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General : Chantix - Champix (varenicline)  
     
Reply
(1 recommendation so far) Message 1 of 21 in Discussion 
From: John  (Original Message)Sent: 12/8/2006 3:15 PM
12/08/06
 
Hi, Joel.  I like the fact that your website is so straightforward and honest.  Do you have any thoughts or experience with the drug called Chantix?  Your're supposed to take it for 12 weeks and  tt's supposed to ease cravings during that time period. thanks.
 
Joann


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Sent: 5/3/2007 12:26 PM
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 Message 8 of 21 in Discussion 
From: JoelSent: 5/3/2007 12:29 PM
Some additional commentaries I have been using when getting questions about Chantix:
 

I am going to attach an email reply I wrote to the first person that wrote me asking about an over the counter smoking aid a few years ago. It also illustrates how I feel about Chantix, and all new products that are going to be introduced over time. I will start giving such products attention when they meet the criteria discussed in the second paragraph below:

I have seen the xxxxxxx ads in my area for quite a while. If I am not mistaken, I think I saw those same ads resurface over and over again over a pretty long time period—maybe years. It’s hard to keep all of the shams straight—they really do all look alike after a while. It is amazing what wild claims you will see for products to help you to quit smoking or lose weight too. It’s ironic that you don’t see such ads for alcoholism or heroin or crack dependencies. Why do you think that is? Because if someone made such wild claims about beating a real drug addiction they would likely be held accountable to back up those claims. It seems though that no such accountability is enforced with tobacco use. It’s a shame though, especially when considering we are dealing with the drug which is every bit as addictive as any of these others—actually more so except maybe for crack, and kills more people than all of them combined. But again, it is not like society really takes cigarettes seriously

I could spend a lot of time researching each and every product that becomes available and makes wonderful claims but in all honesty, I have zero interest in any of them. You know when I will actually look into a product in depth. It is when I am out in the real world and all of a sudden encounter a few people, maybe five in a short time period who tells me that they actually have quit smoking by using the product?U>and that they were now off of the product and cigarettes for a solid year. This shouldn’t be hard for me to find considering I ask at least 50 new people a month, and sometimes hundreds of new people a month how they quit smoking and how the people they know who have quit smoking and have been off for at least a year, had actually first stopped. Well, this year I asked several thousand people—many of them physicians and dentists who also in turn deal with hundreds to thousands of people. You know how many times xxxxxxx was brought up? Zero. Do you know how many times somebody has emailed a question about xxxxxxxx? Counting your email—one. Kind of gives you a clue to what kind of word of mouth this miracle product is getting from its users.

For now Chantix is going to get a lot of good press for quite a while, being that you will soon have a pharmaceutical powerhouse pushing it as hard as possible. Until we can get some real world time behind us we cannot prove or disprove that the product is going to have any real impact on long-term success for its users.

Just last week I had my first live encounter with a person who used Chantix. (Live encounter defined as not Internet based emails from strangers). He has tried Chantix twice now, both times for three months each. Each time he came off the Chantix he said he started suffering what he described as the same withdrawals he had when he had tried to quit in the past and relapsed within days to smoking. He finally quit cold turkey and now he is off smoking for a few weeks and feeling much better than he has in a long time.

I should also note, both John and I are getting frequent emails from people regarding Chantix. There are many that praise the product as having helped people get various time periods under their belt smoke free, but the vast majority of these emails are from people who are still using the medication. We don't get many from people who got off the medication without problems and maintained their smoke free status.

Also particularly troubling to us is the number of emails we are getting from people with side effects, some quite severe to using the medication. One just sent us a link to an Internet board that had lots of people complaining of symptoms that were lasting a whole lot longer than the few days of withdrawal people may get when just going cold turkey. That has always been something I have seen as a problem with quit smoking aids out there, they either prolong the withdrawal period by keeping nicotine in the system or have their own side effects that cause people to experience physical complaints and symptoms much longer than people who simply go cold turkey. Cold turkey "may be" harder the first few days but physically, symptoms ease up quickly and it is a really safe method to quit. Here is the link to another string we have had previously at AskJoel that addresses this safety issue: "Isn't quitting cold turkey too dangerous?"

 



Reply
 Message 9 of 21 in Discussion 
From: JoelSent: 5/17/2007 3:22 PM
From above:

Just last week I had my first live encounter with a person who used Chantix. (Live encounter defined as not Internet based emails from strangers). He has tried Chantix twice now, both times for three months each. Each time he came off the Chantix he said he started suffering what he described as the same withdrawals he had when he had tried to quit in the past and relapsed within days to smoking. He finally quit cold turkey and now he is off smoking for a few weeks and feeling much better than he has in a long time.

I should also note, both John and I are getting frequent emails from people regarding Chantix. There are many that praise the product as having helped people get various time periods under their belt smoke free, but the vast majority of these emails are from people who are still using the medication. We don't get many from people who got off the medication without problems and maintained their smoke free status.

