Venlafaxine ( Effexor , Efexor ) is an arylalkanolamine serotonin-norepinephrine reuptake inhibitor (SNRI). First introduced by Wyeth in 1993, it is licensed for the treatment of major depressive disorder (MDD), as an anxiolytic, and comorbid indications. In 2007, venlafaxine was the sixth most commonly prescribed antidepressant on the U.S. retail market, with 17.2 million prescriptions. In children and adolescents, venlafaxine (like other anti-depressants) has a potential to increase suicidal thoughts, attempts and events of self-harm.
Indications
Approved
Venlafaxine is used primarily for the treatment of major depression, generalized anxiety disorder, social anxiety disorder, obsessive–compulsive disorder, panic disorder, and menopausal hot flashes in adults.
Depression
Multiple double blind studies show venlafaxine's effectiveness in treating depression. Venlafaxine has similar efficacy to the tricyclic antidepressants amitriptyline (Elavil) and imipramine and is better tolerated than amitriptyline. Its efficacy is similar to or better than sertraline (Zoloft) and fluoxetine (Prozac), depending on the criteria and rating scales used. Higher doses of venlafaxine are more effective, and more patients achieved remission or were "very much improved". The efficacy was similar if the number of patients who achieved "response" or were "improved" was considered. A meta-analysis comparing venlafaxine and combined groups of SSRI or tricyclic antidepressants showed venlafaxine's superiority. Judged by the same criteria, venlafaxine was similar in efficacy to the atypical antidepressant bupropion (Wellbutrin); however, the remission rate was significantly lower for venlafaxine. In a double-blind study, patients who did not respond to an SSRI were switched to venlafaxine or citalopram. Similar improvement was observed in both groups.
Consumer Reports , which in 2004 had rated venlafaxine as the most effective among six commonly prescribed antidepressants, no longer recommends it. Fluoxetine, citalopram, and bupropion have been chosen as Consumer Reports Best Buy drugs in the updated version of their guide, based upon effectiveness, safety, side effects, and cost.
Off-label / investigational uses
Many doctors are starting to prescribe venlafaxine "off label" for the treatment of diabetic neuropathy (in a similar manner to duloxetine) and migraine prophylaxis (in some people, however, venlafaxine can exacerbate or cause migraines). Studies have shown venlafaxine's effectiveness for these conditions. It has also been found to reduce the severity of 'hot-flashes' in menopausal women.
Substantial weight loss in patients with major depression, generalized anxiety disorder, and social phobia has been noted, but the manufacturer does not recommend use as an anorectic either alone or in combination with phentermine or other amphetamine-like drugs. Venlafaxine hydrochloride is in the phenethylamine class of modern chemicals, which includes amphetamine, methylendioxymethamphetamine (MDMA), and methamphetamine. This chemical structure likely lends to its activating properties; however, some patients find venlafaxine highly sedating despite its more common stimulatory effects.
Venlafaxine is not approved for the treatment of depressive phases of bipolar disorder; this has some potential danger as venlafaxine can induce mania, mixed states, rapid cycling and/or psychosis in some bipolar patients, particularly if they are not also being treated with a mood stabilizer.
Due to its action on both the serotoninergic and adrenergic systems, venlafaxine is also used as a treatment to reduce episodes of cataplexy, a form of muscle weakness, in patients with the sleep disorder narcolepsy.
Venlafaxine was found in one study to be equal to Anafranil in the treatment of OCD with fewer side effects.
Due to its tendency to increase blood pressure and its modulative effects on the autonomic nervous system, venlafaxine is often used to treat orthostatic intolerance and postural orthostatic tachycardia syndrome.
Contraindications
Venlafaxine is contraindicated in children and adolescents because it can increase suicidal thoughts, attempts, and self-harm (see Venlafaxine#Suicidality). Furthermore, studies of venlafaxine in these age groups have not established its efficacy or safety. Venlafaxine is not recommended in patients hypersensitive to venlafaxine. It should not be taken by anyone who is allergic to the inactive ingredients, which include gelatin, cellulose, ethylcellulose, iron oxide, titanium dioxide and hypromellose. It should never be used with a monoamine oxidase inhibitor (MAOI), as it can cause potentially deadly serotonin syndrome. At least 14 days must pass between the use of venlafaxine and MAO inhibitors. Caution should also be used in those with a seizure disorder.
