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Chantix (Varenicline Tartrate) - Summary

 
 



WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS

Serious neuropsychiatric events including, but not limited to, depression, suicidal ideation, suicide attempt, and completed suicide have been reported in patients taking CHANTIX. Some reported cases may have been complicated by the symptoms of nicotine withdrawal in patients who stopped smoking. Depressed mood may be a symptom of nicotine withdrawal. Depression, rarely including suicidal ideation, has been reported in smokers undergoing a smoking cessation attempt without medication. However, some of these symptoms have occurred in patients taking CHANTIX who continued to smoke.

All patients being treated with CHANTIX should be observed for neuropsychiatric symptoms including changes in behavior, hostility, agitation, depressed mood, and suicide-related events, including ideation, behavior, and attempted suicide. These symptoms, as well as worsening of pre-existing psychiatric illness and completed suicide, have been reported in some patients attempting to quit smoking while taking CHANTIX in the postmarketing experience. When symptoms were reported, most were during CHANTIX treatment, but some were following discontinuation of CHANTIX therapy.

These events have occurred in patients with and without pre-existing psychiatric disease. Patients with serious psychiatric illness such as schizophrenia, bipolar disorder, and major depressive disorder did not participate in the premarketing studies of CHANTIX, and the safety and efficacy of CHANTIX in such patients has not been established.

Advise patients and caregivers that the patient should stop taking CHANTIX and contact a healthcare provider immediately if agitation, hostility, depressed mood, or changes in behavior or thinking that are not typical for the patient are observed, or if the patient develops suicidal ideation or suicidal behavior. In many postmarketing cases, resolution of symptoms after discontinuation of CHANTIX was reported, although in some cases the symptoms persisted; therefore, ongoing monitoring and supportive care should be provided until symptoms resolve.

The risks of CHANTIX should be weighed against the benefits of its use. CHANTIX has been demonstrated to increase the likelihood of abstinence from smoking for as long as one year compared to treatment with placebo. The health benefits of quitting smoking are immediate and substantial. [see and ] Warnings and Precautions Adverse Reactions 6.2)

 

CHANTIX SUMMARY

CHANTIX tablets contain varenicline (as the tartrate salt), which is a partial agonist selective for α β nicotinic acetylcholine receptor subtypes.

CHANTIX is indicated for use as an aid to smoking cessation treatment.


See all Chantix indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Chantix (Varenicline)

Smoking cessation drug not boosting number of smokers who quit
Source: Smoking / Quit Smoking News From Medical News Today [2015.08.18]
The introduction of a new prescription smoking-cessation aid, varenicline, in 2006 has had no significant impact on the rate at which Americans age 18 and older successfully quit smoking, according...

more news >>

Published Studies Related to Chantix (Varenicline)

Pharmacokinetic-pharmacodynamic modeling of the effect of varenicline on nicotine craving in adult smokers. [2015]
relationship of varenicline on relief of craving... CONCLUSIONS: Craving reduction is associated with increased varenicline

Effects of varenicline on smoking cessation in adults with stably treated current or past major depression: a randomized trial. [2013]
in smokers with depression treated with varenicline versus placebo... CONCLUSION: Varenicline increased smoking cessation in smokers with stably

Dissociable effect of acute varenicline on tonic versus cue-provoked craving in non-treatment-motivated heavy smokers. [2013]
randomized, double-blind, placebo-controlled, cross-over design... CONCLUSIONS: Acute varenicline selectively attenuates tonic but not cue-provoked

Effects of 21 days of varenicline versus placebo on smoking behaviors and urges among non-treatment seeking smokers. [2012]
Varenicline promotes smoking cessation and reduces urges to smoke. However, the mechanisms associated with these effects and their time course are not well characterized...

The effects of extended pre-quit varenicline treatment on smoking behavior and short-term abstinence: a randomized clinical trial. [2012]
Preclinical research and learning theory suggest that a longer duration of varenicline treatment prior to the target quit date (TQD) would reduce smoking rates before cessation and improve abstinence outcomes. A double-blind randomized controlled trial tested this hypothesis in 60 smokers randomized to either an Extended run-in group (4 weeks of pre-TQD varenicline) or a Standard run-in group (3 weeks of placebo, 1 week of pre-TQD varenicline); all the participants received 11 weeks of post-TQD varenicline and brief counseling...