Also particularly troubling to us is the number of emails we are getting from people with side effects, some quite severe to using the medication. One just sent us a link to an Internet board that had lots of people complaining of symptoms that were lasting a whole lot longer than the few days of withdrawal people may get when just going cold turkey. That has always been something I have seen as a problem with quit smoking aids out there, they either prolong the withdrawal period by keeping nicotine in the system or have their own side effects that cause people to experience physical complaints and symptoms much longer than people who simply go cold turkey. Cold turkey "may be" harder the first few days but physically, symptoms ease up quickly and it is a really safe method to quit. Here is the link to another string we have had previously at AskJoel that addresses this safety issue: "Isn't quitting cold turkey too dangerous?"


I am going to attach a video here that talks about my first encounter with a person using NRT in the form of nicotine gum in the early 1980's. From numerous emails and from observing comments written on different boards, I am starting to get a sense that people's experience with Chantix is often the same as it is with NRT, that the drug is simply postponing the readjustments that a person often goes through when they first quit smoking.

Video Title
Dial-Up
HS/BB
Audio
Length
Added
My first encounter with NRT 3.99mb 16.1mb 2.13mb 14:37 11/16/06

 

 


Reply
(1 recommendation so far) Message 10 of 21 in Discussion 
From: JoelSent: 5/30/2007 11:08 PM
From: John (Gold) Sent: 5/30/2007 5:34 AM
Chantix and Champix
 
This year varenicline (Chantix and Champix) is the new kid on the block. Pfizer boasts that it aided 1 in 5 clinical trial users in quitting for a year. But aside from Chantix/Champix use, a number of study design factors may have heavily influenced outcome. More alarming, there's mounting user concerns that Pfizer has failed to adequately warn smokers about adverse events, including "frequent" risk of significant muscle and joint pain (what Pfizer lists as "arthralgia, back pain, muscle cramp, musculoskeletal pain, myalgia" - see page 14), without telling users how frequently, or that symptoms may persist long after varenicline use has ended.
 
 
 
 
 
Link to Pfizer's complete list of  
Chantix / Champix Adverse Events
 
 
 
 
 
But if the Chantix / Champix user makes it past the side-effects, they  truly will experience up to 60% of the dopamine output that nicotine would have generated if sitting on the exact same acetylcholine receptors.  The trick with Chantix / Champix isn't in feeling comfortble while using it but adjusting to living without it, as more than half of clinical trial users who quit smoking for 3 months while using varenicline relapsed within a year.
 
If you have a friend or loved one using Chantix or Champix there's absolutely no reason, whether they continue using it or not, that they  cannot go the distance and succeed, so long as zero nicotine finds its way back into their bloodstream.   Key is relapse prevention.  You may want to send them the link to downloading Joel's free PDF book "Never Take Another Puff" which can be downloaded at:
 
 
 
Reporting Adverse
Chantix / Champix Events
 
If you know someone using Chantix or Champix who experiences significant side effects encourage them to ...
 
 immediately call their physician
 
Also, encourage them to report the adverse reaction to their national health officials.   Here's a few links:
 
U.S. Food & Drug Administration - http://www.fda.gov/medwatch/
 
U.K. Medicines and Healthcare Products Regulatory Agency
 
Australian Therapeutic Goods Administration
 
Canadian Adverse Drug Reaction Monitoring Program
 
 

Reply
 Message 11 of 21 in Discussion 
From: JoelSent: 8/2/2007 2:25 AM
 
From above:

Just last week I had my first live encounter with a person who used Chantix. (Live encounter defined as not Internet based emails from strangers). He has tried Chantix twice now, both times for three months each. Each time he came off the Chantix he said he started suffering what he described as the same withdrawals he had when he had tried to quit in the past and relapsed within days to smoking. He finally quit cold turkey and now he is off smoking for a few weeks and feeling much better than he has in a long time.

I should also note, both John and I are getting frequent emails from people regarding Chantix. There are many that praise the product as having helped people get various time periods under their belt smoke free, but the vast majority of these emails are from people who are still using the medication. We don't get many from people who got off the medication without problems and maintained their smoke free status.

Also particularly troubling to us is the number of emails we are getting from people with side effects, some quite severe to using the medication. One just sent us a link to an Internet board that had lots of people complaining of symptoms that were lasting a whole lot longer than the few days of withdrawal people may get when just going cold turkey. That has always been something I have seen as a problem with quit smoking aids out there, they either prolong the withdrawal period by keeping nicotine in the system or have their own side effects that cause people to experience physical complaints and symptoms much longer than people who simply go cold turkey. Cold turkey "may be" harder the first few days but physically, symptoms ease up quickly and it is a really safe method to quit. Here is the link to another string we have had previously at AskJoel that addresses this safety issue: "Isn't quitting cold turkey too dangerous?"


