DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Effexor (Venlafaxine Hydrochloride) - Summary

 
 



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 XR 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 XR 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 XR is an extended-release capsule for oral administration that contains venlafaxine hydrochloride, a structurally novel antidepressant.

Major Depressive Disorder

Effexor XR (venlafaxine hydrochloride) extended-release capsules is indicated for the treatment of major depressive disorder.

The efficacy of Effexor XR in the treatment of major depressive disorder was established in 8- and 12-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III-R or DSM-IV category of major depressive disorder (see Clinical Trials).

A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two-week period: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.

The efficacy of Effexor (immediate release) in the treatment of major depressive disorder in adult inpatients meeting diagnostic criteria for major depressive disorder with melancholia was established in a 4-week controlled trial (see Clinical Trials). The safety and efficacy of Effexor XR in hospitalized depressed patients have not been adequately studied.

The efficacy of Effexor XR in maintaining a response in major depressive disorder for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of Effexor (immediate release) in maintaining a response in patients with recurrent major depressive disorder 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 DOSAGE AND ADMINISTRATION).

Generalized Anxiety Disorder

Effexor XR is indicated for the treatment of Generalized Anxiety Disorder (GAD) as defined in DSM-IV. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.

The efficacy of Effexor XR in the treatment of GAD was established in 8-week and 6-month placebo-controlled trials in adult outpatients diagnosed with GAD according to DSM-IV criteria (see Clinical Trials).

Generalized Anxiety Disorder (DSM-IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. It must be associated with at least 3 of the following 6 symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, sleep disturbance.

Although the effectiveness of Effexor XR has been demonstrated in 6-month clinical trials in patients with GAD, the physician who elects to use Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).

Social Anxiety Disorder

Effexor XR is indicated for the treatment of Social Anxiety Disorder, also known as Social Phobia, as defined in DSM-IV (300.23).

Social Anxiety Disorder (DSM-IV) is characterized by a marked and persistent fear of 1 or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others. Exposure to the feared situation almost invariably provokes anxiety, which may approach the intensity of a panic attack. The feared situations are avoided or endured with intense anxiety or distress. The avoidance, anxious anticipation, or distress in the feared situation(s) interferes significantly with the person's normal routine, occupational or academic functioning, or social activities or relationships, or there is a marked distress about having the phobias. Lesser degrees of performance anxiety or shyness generally do not require psychopharmacological treatment.

The efficacy of Effexor XR in the treatment of Social Anxiety Disorder was established in four 12-week and one 6-month placebo-controlled trials in adult outpatients with Social Anxiety Disorder (DSM-IV) (see Clinical Trials).

Although the effectiveness of Effexor XR has been demonstrated in a 6-month clinical trial in patients with Social Anxiety Disorder, the physician who elects to use Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).

Panic Disorder

Effexor XR is indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks.

Panic disorder (DSM-IV) is characterized by recurrent, unexpected panic attacks, ie, a discrete period of intense fear or discomfort, in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: 1) palpitations, pounding heart, or accelerated heart rate; 2) sweating; 3) trembling or shaking; 4) sensations of shortness of breath or smothering; 5) feeling of choking; 6) chest pain or discomfort; 7) nausea or abdominal distress; 8) feeling dizzy, unsteady, lightheaded, or faint; 9) derealization (feelings of unreality) or depersonalization (being detached from oneself); 10) fear of losing control; 11) fear of dying; 12) paresthesias (numbness or tingling sensations); 13) chills or hot flushes.

The efficacy of Effexor XR in the treatment of panic disorder was established in two 12-week placebo-controlled trials in adult outpatients with panic disorder (DSM-IV). The efficacy of Effexor XR in prolonging time to relapse in panic disorder among responders following 12 weeks of open-label acute treatment was demonstrated in a placebo-controlled study (see CLINICAL PHARMACOLOGY, Clinical Trials). Nevertheless, the physician who elects to use Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).


See all Effexor indications & dosage >>

NEWS HIGHLIGHTS

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

Specificity profile of venlafaxine and sertraline in major depression: metaregression of double-blind, randomized clinical trials. [2014]
Despite the well-known efficacy of selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) in the treatment of major depressive disorder, there is a lack of indications for each drug in different groups of patients...

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...

more studies >>

Clinical Trials Related to Effexor (Venlafaxine)

Co-Administration of LDX (SPD489) and Venlafaxine XR (EFFEXOR XR) in Healthy Volunteers [Completed]
This study will examine the effects of co-administration of SPD489 and the antidepressant EFFEXOR XR on the pharmacokinetics of lisdexamfetamine, d-amphetamine, and EFFEXOR XR. In addition, serial blood pressure and pulse measures will be obtained and examined to ensure that there are no unexpected changes in vital signs following co administration of SPD489 and EFFEXOR XR that would impact the further study of this drug combination. The hypothesis is that a drug drug interaction could possibly exist.

Study to Examine the Effect of Gastric Bypass Surgery on Venlafaxine ER Blood Levels [Active, not recruiting]
The purpose of the study is to determine whether a significant and predictable change in bioavailability of extended-release venlafaxine occurs following Roux-en-Y gastric bypass.

Venlafaxine 25 mg Tablets Under Fasting Conditions [Completed]

Venlafaxine 25 mg Tablets Under Non-Fasting Conditions [Completed]

Venlafaxine Hydrochloride 150 mg Extended-Release Capsules Under Fed Conditions [Completed]
The objective of this study was to compare the rate and extent of absorption of venlafaxine hydrochloride 150 mg extended-release capsules (test) versus EffexorŽ XR (reference) administered as 1 x 150 mg extended-release capsule under fed conditions.

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: 2015-08-10

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2015