Smoked: Chantix May Cause Many Serious Problems
30 CommentsBy Ed Silverman // May 21st, 2008 // 6:04 pm
The smoking-cessation drug has generated headlines over links to suicide, but the Pfizer pill is now being tied to other serious adverse events reported to the FDA, according to a study published in Drug & Therapeutics Bulletin. And the authors urge the FDA and Pfizer to conduct epidemiological studies to assess further risks and to issue new warnings. Wall Street, meanwhile, is worried the study will cause Chantix sales to go up in smoke.
Chantix is suspected of causing a “wide spectrum of injuries,” including serious accidents and falls, potentially lethal cardiac rhythm disturbances, severe skin reactions, acute myocardial infarction, seizures, diabetess, psychosis, aggression and suicide, the authors write. The findings prompted the Federal Aviation Adminstration to ban pilots and air traffic controllers from using the drug.
In last year’s fourth quarter, Chantix accounted for 988 serious injuries in the US reported to the FDA, more than any other individual drug in this time period. By comparison, the FDA received a median of five reports of serious injury for 769 different drugs. Only 35 drugs accounted for 100 or more reports, according to the study, which was conducted by the Institute for Safe Medication Practices.
The FDA recently issued a Public Health Advisory noting suicidal ideation, and attempted and completed suicide, but there were no numbers of reported psychiatric events among treated smokers, the authors note. From May 2006 through December 2007, the FDA received 227 reports of suicidal acts, thoughts or behaviors, 397 cases of possible psychosis and 525 reports of hostility or aggression. These included 28 cases of suicide and 41 mentions of homicidal ideation, 60 cases of paranoia and 55 cases of hallucination. The categories weren’t mutually exclusive.
However, the adverse event reports describe other kinds of serious harm for which no warnings now exist, either from the FDA or Pfizer. These include accidents and injuries; vision disturbance; heart rhythm disturbances; seizures and abnormal muscle spasms or movements; moderate to severe skin reactions and diabetes, according to the authors. (Here is the summary).
“We have immediate safety concerns (about people taking Chantix while) operating aircraft, trains, buses and other vehicles, or in other settings where a lapse in alertness or motor control could lead to massive, serious injury.” They also cite nuclear power reactors, high-rise construction cranes or life-sustaining medical devices.
“The extent to which Chantix has already contributed to accidental death and injury has not yet been investigated because these adverse effects had not been previously reported,” they write. “We urge the FDA and the manufacturer to provide warnings to doctors and patients for those adverse effects that can be adequately documented through existing data, and to undertake on a priority basis epidemiological studies or other research to assess other potential risks.”
A Pfizer spokesman sends us this statement: “We closely monitor post-marketing reports of adverse events that we receive for our medicines as part of our commitment to accurately reflect each product’s efficacy and safety profile in labeling. Pfizer reports all such events to the FDA and other regulatory agencies and communicates safety information to physicians and patients in a variety of ways including through labeling and educational materials.
“Based on Pfizer and the FDA’s continuous review of all available safety information, including adverse event reports received to date, the current Chantix label accurately reflects the product’s efficacy and safety profile. For example, the current label includes safety information pertaining to certain serious neuropsychiatric symptoms, as well as driving and operating machinery.
“We understand that the Institute for Safe Medication Practices report was based solely on a review of post-marketing adverse event reporting data. It is important to understand the limitations of spontaneous adverse event reporting. Often these reports lack sufficient medical information and/or have confounding factors that prevent a meaningful assessment of causality.”
Meanwhile, Sid Wolfe of Public Citizen also issued a statement saying the large number of adverse reactions “adds new urgency to our previous safety concerns about Chantix. It also highlights the dangerous inadequacy of the response of Pfizer and the FDA to the rapidly increasing number of serious, life-threatening adverse events seen with this drug.”
He goes on to reiterate concerns he expressed last year in which he cited an “inadequate amount of information” about psychiatric adverse events that occurred in the randomized trials preceding Chantix approval. In one of the studies, 6.8 percent of patients using Chantix had psychiatric adverse events as opposed to only 2.4 percent of those given a placebo, Wolfe says.
The study prompted Tim Anderson, an analyst at Sanford Bernstein, to issue this note: “In the current safety-conscious environment, where will this lead to next? With the recently updated Chantix label (includes a bolded warning, but not a Black Box warning) it is unclear whether additional regulatory action will be taken.
“What is clearer, however, is that consensus forecasts for Chantix appear to be too high given current prescription trends. The most recent weekly prescription figures show that new prescriptions for Chantix are declining by nearly 30 percent year-over-year. This compares to consensus forecasts that have Chantix growing in 2008 and beyond. On the current trajectory, consensus sales forecasts for Chantix could be too high by as much as $500 million to $1 billion by 2012.