I am going to attach a video here that talks about my first encounter with a person using NRT in the form of nicotine gum in the early 1980's. From numerous emails and from observing comments written on different boards, I am starting to get a sense that people's experience with Chantix is often the same as it is with NRT, that the drug is simply postponing the readjustments that a person often goes through when they first quit smoking.

Video Title
Dial-Up
HS/BB
Audio
Length
Added
My first encounter with NRT 3.99mb 16.1mb 2.13mb 14:37 11/16/06

 


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The number of members that recommended this message. 0 recommendations  Message 12 of 21 in Discussion 
Sent: 9/11/2007 2:35 AM
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 Message 13 of 21 in Discussion 
From: JoelSent: 9/11/2007 2:39 AM
 
John received this emailed letter a couple of days ago. It is indicative of numerous letters we receive and we thought it would be a good addition to issues being raised in this string:
 

Hi John,  

Thank you for the wonderful web site, which I discovered a month ago while in the midst of a Chantix withdrawal anxiety episode.  Your knowledge, insights and encouragement helped me a great deal, as I'll explain in more detail a bit later.

I found your article on Chantix quite illuminating, and was able to learn from it why the drug appeared to have worked in ending my 30-year nicotine habit.   Yes,  the good news to report is that I now consider myself a successful nicotine ex-addict.   Chantix played a role, but I  believe the designer drug is basically a fraud.  Allow me to explain.

First some background.  I was a pack-a-day cigarette smoker in my 20s.  I tried to quit many times, but each time the withdrawal symptoms overwhelmed me.  Plus, I didn't understand what was happening.

I switched to cigars in my 30s, believing I wasn't inhaling, and while I definitely wasn't inhaling as much, obviously I was still getting nicotine through my mouth and throat tissues.

When Nicorette gum was introduced, I was probably one of the company's first customers.  The first time I used it, it worked for me for three months -- no tobacco at all  -- but the reality was that I was still a nicotine addict. 

And there were times when I couldn't afford the high price of the gum, or for quite a long time, you had to get a prescription, which was a hassle.  So, believe it or not, for the next 15 years I wentback and forth between the gum and cigars.  As my earnings increased, I was able to afford the gum more often, and tried to wean myself entirely from tobacco, and I was largely successful.  But sometimes my jaws would get tired.  I also tried the patch once, and that didn't last even a day.  They wouldn't stick to my skin.  Every attempt to quit failed.  I did, however, begin jogging regularly 15 years ago, and that helped with lung capacity.

Finally, a few years ago, I asked my doctor for help, and he prescribed Zyban (with little explanation of what to expect or how it worked).  Itdid work, to control withdrawal sympoms for a few days, but not completely, and I relapsed.  It was back to gum, for the most part, with a cigar once a day.  During this period, my resentment over being controlled by the nicotine industry mounted, especially with the knowledge that NRT is the most expensive of all forms of nicotine, and I seemed to be chewing more and more.

Then about three years ago, my father, a life-long smoker, contracted lung cancer, small cell, inoperable.  He underwent a miserable six months of chemo and radiation therapy, and went into remission.  Well, that ended any further tobacco use, but I still could not quit the gum.

Earlier this year, my father's lung cancer returned.  He was maxed out on radiation, his doctors said they weren't sure what they could do.  He finally found a surgeon who said that he could operate -- and save his life -- but the left lung had to go.  All of it.  I traveled to Indiana for the operation in early April.  The whole experience was incredibly emotional, but the medical staff at Indiana University Hospital were fantastic -- totally professional, and the operation was a success.  My father's doing fine right now.

Needless to say, that experience led me again to try to find a way to end my nicotine addiction.  I can't believe I failed to find your website, it would have been such a big help.  Instead, I came across Chantix.  The hospital where my wife works endorsed it for hospital personnel who wanted to quit, calling it "promising."  My wife reported a colleague had been successful after taking the drug for two months.  The literature claimed a 44% success rate.

So I asked my doctor (not the one who prescribed Zyban) about the drug in April.  He had never prescribed Chantix to anyone, said he didn't know much about it, but that a Pfizer representative had happened to have left him with a sample -- a month's supply.  Did I want to try it.

I jumped at the chance.  Yes, I had doubts about being a guinea pig for big pharma, but I couldn't find anything too negative about the drug, so off  I went.  My last piece of gum chewed was April 27.  And like magic, at 2 mg a day of Chantix, no withdrawal symptoms (well, nothing major, some gastro effects briefly, some strange dreams, some early awakening, but I reasoned that these could also be side effects of nicotine cessation).  Since I had a free month's supply, I was elated.  My wife noticed how calm I seemed.  I felt calm.  And no relapse at all.  No desire for tobacco or gum!  Great!

Toward the end of the month, I cut my dose, first to 1.5 mg -- no sweat, fine so far -- then to 1 mg, and finally the last few days, just 0.5 mg per day.  This effectively made the four week supply last five weeks, and then I reported back to my doctor.  I was pleased.  He was pleased.

 "I don't need to keep taking it, do I," I asked. 

" No, no reason I can see," he replied.

