Thursday, July 2, 2009

Chantix FDA Warning

The Food and Drug Administration has recommended a safety labeling change for varenicline( Chantix) which is manufactured by Pfizer and is used as an aid to nicotine cessation. This seems to me to be a good idea as it has been known to have psychiatric side effects in some people.

My experience with Chantix has been mixed. It clearly is effective and has worked for a number of my patients who were motivated to quit smoking. But I had a few experiences that have taught me a few lessons and made me more cautious about prescribing this medication. One case is that of Mrs.G, a 45 year old woman who was at Cottonwood for treatment of alcoholism. She had a history of depression and was on antidepressant medication although she was not depressed at the time of admission. She was doing quite well in treatment and understanding the link between tobacco use and alcoholism decided to quit smoking while she was here. She had tried quitting before with the help of the nicotine patch but was unsuccessful so I prescribed Chantix. About one week later she went into a profound depression which was worse than she had ever had before. There had been no apparent psychological trigger so we discontinued the Chantix and about 5-6 days later the depression had resolved completely. Fortunately she was able to quit smoking, used the nicotine patch again and was successful this time.

Not that long afterwards I had a similar experience with Mr. S., a 38 year old man who was at Cottonwood for treatment of polysucbstance dependence. He had a concurrent anxiety disorder which we treated along with his substance abuse problem. He did not want to attempt to quit smoking here but was doing well at the time of discharge so he decided it might be a good time to quit. I prescribed Chantix for him at the time of his going home and did warn him about the possibility of return of anxiety or depressive symptoms while taking Chantix. He called me in a frantic state about 10 days later saying he had a severe exacerbation of his anxiety disorder. I recommended he stop taking the Chantix and several days later his anxiety resolved. Interestingly enough to me he had not recalled our previous conversation about Chantix side effects. This taught me two lessons, first to not prescribe any new medication as the patient is leaving, and secondly a reminder that many patients have too much to remember and may not remember verbal instructions.

It has been known since February of 2008 that some people on Chantix develop behavior changes, depression, or suicidal thoughts. The manufacturer Pfizer did not attempt to hide this data but immediately made changes in the product labeling to include these side effects. What is new in the FDA recommendation is that Chantix carry a "black box " warning in the prescribing instructions. The black box warning means that this information is highlighted in bold letters in a black box which is the first thing a prescriber will see when looking up the medication.

Does this mean Chantix should not be used? This information about Chantix needs to be taken to account in the context that tobacco related illnesses are by far the greatest cause of death in the United States. The people that I see at Cottonwood though may represent a high risk group for psychiatric side effects so will continue to use Chantix only when other smoking cessation efforts fail.

Thought for the day

I will say it once more. All medical treatments carry some risk as well as their benefits.


  1. I think chantix is working wonderfully for me, I have had some odd dreams and a little trouble falling alseep but I have not actually desired a cigarrett for almost a week now. Worth it in my book.

  2. My husband and I both took chantix at the same time about 3 years ago. Minus upset stomachs, we thought it worked great. We then realized that neither of us could pay attention to anything. We couldn't even read a paragraph. Neither of us had ever had this sort of problem before.We called it "Chantix ADD" Although it is not as severe as when we first stopped taking the drug, it is still very debilitating at times. We are still smoke free though. Take your chances. It all depends on what is important to you. I would personally like my concentration back.


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