Chantix problems were not fully reviewed before drug was approved

Harvey Kirk

By Harvey Kirk
Posted March 4, 2008


Before a new drug is sold, the manufacturer is supposed to establish that it is safe and effective through a series of clinical trials. However, in the case of the stop-smoking medication Chantix, problems which have recently linked the drug to reports of suicides and suicidal thoughts, were not fully researched by Pfizer before they introduced the drug. As a result, many smokers were not warned about the serious and potentially fatal Chantix side effects.

>>INFORMATION: Chantix Problems and Suicide

During clinical trials performed before the approval of Chantix, individuals with a psychiatric history or current psychiatric symptoms were not included in the studies. As a result, Chantix problems were not evaluated among people with common conditions such as depression, bipolar disorder and schizophrenia. However, many people with depression or other forms of psychiatric illness are smokers, and a large portion of the prescriptions for Chantix were made to people with these problems.

Depression, bipolar disorder, schizophrenia and other psychiatric symptoms are quite common among chronic smokers to whom the drug was aggressively marketed. In addition, there is a strong association between smoking and increased rates of depression and other psychiatric problems, yet the Chantix manufacturers chose not to evaluate the side effects their drug has on these people.

The glaring omission is particularly troubling since depression has been linked with increased addiction to nicotine and difficulty quitting smoking. Those who want to stop smoking and can do so easily, often do not require medical interventions to help them. Those who have repeated failed attempts at quitting are more likely to be vulnerable to the effects of nicotine and often have higher levels of depression.

Chantix works by targeting nicotine receptor sites in the brain, which should have given clear indication that the medication may have an effect on mood and behavior. Nicotine receptor sites are linked with the release of neurotransmitter dopamine, which is associated with a variety of psychiatric illnesses and treatments. The connection between dopamine and medical illness has been well established, and Pfizer should have understood the importance of including patients with depression problems in their clinical trials.


The lawyers at Saiontz & Kirk, P.A. represent individuals who are pursuing a Chantix lawsuit as a result of serious or fatal self-inflicted injuries which were caused by the medication. Chantix problems have been associated with an increased risk of suicides and erratic behavior. To determine if you, a friend or family member may be entitled to compensation, request a Chantix lawsuit evaluation.

28 Comments • Add Your Comments

  • Richard says:

    started having side effects and stopped med on dr order. then withdrew still withdrawing. all of the side effects except cancer and death. still only on day 6 hope no permanent damage. lost work for me and roomate. had to be monitored. nov fda revied 55 suicides 199 suicidal thoughts homicide cant concentrate enough to this IS HELL.

    Posted on March 20, 2008 at 6:31 am

  • dreamscerulean says:

    I went to a patient first in richmond and recieved a prescription for this… doctor never asked if I was bipolar or had any such problems and Im sure that they had it in my profile. Now reading some of the interaction stories and sitting here playing pro and con… I need to quit smoking but havent been able to go cold turkey or cut down, cant stand the habit and am disgusted at myself over it… Have been able to mostly keep myself stable without meds and dont know wheither or not to start taking the pills

    Posted on March 23, 2008 at 12:50 am

  • L says:

    I took Chantix to quit smoking in February of 2007. It worked; I kicked a 30-year habit.
    The severe depression left after I stopped taking the drug (along with kidney pain).
    However, I developed chronic depression, the dark clouds that hang over each feeling, and it doesn’t go away. It subsides now and then, but it’s always there.
    Was it the Chantix that caused this? I can only assume so, since I was never this depressed for such a long period of time.
    I also found that I could not go back to smoking; the Chantix removed all pleasure from smoking.
    Know what you are doing before taking this drug.

    Posted on April 24, 2008 at 2:03 am

  • Cassie says:

    Started taking Chantix in Dec. 2007. After 1 month of taking the meds myself and my family noticed a huge change in my behavior. I dropped out of school, started planning to divorce my husband, rarely left the house, and went from someone who never drank to one who drinks every night.

    Since I have realized these changes and their cause, I’ve been trying to overcome it, but haven’t had much luck. My Dr. suggested anti-depressants and therapy, but the thought of taking another drug doesn’t make feel to comfortable.

    Even though I have smoke-free for 5 months I can’t help but to think at what cost.

