March 11, 2009

JAMA Article Critical Of Chantix

I've not written much about Chantix since last year, simply because the noise around Pfizer's stop-smoking pill had seemed to die down after oodles of reports of suicide, suicidality and odd behavior connected to the drug. Now, JAMA has a news article out on the drug and its problems, and the fact that it appeared in JAMA is significant. It's one of two medical journals that almost every doctor in America reads (at some point) and it's not usually too harsh on meds (in my experience at any rate). The other is the New England Journal of Medicine.

"Emerging evidence suggests the smoking-cessation drug varenicline (Chantix/Champix) is among a growing list of medications that might cause serious psychiatric adverse events....

"The latest findings emphasize the importance of physicians monitoring pa-
tients taking varenicline for such adverse events. They also raise questions about how well new drugs are being screened for unwanted psychiatric effects. Continued reports of crashes and other serious adverse events among patients taking this drug also have raised concerns about other possible risks."

That kind of language in JAMA will hopefully mean something to physicians who prescribe the drug and encourage a high degree of caution. It's especially nice to see this in the journal since I have been waving red flags about this drug since September 2007, when reports began surfacing of troubling reactions to the drug.

I've speculated on a few occasions that bad reactions to the drug seemed to mostly crop up in people who had some kind of psychiatric diagnosis history (especially depression) or who had had awful reactions to anti-depressants. I was about half right.

"Half of the patients reporting either suicide ideation or suicidal behavior had a history of psychiatric problems, 26 percent had no such history, and 24 percent had an unknown psychiatric history."

I'm surprised that so many people taking this drug had no psych history and yet ran into big problems. That ought to tell you--and doctors--just how tricky a drug this is. The article also notes that bupropion (Wellbutrin, Zyban) also has plenty of problems as well.

If you think I am exaggerating, go skim through the FDA's adverse events database on Chantix through the FDAble.com site. There are 8,290 adverse events reports through September 2008. That's a ton for a drug that first hit the market in 2006.

You can also read the FDA's drug safety newsletter on the two drugs here (pdf).

Posted by Philip Dawdy at March 11, 2009 12:03 AM
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Comments

Chantix is a scary drug. The 8,000+ adverse reactions in two years is about the same [actually a little less] as Prozac received when it was first marketed - that is 35,000+ in 7 years on the market.

Here is some data [copy & past of part of the story] on the antidepressant Wellbutrin {Zyban for smoking}. It is a scary drug also.

Go to this site for the full story.

http://www.ssristories.com/show.php?item=950

Paragraphs 10 and 11 read: "Debby Painter and I have since requested certain FDA documents through the “Freedom of Information It’s OK For You to Have Act”. We eventually received the FDA’s MedWatch data on Wellbutrin from 11/01/97 through some unspecified time up until February 2003 (the date on the attached letter). The FDA makes every attempt to avoid being specific. They also chose not to specify which formulations of Wellbutrin these reports referred to. The report I received listed 37,822 total adverse reactions and “total death outcomes” were 468, which I’m assuming included my personal favorite: 16 reports of “pulse absent”. There were 202 reports of “completed suicide” and 152 suicide attempts listed as such, although others were given more euphemistic designations like the 216 “non-accidental” overdoses. Other unusual adverse reactions were “murderer (2 reports), “rapist”, “incest” and “divorce”.

Paragraph 12 reads: "Debby and I also eventually received very abbreviated and much redacted copies of portions of the NDAs (New Drug Applications) for all Wellbutrin formulations, the last one arriving over a year after the FDA received the request. The Wellbutrin IR (immediate release) NDA documented 14 deaths, including 9 suicides, in the initial clinical trials12. There were also 14 suicide attempts. Glaxo reported to the FDA that these “adverse events” were “not attributable to the study drug” and that was good enough for the FDA. Somehow these “events”, or what is known in English as “deaths”, never appeared in the Product Information Guides (PIGs) or the PDR (Physician’s Desk Reference) under “warnings and precautions” or “adverse reactions” which is supposed to include ALL ADVERSE EVENTS OBSERVED during clinical trials, not just those that the company decides that it’s OK for us to know about. However, being masters in the art of covering their corporate butt, Glaxo nonchalantly tossed this disclaimer into the PIG: “all treatment emergent adverse events are included except...those events not reasonably associated with the use of the drug...” So, you have 23 non-suicidal people (suicidal people were excluded from participating in these antidepressant drug tests) who COINCIDENTALLY take the same experimental drug and COINCIDENTALLY wind up wanting to kill themselves.

