FDA Announces New Warnings on Chantix, Zyban and Wellbutrin

Chantix warnings and side effectsAs reported in this recall alert from November 2007, the drug varenicline (marketed as Chantix and used to help patients quit smoking) has been associated with troubling neuropsychiatric symptoms, such as suicidal thoughts and rage. The the comments section on that page for substantiating anecdotal reports from our readers.

New FDA analysis of adverse event reports shows that when neuropsychiatric symptoms occur, they usually develop during drug treatment, but symptoms can also develop after the drug is stopped. In addition to varenicline (Chantix), FDA is also warning of similar side effects associated with bupropion (Zyban, Wellbutrin) and generic forms of the drug, prescribed to help patients quit smoking.

FDA is now requiring the manufacturers of these smoking cessation aids to add new Boxed Warnings and develop patient Medication Guides highlighting the risk of serious neuropsychiatric symptoms in patients using these products.

The FDA has advised helathcare professionals to tell patients to stop taking varenicline / Chantix or bupropion / Zyban and to contact a healthcare provider immediately IF they experience any sort of mood swing or changes in behavior that are not typical of nicotine withdrawal.

According to MedlinePlus, a service of the US National Library of Medicine and the National Institutes of Health, symptoms of nicotine withdrawal include cravings, tension, irritability, difficulty concentrating, trouble sleeping and increased appetite, but they do not list suicidal thoughts or bouts of intense rage as withdrawal symptoms typical when smokers try to quit smoking. If you experience these symptoms while taking drugs like Chantix, Zyban or Wellbutrin, health professionals have been told by the FDA to advise you to quit taking the drugs right away and to contact your doctor to discuss the symptoms.

(Editor’s Note) I tried every quick-smoking gimmick in the book for about a decade: Patches, Pills, slowly going off, sudden cold turkey. Most of them worked temporarily, but none of them made me a “non-smoker”. I would still think about smoking and feel like I was missing out on something. Then I read a book called The Easy Way to Stop Smoking and it changed my whole outlook. I continued to smoke while reading the book, as instructed, but by the time I got to the end I really, honestly, truly did not want a cigarette anymore. The best thing about it was I didn’t miss them one bit. It really WAS easy. Just thought I’d pass that along in case any of you are going through what I was going through at the time. I haven’t smoked in about five years now.

About

Everett Sizemore is the owner and Editor of US Recall News: http://www.usrecallnews.com. He is dedicated to educating people about consumer safety, social activism and corporate responsibility by bringing information to Americans about the products they use every day.

There are 19 comments. Add yours.

  1. Glendora Teague

    I started taking Chantix in September of this year and at first it worked great. I had been smoking for more than 20 years and more than a pack a day so I was determined to quit. After the first week I felt great I was smoking maybe 1 or 2 cigarettes a day and no side effects other than some vivid dreams. I was very impressed as I felt 100% better. I continued taking as directed and while I still had cravings I could tolerate them. After my 5th dose pack I started feeling very confused and angry and I have never been an angry person. I have always been very patient and had a good memory and all at once I couldn’t keep my thoughts straight and couldn’t remember anything. I did quit smoking but I felt as if I was losing my mind. I had no choice but to quit taking this medication. It has been about a month since I quit taking the Chantix and I feel like I am getting back to normal again of course I am smoking again(1-2 cigarettes a day) I would not recommend this med to anyone but then everyone is not affected the same way.

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  2. christina

    Just wanted to cooberate what the editor said about the book The Easy Way to stop smoking. It worked for myself and two of my friends I passed it on to. Each of us was a half pack day or more smoker. For any of you desperate to quit, try this. It is way cheaper than the chantix and you won’t try to strangle anyone.

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  3. musicman

    I began taking Bupropion HCL about 3.5 weeks ago. After 2.5 weeks, I suddenly started smelling cigarette smoke everywhere I went, even when I knew darn well there was no cigarette smoke around. I am taking it for depression, not smoking cessation. I wonder if this is like Bama who had a car exhaust smell in his/her nostrils. It’s faded a bit in the past few days – I just hope it doesn’t persist even after I stop taking the medication.