First day without Chantix, no problem.  Second day, third day, nothing much, although I wondered why I was feeling slightly anxious, especially since we were on vacation at the time and there was nothing stressful going on.  By day five, I was immersed in dread, waking in the middle of the night short of breath, feeling dizzy, panicky, shaky, light-headed.  I didn't know what to do.  I thought maybe it would get better the next day, but no, more of the same.  The only relief I got was from drinking.  Two evenings in a row,  I drank far more than the recommended two glasses of red wine, and basically put myself to sleep to get through the night.

The next day, more symptoms.  I did some online research and the closest description was GAD, generalized anxiety disorder.  The websites I did find basically were of little help, but suggested that the symptoms could continue for a long time.  Again,  I wish I had found your site!

I called my doctor and asked to be put back on the Chantix.  By noon I had the prescription, and within an hour of taking 1 mg, I began to feel relief.  That fast.  That afternoon I was able to install a new dishwasher in our kitchen, a task I'd never done before.  Pulled if off without a hitch in four hours, without swearing, cursing or getting upset.  That's how powerful Chantix is.  I popped the other 1 mg pill with dinner and by 8 p.m., I was calm as could be, no symptoms at all.

That was June 8.  I took Chantix until August 4.  Five days later, I was again in the throes of major withdrawal symptoms, same as before.  That's when I googled "Chantix withdrawal symptoms" in the hopes someone else knew what was going on.  That's when I found your site and the article questioning the efficacy of Chantix.  And everything began to finally make sense.  I realized I had to go cold turkey from Chantix.  Your description of the withdrawal syndrome helped so much.  I realized that I was probably in the middle of about a 10-day withdrawal period, and that the first time I probably could have made if I had known that relief was on the way.  In addition, I knew nothing at all until that point about the effect on blood sugar and fat that nicotine, and it's powerful cousin Chantix, exerted.  I used to go all day without eating, or maybe just have a single meal at lunchtime, with a few snacks.  Some days I fasted all day.

I now realize that the only way I was able to do that was because -- as you point out -- I was feeding myself with nicotine doses, and for nearly four months, Chantix doses.

That designer molecule at 2 mg is as powerful as 20 pieces of 4 mg Nicorette -- 80 mg daily! 

Anyway, It's been more than a month since my last dose of Chantix.  No relapses, symptoms gone.  I've had to re-train myself to eat differently, grazing on small snacks through the day, but heck, that's been fun.  I gained about six pounds during the past five months.  About five weeks ago, I doubled the amount of miles I normally jog -- in the past that's how I was able to lose weight.  I know from experience it will probably take me another month or two of increased exercise to lose this amount of weight, but that's okay, I love jogging -- I get runner's high, and it feels great.  Plus, now of course, my lungs are completely free of gunk.

I'm sleeping better than ever, longer, deeper, no more waking up and chewing a piece of gum.  I have more time and quite a bit of more money each month.  Most importantly of all, I'm free from the grip of the death merchants.  I  must express my gratitude to you, because once I found your site, I realized what I had to do to break free.  I am celebrating each day -- hell, why everyone doesn't celebrate each anyway is beyond me.  But I know having gone through this and accomplished my goal of freedom, I will never be enslaved again.

I cannot blame anyone for my nicotine habit, but I do think the medical professionals I sought help from should have been better educated -- none ever gave me much help, and never explained some of the things I learned on your website.

Many thanks. 


Reply
 Message 14 of 21 in Discussion 
From: JoelSent: 10/6/2007 2:16 PM

John and I are not the only people hearing about serious side effects from Chantix/Champix. Here is a link John found yesterday to a response board with numerous complaints:

http://cbs11tv.com/local/local_story_267233942.html

Every now and then both John and I get emails from people who are angry that we have put up information that gives people warnings about potential issues with the efficacy and safety of the drug. We also get emails from people who were wondering why they were not aware of some of the problems that the drug has caused them before they started taking it.

I am sure that there are people who stop the drug once the effects become pronounced who simply throw away their quits. This I think is a real mistake. As I said above in the commentary I first wrote regarding Zyban when it was introduced:

"I am troubled when I see people report on the board that they can’t quit smoking because they can’t tolerate the medication. They are feeling handicapped before they start to quit and they are giving the drug too much credit. Again, you can quit with it if it is tolerable and you and your doctor feels it is safe for you to use. You can quit without it too if you really want to stop and are willing to put in the effort it takes to quit. That is the truth in both cases though, with Zyban or without. Your quit will succeed either way if you always understand the importance of knowing to never take another puff!"

I have the same belief about Chantix now. People who stop taking it should not automatically think that they have lost their ability to quit. They can maintain the quit that they started while on the drug, or even quit smoking after stopping the drug if they had not done so earlier, and sustain that quit over the long-term if they simply make and stick to a personal commitment to never take another puff.