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Clinical Trials Related to Chantix (Varenicline)

Study of Mood Effects of Varenicline (Chantix) in Depressed Outpatient Smokers [Recruiting]
This study will assess whether varenicline (chantix) has antidepressant properties when used in addition to other psychiatric medication. It will also assess whether varenicline improves the inability to feel pleasure (i. e. anhedonia), and if it is well-tolerated when used with psychiatric medications.

Enrolled patients will be assessed for improved mood, improved anhedonia, overall sense of health, side effects as well as tobacco use for 6-8 weeks.

Medication will be provided free of charge.

Varenicline and Bupropion for Smoking Cessation [Recruiting]
This study provides an opportunity to combine varenicline and bupropion SR and capitalize on the potential additive benefit. The investigators hypothesize that this will further increase long-term (≥ 6 months) smoking abstinence rates.

Evaluation of Varenicline (Champix) in Smoking Cessation for Patients Post-Acute Coronary Syndrome (EVITA) Trial [Not yet recruiting]
The EVITA study is a clinical trial that will test the effect of varenicline (Champix™), a new drug used to help people quit smoking, in patients who have suffered a heart attack. Varenicline has been recently shown to increase the number of otherwise healthy people who quit smoking compared to placebo (sugar pill). Although varenicline has been shown to reduce smoking in healthy populations, its effectiveness in patients recovering from a heart attack is unknown. The EVITA trial will help answer this question.

A total of 300 patients who have recently suffered a heart attack and are active smokers will be recruited in the study. For twelve weeks, half the patients will receive varenicline and the other half will receive placebo pills. Patients will be followed for a period of 12 months. During this time, patients will receive telephone calls and go to clinic visits in order to assess if they are smoking. These follow-ups will also assess any side effects and clinical events such as another heart attack or hospitalization that patients may have had. Smoking cessation will be checked using exhaled carbon monoxide readings and self-reports.

The EVITA trial will be the first study to examine the use of varenicline in patients who have recently had a heart attack. These patients, if they continue to smoke, are at high risk of having another cardiac event. If varenicline is shown to be useful in this population, it will have a major impact on prevention of cardiac events in patients who have suffered a heart attack.

Does Varenicline Influence Alcohol Consumption in Alcohol Dependent Individuals? [Recruiting]
The aim of the present clinical trial is to investigate whether 14 weeks of treatment with a prescription medication for smoking cessation (European trade name: Champix(R); US trade name: Chantix(R)), can reduce alcohol consumption in alcohol dependent individuals.

Study of Varenicline (Champix) for Smoking Cessation/Reduction in Patients With Bipolar Disorder [Recruiting]
Bipolar Disorder is a chronic relapsing mental disorder characterized by periods of elevated, expansive and irritable mood, often alternating with periods of significant clinical depression. People with Bipolar Disorder are typically heavy smokers who have difficulty quitting, and this is associated with significant tobacco-related medical illness and death.

The proposed study will be a double-blind, placebo-controlled 10-week clinical trial of the safety and efficacy of varenicline (Champix™) in thirty subjects with Bipolar I Disorder. This medication is the latest first-line pharmacotherapy for smoking cessation and has been shown to be efficacious for smoking cessation, but has not yet been systematically studied in persons with Bipolar Disorder.

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Reports of Suspected Chantix (Varenicline) Side Effects

Depression (1644)Anxiety (1344)Abnormal Dreams (1126)Nausea (1078)Suicide Attempt (766)Insomnia (654)Aggression (608)Drug Ineffective (604)Suicidal Ideation (572)Feeling Abnormal (516)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 44 ratings/reviews, Chantix has an overall score of 6.84. The effectiveness score is 8.68 and the side effect score is 6.05. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Chantix review by 51 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   SMOKING CESSATION
Dosage & duration:   1 MILLIGRAM (dosage frequency: twice a day) for the period of 4 MONTHS
Other conditions:   NONE
Other drugs taken:   NONE
  
Reported Results
Benefits:   ALLOWED ME TO QUIT SMOKING WITHOUT THE PHYSICAL WITHDRAWL
Side effects:   OCCASSIONAL NAUSA SHORTLY AFTER TAKING, OCCASSIONAL GAS, SLEEPING DIFFICULTY
Comments:   1 TABLET IN THE AM ONE IN PM

 

Chantix review by 25 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Severe Side Effects
  
Treatment Info
Condition / reason:   Quit Smoking
Dosage & duration:   1 mg taken twice a day for the period of 2 weeks
Other conditions:   None
Other drugs taken:   None
  
Reported Results
Benefits:   I quit smoking!!!! And so did my husband who was also taking it. I smoked about 1 pack a day and he smoked about 2 packs a day. Our lives have changed because of this drug and our children will be healthier too!
Side effects:   Severe nausea and drowsiness. After the pill in the morining I would get extremely nauseous and sleepy.
Comments:   I couldn't even keep my head up at work because I was so drowsy. I would have to go lay down in the break room. It got so bad I had to quit taking it. But I decided since it had been 2 weeks smoke free I wouldn't start again just because I couldn't handle the pills. My husband and I have been smoke free for 1 year 2 months!