http://www.forces.org/evidence/kill/cintorrino.htm
SMOKE AND MIRRORS;
How Glaxo's Zyban can help you stop smoking if you're willing to stop breathing

Imagine going to your family doctor to get a referral for a stress test. Your blood pressure is high and you have some other minor complaints. Your wife’s uncle is a cardiologist and he suggested that this is what you do. Nothing scary about that. Much less terrifying than, say, a rectal exam. Your doctor tells you that you should not get that stress test. They’re dangerous. Instead, you really ought to stop smoking and there is a pill that can get you to do just that. You would later read in your medical records that you were “counseled strongly” to stop smoking although you were “precontemplative” about the whole idea. He hands you a prescription and heads for the door, saying something about leaving for vacation and running late. You take your first pill later that day because it was prescribed by a licensed medical doctor and it’s safety and efficacy has been confirmed by the United States Food and Drug Administration. And everyone knows that smoking is bad for your health. Five weeks later you lose your mind. Later on you start losing control of the rest of your body. And, yeah, you still smoke.

Posted by: Rosie at March 11, 2009 05:50 AM

Philip~

I was a bit surprised, and disappointed, to learn that you more or less expected a correlation between adverse reactions to Chantix and folks with a prior psychiatric history. This default way of thinking is dangerous IMHO and generally tends to cast doubt on the reliability of the people reporting suicide ideation from taking Chantix and other drugs that affect the CNS (ie SSRI’s, Fluroquinolines, and Accutane). After my severe adverse reaction to an SSRI I suffered terribly and one symptom was suicide ideation. I was NOT depressed before starting the SSRI, the SSRI CAUSED the suicide ideation and no one would believe me because I was on an antidepressant…..“ it must be the depression it can’t possibly be the drug”….what a circular cluster fuck! At least people on Chantix will be taken more seriously that I was because they are not stigmatized by the class of drug they are taking.
And what constitutes a history of psychiatric problems? This phrase really should be defined in an article like this. Does it include situational depression, ADD, anxiety? Who decides if the patient has a prior history, the patient? I ask because I was duped into thinking I was clinically depressed 10 years ago after a relationship break-up because I was upset for over two weeks. Does 2 weeks of having depressive symptoms still result with a “clinical depression” diagnosis these days? If it does the concept is beyond ridiculous to me and I believe that it was probably devised by Big Pharma’s brilliant marketing department.

Posted by: Me at March 11, 2009 06:52 AM

I thought the VA testings would wake up some people. Obviously not. I remember the pentagon visited my site the day I posted that ugly, sad story.

In regards to the data and your line, "I'm surprised that so many people taking this drug had no psych history and yet ran into big problems."

I have a personal note (as usual) regarding a dear, dear friend of mine. She is one of the healthiest gals I know. No psych history. Just a little depression after giving birth to her first child in her mid-thirties, it was all situational and I wouldn't call it postpartum depression. Anyway, 3 years after giving birth she wanted to quit smoking, enter Chantix.

After starting the drug, the conversations I had with her TERRIFIED me and I am not easily terrified after years and years of this bullshit. I did not recognize her.

One week into Chantix she experienced extreme agitation, anxiety and depression. Her "lovely" doctor then added Wellbutrin and Buspar for the anxiety and depression and Miraplex (for her restless leg syndrome, oh please) Next thing you know-she was on the edge. I urged her to find a new doctor, wean off the pills and treat the side effects from the multiple pills with acupuncture and supplements. I’m happy to say with the help of acupuncture and supplements she’s doing much better. And she's smoking again but, hell, I would be too. I can tell you this, if she ever comes face-to-face with the jokers behind Chantix-There Will Be Blood.