Joel

Also from above, comments directly related to Chantix/Champix use:

I should also note, both John and I are getting frequent emails from people regarding Chantix. There are many that praise the product as having helped people get various time periods under their belt smoke free, but the vast majority of these emails are from people who are still using the medication. We don't get many from people who got off the medication without problems and maintained their smoke free status.

Also particularly troubling to us is the number of emails we are getting from people with side effects, some quite severe to using the medication. One just sent us a link to an Internet board that had lots of people complaining of symptoms that were lasting a whole lot longer than the few days of withdrawal people may get when just going cold turkey. That has always been something I have seen as a problem with quit smoking aids out there, they either prolong the withdrawal period by keeping nicotine in the system or have their own side effects that cause people to experience physical complaints and symptoms much longer than people who simply go cold turkey. Cold turkey "may be" harder the first few days but physically, symptoms ease up quickly and it is a really safe method to quit. Here is the link to another string we have had previously at AskJoel that addresses this safety issue: "Isn't quitting cold turkey too dangerous?"

 


 

I am going to attach a video here that talks about my first encounter with a person using NRT in the form of nicotine gum in the early 1980's. From numerous emails and from observing comments written on different boards, I am starting to get a sense that people's experience with Chantix is often the same as it is with NRT, that the drug is simply postponing the readjustments that a person often goes through when they first quit smoking.

 

Video Title
Dial-Up
HS/BB
Audio
Length
Added
My first encounter with NRT 3.99mb 16.1mb 2.13mb 14:37 11/16/06
 

 


Reply
 Message 15 of 21 in Discussion 
From: JoelSent: 10/17/2007 1:55 AM
Video discussing my current views on Chantix:
 
Dial up version:  www.whyquit.com/videos/chantix.wmv  12MB

High speed version:  www.whyquit.com/videos/chantix_bb.wmv 35.95MB

Video Length: 32 minutes, 10 seconds

It is a bit long and I will soon make a more concise version of the video. This one for now though gives the most comprehensive insight of my views of Chantix.


Reply
The number of members that recommended this message. 0 recommendations  Message 16 of 21 in Discussion 
Sent: 10/17/2007 11:04 PM
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Reply
 Message 17 of 21 in Discussion 
From: JoelSent: 10/18/2007 3:16 AM
 
I tried to reshoot the video, making it more concise and incorporating a few concepts explaining how we want to be able to help people who are using Chantix. My hope was to make a shorter video. Unfortunately, the end result came out to be 16 minutes longer.

Video Title: WhyQuit's Candid View About Chantix

Dial Up Version
http://www.whyquit.com/videos/chantix2.wmv
17.78 mb

High Speed Version
53.33 MB
http://www.whyquit.com/videos/chantix2_bb.wmv

Audio version
7.11 MB
http://www.whyquit.com/videos/chantix_audio.wmv


Total length: 48 minutes, 16 seconds

Yes it is a bit lengthy, but considering that people are asking us for our opinion on an issue that is regarding their health and safety, I believe that it is worth the time of any individual who wants to understand our in-depth views of the potential value and the potential risks of this and any other quitting product.

Joel


Reply
 Message 18 of 21 in Discussion 
From: JoelSent: 11/21/2007 1:16 AM
From: John (Gold)  (Original Message) Sent: 11/20/2007 4:13 PM

Early Communication About an Ongoing Safety Review
Varenicline (marketed as Chantix)

This information reflects FDA’s current analysis of available data concerning these drugs. Posting this information does not mean that FDA has concluded there is a causal relationship between the drug products and the emerging safety issue.  Nor does it mean that FDA is advising health care professionals to discontinue prescribing these products. FDA is considering, but has not reached a conclusion about whether this information warrants any regulatory action. FDA intends to update this document when additional information or analyses become available.


FDA has received reports of suicidal thoughts and aggressive and erratic behavior in patients who have taken Chantix, a smoking cessation product.

Suicidal Thoughts

The manufacturer of Chantix, Pfizer, Inc., recently submitted to FDA postmarketing cases describing suicidal ideation and occasional suicidal behavior.  FDA currently is reviewing these cases, along with a number of recent reports in the popular press and internet sites.  A preliminary assessment reveals that many of the cases reflect new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment.  The role of Chantix in these cases is not clear because smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illness.  However, not all patients described in these cases had pre-existing psychiatric illness and not all had discontinued smoking.

Aggressive and Erratic Behavior

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.

Drowsiness

FDA is evaluating reports from Pfizer of drowsiness in patients taking Chantix.  Reports described patients who experienced drowsiness that affected their ability to drive or operate machinery.

FDA recommends the following:
  • Healthcare professionals should monitor patients taking Chantix for behavior and mood changes.
  • Patients taking Chantix should contact their doctors if they experience behavior or mood changes.
  • Patients should use caution when driving or operating machinery until they know how quitting smoking with Chantix may affect them.

