Talk:Varenicline

Removal of alcohol dependance

I'd appreciate a link to the official statement regarding the use of phase 3 human test studies being the minimum quality standard for citation in medical articles on wikipedia. In my opinion, citation of an article released by the National Institute of Health of the United States Federal Government should constitute notable and reliable enough information to meet inclusion standards. --Linkinlogs 00:10, 4 November 2007 (UTC)

About the link to alcohol consumption: Regarding the fact that was an animal study.. The study was mentioned all over mainstream media. I know that's not the most reliable place for medical information, but since the pill is already used on humans I thought it was relevant. A lot of times animal studies are about substances that end up not being effective in humans, but this one works with nicotine. I figured that means that there is a reasonable chance this will mean something in humans, and at the very least it will bring about more research. Maybe it was a stretch to say it may be effective against alcoholism, but it's definitely made a buzz in the mainstream media and I got the impression that it's getting a lot of attention. But I'm no expert in medicine, nor am I an experienced editor here (this was my first one). But that was my thinking behind it. --SlamboS 00:45, 12 July 2007 (UTC)

Someone keeps putting chantixresources.com in the resource link. It appears to be spammish. 68.169.183.172 15:23, 15 August 2006 (UTC)Zylo

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JAMA this weeks contains four trials all demonstrating effectivity against placebo and even bupropion.

• 352/329/344 varenicline/bupropion/placebo - 12 week course - better than bupropion and placebo at 12 weeks but equally good as bupropion at 52 weeks - 28.1% nausea
• varenicline+weekly counselling vs bupropion or placebo - better than both at 52 weeks - nausea - dropout rate about 10% for all modalities
• varenicline vs placebo with extension for those who were abstinent for >7 days - difference very small

An editorial raises some concerns about inclusion bias and generalisibility of the results[1]. I've hesitated to cite the first three studies without taking a closer look at these writers' objections. JFW | T@lk 22:27, 4 July 2006 (UTC)

This drug I believe is now available in the UK on prescription. This I feel should be added to the article.

In the news:

http://www.sciam.com/article.cfm?chanId=sa013&articleId=ACE9FF1E-E7F2-99DF-31F26EC00AA05F4A&modsrc=most_popular

http://abcnews.go.com/GMA/OnCall/story?id=3623085&page=1 Jayedwards5 18:02, 20 September 2007 (UTC)

Perhaps a bit more detail and discussion? Most of this seems to amount to heavy speculation. JFW | T@lk 23:44, 19 September 2007 (UTC)

Agreed that it is speculation, but as someone who is actually using it and watching the message boards, I've seen enough people mention aggression and psychosis as a potential problem [2] (as an example). As stated, I've cited reliable sources in an effort to fairly inform. In fairness, I have put Pfizer's response in as well. And in fact, I've come out in defense of Chantix on several of these boards attempting to avert panic. However, the fact that it is so often discussed makes it relevant. Jayedwards5 00:04, 20 September 2007 (UTC)JayEdwards5

I wish you'd discussed this first before reinserting it again. Speculation on message boards is NOT a reliable source, even if you balance it with some information from Pfizer that is not actually a response to that speculation. The best way of averting panic is being selective in what enters article spice on Wikipedia. You could consider WP:RFC to see if other users agree with your view, but please do not reinsert the material in question until my concerns have been addressed. JFW | T@lk 16:55, 20 September 2007 (UTC)

The fact that the unsettling side effects are discussed on message boards alone would perhaps constitute speculation; the fact that these effects are listed on Pfizer's own web site[3] combined with the heavy play they receive from people actually taking this medicine takes it to another level and makes it relevant. The fact that it has made national news by definition makes it newsworthy. I included links to sources (NOT message boards) which discuss both sides to the story (the abcnews article contains Pfizer's response in detail). And the best way to avoid panic is not censorship; it is to keep people well-informed. Arbitrarily deleting information that is relevant, newsworthy, as neutral as possible, cited, and significant to those considering taking a new medication, even though it may be inflammatory, suggests a hidden agenda. Jayedwards5 17:14, 20 September 2007 (UTC)

I've asked you to stop reinserting this until we've arrived at consensus. It's a shame you're in such a rush. Now which effects from Pfizer's website are you interested in? Why do we need an ABC news article with uninformed speculation if there is a website from the manufacturer? I'm displeased at your reference to "censorship"; that is not a fair description of my objections; please remain civil. Think of WP:RFC instead of reverting. JFW | T@lk 19:12, 20 September 2007 (UTC)

If what you mean by "consensus" is that only you agree with what is posted, then you have not only sabotaged the spirit of Wikipedia, but have taken on the role of censor. The news article cites "reports"; the statement notes that reports have been made. No conclusions are proffered. What was inserted would not be considered controversial except by those who would have a vested interest in whether inflammatory reports reached the public. There would be no other reason for the removal of said statements other than that. Pfizer's website is merely their side; if Wikipedia merely allowed what a manufacturer states, WP would simply be a search engine. What would Brown & Williamson's page look like? What was inserted was properly cited and informative, and included facts, not speculation. You are not the final arbiter of what constitutes facts. If statements are cited, are relevant, and are important, they belong. So rather than deleting, why not put in a subsection that deals with these reports instead of attempting to sweep them under the rug? That way the general public, armed with ALL the information, can draw their own conclusions. Jayedwards5 19:31, 20 September 2007 (UTC)

I need not be lectured on the spirit of Wikipedia; people try to insert all sorts of nonsense in the name of the "spirit of Wikipedia". I also resent being called a "censor".

