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Quit-smoking drug linked to serious psychiatric side-effects: FDA

WASHINGTON - The U.S. Food and Drug Administration issued a public health warning Friday about a highly touted smoking cessation drug after it was linked to potentially serious neuropsychiatric symptoms.

Adverse effects have been reported in relation to the prescription medication Chantrix (varenicline), which is sold in Canada under the brand name Champix, including changes in behaviour, agitation, depressed mood, and suicidal thoughts and behaviour.

The FDA has requested that Pfizer, the drug's manufacturer, add the new safety information to the warnings and precautions section of the medication's prescribing information or labelling. The agency also is working with Pfizer to finalize a medication guide for patients.

"Chantix has proven to be effective in smokers motivated to quit, but patients and health-care professionals need the latest safety information to make an informed decision regarding whether or not to use this product," Dr. Bob Rappaport, director of the FDA's division of anesthesia, analgesia and rheumatology products, said in an advisory.

"Patients should talk with their doctors about this new information and whether Chantix is the right drug for them, and health-care professionals should closely monitor patients for behaviour and mood changes if they are taking this drug."

Chantix, approved by the FDA in May 2006 and as Champix by Health Canada a year ago, acts on sites in the brain affected by nicotine. The drug helps ease withdrawal symptoms and blocks the effects of nicotine if users resume smoking.

The FDA said patients should tell their doctors about any history of psychiatric illness prior to starting the drug, as it may worsen the condition, even if currently under control. It may also cause an old psychiatric illness to recur.

The agency noted that patients with psychiatric illnesses were not included in the studies conducted for the drug's approval.

Patients taking the smoking cessation aid should be alert for any changes in mood and behaviour, as should their families and health providers, said the advisory. Symptoms may include anxiety, nervousness, tension, depressed mood, unusual behaviours and thinking about or attempting suicide.

In most cases, neuropsychiatric symptoms developed during treatment with the drug, but in others, symptoms developed following withdrawal of therapy.

Patients taking the drug:

-Should immediately report changes in mood and behaviour to their doctor.

-May experience vivid, unusual or strange dreams.

-May have impaired ability to drive or operate heavy machinery.


Hi there. I just started 3 days ago, on that new smoking drug called ''Champix''
So far, no problems, but just started.......
I will watch out for any mood problems, as my Endo Dr. thinks I have the mild form of Bi-polor..and I'am not being treated for it at present, as feel I can handle any mood swings I have with exercise, meditation, good diet, ect.

It makes me nervous to hear this, hope I'am one of the lucky ones, who can quit, without any of the side-efects...during, and after...thanks so much for posting this....Kathy:



It's not unusual for a new medication to exhibit reactions not seen during human trials prior to the medication's approval and release, mostly because the exposure is to a much broader cross section of the population.

As you have stated, keep in touch with your prescribing doctor, and report any untoward effects you might experience.

Did you say your prescribing physician is an endocrinologist?

I have the mild form of Bi-polor

Has this been officially diagnosed by a specialist?

You may consider requesting a referral to a psychiatrist who can evaluate the degree of your mood disorder and can help you monitor any mood changes that may or may not be caused by Champix.

Work closely with your doctor on this one.


I too was thinking of going on Champix to help me in my battle to quit smoking.The article raises some red flags for me.When I tried Zyban to quit smoking,it had adverse effects that sent me to hospital and I hope this one wont be the same


IMO the use of smoking therapeutic aids should be used in consultation with a specialist such as a psychiatrist. The pharmacology of these meds is well understood by physicians in psychiary.

This in addition too the fact that a psychiatrist can assess any other relevant disorder or condition which might need to be considered, and any other medication which may interfere with the smoking treatment which may need to be adjusted.

Psychiatrists are experts in these medications and can fine tune the dosages of a combination of medications to achieve the best effectiveness for each patient with the minimum of adverse reactions.


Thanks for your suggestions. I was seeing my Endo(I have thyroid issues) and he knows me well, as I used to work in a hospital, and worked with this Dr. He thought 2 yrs. ago, that I had Bi-Polar disease, he then referred me to a Psych, this Dr. ordered 2 meds(forget the names) and I stayed on them for 3 months, and just got so much worse...anxiety, anger, depression..all got worse, so I took myself off it very slowly, and felt so much better after.
This yr. when I went to see him, he says he thinks I have the mild form of I am doing a mood chart by myself, and still don't really believe I have this. The reason I think this, is because I also have chronic fatigue, and fibromyalgia, and with this alone, your mood can change, and to me, its mostly because the lack of sleep, and the horrible pain.
To help myself, I do guided meditations, exercise, and just try to keep a positive attitude...this has helped me more, than those medications.

Sometimes I think some Dr.'s don't look at the whole health history, before making another diagnosis...thats just my view...but I'am sticking with it.


Sometimes I think some Dr.'s don't look at the whole health history

Information may be missed if it is not made available for the consulting physician.

There may be some physicians, as you allude to, who for various reasons may not review the entire patient's history, but I would submit these would be in the vast minority.

When referred to a consulting physician, it's up to the patient to ensure the consulting physician has all the details of one's medical history available. This can be done by consolidating history collected from one's Family Physician, any other consulting specialists, along with copies of all recent diagnostic testing.

IAC your Family Physician should have copies of all reports from your consulting specialists, if you have worked with your Family Physician as your hub.

We must be full partners in our health care, so each one of us must ensure there is one location where there exists a complete and up to date medical history which can be photocopied and sent to whichever consultant requires it.

As a partner in your healthcare, you should also keep at home in your personal file, photocopies of all diagnostic test results going back at least five years. Your doctor should provide these to you at no charge, and this information can prove invaluable in many situations when medical details are needed.

I would have reservations about an endocrinologist providing a diagnosis for bi-polar disorder, and would feel more comfortable being seen by a specialist in psychiatry.

Is there any reason to prevent you from consulting a psychiatrist at this time?


Hi asked if there was any reason I am not seeing a psychiatrist at this time. I really do not see the need for one. I truly believe that if my moods change, its because I didn't sleep at all(re:pain from arthritis, fibromyalgia).

I have been keeping a mood chart, and every time I am down in energy, its because I didn't sleep the night before, and its always because of pain. I even chart if my energy is down, and I am depressed(have little codes on the calender. The only time I have decreased energy and depression, is if the lack of sleep and pain has been going on for more than a few me this would make anyone feel tired and out of sorts.

I did mention that I did see a psychiatrist, and went on 2 different meds. and just felt I don't think Bi-polar is the correct diagnosis for me.

I always give a print-out sheet of all my health problems, surgeries, allergies, to every Dr. I see, and medications I am taking, and herbs I am taking.

I learned while going thru CPP, to keep files on myself, and get all tests/lab-work, etc. for myself to file.

I came to this site to find out more about that mild form of Bi-polar, and how others deal with it...I'am forgetting the name right now...but still don't think I have it.....and didn't care for the last psychiatrist I saw, as I said, he seemed to forget that I also have fibromyalgia, and chronic fatigue?

Thanks for your input...this is a very good site....Kathy


Hi ''Into the light''...yes, thats the name...'cyclothymia'' I've done alot of research on this, I could have it, or not???
I do not feel the need for any medication for myself at this time, as don't feel I need it..thanks for responding so quickly...Kathy
if you don't feel you need it, that's ok, you know yourself best. if however at any time your mood swings are causing you distress it might not be a bad idea to look into what may be going on - not that it necessarily is cyclothymia.

all the best :)
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