This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs.  FDA is working with Pfizer, Inc., to further evaluate the potential association between Chantix and suicidal thoughts, aggressive and erratic behavior, and impairment that affects one’s ability to drive or operate machinery.  FDA is working to complete the analysis of the materials submitted by Pfizer.  As soon as this analysis is completed, FDA will communicate its conclusions and recommendations to the public.

The FDA urges both healthcare professionals and patients to report side effects from the use of Chantix to the FDA's MedWatch Adverse Event Reporting program 

Source: http://www.fda.gov/cder/drug/early_comm/varenicline.htm

 

Title Dial Up High speed Audio Length Added
 WhyQuit's candid views about Chantix (and Champix)  17.8mb  53.3mb  7.11mb  48:16  10/19/07

 


Reply
 Message 19 of 21 in Discussion 
From: JoelSent: 4/1/2008 7:00 PM
From: John (Gold)  (Original Message) Sent: 4/1/2008 11:24 AM

New Safety Warnings about Chantix (Video, print, and e-mail functions)
Windows Media Closed CaptionedRealPlayer Closed CaptionedWindows Media Cable/DSLRealPlayer Cable/DSLMPEG Download. (Right-click and pick 'Save Target As' to save to disk.)Print StoryE-mail Story

FDA is alerting healthcare professionals about new safety warnings for Chantix (varenicline), a drug used to help people stop smoking.

Chantix has been linked to serious neuropsychiatric problems, including changes in behavior, agitation, depressed mood, suicidal ideation and suicide. The drug can cause an existing psychiatric illness to worsen, or an old psychiatric illness to recur. The symptoms can occur even after the drug is discontinued.

People who are trying to give up smoking often experience mood swings, irritability and other changes in behavior. But as the reports accumulate, it becomes clearer that there is a link with the drug. For example, some of the patients who experienced these psychiatric symptoms hadn't actually quit smoking.

Physicians and patients have to make an informed decision about whether Chantix is suitable, but in order to do that, it's important that they exchange some important information. For example, physicians should inquire about past psychiatric illnesses before they prescribe Chantix, and patients should be educated to volunteer this information. The premarketing studies of Chantix did not include patients with serious psychiatric illnesses, so the safety of Chantix in these patients hasn't been established.

It is also important for everyone involved in the patient's care (including family members and caregivers) to be vigilant about changes in mood and behavior during the treatment. Things to watch out for include anxiety, nervousness, depressed mood, vivid or unusual dreams, and thinking about or attempting suicide. These changes should be immediately reported to the physician.

Patients should also know that the drug can impair their ability to drive or operate heavy machinery.

To help educate patients about all of these issues, FDA is working with Pfizer, the manufacturer of Chantix, to develop a Medication Guide that will be dispensed with each prescription.

Additional Information:

FDA MedWatch Safety Alert. Varenicline (marketed as Chantix). February 1, 2008.
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Varenicline

FDA Press Release. FDA Issues Public Health Advisory on Chantix. February 1, 2008.
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01788.html


Reply
 Message 20 of 21 in Discussion 
From: JoelSent: 4/3/2008 10:27 PM

FDA pulls video clip
admitting Chantix suicide link

Click this link to watch a 4/1/08 FDA video clip discussing Chantix risk factorsOn Tuesday FDA Patient Safety News released a video clip sharing safety warnings about "serious neuropsychiatric problems" in users of Pfizer's quit smoking pill Chantix, including suicide. Featured yesterday in a WhyQuit article exploring concerns raised by the video, this morning FDA site links to the clip were no longer functional.

The FDA has yet to respond to inquiry as to why the video clip was pulled and whether or not Pfizer played any role in the FDA's decision to do so.

A copy of the pulled FDA Chantix clip is being made available for viewing at WhyQuit. WhyQuit shares this clip based upon the FDA's Patient Safety News website assertion that, "FDA Patient Safety News is a product of the US Federal Government, and as such is NOT copyrighted or restricted in any way. We encourage the further use and distribution of the video or text of the program by anyone ?either in its entirety or as individual stories."

In a separate development, it's reported that Public Citizen, a non-profit Washington based consumer protection watchdog, has called upon the FDA to require a "black box" warning label for Chantix due to suicide and other behavioral risk factors. Reserved for drugs linked to serious or life-threatening adverse events, a "black box" warning is the strongest warning the FDA can mandate.