If the "reports" you talk about cannot be cited independently (e.g. FDA notifications), how notable are they? That's not sweeping under the rug, that's being deliberately selective to distinguish high-quality (e.g. scientific research) from low-quality (message boards) sources.

Please be mindful of the three revert rule. JFW | T@lk 20:12, 20 September 2007 (UTC)

The sentence in the article, "There have been reports of people experiencing mood and behavior changes while taking Varenicline, including psychosis, depression and suicide", is not backed up by the ABC news article, and is misleading. According to the ABC News report, it states that there were isolated incidents of psychotic and suicidal behavior, but it occurred in patients taking both the drug as well as placebo, so I don't think this is very strong evidence at all. I'm not disputing the reliability of ABC News here; in this case, they seem to be providing reasonable information, although the article in question deals more with one person instead of the study or clinical trial itself, so if we're talking about actual facts, it's better to use information from the manufacturer or clinical trial here. The ABC News source seems to focus more on one musician's case than the study on the drug itself. Dr. Cash 20:14, 20 September 2007 (UTC)

It looks to me like the most you can claim from the above abc news article is that a girlfriend of a famous person has stated that she believes that she thinks side effects from this drug caused her boyfriend to act irrationally which subsequently resulting in him being shot. Remember 20:26, 20 September 2007 (UTC)

Also if suicidal ideation occurred in both the control and experimental arm of the clinical trials it suggests that deprivation of smoking causes suicidal ideation, not varenicline. Remember 20:28, 20 September 2007 (UTC)

One last note, it appears that suicidal ideation is higher for smokers in general so it may not be a surprise that suicidal ideation would occur in a clinical trial of smokers in both the active and control arms. Also smokers tend to be schizophrenic, which may be more responsible for the irrational behavior than the barenicline. See [4] ("Comorbidity of schizophrenia and smoking is extremely common.[4] Multiple studies have shown the incidence of smoking among schizophrenics to range from 75% to 90%, compared with an incidence in the general population of approximately 25% to 30%. Ninety percent of schizophrenic smokers started smoking before they became symptomatic from schizophrenia. No association has been found between smoking in schizophrenia and medication. Smoking increases the risk of suicide. The odds ratio of making a suicide attempt for a smoker is 2.0 compared with that of a nonsmoker. The odds ratio for having suicidal ideation as a smoker is 1.4 compared with a nonsmoker. This relative risk is less than that for depression but greater than that for schizophrenia.")Remember 20:34, 20 September 2007 (UTC)

wow...there seems to be some confusion here. First, 'smokers tend to be schizophrenic'? Ummm...no; remember the direction the relationship is taking -- if some studies have shown that up to 90% of schizophrenics smoke, that is *not* the same as saying smokers 'tend' to be schizophrenic, or even that 'a lot' of smokers are schizophrenic. Saying that smokers tend to be schizophrenic is like reading a study that says most Hollywood actors wear mascara when on camera and then claiming that mascara wearers tend to be working actors. Just because a generalised statement can be made in one direction (and we aren't even sure that is correct!) does not mean that another statement can be made in the opposite direction.

One might safely say 'many schizophrenics are smokers', and depending upon how much faith one places in the studies one has read, might even be willing the place a bet that the next person who walks into the rec room of a mental hospital for schizophrenics is a smoker. But it does not work the other way around; I cannot sit in the park watching people smoking all day long and think I have seen a single schizophrenic, diagnosed or not.

Additionally, although the comorbidity of smoking and schizophrenia is common, no relationship can be assumed from this fact alone. Correlation does not imply causation -- IN ANY DIRECTION. There is a direct correlation between ice cream sales and drownings -- as ice cream sales rise, drownings also increase. Does chocolate cherry chip *cause* drownings? No. Does being about to drown *cause* people to eat ice cream? No. It could just be that more people swim and eat ice cream in the summer.  :-) Sometimes 'facts' are just coincidences, or there is a mediating variable in there that is difficult (or less intuitive than the mis-identified relationship) to discern, or there is a good potential avenue for further study, but a correlational relationship alone does not cement (or even imply) a necessary and sufficient condition.