“Our estimates have been too high as well – given prescription trends we are lowering our sales forecasts for the product. Our 2008 worldwide Chantix sales forecast drops from $1.14 billion to $909 million; our 2012 forecast drops from $1.65 billion to $720 million.”
Laurie
“We understand that the Institute for Safe Medication Practices report was based solely on a review of post-marketing adverse event reporting data. It is important to understand the limitations of spontaneous adverse event reporting. Often these reports lack sufficient medical information and/or have confounding factors that prevent a meaningful assessment of causality.”
Once again…..lets deny the reporting of adverse events by those who actually HAD the adverse event, even if the possibility of that adverse event is LISTED in the literature in bold lettering.
The irony is amazing!
Ted
Stop picking on Pfizer & Chantix, let’s get back to talking about ENHANCE!
Matt
Hey, smoking causes “Many Serious Problems”, as well.
Jane
Matt “Hey, smoking causes “Many Serious Problems”, as well.”
So why compound those “many serious problems” by taking this drug?
Vince
According to an article in todays NYT the FAA has banned pilots and air traffic controllers from using this product.
Ed Silverman
Hi Vince,
Yes, thanks, that’s noted in the second graph of the post. But I appreciate that you took the trouble to write in.
Regards
ed
Atlex
Ed,
To put the FAA issue in perspective, how many other drugs are banned for use in pilots? I seem to remember that the more sedating antihistamines (eg, Benadryl) are restricted or banned. There must be others, yes?
Atlex
Alan
Big Tobacco must be loving this. Anyone stopped for just a moment to consider that they may be driving this issue with Chantix since it poses a threat to their weakened profits? I can imagine the rash of negative responses I get to even mentioning this, but think about it. Who gains from this the most? None of the information is new that is being reported. Makes you wonder…
And to answer Atlex, there is a laundry list of drugs the FAA bans.
Stacie
What is disturbing to me is that who knows how many of the people that actually committed suicide by using Chantix and their suicide was just wrote off as something else. I have been personally effected by this drug. I seen this drug take someone I love with all of my heart and turn them into a totally different person. I was lucky my sister didn’t succeed in her attempt to take her life. We have been given a gift. I plan on letting everyone I know about this drug and it’s adverse effects. It’s time for these drug companies to start being held accountable for their actions and their lack of thorough testing just so they can hurry and start turning a profit. I hope none of you have to go through what my family has.
Best Regards,
Stacie
Pharma Giles
I’ve been trying so hard to give up taking Chantix. I know it’s bad for my health but I just can’t help myself. Then I discovered cigarettes. I now smoke 20 a day and haven’t touched a Chantix for weeks.
Cigarettes. Better for your health than Chantix. I recommend them…
Carole
This is very important information to have considering I have had some of these severe reactions that please take note “IS NOT IN THE INFORMATION BOOKLET”. And many doctors didn’t know that many side affects existed while taking this drug. I took it for 3 1/2 months and now no longer taking it for I was very sick from it. Please PLease take this info serious. Smokes can kill you yes but not as fast as this drug could put you very close to death as well.
Laurie
“Cigarettes. Better for your health than Chantix. I recommend them…”
No one has ever said that cigarettes aren’t devastating to ones health. The “cigarettes harm more” argument is ridiculous. Everyone knows that cigarettes are harmful. What people don’t know is that the drug to help quit smoking can cause totally out of character fatal reactions. There are other ways to successfully quit smoking and leading patients to believe that Chantix is without flaw is negligent.
Lisa Van S
Atex,
FAA has banned Paxil,.. not sure if other SSRI’s are included.
Chris
But how many of the AEs or other side effects can be solely attributed to Chantix as opposed to the consequence of quitting smoking per se, or to other conditions existing in the smoker, or indeed to other substances the smoker was using? No doubt there are serious and undesirable effects being associated with Chantix, and if proven it should be restricted; if not though can we see what else might be happening because of the other things going on?
(And for goodness’ sake, the word _ideation_ is appalling and should be snuffed out of the language pronto. It belongs with ‘informational message’. Can we not do better than this?)
Laurie
When was the last time you read about someone killing themselves, killing someone else, having a complete personality change resulting in violence, losing control over their balance or being psychotic because they quit smoking? And as for proving it…it’s in the clinical trials reported BY Pfizer, which is why they have at least some of this in their drug insert.
At least know it’s starting to be reported widely instead of 2 point font in a drug insert that NO ONE sees!People who are reporting these symptoms are doing it because it was so drastic a change that they took the time to report it to the FDA, a system that admits only gets about 10% of the actual adverse events.
As most have admitted causality is hard to definitively prove, but dismissing first hand reports of adverse events is just bad medicine.
Remember, the true effects of a drug is only know when they are released for use to the general population. The ONLY method of follow up is the Medwatch system. Not taking these reports seriously and warning when a pattern is discovered leaves a society at risk.
harpy
Well, now truckers have been banned from using Chantix, too.