Posted by: kim at March 11, 2009 11:03 AM

What the JAMA commentary failed to point out (maybe they didn't know this) is that people with a history of mental disorders were EXCLUDED from the pre-release Chantix clinical trials, making it even more potentially dangerous for how it is currently being utilized, i.e. given to everyone.

Posted by: Doug Bremner at March 12, 2009 02:35 PM

There is NO JUSTICE. First the tobacco companies abused us by their lies. Now pharma is doing the same thing. Both are trying their best to kill us in the name of PROFIT for their products. We know most doctors are in it for the money not because they care so much and wish to help their patients. CHANTIX IS POISON! It kills faster then nicotine. No one is even looking into the 150+ MEDICAL side effects. If you have any of those you will not find a lawyer to go after Pfizer. So go ahead take a chance on chantix, if it doesn't kill you ... it will make your family and friends want to because it will bring out the WORST in you. After all that is much better then the few side effects from no nicotine. We all know how stopping nicotine will make you commit suicide or violent acts. No it is not chantix, the FDA really does protects us and the Easter bunny will be here before you know it laying golden eggs and all our worries will be over!

Posted by: Chantix Hater at March 15, 2009 05:49 AM

The reason you thought all the noise had died down surrounding this “new novel drug”, is because Pfizer has spent billions to insure you of these thoughts. Believe me, the ones that have suffered at the hands of this drug is here, still seeking information and answers while the FDA has taken a leave of absence concerning all thing “Chantix”. It is criminal to all who suffered from this drug to the extent in which Pfizer and their teams of smoking cessation “experts” have wrongly accused the patients of being mentally ill before the use of this deadly drug, or the laughable made-up idea that the mental illness was somehow lying in wait. Chantix not only causes suicidal thoughts and what many would call mental illnesses, but it also has causes many extreme health problems and diseases. This problem has been overlooked because Pfizer has had an outrageous campaign promoting all these false facts as they relate to psychiatric illnesses. Because Pfizer has enabled so many Drs and healthcare workers by promoting this drug as one that does nothing but make one quit smoking is itself a crime.

Pfizer knew before the launch date of Chantix the many health problems caused by this “novel drug”. Not convinced? Read the FDA website where Pfizer submitted their trial data to the FDA and was questioned by an FDA examiner to the truthfulness of these trials. No more follow-ups by the FDA to these allegations of trial lies as Pfizer assured the FDA these trials were in fact the truth! To this end, Chantix was launched and then followed with lies.

So yes, you are correct in the fact that you don’t hear anything concerning Chantix openly anymore. That is from the fact that many who has suffered at the hands of Pfizer has been lambasted by pharma paid individuals that revel in others misfortune. Google Chantix and you will find a web that has dominated in hurting many people who have tried to oppose this drug. Even “experts” have joined in on the fun of bashing those that have tried to tell the truth and expose Chantix for the evil that it really is. Why not? No one even cared when these same experts tried to make smoking a disease so insurance would pay for their conflicts of interest.

Most of the people that have suffered the adverse effects of Chantix are here. Many have even died. The ones that survived the ordeal are looking for some hope and some are even defiantly seeking some justice!

Posted by: JohnQ at March 15, 2009 07:39 PM

Chantix and deaths - Why are doctors’, pharmacy’s and the public not educated on the negative
side effects? Why would any health professional prescribe Chantix to anyone with any form of mental illness? Here is why I ask - On September 15, 2008, I found my only child, age 32, dead in her bed. Danielle was totally disabled by mental illnesses for about 12 years. She had been diagnosed with but not limited to, Bi-Polar, Post Traumatic Stress, Severe Depression, self-mutilation and Board Line Personality Disorder. Every day she took a regiment of medications, on time and as prescribed -

Risperdal 1 mg twice a day
Zolpidem 10 mg per day
Doxepin 150 mg per day
Clonazepam 1 mg - twice a day
Depakote Er 500 mg tablets x 3 at bedtime