    Posted on May 7, 2008 at 8:37 pm

  • JusticeB says:

    I am Bi-Polar and started Chantix in March, 2008. My lung doctor warned me about the depression/suicide problems that were arising but because I always lean toward the manic side of things my family and I thought we would recognize problems as they might arise. Well, no one mentioned the extreme agitation and extreme mania that might come with Chantix messing with dopamines. By day 9, my marriage was on the rocks, I became violent, and extremely irritable, I was now unable to sleep and crying uncontrollably. By day 13, 92 consecutive hours with NO SLEEP AT ALL NOW, my family asks me to take one of my bi-polar meds that I had actually been off of since November, 2007 Seroquel to try to get some rest. At 1:00am I took a half of pill (50mg) and at 1:10am I had a grand mal seizure and completely stopped breathing. My husband began rescue breathing for about 1 to 1.5 minutes and saved my life. I was taken to the ER where I again had another grand mal seizure around 5:15am and then another small seizure around 7am. I don’t recommend that anyone take this medication without the proper information from Pfizer. My specialists, a psychiatrist, neurologist, and pulmonologist, were all unable to advise me as well as the pharmacy b/c all that was released was depression/suicide information

    Posted on June 16, 2008 at 1:18 pm

  • Debbie says:

    Im now confused!!! This is scarey as to the stories i just read on chantix.. Got any other suggestions on quitting?

    Posted on June 25, 2008 at 4:16 pm

  • Katrina says:

    Me and my husband started taking Chantix together in January 2008 after my womens doctor found a lump on my breast(which was nothing). We both have smoked for 20+ years and we was wanting to quiet anyway. I thought ,a mirical drug, by the way my doctor talked about it, what could go wrong?? About 2 weeks into the medican I started looking at my husband with hate and did not want him any where around me. I would have thoughts of killing HIM, not myself. I knew something was wrong and I just kept telling myself, I just am depressed about quieting smoking. One night he was watching TV, we had been on the meds for about a month and he heard about the law suits on the suicid. He came running down the stairs and told me and I quiet right then and there,and thought I will get better now. Boy was I wrong, I am still depressed I am on anti-depressants. I went on that med around May of 2008. When I stopped taking Chantix the wanting to kill my husband stopped but the depression staied. I went to my primary care doctor he told me this anti-depressant would help. I am better some days but I am scared I will never be MYSELF.
    My husband just broke down last night and told me he is still having suicidal thoughts and has for a long time but has kept it to himself and he quiet the Chantix the sametime I did. I wish there was help for us out there that trusted our Doctors to help us and the doctors was trusting the FDA. Who do we trust and who do we let help us. I know there is cases worse than ours and I am so very sorry to those people.

    Posted on July 18, 2008 at 5:51 pm

  • mixed emotions says:

    I am nurse and have spent a significant amount of time studying psychiatry and have been a smoker for 7 years. I would have to agree that with the amount of people that have quit smoking with little to no side effects from this medication that it is a miracle drug.

    On the topic of side effects…

    In practicing medicine I have found that ALL drugs have side effects for SOME people. If you have a side effect from a drug don’t take it. This quit smoking miracle pill may not be for you. It is the responsibility of the patient to report medication side effects and the responsibilty of the doctor to investigate a proper alternative. With medications that do cause side effects it comes down to a consequences vs. benefits debate. With some people with the suicidal thoughts it may be a debate of suicide vs. lung cancer or rather die now or later. You have the choice and they aren’t going to take a drug off the market becuase some people are experiencing extreme side effects.

    In the case of long lasting psychiatric conditions following the course of medication…

    Psychiatric conditions can often lay dormant in individuals who have never shown any sort of mental illness. Usually a tramatic event, reaching a certain age, or subtance abuse triggers the illness to show itself. The substance abuse, your age, nor the tramatic event CAUSED the problem. The problem has always been there, you just didn’t know about it. My speculation is that due to Chantix’s neurotransmitter involvement, that it is just another trigger of undetected mental illness in certain indiviuals. If taking Chantix has been the trigger for you, I strongly suggest you start therapy and see a psychiatrist so that you can handle the issue at hand.

    I don’t want to come off as insensitive. After all, I have major depressive disorder and know how haunting manic & suicidal episodes can be. Smoking is hugely associated with mental illness. So if you are having issues with this drug, stop taking it & see a psychiatrist. I have had great success with this drug, but I am also on an anti-depressant, so I haven’t had psych issues with it. Anyway, good luck to all of you.

    Posted on July 22, 2008 at 11:27 pm

  • stacie says:

    I took chantix about 2 1/2 years ago and my doctor knew I am bipolar and said it was safe. But it was not! I felt worse and had so many problems off if it, I could not handle it, god it was it so bad!!!!

