IS THE FDA'S INVESTIGATION OF CHANTIX (VARENICLINE) TOO LITTLE TO LATE?

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FDA has received reports of suicidal thoughts and aggressive and erratic behavior in patients who have taken Chantix, a smoking cessation product.

Suicidal Thoughts

The manufacturer of Chantix, Pfizer, Inc., recently submitted to FDA postmarketing cases describing suicidal ideation and occasional suicidal behavior. FDA currently is reviewing these cases, along with a number of recent reports in the popular press and internet sites. A preliminary assessment reveals that many of the cases reflect new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment. The role of Chantix in these cases is not clear because smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illness. However, not all patients described in these cases had pre-existing psychiatric illness and not all had discontinued smoking. (UPDATE: NEW FDA HEALTH ADVISORY ON CHANTIX) .

Aggressive and Erratic Behavior

FDA is aware of a highly-publicized case of erratic behavior leading to the death of a patient using Chantix to attempt to quit smoking. Although other factors, including alcohol consumption, appear to have played a part in this specific case, FDA asked Pfizer for additional cases that might be similar. We are currently evaluating the material Pfizer submitted in response to our request.

Drowsiness

FDA is evaluating reports from Pfizer of drowsiness in patients taking Chantix. Reports described patients who experienced drowsiness that affected their ability to drive or operate machinery.

FDA recommends the following:

• Healthcare professionals should monitor patients taking Chantix for behavior and mood changes.
• Patients taking Chantix should contact their doctors if they experience behavior or mood changes.
• Patients should use caution when driving or operating machinery until they know how quitting smoking with Chantix may affect them.

This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. FDA is working with Pfizer, Inc., to further evaluate the potential association between Chantix and suicidal thoughts, aggressive and erratic behavior, and impairment that affects one’s ability to drive or operate machinery. FDA is working to complete the analysis of the materials submitted by Pfizer. As soon as this analysis is completed, FDA will communicate its conclusions and recommendations to the public.

The FDA urges both healthcare professionals and patients to report side effects from the use of Chantix to the FDA's MedWatch Adverse Event Reporting program

• online at www.fda.gov/medwatch/report.htm
• by returning the postage-paid FDA form 3500 available in PDF format at www.fda.gov/medwatch/getforms.htm to 5600 Fishers Lane, Rockville, MD 20852-9787
• faxing the form to 1-800-FDA-0178
• by phone at 1-800-332-1088

An anonymous reader shares their experience with Chantix

I am writing after having been off of Chantix for 8 months, but I continue to have issues I did not have prior to taking this medication.
My experience: I took Chantix for 6 days in February, but developed the joint and muscle pain by the 6th day, and stopped taking it according to my dr's instructions. I did not make it to the 'quit' date.
While taking I also experienced euphoria, dissociation, and lethargy. 2 days upon stopping, I went into a complete meltdown of suicidal thoughts, depression, crying for no reason, panic, agitation, lack of concentration....it was a nightmare.
It took 2 antidepressants and something for anxiety to get my moods back in order somewhat...however, 8 months later I continue to have the joint pain, muscle stiffness (alot of people seem to be reporting this problem well after they stop the drug), but most disturbing to me are the mental effects.
I continue to have what is best described in the literature as bradyphenia, or delayed thinking (the information is there, it just seems to take longer to access it), mental confusion, and memory problems.
I have heard this argument... 'some problems can be associated from the person having quit smoking'. I did not quit smoking, so I cannot equate any of the problems I am having to nicotine cessation.
There needs to be stronger warnings to the possible severity of the mood issues, among other things. I know Chantix can affect one's dopamine levels, but would you have an opinion on if the memory issues could be caused by the fact that Chantix can also 'moderately' bind to the 5HT3 receptor?
Just looking for some answers.

• IS THE FDA'S INVESTIGATION OF CHANTIX (VARENICLINE) TOO LITTLE TO LATE?

• FDA URGES YOU TO REPORT SIDE EFFECTS FROM CHANTIX

• DEPRESSION, SUICIDAL IDEATION AND SUICIDE ATTEMPTS REPORTED IN PATIENTS USING CHANTIX

• *How Does Chantix Work? Common Side Effects?*
• *Chantix Testimonials*

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