Also, the 'fact' that '[n]inety percent of schizophrenic smokers started smoking before they became symptomatic from schizophrenia.' and attempting to make meaningful fact out of that statement alone is leaning towards being an example of the post hoc ergo prompter hoc fallacy. Someday a relationship may be able to be drawn (e.g., self-medication in the form of nicotine to replace Substance X which is being depleted) based upon empirical research (not reasoning and relationships), but at this time no such relationship can be honestly stated, and so this fact is only an interesting tidbit of trivia. Hold it in your mind in case other indicators of a relationship arise, but one would be wrong to base action upon it. Considering that the average age of diagnosis as a schizophrenic (for men per Wikipedia is appx 20 - 28 yrs) -- just statistically -- is higher than the average age of starting to smoke (17.8 years; Kavari, 2005), it is not surprising that the majority of people start to smoke before the average age of diagnosis, period...including those who don't have schizophrenia, and therefore aren't diagnosed with it. The average age of first sexual intercourse (16.5 years; Rotermann, 2005) precedes schizophrenia dx as well; is there a relationship there? How about one between sex and smoking?  ;-)

The unfortunate side to this is that there is little to no definite knowledge about the mechanism of action for many (if not all) psychoactive drugs, or even the neurotransmitters involved (which is why “unknown mechanism of action” is included on virtually every drug which effects behavior or mood). It is virtually all speculation. But if speculation is all we have to go on then consider the possibility that it is true (otherwise we have nothing to theorize and it is a dead topic). Smokers tend to be less healthy than your average person; the less healthy a person is (sleep, physical/emotional stress, diet, etc) the less able their body is to produce the necessary neurotransmitters. Nicotine holds a higher affinity to neuroreceptors than dopamine, so, when you smoke, dopamine is kicked from it’s place, and mills about in the synaptic gap until the nicotine decays, and the dopamine is then able to flood back, and get the smoker high. What is important is that the dopamine may stay for a short period in the synaptic gap (at least the duration of the halflife of nicotine). If it remains too long in the gap however, it may be washed away and reintegrated into the body. If a body is deprived too long of dopamine however (due to say, prolonged exposure to nicotine eg. Extended release patches) the person begins to experience some strange changes. Look up dopamine deprivation or deficiency. What is unique about varenicline is it’s halflife (about 24 hours) vs nicotine (which is about 1-2 hours). We might assume that dopamine synthesis takes more than 24 hours. Now we have a situation where a person with deficient dopamine levels is now suffering the continued depletion of their reserves, and, if this reserve is sufficiently low enough; the possibility that they may be completely or nearly completely deprived of dopamine. Which, would explain many of the symptoms described by people on the whyquit website. Of course, this is all speculation and theory, but not illogical or irrational. I do find it odd however, that Pfizer excluded anyone who could have met any criteria for dopamine deficiency from their studies that were submitted to the FDA, and, provided that, they also forgot to list that it was not then approved for anyone who they did not actually study, leading to MD’s prescribing it to an untested population which may, or may not, have been radically effected by it. I worked in pharmacy for 7.5 years, and this drug, it’s supportive studies, and Pfizer’s refusal to closely examine it, has always given me an itch I couldn’t scratch. 64.186.109.208 (talk) 04:25, 26 September 2011 (UTC)

Also as a smoker, who has attempted to quit several times on many cessation products, I can tell you that many of the symptoms described are not symptoms that you would experience going “cold turkey,” but are much closer to the patches extended release symptoms (night terrors, nightmares, lucid dreams, etc). —Preceding unsigned comment added by 64.186.109.208 (talk) 23:57, 16 May 2011 (UTC)

Ok, so I am being facetious a bit now, but I hope you get my points. Smoking is bad for you, but it does not have to be paired with schizophrenia to be a bad thing; it is a bad thing all on its own. Someone who smokes should not be alarmed that they may be schizophrenic, or suicidal. Someone who is schizophrenic is not *destined* to commit suicide, they are only more likely statistically. We have to remember that *people* are statistics, but a person is an *individual*. In other words, YMMV.  :-)

Lastly, 'Also if suicidal ideation occurred in both the control and experimental arm of the clinical trials it suggests that deprivation of smoking causes suicidal ideation, not varenicline.' gets another ummm...no. If you are studying the effects of Varenicline (or smoking cessation, which would be different, yes?) and have just the treatment and control groups, Varenicline is as much responsible for their suicidal ideation as it is for their thinking about what to eat for dinner, because both groups are doing that as well. Hopefully if one were actually studying the effects of Varenicline on suicidal ideation, they would have a more rigourous experimental framework in order to establish a link. I cannot decide to study whether or not Varenicline helps people quit smoking, gather my participants and assign them to groups, then notice at the end that 50% of one group killed themselves and try to put forth any intelligent explanation as to why (other than educated musings, but those are largely meaningless). I was studying VARENICLINE and SMOKING CESSATION. PERIOD. Although it is really exciting to have ideas about all kinds of things, as a researcher I should use caution as to what I have opinions about (especially what with all the attrition in my studies! ;-) ), when I am making my opinions publicly known. Sadly, these days, between 'science writers' and corporate shills put forth as experts, most people are as confused as ever about the difference between fact and opinion, especially once statistics, empirical research, and/or logic come into play.