Glaucoma
Venlafaxine can increase eye pressure, so those with glaucoma may require more frequent eye checks.
Pregnant women
There are no adequate, well-controlled studies of venlafaxine in pregnant women. Therefore, venlafaxine should only be used during pregnancy if clearly needed. Prospective studies have not shown any statistically significant congenital malformations. There have, however, been some reports of self-limiting effects on newborn infants. As with other serotonin reuptake inhibitors, these effects are generally short-lived, lasting only 3 to 5 days, and rarely resulting in severe complications. Use of Venlafaxine in pregnancy should be considered on a case-by-case basis.
Heart disease and hypertension
The FDA asked the manufacturers of all SNRIs to include the risk of persistent pulmonary hypertension (PPHN) in prescribing data as of July 19, 2006. Medications containing venlafaxine caused a mean heart rate increase of 4 bpm in clinical trials, along with a sustained increase in blood pressure in some.
Adverse effects
Suicide
The US Food and Drug Administration body (FDA) requires all antidepressants, including venlafaxine, to carry a black box with a generic warning about a possible suicide risk. In addition, the most recent research indicated that patients taking venlafaxine are at increased risk of suicide.
A study conducted in Finland followed more than 15,000 patients for 3.4 years. Venlafaxine increased suicide risk 1.6-fold (statistically significant), as compared to no treatment. At the same time, fluoxetine (Prozac) halved the suicide risk.
In another study, the data on more than 200,000 cases was obtained from the UK general practice research database. The patients taking venlafaxine had significantly higher risk of completed suicide than the ones on fluoxetine (Prozac) (2.8 times) or citalopram (Celexa) (2.4 times). Even after taking into consideration the fact that venlafaxine was generally prescribed for more severe depression, venlafaxine was associated with 1.6-1.7 times more suicides than fluoxetine or citalopram. This difference was no longer statistically significant due to the rarity of completed suicides. However, for the attempted suicides (more frequent event) the 1.2-1.3 times higher risk for venlafaxine still stayed statistically significant after the adjustment.
An analysis of clinical trials by the FDA statisticians showed the incidence of suicidal behaviour among the adults on venlafaxine to be not significantly different from fluoxetine or placebo. A possible explanation for this discrepancy is that suicidal patients are generally excluded from clinical trials, and so clinical trials do not represent the real population of patients.
Venlafaxine is contraindicated in children, adolescents and young adults. According to the FDA analysis of clinical trials venlafaxine caused a statistically significant 5-fold increase in suicidal ideation and behavior in persons younger than 25. In another analysis, venlafaxine was no better than placebo among children (7–11 years old) but improved depression in adolescents (12–17 years old). However, in both groups, hostility and suicidal behavior increased in comparison to those receiving a placebo. In a study involving antidepressants that had failed to produce results in depressed teenagers, teens whose SSRI treatment had failed who were randomly switched to either another SSRI or to venlafaxine showed an increased rate of suicide on venlafaxine. Among teenagers who were suicidal at the beginning of the study, the rate of suicidal attempts and self-harm was significantly higher, by about 60%, after the switch to venlafaxine than after the switch to an SSRI.
Common side effects
NOTE: The percentage of occurrences for each side effect listed comes from clinical trial data provided by Wyeth Pharmaceuticals Inc. The percentages indicate the percentage of people that experienced the side effect in clinical trials.
- Headache (34%)
- Nausea (21-35%)
- Insomnia (15-23%)
- Sexual dysfunction (14-34%)
- Dry mouth (12-16%)
- Dizziness (11-20%)
- Sweating (10-14%)
- Decreased Appetite (8-20%)
- Abnormal ejaculation (8-16%)
- Hypertension (4-5%)
- Vivid/Abnormal dreams (3-7%)
- Akathisia (Agitation) (3-4%)
- Decreased libido (3-9%)
- Increased yawning (3-5%)
- Apathy
- Constipation
- Ongoing Irritable Bowel Syndrome
- Fatigue
- Vertigo
- Orthostatic hypotension (postural drop in bl
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