any of my patients.
Comments:   75 mg per day starting dose for anxiety and panic attacks.

See all Effexor reviews / ratings >>

Page last updated: 2014-11-30

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