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  4. Vickie Sales

    I was diagnosed with major depression in 2000. Nothing would make me happy, not even drugs or alcohol. I was 5yrs sober and crying everyday. I thought I was doomed. I had tried all the SSRIs, which none of them worked. When I was taken the SSRIs I felt the same(depressed) and never did have any withdrawal problems. In 2002 I started the treatment for Hepatitis C and the treatment caused more depression. (I had lied to my Doctor about my continuing depression and was not seeing a good Psy. Doctor). Needless to say, that was the wrong thing to do. I relapsed on a powerful street drug for one night and almost got killed by some man betting me up. I committed myself that day, which turned out to be the best thing that every happened to me. My Psy. Doctor put me on Wellbutrin and told me I should have been on it in 2000. The other regular Doctors thought it would harm my liver. Within the first few days of taking it, I know I was on the road to recovery. I had forgot what it was like to feel normal (that was at age 10). Only, by the grace of God, I have been sober now for 7yrs. I have gone through some pretty stressful things and I handled them like a normal person. I had 4yrs free from cigarettes too. I one day guit with no withdrawals. My family was totally amazed because of all the years it took for me to quit drugs.
    I have PMS problem and my Psy. Doctor decided to try something else. Wrong thing to do. My depression came back just like it was before . Some could say I was withdrawing, but I knew better. It was my sickness returning. I started back smoking and I called the Psy. Doctor that day. He order me back on wellbutrin. It is now two years later and I am just now starting to feel better. I never did go over six cigarettes a day. January, I was able to put them down aging, but I have smoked one when I was upset. They make me sick to my stomach now.

    Depression medicine is nothing to fool around with and it needs to be monitor by a qualified Doctor. My regular Doctor is not 100% qualified for this. Antidepressant is not for everybody and it can be a long road to find what dose work. Just because I have to take it everyday dose not mean that I am addicted to it. I know what that is like. It means that my brain dose not make dopamine. Just like the pancreases can stop making insulin. Is a diabetic addicted to insulin? No! They have to take it to stay alive, just like I have to take antidepressants to stay alive. I was insane before wellbutrin, I am sane with wellbutrin and without it I will be insane aging.This insanity will kill me or someone else will.
    I felt angry when I saw the law suits against these drugs.The more lawsuit that win the more I have to pay for what makes me better. I have a friend with OCD and she will not take her paxil because of these lawsuit. She is normal on them, but with out them she drives us all crazy, because we love her and we don’t want to see her hurt or hurt herself. She is the reason I found this site. I am glad to get my side of the story out.

    c

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  5. Cynthia Jones

    I quit smoking with Chantix November 18, 2009. What a blessing Chantix has been for me. The only side-effect I had from it was constipation and that’s it. You are allowed to smoke the first week while taking Chantix & then the 7th day is your quit date.

    I actually was a bit afraid to quit because I had smoked a pack-and-a-half a day for 18 years & the idea of never being able to smoke again was a bit scary (part of the psychological addiction to smoking). However, on the 8th day I bit the bullet & did it. I have been smoke free every since.

    *Noteworthy is that during the first week of treatment while I was still allowed to smoke I had cut way down from the usual 20 to 30 cigarettes per day to maybe 2 or 3.

    Also, I only took the Chantix for 2 months & have been off it now for 1 months. I still have not developed any negative side-effects….no nightmares or anything. Every person is different but it worked wonders for me and after 3 months of being smoke-free, I have no intentions of EVER picking up another cigarette again.

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  6. Gina

    I took Chantix for the firt time in April 2009. I quit for 8 months, not one single cigg. during those 8 months. On Christmas Eve 2009, I smoked…tht one cigg led to another and within a week, I was smoking again. I am now taking Chantix again, and as I expected..It is working.. I have not smoked in 3 days and I will Neer smoke again. I now realize that even after 8 months of not smoking, with the treatment via Chantix…it is still very easy to fall back into your old ways. So I caution anyone out there…If U have successfully quit smoking using Chantix, please do not think it changes the way you react if you smoke again…your addiction will take over..again.

    My complaints this go-round are irritability and bad dreams. Totally the opposite from the firt time I took it. I am not enjoying my dreams, whereas, last time, I looked forward to the amazing dreams I knew I would have that night. It was that predictable… Chantix also increased my appetite last time…I gained 10lbs. This time, my appetite is decreased… I do get nauseated sometimes, and I don’t want to eat.. I drink tons of Very Vanilla soymilk and that helps =).

    Anyway, I love Chantix and I can tolerate the side-effects, if it means that I can call myself a “non-smoker”

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  7. chris

    hubby taking chantix for smoking but i noticed right away he cut back on his drinking. good thing. however, i noticed that if does drink too much while taking his chantix that he gets very irritable and upset. it is not a pleasant time. i don’t know what’s worse, his drinking daily and dealing with that or the occasional nasty day while taking chantix. once when he quit the chantix, it was very noticble how much he was drinking again. he does have a problem with smoking and drinking. without the chantix its worse.

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  8. Dawn

    I’m on day 15 of Chantix & I’ve been smoke free for 4 days. I, too, still have VERY MINIMAL cravings but they are triggered by my routine of scheduled smokes. ie. after coffee, after eating etc… It’s getting easier and I have actually lost weight. I smoked 2 packs a day for 25 years and do consider this a miracle pill. I did NOT want to quit! I enjoyed smoking but due to a smoking related health issue, I had to quit. I have not had any side effects either. Give it a shot if you have even the smallest desire to quit!

