|
|
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.
|
|
NEWS HIGHLIGHTS
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...
Clinical Trials Related to Chantix (Varenicline)
Varenicline as a Treatment for Methamphetamine Dependence [Completed]
The primary purpose of the study is to determine the effects of treatment with varenicline
(1 and 2 mg daily), compared to treatment with placebo, on methamphetamine-induced craving
and subjective effects in methamphetamine-dependent human volunteers.
Varenicline Treatment for Smoking Cessation in Patients With Bipolar Disorder [Completed]
The investigators' hypothesis is that add-on varenicline will be effective (versus placebo)
in initiating abstinence from smoking in subjects with stable, euthymic bipolar disorder who
are motivated to quit smoking within four weeks. This primary outcome will be assessed from
randomization to 12 weeks or end of the treatment phase of the study. Secondarily, the
investigators also hypothesize that varenicline will prevent relapse in the subsequent
12-weeks follow-up non-treatment phase. Furthermore, the investigators plan to test the
effectiveness of varenicline in reducing nicotine withdrawal symptoms or urges to smoke, as
well as its safety for use in stable bipolar patients when used as an add-on treatment for
smoking cessation.
The investigators plan to test these hypotheses by conducting a randomized,
placebo-controlled add-on treatment trial of Chantix with 60 recruited subjects diagnosed
with DSM-IV bipolar disorder for a period of three months. The investigators will follow-up
with them three months later to evaluate extended abstinence.
A Single Dose Study Investigating the Absorption and Elimination as Well as the Tolerability of Varenicline Transdermal Delivery System (e.g., a Patch) as Compared to Oral Varenicline in Adult Smokers. [Completed]
Study of Mood Effects of Varenicline (Chantix) in Depressed Outpatient Smokers [Completed]
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.
Tailoring Varenicline to Individual Needs (TVIN Study) [Completed]
Varenicline is a partial nicotinic agonist which acts on alpha4 beta2 nicotinic receptors.
It is presumed to alleviate withdrawal discomfort, but also to diminish rewarding effects of
cigarettes. The standard varenicline dosing has been formulated to avoid adverse reactions
(primarily nausea) in sensitive clients. The downside of this cautious approach is that a
substantial proportion of clients may be under-dosed. A blanket dose increase would
inevitably increase the incidence of side effects, but it is likely that tailoring
varenicline dosing to clients' needs would be safe and may further increase varenicline's
efficacy.
This study will recruit 200 smokers who report little change to their enjoyment of
cigarettes and no nausea, during the first week of varenicline use. These smokers will be
randomised to receive the standard dose plus placebo or plus individualised varenicline dose
up to 5mg, titrated over the next week prior to their target quit day. Urges to smoke, and
other withdrawal symptoms, experienced during the study period will be compared between
groups to see if the tailored therapy may be useful.
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 / COMMENTSBased 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
|
|
|
|
Page last updated: 2015-08-10
|
|
-- advertisement --
|