You might want to check out these links before further speculation: http://en.wikipedia.org/wiki/Questionable_cause http://en.wikipedia.org/wiki/Data_dredging

And, honestly, I am *not* saying that I favour smoking. I don't. I am just concerned over some of the comments having the cloak of facts when I differ with that opinion, and worry that someone might take some of it to heart. Ancodia 17:55, 3 October 2007 (UTC)

I find it interesting that less than a year after this heated discussion, numerous prominent newspapers have reported on possible adverse health effects of this drug. I may be stirring the pot here, but I think it goes without mentioning that we should all remain open to *all* viewpoints that may cross our paths. AniRaptor2001 06:37, 18 May 2009 (UTC)

Article requires updating in light of story linked below? Australia, QLD - Coroner finds that anti-smoking drug, Champix, contributed to young man's suicide — Preceding unsigned comment added by 182.239.194.197 (talk) 21:13, 14 September 2017 (UTC)

NICE

Technology appraisal: http://guidance.nice.org.uk/TA123 JFW | T@lk 08:51, 27 July 2007 (UTC)

Please Add...

It would be nice if someone could explain in layman terms how this drug works, what it does, etc. —Preceding unsigned comment added by 69.3.229.197 (talk) 14:30, 10 October 2007 (UTC)

In layman's terms, nicotine changes the brain by growing receptors to a particular pleasure center. When nicotine is withheld, these receptors begin to get agitated, sending out the message "time to light up".

I may not understand the above description because I am not a layman. But the effects of nicotine are a bit more complex than that. It is true that one effect of chronic nicotine treatment is the increase of high affinity binding sites in the brain. This is different to "growing receptors". We do not know what it means actually. For a long time, it has been assumed to be an increase of alpha4beta2 nicotinic receptors. Then other explanations came up, like a shift between different isoforms of receptors, an effect on receptor folding etc. But in any case, this is not, as far as I am aware, involved in nicotine addiction. Or let's say not in nicotine dependence. I just could not understand what "When nicotine is withheld, these receptors begin to get agitated, sending out the message "time to light up" means.Nicolas Le Novere (talk) 17:27, 1 January 2008 (UTC)

Chantix works by blocking messages involving the pleasure center effected by nicotine, both incoming and outgoing. It first works by dulling the message that says it's time to light another cigarette (feed the addiction), so one doesn't want to smoke as many. Second, when one does light up, it just won't taste good. There's no satisfaction. Because these messages are blocked and the receptors not used, the receptors slowly go away, lessening the desire to smoke a great deal.

Not at all. Varenicline is a nicotinic agonist. It imitates nicotine effect. Yes it is "dulling the message that says it's time to light another cigarette" exactly like nicotine would do. It does not cause the receptors to go away. Even if it would, it would not lessen the desire to smoke a great deal. Nicolas Le Novere (talk) 17:27, 1 January 2008 (UTC)

It is not a vehicle for nicotine, so it doesn't prolong the addiction, unlike patches and inhalers.

Varenicline works exactly like nicotine, and we could perfectly do patches and inhalers of varenicline. The difference between varenicline and nicotine, is that the former affects only some nicotinic receptors, and affect them partially. Since nicotine has many effects on the brain, positive and negative, it is better.Nicolas Le Novere (talk) 17:27, 1 January 2008 (UTC)

Smokers still need to pick a quit day (because they smoke not just to kill the craving, but out of habit, from stress, in celebration...) and they'll still have occasional cravings, some coming out of nowhere long after the smoker has quit, so online support is also provided. There is at least one free self-hypnosis resource that many, many people have used to help in ending their addiction to nicotine (google: quit smoking online and select the first result).

The success rate for Chantix appears to be about 44% after three months, far above other products on the market. The one year success rate is about 22%, still far higher than other methods of quitting. The reason for this drop is because Chantix is a tool, not a magic pill, and nicotine is an insidious addiction.

The reason is first that tobacco is not just nicotine. For instance, tobacco smoke contains inhibitors of monoamine oxidase, that certainly participate to addiction and explain that chewed tobacco is far less addictive than smoked one. Second, tobacco smoking is more than a pharmacological addiction. Social and environmental cues are very important (otherwise noone would start to smoke. The first effect of tobacco smoke is to make you puke. One start to smoke mainly to comply with social rules). Third although varenicline is better than nicotine, it missed its target. It does not target the right receptors. For various reasons, that would be far to complicated to explain here (but that have to do mainly with social structure of scientific research, including stiffness of the opinion, power of simplistic explanations, lack of understanding of basic pharmacology by molecular biologists, but also with the slowness of drug development) most of the current clinical trials are targeting alpha4beta2 receptors, while the scientific community is now focussing on alpha7, alpha6beta2beta3 and alpha4alpha6beta2beta3 receptors. Nicolas Le Novere (talk) 17:27, 1 January 2008 (UTC)