XXX



Reply
 Message 21 of 21 in Discussion 
From: JoelSent: 5/21/2008 11:50 PM
| and 7mb audio only format, length 48 minutes, recorded 10/19/07 by Joel Spitzer
  • Flawed research equates placebo to cold turkey - John R. Polito, 03/07
  • Nicotine Fix - Behind Antismoking Policy, Influence of Drug Industry - Kevin Helliker, 02/07
  • Evidence of Collusion: Pharma-Govt Smoking Guidelines - AHRP, 02/07
  • WSJ Highlights Financial Conflicts of Chair of Federal Guidelines Panel - Michael Siegel, MD 02/07
  • Nixing the Patch: Smokers quit cold turkey - Ken Millstone, 02/07
  • New Study Challenges Thinking on Use of NRT During Pregnancy - Michael Siegel, MD, 02/07
  • Nicotine for the Fetus, the Infant and Adolescent - H.K. Ginzel, MD, 02/07
  • The secret to quitting smoking - John R. Polito, 01/07
  • Financial Ties Between Guideline Panels and Big Pharma Run Deep - Michael Siegel, MD, 01/07
  • Chantix - an 8 in 10 failure rate or worse? - John R. Polito, 12/06
  • Do physician's have a legal duty to ignore Guideline Recommendation 7? - John R. Polito, 12/06
  • Chantix likely as ineffective as NRT - John R. Polito, 11/06
  • Is the U.S. government's quitting policy killing smokers? - John R. Polito, 10/06
  • Will Chantix really help me quit smoking? - John R. Polito, 08/06
  • It's unlikely this NRT study was blind - John R. Polito, 08/06
  • Conference Sponsorship by Pharma Precludes Objective Symposium - Michael Siegel, MD 07/06
  • 13th World Conference on Tobacco or Health Drenched in Nicotine - John R. Polito, 07/06
  • Cold Turkey Twice as Effective as NRT or Zyban - John R. Polito, 05/06
  • Nicotine Not Medicine, Its Use Not Therapy - John R. Polito, 04/06
  • How to use behavorial findings to sell NRT - John R. Polito, 01/06
  • GlaxoSmithKline Attacks Cold Turkey Quitting - John R. Polito, 12/05
  • UK Guidance for NRT use in pregnancy and by children - ASH London, 12/05
  • June 2000 Guideline Chairman Michael Fiore's Testimony - see PDF pages 14 & 15, 05/05
  • The Nicotine Patch, Gum and Lozenge - Mounting Evidence of a Sham - John R. Polito, 04/05
  • 40 Years of Progress? - Joel Spitzer, 10/04
  • Widespread Blinding Failures Put NRT Studies in Serious Question - John R. Polito, 06/04
  • Nicotine Gum Maker's Concern Raises Concerns - John R. Polito, 05/04
  • A Quitter's Dilemma: Hooked on the Cure - New York Times, 05/04
  • Quebec CT Quitters Disprove "Double Your Chances" NRT Assertion - John R. Polito, 04/04
  • Are nicotine weaning products a bad joke? - John R. Polito, 10/03
  • Is CT Quitting More Productive & Effective than NRT? - John R. Polito, 07/03
  • Are Teens Getting Hooked on NRT? - John R. Polito, 06/03
  • March 2003 OTC NRT Meta-Analysis Finds 93% Midyear Relapse Rate - John R. Polito, 03/03
  • Quitting Methods - Who to Believe? - Joel Spitzer, 2003
  • JAMA Study Concludes NRT is Ineffective - John R. Polito, 09/02
  • Real-World Nicotine Patch and Gum Rates - John R. Polito, 06/02
  • Does the OTC Nicotine Patch Really Double Your Chances of Quitting? - John R. Polito, 04/02
  • Is Nicotine Replacement Therapy The Smoker's Last Best Hope? - John R. Polito, 11/00
  • Financial Disclosures for June 2000 Guideline Panel - U.S. Public Health Service, 06/00
  • June 2000 Guideline Recommendation 7 - pharmacotherapy use by all quitters - 06/00
  • </TABLE>



    Chantix blamed for 3,063
    serious injuries and 78 deaths

    May 21, 2008

    A study released today examined 6,363 U.S. Food and Drug Administration (FDA) adverse drug reaction reports implicating Pfizer's quit smoking pill Chantix (varenicline) and found that 3,063 involved serious injuries. Its recommendation? "We recommend that patients and doctors exercise caution in the use of varenicline and consider the use of alternative approaches to smoking cessation."

    Authored by The Institute for Safe Medication Practices (ISMP), a non-profit medication watchdog, ISMP looks for safety flags while monitoring all adverse events reported to the FDA for all medications.

    ISMP monitoring noted that "by the 3rd quarter of 2007 varenicline produced a signal not previously seen for any other drug. It produced more serious reports than any other drug for multiple types of events: more potential cases of angioedema, cardiac arrhythmia, diabetes and severe cutaneous injury. By the 4th quarter of 2007 varenicline accounted for more reports of serious drug adverse events in the United States than any other drug."

    During the 4th quarter of 2007 the FDA received 998 reports of serious varenicline adverse events compared to only 372 for the addictive troublemaker oxycodone, a potent medication for relief of moderate to severe pain. While ISMP estimates that a total of 3.5 million Chantix (varenicline) prescriptions were written in the U.S. since FDA approval in May 2006, government estimates place annual oxycodone prescriptions written at more than 7 million.

    The study found that while the FDA has issued warnings regarding Chantix's link to suicidal acts, thoughts or behaviors, psychosis, hostility and aggression, it has ignored "other kinds of serious harm for which no warnings now exist, either from the FDA or from the manufacturer, Pfizer Inc."