    Posted on November 15, 2008 at 12:55 am

  • Not mixed emotions says:

    I am baffled that a nurse would state that regardless of the fact that it may have severe (suicide/homicide thoughts) side effects, that the drug shouldn’t be taken off of the market. That is insane! Drugs that cause such issues as this drug obviously does, should not be on the market! There are alternatives to quitting smoking. Die now or later. How bazare! People have smoked for years and many do not die from smoking! Smoking is not healthy, however, I would rather smoke than to turn into a dangerous person to be around where I have little or no control of my emotions/thoughts. I do not believe that this drug is only affecting individuals with mental problems. I believe this drug causes mental problems. This drug is dangerous. It affects lives, and not only the lives of those taking the drug, but also the lives of everyone who care about them. Doctors should be more informed when it comes to prescibing drugs! I do not believe it is a good idea for doctors to receive trips/gifts for promoting drugs. Please do not take this drug. It is causing problems that do not go away simply because you stop taking the drug. I have repeatedly heard individuals state that they are still experiencing problems after a year or more after quitting the drug. Smoking is better than suicide! The pharmacutical companies should look for a less dangerous alternative. It boggles my mind that the FDA would approve this and many other drugs!

    Posted on December 23, 2008 at 2:27 pm

  • rt says:

    All of the comments I’ve see here make me wonder. I’ve been taking Chantix for over 2mths now. I have a history of depression and spoke with my doctor about the side effects. Weighed my options and made a DECISION. The same as anyone else here. Take resposibility for your actions. I feel bad for you if you have had any bad experiences but you should have known the risks before taking the drug. If you didn’t do any research yourself I don’t reakky feel bad for you. Always check out a medication your doctor reccomends do blindly follow what your told. Like I said inform yourself then make a decision and deal with it. Stop blaming everyone for your problems and maybe you can figure out what’s happening to you and have a better life.

    Posted on January 25, 2009 at 9:33 pm

  • Julie says:

    I finally quit smoking after 15 years of doing so by using Chantix. I have been miserable ever since. I took it for three months because I just couldn’t give up that last smoke. It made me incredibly nauseous. Now, I am officially a non-smoker, but I am severely depressed, my brain feels like it’s sloshing around in my head, I have no energy, all the symptoms of Type II diabetes and severe nerve pain near every joint from the waist down. I am hanging onto my relationship by a thread because my personality has completely changed. I mentioned the side effects to my doctor whom I have been seeing for 7 years and he told me not to worry. I trusted him. He trusted Pfizer. Who the hell is accountable for this kind of thing?

    Posted on March 9, 2009 at 11:42 pm

  • christina says:

    My husband and I took chantix in 2008 together. We quit smoking only after taking the pills for a few weeks, and we discontinued as soon as we were able. I was also taking welbutrin while I was taking the chantix. I had a lot of nausea, and I had really vivid nightmares. But I had quit smoking, and thought we were fine. About a year later my husband lost his job, and we started back. A few months back we decided it was time to quit. We found what was left of our meds, and began taking the chantix again. Immediately I began feeling wrong. I felt the over powering urge that something wasn’t right. Like the world would end. I couldn’t sleep. I was scared to try. The nightmares were so bad that I stayed awake for days. I started to getting hives, and was getting depressed. I hated myself, and I didn’t trust anyone. I always felt like something was wrong. I felt a zombie at times, and others like I was mental. I begged my husband to help me. He thought I was just losing it. He had no symptoms what so ever. Finaly I cried for 3 days straight wouldn’t talk to anyone. I quit cold turkey after only 2 weeks. It got much worse before it got better. Its been 3 weeks, and some things have gotten better. Its not as extreme but all the paranoia the dreams are still there, just not as often or as severe. I’m scared it wont ever go away. The only thing that I can think is that I wasn’t taking hte welbutrin. I flushed the pills down the toilet. I don’t advise anyone to take it. I would rather die of lung cancer than lose my mind permanently. I’ve already lost my husband because of this. He wouldn’t believe me. I advise anyone. ITs not worth it.