Plagurize much, Nicky?? —Preceding unsigned comment added by 12.86.230.202 (talk) 16:07, 12 January 2010 (UTC)

Carter Albrecht

Albrecht's girlfriend is convinced that Chantix contributed to his tragic death; fine, nevermind Albrecht's blood alcohol content of 0.29 mg/dl, three times the legal driving limit in Texas. Albrecht's girlfriend isn't a medical or pharmaceutical expert, and since the ABC News article doesn't have a byline, I have serious doubts about the credibility, reliability, and accuracy of the source. The neurological side effects are no different from diphenhydramine, which is available OTC in the states. —Viriditas | Talk 11:56, 31 December 2007 (UTC)

You are reading too much into the note on Albrecht. The FDA said that it is aware of that case (without mentioning the name though) and asked Pfizer if there have been anything similar. The fact that he took varenicline with a high dose of alcohol is mentioned in the article and by the FDA. The description of the incident is taken from ABC only to give some background to the somewhat cryptic FDA announcement. Nowhere it is stated that varenicline is to blame, and Albrecht's girlfriend is not mentioned as a source or any kind of authority at all. It is up to the FDA to decide, and the article clearly states that. My guess is that the FDA will come up with a stronger language regarding taking alcohol with varenicline. Paul gene (talk) 19:48, 31 December 2007 (UTC)

I haven't read anything into it; I was merely quoting the source used and summarizing the autopsy results. Since the FDA doesn't mention Albrecht by name, I fail to see why it is included in the article, as the report in ABC News is less than credible, and quotes Albrecht's girlfriend as a medical authority when she isn't. —Viriditas | Talk 21:41, 31 December 2007 (UTC)

Since the FDA does not mention Albrecht by name, it is nice to have the background. According to WP:RS, reliable source is a source known for careful fact-checking, and ABC as a major news organization, certainly qualifies. Their reporting is also balanced, since in addition to Albrechts' girlfriend they also quote Pfizer representative. ABC did not offer their own interpretations of the incident, they used experts to do that, they merely reported the facts Paul gene (talk) 22:33, 31 December 2007 (UTC)

Always consider the source. We do not use secondary and tertiary media sources to describe scientific or medical issues without also confirming authoritative sources, which in this case would be a peer-reviewed journal, an official press release from Pfizer, or a press release from the FDA; Neither apparently exists. Each source must be evaluated on its own merits, not as a group. This source in particular [5] has no byline, does not quote Pfizer in the context of the claim being reported, and posits original research ("Did Combination of Stop-Smoking Drug and Alcohol Contribute to Carter Albrecht's Bizarre Behavior?") without appealing to any named experts. You said they used experts; who are they? Looking at the article, there is a mention of a pharmacy handout for Chantix detailing the warnings, and a physician by the name of Richard Honaker. But none of these "experts" address the issue of Albrechts death, which is my point. The girlfriend is not a medical authority. —Viriditas | Talk 23:38, 31 December 2007 (UTC)

No, I did not use the ABC report for any kind of medical claims or interpretation, but only for the description of what actually happened, so it is a primary source. Primary sources can be used if they come from a reliable source (major news organization in this case) and used in a simple description. And the source does quote Pfizer, and it is in the context of Albrecht's death (note the mention of alcohol): "We are very committed to patient safety," Ponni Subbiah, a Pfizer representative, told ABC News. "We continually monitor adverse events. To date there is no evidence to suggest that Chantix is associated with violent behavior. And I think it's important to keep in perspective that alcohol use in itself is associated with violent behavior." ABC also quotes an MD who regularly prescribes varenicline, so he is an expert: "Richard Honaker prescribes Chantix to patients and while he urges caution with the drug, he believes the possible risks may still be worth the benefit."More patients by far are able to quit smoking with this drug than anything else we have," Honaker said." Still I was conservative and did not include any of this. The rest of the note is taken from the FDA announcement: " FDA is aware of a highly-publicized case of erratic behavior leading to the death of a patient using Chantix to attempt to quit smoking. Although other factors, including alcohol consumption, appear to have played a part in this specific case, FDA asked Pfizer for additional cases that might be similar. We are currently evaluating the material Pfizer submitted in response to our request."Paul gene (talk) 01:38, 1 January 2008 (UTC)

You selectively interepreted a primary source as I show below. —Viriditas | Talk 03:36, 1 January 2008 (UTC)

Instead of focusing on Albrecht, we should be focusing on the "vivid, often-frightening dreams" that are reported as a side-effect. This has occurred in Benadryl-users (at small doses) for more than five decades, and that drug is OTC. If this was as serious a problem as Albrecht's girlfriend claims, you would expect to hear more about it considering the length of time people have been taking allergy medication. —Viriditas | Talk 23:53, 31 December 2007 (UTC)

