RE:Original Chantix thread from AskJoel
(Date Posted:11/17/2008 13:02 PM)
Chantix and Champix
This year varenicline (Chantix
) 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:
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.K. Medicines and Healthcare Products Regulatory Agency
Australian Therapeutic Goods Administration
Canadian Adverse Drug Reaction Monitoring Program
|From: Joel||Sent: 9/10/2007 8:39 PM|
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:
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.
|From: Joel||Sent: 10/6/2007 8:16 AM|
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:
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.
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RE:Original Chantix thread from AskJoel
(Date Posted:11/17/2008 13:04 PM)
|From: Joel||Sent: 11/20/2007 7:16 PM|
|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.
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.
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
|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|
|From: Joel||Sent: 4/1/2008 1:00 PM|
|From: John (Gold) (Original Message)||Sent: 4/1/2008 11:24 AM|
|New Safety Warnings about Chantix|
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.
FDA MedWatch Safety Alert. Varenicline (marketed as Chantix). February 1, 2008.
FDA Press Release. FDA Issues Public Health Advisory on Chantix. February 1, 2008.
|From: Joel||Sent: 4/3/2008 4:27 PM|
FDA pulls video clip
admitting Chantix suicide link
On 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.
No Copyright - This Article is Public Domain.
Last updated April 3, 2008 at 16:18 EST
Previous WhyQuit Varenicline Articles
| and 7mb audio only format, length 48 minutes, recorded 10/19/07 by Joel SpitzerFlawed research equates placebo to cold turkey - John R. Polito, 03/07Nicotine Fix - Behind Antismoking Policy, Influence of Drug Industry - Kevin Helliker, 02/07Evidence of Collusion: Pharma-Govt Smoking Guidelines - AHRP, 02/07WSJ Highlights Financial Conflicts of Chair of Federal Guidelines Panel - Michael Siegel, MD 02/07Nixing the Patch: Smokers quit cold turkey - Ken Millstone, 02/07New Study Challenges Thinking on Use of NRT During Pregnancy - Michael Siegel, MD, 02/07Nicotine for the Fetus, the Infant and Adolescent - H.K. Ginzel, MD, 02/07The secret to quitting smoking - John R. Polito, 01/07Financial Ties Between Guideline Panels and Big Pharma Run Deep - Michael Siegel, MD, 01/07Chantix - an 8 in 10 failure rate or worse? - John R. Polito, 12/06Do physician's have a legal duty to ignore Guideline Recommendation 7? - John R. Polito, 12/06Chantix likely as ineffective as NRT - John R. Polito, 11/06Is the U.S. government's quitting policy killing smokers? - John R. Polito, 10/06Will Chantix really help me quit smoking? - John R. Polito, 08/06It's unlikely this NRT study was blind - John R. Polito, 08/06Conference Sponsorship by Pharma Precludes Objective Symposium - Michael Siegel, MD 07/0613th World Conference on Tobacco or Health Drenched in Nicotine - John R. Polito, 07/06Cold Turkey Twice as Effective as NRT or Zyban - John R. Polito, 05/06Nicotine Not Medicine, Its Use Not Therapy - John R. Polito, 04/06How to use behavorial findings to sell NRT - John R. Polito, 01/06GlaxoSmithKline Attacks Cold Turkey Quitting - John R. Polito, 12/05UK Guidance for NRT use in pregnancy and by children - ASH London, 12/05June 2000 Guideline Chairman Michael Fiore's Testimony - see PDF pages 14 & 15, 05/05The Nicotine Patch, Gum and Lozenge - Mounting Evidence of a Sham - John R. Polito, 04/0540 Years of Progress? - Joel Spitzer, 10/04Widespread Blinding Failures Put NRT Studies in Serious Question - John R. Polito, 06/04Nicotine Gum Maker's Concern Raises Concerns - John R. Polito, 05/04A Quitter's Dilemma: Hooked on the Cure - New York Times, 05/04Quebec CT Quitters Disprove "Double Your Chances" NRT Assertion - John R. Polito, 04/04Are nicotine weaning products a bad joke? - John R. Polito, 10/03Is CT Quitting More Productive & Effective than NRT? - John R. Polito, 07/03Are Teens Getting Hooked on NRT? - John R. Polito, 06/03March 2003 OTC NRT Meta-Analysis Finds 93% Midyear Relapse Rate - John R. Polito, 03/03Quitting Methods - Who to Believe? - Joel Spitzer, 2003JAMA Study Concludes NRT is Ineffective - John R. Polito, 09/02Real-World Nicotine Patch and Gum Rates - John R. Polito, 06/02Does the OTC Nicotine Patch Really Double Your Chances of Quitting? - John R. Polito, 04/02Is Nicotine Replacement Therapy The Smoker's Last Best Hope? - John R. Polito, 11/00Financial Disclosures for June 2000 Guideline Panel - U.S. Public Health Service, 06/00June 2000 Guideline Recommendation 7 - pharmacotherapy use by all quitters - 06/00
|From: Joel||Sent: 5/21/2008 5:50 PM|
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