    Posted on May 8, 2009 at 4:21 pm

  • peter says:

    i a bi-polar and i started taking chantix a year ago,i finally stopped smoking on my own 6 months ago. my dortor never told me the side affort of this pill, u until about 2 months ago i had the fl for 3 weeks, after the fu was out of my body i was feeling blahhhh, i was so tired all the time, i wanted to sleep, my musacle’s in my whole body was aching, i just could not get out of my way, it took a lot out of me just to walk from my bedroom to bathroom, and alot out of me to walk over to the store and back. it took me a half hour t walk to my doctor’s office which it usually takes me 5 minues t get there, well on may 12th i could not walk. delta ambulance took me to the er and the doctor there told me that chatix was causing all this to my body..shetold me to stop using chantix and i did. so now i am feeling better.. also i was having real bad migrain’s… to me they should take CHANTIX of the market and not use this med anymore….

    Posted on May 15, 2009 at 3:25 pm

  • charlie says:

    I smoked for 30 years took chantix and also kicked the habit, but I to have had kidney pains, doctor doesnt know why. I have had some thougfhts I shouldnt be having and I have extreme mood swings and hostility for minor things that happen I should not lose control like I do now, I never did before, scarry hope this goes away.

    Posted on October 1, 2009 at 9:24 pm

  • BEAR says:


    Posted on January 28, 2010 at 3:24 pm

  • Susan says:

    First, I am and always have been a very happy and positive person, period!! I am very shocked at my behavior because of taking Chantix. I know it is the drug, my family knows it is becausee of Chantix. Again, I am a happy person and to have such a change in behavior because I decided to take a drug(Chantix) that was FDA approved to help me stop killing my self with another approved legal drug (Marlbora)…it is crazy. Some people think its you not the drug ….thats a LIE. CHANTIX WORKS, YES, BUT HOW LONG WILL i PAY THE PRICE? My kids do not know what to think, crazy Mama…Im not even sure why Im writing this….does it matter….wish I could reverse the effects….guess I will wait for dear ol normality to come back one day. I miss me!!!!! Please God bring her back!!!! I hate this person I have become!!!

    Posted on July 10, 2010 at 6:27 pm

  • lu says:

    oh my god, im considering Chantix because i want to stop the horrible habit of smoking….but this is very scary to read…i dont know what to do now. does anyone used a different drug or another way of quitting that owkrs and will not make you want to kill people or yourself?!?!?!!?

    Posted on November 10, 2010 at 4:15 pm

  • Paul says:

    After reading some of the comments I am wondering about whether the Chantix is even causing the problems.
    I have been a smoker over 35 years and have quit a few times over the years and observed several people try to quit. A lot of times they have some of the symptoms that is mentioned here simply due to the fact that they are no longer smoking. I know for a fact that when I quit or tried to quit I had a lot of similar symptoms, depression, agitation, sleep problems etc. but anyone that smokes and have tried to quit knows this. From what I gather there is a possibility that the drug Chantix does not actually cause the symptoms but extremely enhances them and makes them worse.

    Posted on June 10, 2013 at 10:46 am

  • Paul says:

    Why do you think people have such a hard time quitting. It’s because of the symptoms that take place when the body no longer has all the chemicals flushing around inside it and you go through withdrawal kind of like a heroin addict it can be devastating

    Posted on June 10, 2013 at 10:56 am

  • ashley says:

    Again I have been given a prescription for chantrex, I even had problems with the patch I decided I will not take as do suffer from depression. I do not trust the maker pfifer they have pushed many dangerous pills, get sued but make so much money it is just a cost of doing business. A nurse who said what she did on here should be ashamed, she doesn’t know what she is talking about. she is brainwashed in the medical field propaganda, time and time again I have found they lie a lot. Do not trust any medical persons or Makers of these drugs

    Posted on January 31, 2014 at 6:13 pm

  • Mary says:

    I’ve Taken Chantix on and off for over Two years and the only troubling side effect was nausea. I’ve smoked for over 45 years. I can’t fully quit I’ve gone for maybe 3 months at a time with out even 1 cigarette . On Chantix I feel safe to not smoke I know the goal it 100 percent but I can’t quit. I have COPD(15 yrs+ (Also Treated for Deppression-Biplolar -for over30years) I have smoked occsionally while taking Chantix . So I’ve smoked maybe A total of two cartons of cigarettes! During this time as opposed to 52 cartons (or over 100+ Cartons. I often have severe breathing issues , thank God for Chantix so sorry that people have terrible side effects. But I honestly believe I’ve had most of them my whole life anyway, so in my case that hasn’t changed and Smoking related issues for me at least are Worse. At least taking Chantix I can live a while longer without added mental and physical anguish that comes from all the Quitting .