Neither the ARNP who wrote the script nor the pharmacist who filled the prescription - talked to or told us of any side effects. A day or two before she took her life, she told me that she made a massive headache and had nausea. Because neither of us were told any of the side effects - my only child is dead. I took her to every appointment, pharmacy, etc. as she also had a fear of driving. It was the Sunday after Dani’s death that I saw the commercial “The Tortoise and The Hare.” I called our local Coroner and raised my concerns. He called me back the next day after calling four (4) different labs of which none of them checked for Varenicline. I understand that all branches of our US military have quit dispensing it.

It is my belief and that of my attorney that Chantix was the major contributing factor to her suicide. Topeka, KS does not have a large enough law firm to handle her case on a contingency basis - so we (myself and David, my Attorney & Friend) have an appointment next week with a large firm in Kansas City. I have filed a complaint with the Kansas Board of Healing Arts, against the physician which the state of Kansas assigned to my daughter because she was on SSI. Never did Danielle see or met the doctor, she was treated only by two (2) ARNP's. I have also filed a complaint with the Kansas State Board of Nursing, against the ARNP (Nurse) who wrote the Chantix prescription, knowing full well my daughter's mental history and NOT even mentioning any side effects, to either of us. The Nursing Board told me that it would be at least a year after Dani's death that their investigation could begin. The length of time way TOO LONG as far as I was concerned. So, I talked to my State Senator and to my State Representative - gee - the Nursing Board opened the file and investigation as of this week. The Board of Healing Arts was very easy to work with and the investigation from their office should be complete by the end of this month.

Due to Atrocious Medical Personnel and Pfizer Pharmaceutical, I am a Childless Mother.

In Loving Memory of
My Daughter
Danielle Meredith Schultz
March 7, 1976 to September 15 2008

Posted by: Childless Mother at March 19, 2009 01:06 PM

Dear Childless,
My sincere condolences on your loss. I'm so sorry for Dani.
My best wishes on your suit. I do hope you'll keep us posted. Do watch out for altered medical records. There were many, many lies on mine. Your lawyer can best advise you about those sorts of issue but be prepared to find out what the medical profession is really all about.
Sigh. No one should go through this. You're not alone here.
Sherry (who nearly died, thanks to klonopin combined with medical ineptitude--including failure to test for klonopin in my blood)

Posted by: Sherry at March 19, 2009 02:36 PM

Sorry about all the deaths caused by this, or at least assisted due to Phizer not wanting to make side effects easily available and the FDA for not doing their job. I recommend googling the video "the corporation" and watch the 3 hour one on google. I just recently did and was amazed.


I am in the Military, was just prescribed this 2 weeks ago. I am now on the 11th day. I started reading about side effects the day I started taking it, or the day before. I was really surprised and almost returned my prescription. I have PTSD and am currently being treated by the same hospital that prescribed this for PTSD. They didn't ask any questions other than "Do you Smoke" during my physical so I am now on Chantix. Then I told my PTSD doctor that I was on Chantix and he didn't bat an eye either. Phizer and the FDA really have a huge cover up going on here if the doctors don't even know what the deal is.


Side effects so far: The first day I felt kinda weird, restless I guess but I didn't feel like doing anything so I took a bath. Since then it's been the same everyday. Mood swings, fog headed, I've been in a great mood a few times, others feel like just sleeping in the middle of the day, sometimes feel like I don't know what to do but I'm anxious to do something. Weird stuff. I am still smoking but feel like I could quit anytime I want now. I have strange dreams. Want to sleep a lot and can sleep. Also, don't try to drink a lot on this. I had 3-4 drinks which is 1/2 my normal weekend amount and was completely messed up as if I had drank a 5th of hard liquor. It defeated the dreams though.