Well, this discussion is about varenicline, not about Benadryl. How are the side effects of Benadryl relevant? I believe that the awareness of the potential danger of combining varenicline with alcohol is important, particularly, since there is a promotion of an off-label use of varenicline for the treatment of alcoholism. I hope the Albrecht case will stop that.Paul gene (talk) 01:38, 1 January 2008 (UTC)

The side effects I describe are those of varenicline, not Benadryl. According to ABC, Albrecht's girlfriend, Ryann Rathbone said:

...that almost immediately after starting the drug, they started having vivid, often-frightening dreams known side effect of the medication..."Nightmare kind of, hallucination kind of dreams where you don't know if it's real or not," Rathbone said. About a week into taking Chantix, after an evening of cocktails, a hallucinating Albrecht started lashing out at his confused girlfriend physically and verbally. "And the things that he was saying did not make any sense. It was like he was in a nightmare," Rathbone said.

Again, these are the same side effects reported with Benadryl, an OTC allergy medicine. Rathbone does not discuss alcohol use, Pfizer does. Is there a reason Pfizer is not quoted in the article? This article states:

FDA is aware of a highly-publicized case of Carter Albrecht

And yet, the FDA does not mention his name. But this is sourced to the ABC news story, which does not mention the FDA.

who was shot to death by his neighbor after, in the apparent state of delirium, hitting his girlfriend and trying to force the entry in the neighbor's house.

That's an interpretation of a primary source and is not supported by relevant authorities. I have every right to remove it.

Although in this case the delirium appeared to be caused by taking varenicline with a high dose of alcohol

Sourced to FDA.

FDA asked Pfizer for additional cases that might be similar. The FDA also recommended that health care professionals and patients watch for behavioral and mood changes.

That is a selective statement that does not reflect the full passage and should be quoted for accuracy. —Viriditas | Talk 03:34, 1 January 2008 (UTC)

NIH entry in side effects

I removed this because the NIH information provided is about nicotine withdrawal symptoms in general and not a comment on, or a refutation of, the reported Chantix side effects. While the link between the two may be both obvious and notable, it seems like editorializing or using the page as a forum for debate to imply the NIH findings are related to Chantix and not to nicotine withdrawal in general. The possible link to withdrawal symptoms is already mentioned, as are other potential reasons for the high number of incident reports. Relevancy would not be in question if a link were provided to an actual NIH study of Chantix as opposed to a website simply citing NIH bullet points. The Editor's note that accompanies this change notes that the article "requires investigation of nicotine withdrawal as potential cause of psychosis in varenicline users, as consistent with NiH findings." Absolutely true if the NIH conducted a study to this effect in re: the subject at hand, but no citation is provided to such an investigation. Homerduo (talk) 23:22, 25 December 2008 (UTC)

Chantix NOT covered by Aetna prescription plan

Chantix costs about $100 a month, and it worked for me, but it is NOT convered by the Aetna prescription plan.

One would think an effective medication to stop smoking should be covered, but why not?

A: Perhaps some actuary at Aetna figured out that it's more cost-effective for smokers to die sooner than for non-smokers to die many years later from "natural" causes.

70.138.247.210 (talk) 18:40, 18 February 2009 (UTC)Bill Ainsworth, Houston, TX

Funny. Yes, Bill, that must be the reason. It can't be that managed care plans maximize profits by avoiding full payment for proprietary drugs, especially new ones. David Spector 21:36, 10 February 2010 (UTC)

2009 studies linked in article

I have removed the link to these because the statement in the article is not backed by the actual studies. The first study makes only a passing mention to psychiatric side effects (at least in the abstract) noting that they are "unproven." The second, more importantly, shows a moderate incidence of psychiatric side effects (something like 1.1%), with two participants in the study attempting suicide during its course. The studies are interesting and should be mentioned, but not in a way that contradicts or distorts their findings. —Preceding unsigned comment added by 24.215.134.174 (talk) 11:40, 18 May 2010 (UTC)

the dangers of this drug

I have added a caution box that is almost certain to be removed, probably by representatives from Pfizer looking to control their product's PR. Unfortunately, so many news articles and magazine articles have been written about how horrid this drug is, that they cannot hide it anymore anyway, and it might as well be here on Wikipedia where everyone can look at. I am sick and tired of the lies and deceit that are allowed to stand barely challenged simply because the outfit that sponsors it has money and influence. This drug has made normal people go absolutely nuts and kill people. Additionally, it can't even really help most of its users achieve the thing it's marketed to achieve. It should have been declared all-around banned across the world years ago, but it's still around, probably chiefly because Pfizer considers its bottom line more important than human lives. Disgusting. Kikodawgzzz (talk) 16:21, 8 September 2010 (UTC)