    Posted on February 18, 2015 at 11:53 am

  • Bob says:

    Never take this medicine. I was married to a person, a good, stable responsible person who is not even a shadow of their former self. Only took Chantix for a month 4 years ago and the depression, rage, isolation & apathy is worse by the day. I have to leave for fear of my safety and know that this person will give up on life without me. It ruins more than just the life of the one who takes the pill.

    Posted on January 15, 2017 at 5:46 pm

  • Beth says:

    When this drug appeared there was NO medical information regarding side effects being permanent nor any mention that these horrific side effects would worsen over time, other than forums like this it is still not listed. The vast majority of people who do research are lead to believe the side effects are temporary and that of they have never had any sign of mental instability they willbe fine. You know who should be responsible? Drug companies, doctors, and regulatory bodies who do not do their due diligence.

    My husband took this drug at half the dose for 3 weeks, 8 years later he is an unrecognisable shell of who he was. Says the enjoyment of smoking was removed but so too was his ability to experience pleasure, happiness, even contentment. You took this drug for 2 months when you made this comment, do you still agree? Did your research prepare you for what was left of you after the medication?

    Posted on January 18, 2017 at 2:18 am

  • Derek says:

    I was able to finally quit smoking with the help of hypnotherapy. One hundred dollars, one hour “asleep” hypnotized, and I have been smoke free for 2 yrs. Some cravings, but with time they have mostly vanished , and are some how easily manageable.
    Too bad I tried Chantix first. Just for a month That stuff made me straight up nutz. Lucky no one was hurt. I would get so aggravated that I would see red. Years later and I still feel like the Chantix has changed me. Maybe it played a part in my quoting smoking… who knows.
    I did buy another hypnotherapy session for a good guy with similar long term smoking history, and he too was able to quit, and w very little stress you would normally associated with the impossible task. So I doubt the chantx was any help for me.
    My verdict Chantix bad….
    Hypnotherapy good…..

    Posted on December 1, 2018 at 12:16 pm

  • MANDIE says:

    Come on people, quitting smoking causes severe depression. If you don’t know that then you obviously need to research the topic. The more you smoked the more likely you are to have depression. I smoked a pack and a half a day, sometimes more. I’m on chantix and I am depressed. Pretty sure if I started smoking and quit the chantix I’d be quite happy. For a little while, until the guilt started in. Also, when you’re a heavy smoker, cigarettes rewire your brain, so when you stop smoking it leads to pretty bad depression for at least three months, maybe longer. I’m fixing to wean myself off the chantix, I don’t know if it’s changed me, I really don’t care if it has. It helped me quit smoking without the side effects of going cold turkey, so I’m happy about that. Everybody gets the little brochure that shows the side effects of this medicine. So if you have a problem with it, that’s your fault for not preparing yourself for the KNOWN side effects. Also, hypnotherapy doesn’t work. It works for a day, until you wake up the next morning, then you’re smoking again. For hypnotherapy to work to help you quit smoking, you’d have to get hypnotized everyday for…I don’t know how long. Chantix has worked for me, my husband says it makes me angrier, well I think the not smoking and wishing I could makes me angry. I think it’s ridiculous so many people are griping about this knowing the side effects before hand. It’s just really sad how irresponsible people are anymore. I totally agree with the nurse that has written in about chantix, she sounds like a very smart woman. What she says makes sense and for anyone to complain about it goes to show their part of the problem in this country, part of the ones that does something then doesn’t want to take responsibility for their decision. Utter ridiculous, part of the reason why we have so many law suits in this country, stupidity and irresponsibility. And greed, can’t forget about greed.

    Posted on August 30, 2020 at 7:13 pm

  • Teresa says:

    I took Chantix at only 1/2 the dose because the 1mg made me too nauseous, and at the end of seven days taking, didn’t want to smoke any more… I got through the physical withdrawals from Nicotine and took .5 Chantix for less than 3 months and stayed quit. A few days after stopping taking any Chantix, I noticed my self becoming VERY depressed, agitated, mad over nothing, so sad all the time and always feel like the world is about to end…and think of killing myself quite often. I never thought about killing myself and that has came after 1-2 weeks of stopping taking the Chantix 🙁
    Maybe 10 years ago, I had a bout with depression, I got past it. No one counselled me that this drug could make me depressed AFTER taking it, the drug precaution only stated to tell your doctor if you had symptoms while taking it. Other than normal withdrawal from smoking, I had no adverse symptoms until I stopped taking it. I had no idea this drug could change the happy happy me into this sad wants to cry 24/7 me that I can’t stand. My family doesn’t want to be around me at all.

    Posted on September 10, 2021 at 7:30 pm

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