The most reliable, proven method of quitting smoking is still cold turkey.
Paula
I have just barely survived a seven-week stint with Chantix. Damn near cost me my sanity. This drug has some SERIOUS side effects. For those posters who have never been addicted to nicotine, and have never tried Chantix…go back to your triple cheeseburgers and beer. This drug needs to be taken off the market, asap.
Ra
This is a first for me. I am grateful that the FDA is banning Chantix for all humans that can cause havoc out in the world. Yet, the adverse reactions are not going to go away over night. This shit stays in your system for sometime. I realized there was something wrong 17 days ago and I am still having many psychiatric symptoms. I mean I am having it all. Hostility, aggression, psychosis like talking to walls, to myself, breaking glass with my own strength, throwing things through and breaking windows, writing on walls, I am having hallucinations, paranoia, yelling, screaming, crying, I cannot sleep, I am binge eating, I cannot make any decision. That is just to name a few of the issues I have had in the last few weeks. Now lets not look at falls, major ones, my skin reactions, uncontrollable movements, the vision disturbances, I have been so disoriented it is unbelievable.
I can go on and on, and hey I was ready to stop smoking because I wanted to, but I thought what the heck if it can make it easier why not. Well, why not is all this that I have written above. Pfizer can say all it wants, the truth is here and being written. Pfizer needs to take care of all the humans that the FDA is banning from this Drug. It will not just go away by them saying no more Chantix for you because you fly a plane or drive a bus, or work in a big plant that feeds 100,000 people. They need to set up some type of treatment setting to help people to come off this shit. I have been in my home for three weeks now, pushing people away, because I am having issues with being in the world. This is not ok, and these people need to see how bad it really is, even for us humans who have good coping skills with being on Chantix. There is much shame that comes from thinking you are insane, but I believe the shame comes from the money making machines that could care less on how this shit effects the human body. It cannot be just said, you have to stop taking it. It needs time to come out of the system, and they ought to do something for all of us.
Thanks for listening.
Jane
Ra, don’t count on the drug maker or the FDA to do anything about this. Just look at what has occurred with the antidepressants and other psyhcotropics. Nope, patients are blamed, and left to deal with the side effects on their own and the drug stays on the market.
Laurie
“Nope, patients are blamed, and left to deal with the side effects on their own and the drug stays on the market”
Exactly! The sad part is that there is no “treatment” for the side effects. There is nothing that is going to fix this quickly. Time for the brain to return to pre drug state is the only treatment, but patients are not told this either.
Shauna
First of all I have to say THANK YOU for these postings as I seriously thought I was going crazy. I was on it for 6 weeks regularly and then after that maybe one pill every 3 or 4 days although I’m not sure why. I took one today but after reading this page as well as now Health Canada starting an investigation into the side effects I’ve thrown what’s left of my prescription away. My biggest reaction to this drug was hostility and aggression to the point where I was out of control. I’m just so thankful I was alone at the time as someone probably would have called the ‘men in the little white coats’!! I have never in my life had this strong hostility. I figured it had to be the Champix and stopped taking it on a regular basis. I have not had those reactions since although I can say that I just still don’t feel myself. Hopefully that I won’t be taking any pills again that I can get back to feeling ‘normal’. While I was on the medication I thought to myself that if this is how I was going to feel while being on it I’d rather take my chances with health issues and seriously considered started smoking again rather than taking the medication. Thankfully I haven’t started smoking again although it’s really weird because I still crave it but I’m not sure whether it’s a physical craving or a mental one. It’s really hard to explain. I still love the smell of cigarette smoke which I’m told by ex smokers that they can’t stand it. Is anyone else having this problem? Have you gotten over it? How long did it last? I know this seems really trivial in relation to the serious side effects but curious if it was just me or not. And again thanks to you all for this information.
Justice in Michigan
Shauna - I quit a bit over twenty years ago. Was at least two packs/day for twenty years.
Strangely enough, I did not find it that difficult, particularly after the first week or so. In retrospect, it is interesting to me that a program I attended - informational, no drugs - specifically advised against creating “support groups.” They suggested that only keeps reminding people of what they think they are “missing” and reinforces the preoccupation with butts.
I would guess that, for a certain number of smokers, drugs like Chantix (or Wellbutrin) do the same thing. They reinforce, rather than extinguish, the preoccupation with cigs - not because of the drugs themselves, but because of the constant reminder of cigs that taking the drugs provokes.
Leave them like a thug (which they are), and don’t look back.
Cheryl
I am so surprised by what I have just read. My husband and I both started taking Champix (Canadian version)on May 6, 2008. I was able to quit at the scheduled time, one week after starting the drug. My husband found it more difficult and continued to smoke for a couple of weeks, but cut down from about 30 cigarettes a day to 3 or 4. He quit completely over a week ago and is doing fine.