I've heard that the hard part isn't taking Chantix and quitting smoking. That's easy. The hard part is the part that Phizer has no interest in mentioning. Coming off the Chantix is when you are really quitting smoking. The Chantix replaces the cigarette. They don't even ween you off Chantix even though they ween you on it. Makes you wonder if they REALLY want you to stop taking Chantix. Also, that is probably why most Chantix users go back to using it. So now instead of being addicted to an RJ Reynolds product you are addicted to Phizer.


Which is better? I don't really know at this point.

Posted by: Joe at March 20, 2009 01:06 AM

I've been on Chantix for three weeks now...not smoking for two of them. Other than some really vivid and weird dreams, I haven't had one problem with it. I, too, wondered about what would happen when the 12 weeks are up and it's time to stop taking the pill, but I'm not concerned. It's helped me stop smoking, something that was doing a lot more harm to my body than these pills will over a short three month period. I'll jump that hurdle when the time comes, and work closely with my doctor if I have any issues.

Honestly, I wish those who just aren't ready to stop smoking or who really don't want to quit would stop laying all sorts of blame to the aids that are given. I would venture to guess that 95% of the complaints on these drugs are made by people who don't have the guts to admit they can't quit or don't want to. The drug becomes the scapegoat for their failings.

Posted by: Dave at March 31, 2009 07:16 PM

Guess again Dave. Ask yourself why the FAA and the DOT has a ban on these drugs. There was no ban on any of the other quit smoking drugs. These are real problems that have been hidden from the public. Since these adverse effects are from a psychotropic drug, the psychotic symptoms have been blamed on the patient. Pharma is really good at blaming the person and not the drug.

Hey, I really hope you survive the ordeal without the mind altering and medical effects. What some people do not realize is that people who are suffering from a drug induced depression or psychosis do not seek help. The patients suffering have no idea as to why they are in such a mind altering state. It is a misguided indulgence to state that these people have not had the guts to quit. Are you already a reformed smoker? Most suffering from this half baked drug have quit and still had psychosis and many medical problems from this wonder drug.

Believe me; Chantix is more dangerous than smoking. There is not that chance of suicide with smoking. Good luck!

Posted by: John Q at April 1, 2009 04:57 PM

I was a smoker, 1 1/2 - 2 packs a day, for 24 years. I had tried to quit with everything, cold turkey, the gum, patch, inhaler..you name it, I tried it. I am PROUD to say that I am now smoke-free for 15 days with Chantix. Although I still have the thoughts of smoking, because of such ingrained habits, I am saying with all honesty, I am not experiencing the physical cravings. I started using it and although I used it for 2 months rather than the 2 weeks suggested before I was ready to quit, I did it. My mother died Feb 24th, 2007 from Emphysema. We suffered along with her for years and when I turned 40, I promised myself I would NEVER put my family or myself through what we went through with my mom. I have a history of depression & anxiety and have been closely monitored while on Chantix & if anyone had an increased chance of mental, emotional, psychological problems with this medication, it would be me or someone like me. It's your choice, but I'll tell you, for me, I would rather take the chance of possible side effects, than continue on a path that WILL shorten my life & possibly put my family in a position to watch me die a progressive, painful death!!! I hope you consider carefully all of your options. I can only say what worked for me and it's working. I know people say this all of the time, but if I am doing it, ANYONE CAN!! 2 months ago, you could never have convinced me that I would really quit. I honestly didn't think I'd ever be able to stop & was kind of resigned to the fact that I was going to die from smoking related disease(s). But I'm doing it, so can you.

Posted by: Allison DiSalvo at April 3, 2009 11:28 AM

About a year ago my e-mail was bombarded by giddy claims from smokers who stopped smoking using Chantix. An addited smoker myself I decided I would try this new drug. My physician gave me a prescription no questions asked. I do not drink but I do take an anti anxiety medicine. My experience was positive as I could go many hours without thinking about a smoke but Chantix does not make you forget your a smoker. The drug is expensive and not covered by my insurance so I never refilled it. On a follow up visit six weeks later my doctor told me to stop taking Chantix as he was not sure how it would react with my Paxil. Unfortunatly I am still smoking. I can attest to the depression releted to my attempts to quit smoking but never to the point of suicidal thoughts. I seemed doomed to suffer the same fate as my father who died from empysema.