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  9. Heather

    I am on day 11 of using Chantix. I smoked the first 7 days since it is allowed, then stopped on the eighth day. I was a 1/2 pack a day smoker for 30 years. During the first week, I smoked less without even trying. It’s only been 4 days, and I do have some cravings for a cigarette, but it is the normal triggers that cause them…after eating, talking on the phone, driving in the car. This is the first time these urges have been manageable and I have very little will power, I am also on Wellbutrin for depression. I’ve had some weird dreams, but nothing scary. I’ve had some issues sleeping, but I always have had sporadic bouts of insomnia. I have not experienced any unusual smells and I rarely drink so can’t comment on using alcohol while taking it.. I am very concerned about relapsing when I do have drinks or am around smokers so I’m keeping away from thise situations.

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  10. Bama

    I took bupropion for approx. 5 wks for depression and developed a smell like car exhaust in my nostrils. I’ve been off the drug since July and I still smell this unpleasant odor. My psychiatrist, who prescribed the drug, declines any knowledge of this side effect and has “never heard of such a thing”. I wonder if anyone else has had this experience. Wonder what to do to get rid of this.

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  11. Sue Howley

    Further to my previous comment. I took it a second time having relapsed several years later. This time I was well aware of how it might make me feel. Forewarned is forearmed as they say.

    I tried staying on half dose but even on the reduced loading it began having the same effect so this time I stopped taking it at the end of week 2. By which time, I’d stopped smoking so job done.

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  12. Sue Howley

    I tried Zyban (buproprion) twice as a smoking cessation strategy. It really helped me to quit. It also me feel quite stimulated.

    At first this was quite nice, lots of energy,despite the disturbed sleep. As each day progressed, however, the feeling became less pleasant. Two weeks in and I was feeling totally wound up, having a hard time controlling my temper. I’m not known for displays of anger, let alone full blown rage.

    By week 3, I’d had two nasty arguments with close friends within days of each other. I just had to stop taking it as the rage I was feeling was so disproportional to the provocation that I didn’t recognise myself anymore. I was like a person possessed.

    I am by the way of sound mind, Rita. This is just the way it affects some people. I think there’s a role for these drugs to play in smoking cessation but people need to realise it doesn’t necessarily suit everyone and to stop taking it if it starts affecting them like this.

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  13. E. Sizemore

    The FDA recently stated that analysis of data shows these major side effects can start happening AFTER patients stop taking the drug in rare cases. See the link in paragraph #2 regarding Chantix, Zyban, Wellbutrin and other varenicline and bupropion drugs used to help you quit smoking.

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  14. judy

    It does not say in the instructions weather you can smoke while taking chantix are you supposed to just take the 1st pill and not smoke again I find that hard to believe. If someone could answer this question for me I would appreciate it for I have not started the meds yet 8/16/09

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  15. Rita St. Clair

    I was a 2 pack a day smoker for a long time and enjoyed every one that I smoked until last January when a 60 year old friend of mine died from emphysema. He was carrying an oxygen tank around with him and continued to smoke until he died. I started thinking about quitting at that time but didn’t because I enjoyed it so much and it helped keep me from putting on weight which is something women do not want to do. I would smoke instead of eat. Being 65 years old and also diabetic, I talked with my doctor in April, 2008, about a drug called Chantix that a friend of mine had taken and had quit smoking. My doctor wrote me a prescription for Chantix and I held onto it for a while as I was not sure I wanted to quit smoking. The pamphlet in the Chantix package said to choose a certain date to start the Chantix and start on that date. It also stated that you could smoke the first week that you were taking Chantix but not to smoke and take it after the first week. Well, I chose May 1 as my start date. By May 3, I did not want to smell smoke, see a cigarette, smell anyone who smoked, or have anything to do with cigarettes. It was amazing how it worked on me. Someone who didn’t think she would ever quit and really didn’t plan to until my friend died.
    I know that the FDA has said that Chantix is not really something they want to leave on the market but I surely hope that anyone who might read this and really, truly feels that they are of sound mind would not go wrong by taking Chantix. I only had one of the symptoms and that was the lucid dreams. I normally don’t dream at all but I had several wild and crazy dreams while I was on the Chantix.
    I am so thankful that I have been quit now for 14 months and don’t even think about smoking. As a matter of fact, I sometimes wonder how I ever smoked at all. I don’t worry about getting close to people because I know that I don’t smell like smoke and my husband says he doesn’t have to smell my smoky hair at night in the bed (LOL). Thank you, Chantix, and I hope the FDA leaves you alone.

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