 

Chantix review by 25 year old male patient

  Rating
Overall rating:  
Effectiveness:   Marginally Effective
Side effects:   Extremely Severe Side Effects
  
Treatment Info
Condition / reason:   Smoking Cessation
Dosage & duration:   1mg taken 2 times a day for the period of 12 weeks
Other conditions:   past history of depression, PTSD
Other drugs taken:   alcohol, caffeine, marijuanna
  
Reported Results
Benefits:   helped somewhat in minimizing the cravings and anxiety while taking it but still required substantial will power to quit. Considering the absolute hell I went through to quit I will probably never go back to smoking.
Side effects:   acute nausea, mental fog, vivid dreams, poor sleep quality, sore eyes, constipation, uncontrollable flatulence, euphoria, turned to dark depression, Psychosis NOS, Major Depressive Disorder, Suicidal ideation, self detrimental behaviour, emotional lability, agression, rage, panic attacks, hallucination, Somatoform Disorder, Delusional Parasitosis, Cholinaergic Prurritus, Hyperacusis, Severe sleep depervation; excessive dreaming, inability to sleep deeply, feeling half awake while sleeping, waking up with sore eyes., Brain Fog, lowered inhibitions, hair roots hurting, excessive hair loss, Irritable Bowel Syndrome, puffy bags under eyes, excessive weight gain, gingivitis, prostate pain, inability to feel orgasm, decreased ability to maintain and achieve erections, anhedonia.
Comments:   I took Champix in March of '08 and I am still suffering from most of the side effects of this poisonous drug. I started to feel some of the bad effects (nausea, mental fog, trouble sleeping, sore eyes, constipation, gas) of Champix while taking it but I was determined to quit smoking. For the first month I felt exceptionally good and I was telling everyone how great it was but the euphoria came crashing down and I went into a deep depression. I was able to make it through the full 3 month course but when I stopped taking it is when I really got messed up. I developed Psychosis NOS, Major Depressive Disorder, suicidal, Emotional instability, aggression, rage, panic attacks, hallucination, Somatoform Disorder, Delusional Parasitosis (bug crawling sensations all over my body), Hyperacusis (sensitivity to certain frequencies of sound causing severe pain and pressure in my ears), Severe Insomnia, Memory Loss, Brain Fog, Lowered Inhibitions, Hair was constantly hurting all of the time and lost lots of it (27 year old male), Irritable Bowel Syndrome (started as extreme constipation and gas, fatigue, Severe Eye pain, unsightly puffy bags under eyes, excessive weight gain, gingivitis, prostate pain, black out and become out of control when drinking, decreased sexual pleasure and ability to maintain erections. I think that is everything!!! I went to the psych ward recently due to being suicidal and at a breaking point with my symptoms and I was treated like scum and given brain damaging neuroleptic (anti-psychotic) drugs against my will. I have made some small improvements since taking Champix but it looks like the nightmare will never truly end. If you are one of the many that gets burned by this medication be warned that the doctors will probably not be able to help you and will most likely deny that anything is even happening to you or that it is related to Champix and the side effects may be permanent. I had a similar reaction in respect to rage and disinhibition from taking Zoloft when I was younger which altered my life substantially and now Champix has put the nail in the coffin. Apparently these two drugs have a similar mechanism but Pfizer with held this information and marketed the drug in a deceiving way not mentioning any of the neuro-psychiatric and mind altering side effects of the drug when it first hit the market in order to boost sales of their poison. The medical community has know for quite some time that dopamine plays a role in mood regulation and the fact the Champix targets the pleasure centre of the brain makes them grossly negligent for not investigating this further and informing consumers. Many people including myself (I turned down a prescription of Zyban due to my experience with Zoloft) would not have taken it if we would have been informed of the risks and Pfizer knew that. SHAME ON THEM FOR RUINING MY LIFE AND MANY OTHERS INCLUDING THOSE WHOM ENDED THE MISERY BY TAKING THEIR OWN LIFE. YOU'VE BEEN WARNED

See all Chantix reviews / ratings >>

Page last updated: 2015-08-18

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