Posted by: michael at July 7, 2009 05:56 AM

I have had some strange experiences after having used chantix and quit taking it. I stopped taking it initialy because it made me feel so gross. I probably took it for about 3 wks. My real question is this: Even after quitting chantix could there be some part of it lying dormant in a body that the use of alcohol could trigger a bizzare ocurrance? Sounds stupid, I know. But I am a weekend social drinker. More than social. Five or 6 beers. I'm not talking blackout here, rather, after I'm already asleep I have had a couple of sleepwalking experiences, which were never a problem before. I would be reluctant to discuss this with an MD as I feel like A. obviously they don't know enough about this drug as it is and B. I feel like I would be made to feel like I was a drunk looking for something to hide behind. Just wanted to know if anyone else has had anything similar.

Posted by: Sarah at July 13, 2009 10:30 AM

In response to this comment of 31st March:
"Honestly, I wish those who just aren't ready to stop smoking or who really don't want to quit would stop laying all sorts of blame to the aids that are given. I would venture to guess that 95% of the complaints on these drugs are made by people who don't have the guts to admit they can't quit or don't want to. The drug becomes the scapegoat for their failings."

I used Champix, quit smoking 8 days later, quit Champix after another 9 days because of the side effects, and I am now another 8 days further and I still don't smoke, and feel I will never again smoke in my life.

I tried to quit many times over the past few years, but I have never felt so sure about myself as this time. The feeling became stronger and stronger the first week I used Champix, and remained with me after I quit Champix.

Is Champix a wonderdrug? To quit smoking - yes. Do doctors know too little about it? Yes!
Would I take it again? I am not so sure, but at least I would like my doctor to tell me a bit more about it next time...

I was feeling really nauseous from day one onwards and sleepy too. But after about 15 days of taking the pills I got "more serious" side effects: my heart was beating in my throat, chest pain, higher blood pressure, hyperventilation and, to top it off, an anxiety attack.

When all these symptoms did not go away I decided (after asking my doctor whether it wouldn't be a problem) to quit the pills immedeately. I went back from 2 x 1 mg a day to 0mg.

Even after 48 hours the side effects remained. My doctors said my problems could be caused by work related stress and I might want to learn about hyperventilating and dealing with stress... This made me a bit pissed off: the pain and other stuff was triggered by Champix, and I wasn't stressed before... so how could I suddenly suffer from a "burn-out"? I never had pain on my chest in my life, nor any anxiety attacks or hyperventilating...

It's a week later now and I have been on the verge of hyperventilating and crying ever since. In fact I feel worse than last week. I feel tension in my arms and tingeling in my finger tips. My muscles are incredibly tense. I cannot concentrate for longer than 3 minutes on my work. This is constant. Emotions and crying come and go in waves that I have no control over. I was sitting behind my laptop this morning and suddenly started crying.

In short: from a happy healthy 30 y.old woman, I now turned into a mess. I hope it is "just" the side-effects of quitting Champix so radically and that I am back to normal next week.

However, I think it is important to let the world know that Champix is a far more dangerous drug than the doctors in my country (Netherlands) seem to know. (And from what I read here, in other countries too.) When I asked (having heard negative stories about Zyban) what the difference was between Champix and Zyban and whether Ch. was not an anti-depressan my GP basically said: "No it is not really an anti-depressant." And he maintained that it was not so heavy on side effects as Zyban! The "not really"should have triggered my critical reflection... but I so much wanted to quit smoking that I was pretty happy with the answer at the time.

Also in NL there is no warning on the box that it might affect your driving skills, or that you should not take it with alcohol, as with any other anti-depressant... The GPs who prescibe it basically do not know more than what I can read myself on the Pfizer page and on the paper included in the box... I hope they will soon tune in with the discussion around the topic that seems to be alive in Canada and USA. I will help my own GP with that for sure.

And for the record: I did quit smoking...

Posted by: Sanne at October 6, 2009 04:49 PM
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