Thankfully, we have not experienced any of the side effects noted in this article. As a matter of fact, after trying to quit a number of times previously, I have found this time much easier. Not easy, but easier.
We are having no mood swings and no food cravings. I have always had to watch my weight, but was prepared to gain at least a few pounds in order to kick this nasty habit. I am eating no more than I usually do and have not gained an ounce.
The only two side effects I have noticed is waking up in the middle of the night and having to read for an hour or so before I can get back to sleep, and remembering my dreams.
I am certainly not discounting everyone elses bad experiences with this drug, but as long as we are not experiencing any negative effects, and it is assisting us in quitting smoking, we will continue using it for the time being. Because of your postings we will certainly be more diligent in watching for any ill side effects.
Oracle
Serious side effects are most likely due to nicotine withdrawal. If you are having serious problems on chantix stop taking it and go back to smoking, it’s the best antidote. If your problems continue while smoking how can you blame the drug..it’s gone after a day or so…
J Jones
I took Chantix for 8 days, my mind was in a fog I became moody, hands started swelling with lots of joint pain. I was still smoking but not as much. This drug is terrible. I took myself off Chantix and in 1 day I noticed just how bad my head was in a fog.This drug needs to be taken off the market.
Stacie
Oracle… I think you are very highly mistaken. Although the drug itself may be “gone” from your system in a couple of days…that is a myth that the after effects are not still there. Take for example cocaine is gone out of your system 24-72 hours…however with a hair sample you can test for cocaine use by a person within the past 8 years. And lets not forget that cocaine was once considered highly beneficial for medicinal purposes and now considered one of the most highly addictive illegal substances in the world!
Birth Control pills although legal…are in an essence the same thing…although you stop taking them the chances of a female conceiving within one year after stopping the drug is slim to none. Again the drug has altered the bodies chemistry!
Any drug that you take…especially one like Chantix alters your chemistry in the brain, there is no time limit on if and when the brain will ever return to it’s normal state. There is nothing to say that the brain will ever be the same.
It took my Sister 6 months before she started experiencing any of the more serious side effects, ie. suicide, severe depression etc.. Although the minor ones were present almost immediately. Now because she didn’t try to end her own life within a certain time there is no law firm, FDA, nor Phizer that will even consider that this drug is responsible for her incident. This makes me absolutely outraged!
Ra…hang in there. Know that you are not alone and reach out to someone. Anyone! Do not be ashamed of what has happened to you. It’s not your fault. Your posting was like reading a transcription of what my Sister said to me.
Best Regards,
Stacie
chris
Chantix caused my husband to have diabetes. It’s BS!
truthman30
Has anyone ever thought that possibly there might be a strong PLACEBO effect with Chanitx?
Placebos have been proven to be almost as good as actual drugs in treating illnesses…
And surely when people are trying to give up smoking by using Chantix, the placebo effect could be even stronger as they feel the drug is helping them to give up, when really what is happening is , their WILL POWER is helping them to quit..
One thing is for sure..
If Chantix was a placebo it would be far safer..
Let’s call a spade a spade..
Chantix is just another antidepressant like Paxil, also with suicidal side effects …
Unfortunately , we have pharma opportunism and pharma exploitation again with the marketing of this dangerous drug as an aid to quitting smoking….
Dannie
Wow people got angry when they tried to quit smoking?!!!
I’v never heard of that…Next thing u know they will start shaking and craving ciggerettes too…..I guess people better quit quitting smoking, or quit cold turkey cuz we all know how easy that is- and there is no way u will have fits of anger and withdraw THAT WAY.
“head was in a fog” - yep u should have a clear head while your body is detoxing, you shouldn’t feel wierd or any discomfort at all.
“chantix gave my hubby diabetes” - yea there is no way he had it before he starting taking it…..he just happend to get it in the few weeks he was taking the drug…….surely all those years of smoking couldn’t have had anything to do with it.
“It took my Sister 6 months before she started experiencing any of the more serious side effects, ie. suicide, severe depression etc” –wow, i didn’t know that taking chantix or any quit smoking aid FOR 6 MONTHS WASN’T A GOOD IDEA!!
Use common sense people!
e-mail
canav1@aol.com
Stacie
Hey Dannie…read the message…she was off it for 6 months and the serious side effects started then…we’re lucky we even had her for that 6 months. She only took the drug for 2 weeks.
Obviously you have no idea what these people and their families are going through…and the shame and embarrassment that comes with thinking that you are losing your mind. You really shouldn’t offer your insight about things that you DON’T know anything about. It’s not constructive and it just adds to the hurt and confusion that people are already experiencing without insensitive people like you.
Be strong everyone…better days are coming!