Chantix Recall Should Be Considered by FDA

Austin Kirk

By Austin Kirk
Posted February 14, 2011


A recent report by the Institute for Safe Medication Practices (ISMP) indicates that side effects of Chantix continue to account for a large number of the serious psychiatric problems reported to the FDA, despite a “black box” warning added to the label and a medication guide that is given to every patient. That should be a sign that the medication needs even more restrictions or other regulatory action, such as a Chantix recall.

>>MORE INFORMATION: Chantix Suicide Side Effects

On this blog, we have been calling for a recall of Chantix for a long time due to the increased risk of suicide, suicide attempt, hostility, aggression, depression and psychosis. In addition, prior studies have suggested that the drug may be no better than other treatment options to help people stop smoking.

Last month, the Institute for Safe Medication Practices (ISMP) released a report (PDF) on adverse drug side effects reported to the FDA in the second-quarter of 2010.

Chantix has now caused more than 8,500 reports involving serious injuries, with a steady stream that exceeds most other prescription medications. According to the report, in the second quarter of 2010 alone there were 130 possible cases of Chantix clinical depression, 112 possible cases of hostility-aggression from Chantix and 70 cases of Chantix psychosis and reports by people who say the drug made them lose touch with reality.

ISMP indicated that these case reports continue to exceed the number reported with the most powerful antipsychotic and antidepressant medications, which are used in much more vulnerable groups of patients with mental disorders.

After observing that these Chantix problems continue to be reported, despite the FDA having deployed most of its regulatory tools short of a Chantix recall, ISMP concluded:

The evidence shows that the numerous regulatory actions from the FDA and other restrictions have not succeeded in achieving substantially safer use of (Chantix) varenicline beyond a possible effect in reducing dispensed prescriptions. A major reassessment of this drug’s place, if any, in a program of treatment to assist in smoking cessation is needed.


The Chantix lawyers at Saiontz & Kirk, P.A. represent individuals throughout the United States who are pursuing a Chantix suicide lawsuit or other injury claim from the medication. Despite information that should have led the drug maker to recall Chantix long ago, the medication has been marketed as a safe method of helping people quit smoking.

If you, a friend or family member have suffered a serious injury or death from Chantix, compensation may be available through an individual Chantix lawsuit. To review a potential claim, request a free consultation and case evaluation.

23 Comments • Add Your Comments

  • t says:

    …YANK IT!!!…

    Posted on February 21, 2011 at 12:26 pm

  • Judy says:

    I lost my husband last December. He was taking Chantix! It needs to be pulled off the market. It is poisen

    Posted on February 23, 2011 at 10:37 am

  • t says:

    ….YANK IT!!!!!!!!!!!!!!!!!!!!

    Posted on February 23, 2011 at 12:41 pm

  • Meisha says:

    TAKE THIS CRAP OFF THE MARKET!! My husband tried to take his own life while taking Chantix… It needs to be band!!

    Posted on February 25, 2011 at 6:15 pm

  • Brant says:

    Chantix is the only thing I have found in my many attempts to quit smoking that has actually worked. I have had no adverse side affects other than maybe strange dreams. The benefits of stopping smoking I feel strongly out weigh the side affects.

    Posted on February 26, 2011 at 2:37 pm

  • jay says:

    living in hell right now because of chantix take it off the market,pay those whos lives have been destroyed by it because monies is the only compensation they can offer to make up for taking my life away.unless the make a wonder pill to reverse the effects of chantix.

    Posted on March 1, 2011 at 4:48 pm

  • Holly says:

    I had the most horrible experience of my life and feel that I may never truely recover. I have been under psychiatric care since 2007 because of Chantix. This was the biggest mistake I have ever made in my entire life and there is no turning back. I suffer from anxiety, depression, and post traumatic stress. A routine physical from an internal med doctor who used me as a guinea pig for Chantix is walking around normal while I am messed up, nice!

    Posted on March 23, 2011 at 11:17 pm

  • Virginia says:

    I agree with Holly except my doctor had all my records for 20 years. He turned his back on me when chantix changed me and not for the better either. I know it was not quitting smoking since I did that cold turkey later. It is about time someone who has the authority uses it instead of ignores. I hope the guy the FDA had answering complaints in 2007 who told me “no one put a gun to your head and made you use it” knows how wrong he was now that his brain is no longer under the influence of chantix!