Hi Kikodawgzzz, I have indeed removed the caution box, although I assure you I don't work for Pfizer :) This issue has actually been discussed in depth, and the reasons behind the decision not to use this sort of thing in articles are presented here and discussed here and here. Best, Fvasconcellos (t·c) 18:27, 8 September 2010 (UTC)

The BMJ-published study

Has been heavily disputed and contradicts all similar statistical analyses done by the ISMP. Please stop editing the article to include this in the lede or the main depression section, unless you also include all the ISMP studies as well. — Preceding unsigned comment added by 64.20.10.122 (talk) 20:22, 1 August 2011 (UTC)

Answer: The ISMP "studies" you mention are simply notes of public report ... the BMJ was an actual study. You can't compare public report with a statistical study with significant findings, but it appears that many believe you can.

And so, according to Wikipedia, Chantix will apparently continue to receive support of it's leading to depression and suicide. Thankfully, as a medical provider who is adept at analyzing proper research, I know better. — Preceding unsigned comment added by 99.95.251.38 (talk) 18:20, 21 August 2011 (UTC)

Well, perhaps you ought to participate in the discussion below. If you are indeed adept at analysing proper research, perhaps you can help us make sense of the quagmire of conflicting data. JFW | T@lk 18:40, 21 August 2011 (UTC)

The bottom line is, if there is indeed conflicting data, then BOTH sides need to be represented, not one over the other simply because an individual deems it to be. — Preceding unsigned comment added by 99.95.251.38 (talk) 19:03, 21 August 2011 (UTC)

Violence as a side effect

Someone should create a subsection which identifies violent behavior as a potential side effect, as two clinical studies have shown the correlation. Potentially could include the numerous violent crime cases in recent years that implicate Varenicline. — Preceding unsigned comment added by 64.20.10.122 (talk) 20:24, 1 August 2011 (UTC)

Edit war: what's going on?

Since at least the beginning of June there has been a low-grade edit war between two editors. One is consistently editing from an IP, another seems to have the account Homerduo (talk · contribs). I believe the dispute is about the relative emphasis on possible complications from varenicline use, how much to focus on the BMJ article, how to clarify the fact that Albrecht's death was not solely attributable to varenicline, etcetera.

My personal view is this: this article follows WP:MEDMOS in broad strokes (the sections), but we are vastly overusing primary sources (see WP:MEDRS for an explanation). This means that individual reports about potential harms make up the lion's share of the article. Now if the drug was so truly terrible, I believe it would have been withdrawn. The data on efficacy still stand. I think there is probably a case for trying to make the article more WP:NPOV but without hiding the fact that there have been reports of problems.

I have asked Homerduo to come to this talkpage to offer some perspective, and I hope that the anonymous opponent will do the same. Further controversial edits will lead to the article being protected. JFW | T@lk 08:00, 12 August 2011 (UTC)

That sounds like a viable solution. The "controversy" section is overloaded with what is essentially trivia, and can be more of a summary than the lengthy list it is now. The problem is, in recent months the severity of the side effects has become more apparent (with the revelation that Pfizer had filed thousands of serious adverse event reports as "non-serious" to the FDA, including hundreds of suicides, and the revelation that at least one person in the very small test group in their own clinical study actually committed suicide as well). Despite what the other editor says, there has been no clinical study to actually determine the role Varenicline has played in these side effects. The BMJ study was simply an analyses of patient and doctor reports submitted to the NHS (essentially a statistical look at anecdotal evidence), and no different than the ISMP reports, which does the same with patient and doctor reports submitted to the FDA. More importantly, the two come to opposite conclusions. There is no clear answer, which is why I felt it inappropriate to have a single, very limited (and disputed) study set apart from all the other data and report, especially when the FDA has ordered Pfizer to conduct a series of studies to determine the possible link to these reported side effects.

As for Albrecht, his case is discussed at length elsewhere on this page. The tone of the edits seemed far too editorial. Albrecht had presumably been inebriated before in his life, and while it must have certainly played a factor, the irrational and violent behavior is something other analyses have linked to Varencicline. I just did not think the commentary-like nature of the edits was appropriate for Wikipedia, though the information should be included. The most relevant element of the Albrecht case is that it was the first widely-reported instance of possible psychiatric side effects, and led to the media exposure Pfizer blames for the large number of alleged instances reported in its wake. Homerduo (talk) 13:03, 12 August 2011 (UTC)

In answer to Homerduo's accusation that the BMJ study is no different than other ISMP reports, I beg to differ. The BMJ study was a database analysis. I see no evidence that ISMP reports can come from anything other than public source reports without a Medical Doctor being involved at all. Perhaps someone could provide a reference showing otherwise? When the FDA receives a certain amount of public complaints, they are required to put a Black Box warning label on the product. This is in no way governed or overseen by any type of medical advice, simply based on number of public complaint.

