FDA Announces New Warnings on Chantix, Zyban and Wellbutrin
July 31, 2009
As 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.
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11 Responses to “FDA Announces New Warnings on Chantix, Zyban and Wellbutrin”
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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.
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
[...] Wellbutrin is used to treat depression, seasonal affective disorder (SAD), attention deficit hyperactivity [...]
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.
[...] Lyme disease, or could be side effects associated with certain medications, such as Chantix and Welbutrin. Below is a list of diseases and conditions associated with symptoms like Suicidal Thoughts and [...]
[...] Wellbutrin (bupropion) is used to treat depression and seasonal affective disorder (SAD). Under the brand name [...]
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.
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.
I would like to know about chantix and alcohol
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.
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.