    Posted on March 25, 2011 at 3:48 pm

  • cindy says:

    I was just at the doctors office and they highly recomened it. Are they getting a cut for pushing this. I have seen that happen on tv. I want to quit but after reading all this I’m afraid to spend the money on it. And I don’t need to be depressed or try to off myself. What should I do?

    Posted on April 20, 2011 at 6:54 pm

  • TERRI says:

    the only SAFE way to TAKE Chantix…is to NOT SWALLOW!

    Posted on October 7, 2011 at 1:43 pm

  • Martha says:

    I take chantix and it is working for me..the only problem I have is the nausea. but that is a side effect of it. When you stop and think about it, quit smoking will cause the depression, anxiety, and mood changes…I recommend it to stop smoking. I have smoked for 37 yrs and close to a 2 packs a day, now since I started it, a pack of cigarettes has lasted me 3 days. And that is something.

    Posted on November 11, 2011 at 12:34 am

  • Vikki says:

    I am a 51 year old female. I have been on and off Chantix for several years, to this day, I cannot of my own free will seem to stop taking the medication. The company claims it is non addictive yet I beg to differ. I have noticed a change in my ability to sleep through the night, freakish nightmares, bouts with depression both on and off the medication, aggression, agitation and nausea. I had a 2 year success in staying smoke free,but only after taking the first 3 month prescription several years ago when the drug was first approved by the FDA. My husband was successful at quitting on Chantix as we both started the process at the same time, he remains cigarette free but does occasionally smokes a cigar. We both agree that during the time on Chantix we would both experience overwhelming craving feelings,so overwhelming that it became a topic for discussion on many occasions. We never could figure out what it was that we were craving and it absolutely was not cigarettes. Since then I have bounced back and forth with a few months at a time of being smoke free only after taking Chantix time and time again. After finally doing some research on the side effects of the medication I am convinced that Chantix has aided if not been completely responsible for my current ailments. I have recently gone to my doctor and requested an anti depression medication called Wellbutrin,I want to note that I have no valid reason for my bouts with depression they come and go without warning. My life is not stressful nor have I ever been one to dwell on things we cannot change. I do know that I have not previously experienced anything like this prior to my exposure to Chantix. I am hoping that I will be able to stop taking the Chantix as well as quit smoking. Wellburtin has been known to be successful in both treating depression and stopping smoking. Failing this I am at a loss as to what to do at this point.I realize now that in trying to resolve one addiction I have acquired another. Please be warned if you are considering taking this drug. Although you may not experience any side effects at first realize that mine started almost 2 years after taking the drug and I continue all these years later to attempt to find a way to get off both the Chantix and the cigarettes.

    Posted on November 16, 2011 at 5:12 pm

  • Chinwi says:

    Thanks for the video! I am on week 3 of the medicine and hanvet touched a cig since i started it! Its hard but now it seems much easier.. thank you for your video again. I wanted to know if real people actually got results!

    Posted on July 3, 2012 at 6:19 am

  • Deirdre says:

    I was on Chantix for 4 1/2 weeks, I have quit smoking, but going to my 2 nd emergency room visit in the last 4 days, extreme nausea …My doctor has mentioned gallbladder problems, I haven’t slept in 2 weeks, I haven’t eaten, I quit smoking but have never been this sick in my life…

    Posted on August 7, 2012 at 5:41 am

  • James says:

    Have you ever thought that it could actually be your body reacting to quitting smoking, i know when i tried to go cold turkey i was freaking out, been taking the drug for a few days only nausea so far only for like 30 min, but smoking is far worse.

    Posted on August 17, 2012 at 12:59 am

  • Lowell says:

    Please outlaw this medication,I took Chantix for five days after a VA Dr gave It to me..I was On a Antidepresent and anti anxiety Medication.I now have trouble making decisions,lost all my freinds ,I never Laugh anymore,It turned me Into a very hatefull person..I think about suicide every day,But I choose to belive In God..That stops me.I was so happy.I also cant stand up for myself anymore.How many other people out there has this happenend to..Its hard to live with fear all the time ,no guts angry at youself

    Posted on December 17, 2012 at 2:33 pm

  • Lynn says:

    My husband became violent and enraged on this medication. He acted in bizarre manners and we became extremely afraid of him. He did not believe anything was wrong with him. Even though he is of chantix, he is still unable to focus, still very agitated at times, seems to be unable to remember his fits of rage or throwing things, screaming profanity, etc. I had to ask him to get help of leave. He chose to leave. This has been a terrible nightmare for our family. He was also on chantix in 2012 prior to having his heart attack. I believe chantix was part of the cause in the heart attack as he was extremely angry when he was on this med back then. Please, for the love of God, people, get Chantix OFF of the market. Our family has been destroyed, my child is afraid of her father. I don’t think he will ever recover to the person he used to be and after reading here, it seems others also have had this happen.