As for Albrecht, Homerduo states that the information of his extreme intoxication "should be included", but apparently just not near an initial statement related to the incident, is that the way it goes? Ridiculous. His blood alcohol level was THREE times the legal limit at the time of the incident. THREE times. Yet you feel you have the authority to withhold that information from the public, because you want them to believe it was the Chantix. Frightening ... but then again, I suppose this is the world we live in, where commercials determine what is believed. Thankfully, I myself can understand extreme intoxication and see it for what it is ... being horrendously drunk. And I also believe that YOUR commentary-like edits are inappropriate for Wikipedia, or any other informative source which should attempt to disclose any and all fact.

One can only wonder why Homerduo and JWolf are so intent on avoiding information which is glaringly evident. Thankfully, neither of you have any jurisdiction over what I choose to prescribe to my patients, most of whom have done very well on Chantix, with little to no side effect profile other than nausea and vivid dreams. — Preceding unsigned comment added by 99.95.251.38 (talk) 19:01, 21 August 2011 (UTC)

You really should stop attacking myself and your opponent. Drop your agenda, focus on the hard data, and try to achieve consensus. I have already explained that I do not declare a bias, but you will get blocked if you attack other contributors. JFW | T@lk 22:44, 21 August 2011 (UTC)

Why is the article lacking so much information...

I'm having a hard time being comfortable with the (tremendous) lack of information about the drug. If anything the full pharmaceutical package insert should be included and paraphrased for laymen terms... Where is the full inclusion of the FDA blackbox warning? This is a VERY important piece of information... Blackbox warnings are NOT generalized, they are each, specifically written for the drug which was deemed dangerous enough to deserve it... — Preceding unsigned comment added by 64.186.109.208 (talk) 06:31, 20 August 2011 (UTC)

The article mentions the fact that the FDA introduced a black box warning. Many useful drugs have black boxes because they can cause side-effects that are well recognised and serious enough to inform the person using it unequivocally.

What other information do you think is lacking? JFW | T@lk 08:54, 21 August 2011 (UTC)

Just feel that it would be more... clarifying if the warning verbatim was included in the article instead of simply that it is assigned one, the information can be found off pfizer's site at http://labeling.pfizer.com/ShowLabeling.aspx?id=557 (it's in two different sections). My issue with the exclusion of the actual verbiage of the warning is that guns, household cleaners, and RX drugs can come with extreme warnings (perhaps they're even the only warnings i've ever seen), my intuitive understanding of the warnings that come with my oven cleaner, or that of my .44 won't give me much perspective on this. likewise my understanding of Isotretinoin, Clozapine, or acetaminophen (or their associated boxed warnings) wont help me much in my understanding of varenicycline. on another note; http://whyquit.com/pr/040208.html (the site opened prior to albrecht, and begins recording testimonials through the albrecht incident; a small pre-media window). CNM 64.186.109.208 (talk) 04:24, 26 September 2011 (UTC)

(updated 10.3.11) sorry, appears that the link i posted was broken or edited. the correct link to the pfizer med insert is now up 0.o be weary the nomenclature. 64.186.109.208 (talk) —Preceding undated comment added 19:42, 3 October 2011 (UTC).

/ShowLabeling.aspx?id=557

2013: FDA links Chantix to more than 500 suicides

• FDA: Anti-smoking drug Chantix linked to more than 500 suicides america.aljazeera.com.

Chantix Litigation 300 mio settlement

• Pfizer Settles Chantix Litigation.84.152.51.27 (talk)

Request for edit to update drugbox

Updated drugbox

Varenicline Clinical data Trade names Chantix AHFS/Drugs.com Monograph MedlinePlus a606024 License data EU EMA: by INN US FDA: Varenicline Routes of administration Oral ATC code N07BA03 (WHO) Legal status Legal status In general: ℞ (Prescription only) Pharmacokinetic data Protein binding <20% Metabolism Limited (<10%) Elimination half-life 24 hours Excretion Renal (81–92%) Identifiers IUPAC name 7,8,9,10-tetrahydro- 6,10-methano- 6H-pyrazino (2,3-h)(3) benzazepine CAS Number 249296-44-4 375815-87-5 PubChem CID 5310966 DrugBank DB01273 Y ChemSpider 4470510 Y UNII W6HS99O8ZO ChEMBL ChEMBL1076903 Y Chemical and physical data Formula C13H13N3 Molar mass 211.267 g/mol g·mol−1 3D model (JSmol) Interactive image SMILES n1c2cc3c(cc2ncc1)[C@@H]4CNC[C@H]3C4 InChI InChI=1S/C13H13N3/c1-2-16-13-5-11-9-3-8(6-14-7-9)10(11)4-12(13)15-1/h1-2,4-5,8-9,14H,3,6-7H2/t8-,9+ Y Key:JQSHBVHOMNKWFT-DTORHVGOSA-N Y   (verify)

Thanks responding to my request Jfdwolff! Cheers. Boghog (talk) 19:12, 12 September 2011 (UTC)