    While the FDA received 78 death reports in which "varenicline was the principal suspect drug," only 28 resulted from suicide. There were "numerous reports suggesting cardiac causes, both thromboembolic and arrhythmic," writes ISMP.

    Among reports of serious events were 173 accidents and injuries, 338 angioedemas, 224 cardiac arrhythmias, 86 convulsions, 139 embolic and thrombotic events, 372 extrapyramidal syndromes, 544 cases of hyperglycemia/new onset diabetes mellitus, 525 reports of hostility/aggression, 397 psychosis and psychotic disorders, 227 reports of suicide/self-injury, 65 severe cutaneous adverse reactions, and 148 vision disturbances.

    Could there possibly be a common thread among such a diverse group of disorders? Yes, says the ISMP study. A subtype of acetylcholine receptor known as alpha 4 beta 2 plays "numerous roles in the brain and body and is central to muscle contractions -- both voluntary movement and heart muscle contractions, as well as the tone of the smooth muscles that line the blood vessels."

    According to the study, Pfizer researchers found that varenicline was most active against alpha 4 beta 2 type acetylcholine receptors. They focused on the fact that it caused the release of dopamine within the brain while blocking nicotine from occupying alpha 4 beta 2 receptors. It notes that "many antipsychotic drugs block dopamine receptors, but they also cause movement disorders. The loss of muscle control seen in Parkinson's disease is the result of the destruction of dopamine-producing cells in the brain."

    The gravity and number of serious injuries attributed to Chantix caused the report to lightly touch on an equally pressing risk analysis concern, the value of Chantix in helping smokers quit. While noting that counseling rich varenicline clinical trials produced 52-week quit rates of approximately 22 percent, it cites two early nicotine gum studies while noting that they achieved comparable rates.

    In fact, a 1976 nicotine gum study headed by Russell found that 23% of nicotine gum users were still not smoking at 1 year. The 1980 nicotine gum study by Raw produced a whopping 38% rate, in 1982 Jarvis found a 31% rate, in 1983 Schneider 30%, in 1984 Hialmarson 29%, in 1986 Daughton 31%, in 1987 Kornitzer 32%, and in 1989 Tonnesen boasted a 44% one year quit smoking rate.

    What wasn't mentioned in the ISMP study was that in real-world competition, outside of clinical trials that were rich in support and counseling, nearly all quitting method surveys to date show that, long-term, cold turkey quitters actually perform better than users of nicotine gum, patch, lozenge and Zyban.

    A 2006 National Cancer Institute quitting method survey of 8,200 smokers found that at 9 months 16% of "on your own" quitters were still not smoking compared to just 14% among quitters relying upon the nicotine patch, gum, lozenge or Zyban.

    While ISMP faults the FDA for neglect in warning Chantix users about risks other than mental and emotional, just as culpable is its approval of Pfizer's clinical trial design when: (1) they involved a record number of provider counseling/support contacts (twenty-five), contacts the FDA knows could account for nearly all effectiveness seen; (2) no assessments to test study blinding was requested or conducted, when the FDA knows that it is probably impossible to blind drug addiction studies, as smokers with any quitting history recognize the onset of full-blown nicotine withdrawal; (3) excluded 28% of study applicants, including nearly all having any significant medical condition, and then permitted Pfizer to market Chantix to groups intentionally excluded; and (4) allowed NRT use between the end of treatment and week 52, and then certified ongoing NRT users as having been successful Chantix quitters.

    If Pfizer knows, via real-world quitting data gathered through its www.GetQuit.com website, that Chantix's real-world effectiveness is substantially less than shown in clinical trials, with Chantix injuries so numerous and serious, does Pfizer have both legal and ethical duties to immediately share that data with both the FDA and smokers considering using Chantix?

    If Chantix isn't living up to Pfizer marketing hype, do reports like this ISMP study obligate Pfizer to be more forthright, honest and clear about both varenicline's safety and effectiveness?

    "These data provide a strong signal that the risks of varenicline treatment have been underestimated, and show that a wide spectrum of serious injuries are being reported in large numbers," ISMP warns.

    "Table 1 shows that in the 4th quarter of 2007, the other highest ranked drugs (e.g. fentanyl, interferon beta, etanercept) are all high alert drugs with black box warnings, are intended for serious illness in patients and have benefits that are accompanied by substantial risks. In comparison, varenicline is intended for use in healthy people to help stop smoking."

    Does it make sense, if inside a very slow burning building, to pay money for the right to use the most dangerous exist path out?

    Never in the history of smoking cessation has any quitting product harmed so many. It makes one wonder whether instead of helping smokers the FDA and Pfizer have declared war upon them.

    XXX

    No Copyright - This Article is Public Domain

    John R. Polito is solely responsible for the content of this article.
    Any factual error will be immediately corrected upon receipt of credible authority
    in support of the writer's contention. E-mail comments to john@whyquit.com



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