    Posted on March 3, 2013 at 7:27 pm

  • jeremy says:

    I took Chantix about a year and a half ago. started to get blood in urine and my PCP told me to stop taking it. Well, yesterday i was diagnosed with bladder cancer. Im a 24 year old male and dont think smoking a pack a day for a few years caused my cancer. but i cant prove it was caused by chantix. i know it was and strongly recommend pulling this crap off the market before it kills more people.

    Posted on March 12, 2013 at 12:36 pm

  • Rebecca says:

    I lost my husband to bladder cancer on November 2, 2013. He had taken chantix to stop smoking in September 2010. He was a very healthy hard working man. When he started having symptoms in June 2013 and went to the doctor,they told him that he had had the cancer for almost 3 years. Some people may say coincidence but I believe it had something to do with the chantix. If I could go back in time knowing what i know now I would never have let him take this drug. I feel that if he had never taken chantix he would still be here with me today. I recommend pulling this drug off the market before any more people have to suffer the consequences of its harmfulness.

    Posted on December 5, 2013 at 11:58 am

  • Jackie says:

    I have had a rash on my arms, neck and back… it literally feels like a third degree burn. Its helped me cut down. I quit for three days but I can’t take this anymore. Once I stopped taking it the rash went away. I decided to try it again and the rash came back. This has been my sixth time trying and I now know the rash is from chanting and it burns like hell. I’m a 36 y.o. White female with very sensitive skin. I do not recommend this product.

    Posted on February 25, 2019 at 1:04 am

  • dwayne says:

    after taking i had a stroke and am now blind

    Posted on February 25, 2019 at 7:25 pm

  • Ronda says:

    I took chantix and I was very itchy had a little bit of a rash and then I started getting dizzy spells and having seizures and I still have seizures to this day and I believe it was caused by chantix cuz I never had this problem before I think this drug should be taken off the market especially after reading everything I just read on here and also cause nausea and everything else for not only me but my husband had some side effects too ridiculous that they come out with a drug that could work but can kill you at the same time and I also had to polyps I’m battling that now too I believe it was all caused by chantix take this off the market

    Posted on March 31, 2021 at 2:50 pm

  • Donna says:

    On April 22 2021 I purchased the starter pack of chantix. One week later I started , years ago I took chantix and was able to be smoke free. Unfortunately due to life circumstances I started smoking again. So I gave it a try again this year. Did not have the same effect. Not only caused nausea but extreme vomiting. Iam on Xanax for anxiety and severe panic attacks which I take as needed. Once I finished the starter pack I suffered more anxiety and nightime panic attacks which would wake me up out of a sound sleep, very scary. Also did not decrease my urge for a cigarette like the last time I took it. I have RLS that has been dormant for years, when starting chantix this time my RLS came back causing me to take a Xanax at night to sleep. I experienced less patience with people and would loose my temper, so not like me I am a very empathetic kind person to all, even my dog who I love as my child got on my nerves. So after the starter pack and starting another month I stopped taking chantix. Sort of back to normal. Shortly after I got the notice of the recall. I probably would have continued as I had to pay over $400 for chantix as my insurance has a deductible for a tier 4 non generic drug, being on a fixed income this was an big expense for me. Unfortunately the recall does not offer a refund. I believe chantix caused my increased anxiety, panic attacks and inability to focus. What a shame as my doctor and I know other people’s doctors who recommended chantix. Not blaming the Doctor as this product has worked. Something is not right with this drug now and should be investigated. I wonder if the generic of it kind in Canada is having the same issue. When I called my pharmacy regarding the recall was told to call my primary care for a alternative or they said another script as they were getting the generic from Canada. Something needs to be done to Pfizer the manufacturer. At the very least people effective by this regardless of any side effects should be reimbursed for for the cost.

    Posted on August 22, 2021 at 1:53 am

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