Chantix (varenicline) safety being reviewed by FDA

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The issue of Chantix safety and particularly its potential psychiatric side effects have been previously discussed on this blog with many informative comments from Chantix users and their family members:
"Chantix: how does this new stop smoking medicine work?” 4/15/07
http://www.healthline.com/blogs/smoking_cessation/2007/04/chantix-how-does-this-new-quit-smoking.html
“Chantix and mental illness: what are the facts?” 08/12/07
http://www.healthline.com/blogs/smoking_cessation/2007/08/chantix-and-mental-illness.html
“Two new studies of Chantix (varenicline)”. 8/19/07
http://www.healthline.com/blogs/smoking_cessation/2007/08/two-new-studies-of-chantix-varenicline.html
"Does Chantix cause mental health problems?" 9/20/07: http://www.healthline.com/blogs/smoking_cessation/2007/09/does-chantix-cause-mental-health.html
Immediate and delayed quitting. 10/14/07: http://www.healthline.com/blogs/smoking_cessation/2007/10/immediate-and-delayed-quitting.html

On November 20th, the US Food and Drug Administration issued an announcement regarding an ongoing safety review of Chantix, focusing on potential effects on suicidal thoughts, aggressive behavior and drowsiness. The full text of yesterday’s announcements by FDA are attached in quotes below.
This will likely get some more headlines in the media and it is important that consumers and patients understand what this announcement means, and don’t over-react.
This “early communication” is simply stating that FDA are analyzing additional data on the potential link between Chantix and these potential side-effects. It has not concluded that there is any causal relationship and FDA is not recommending that doctors stop prescribing Chantix, nor that patients stop taking it, unless they have reason to believe that they are starting to experience potentially dangerous side effects of the medication,. In that case patients should discuss this with their doctor, bearing in mind that irritability and depression are nicotine withdrawal symptoms that commonly occur on stopping smoking without any medication. The FDA announcements are inside the quotation marks below:

Chantix (Varenicline)
Audience: Healthcare professionals, consumers[Posted 11/20/2007]
FDA informed healthcare professionals of reports of suicidal thoughts and aggressive and erratic behavior in patient who have taken Chantix, a smoking cessation product. There are also reports of patients experiencing drowsiness that affected their ability to drive or operate machinery. FDA is currently reviewing these cases, along with other recent reports. 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 the cases had preexisting psychiatric illness and not all had discontinued smoking. Healthcare professionals should monitor patients taking Chantix for behavior and mood changes. Patients taking this product should report behavior or mood changes to their doctor and use caution when driving or operating machinery until they know how quitting smoking with Chantix may affect them. [November 20, 2007 - Ongoing Safety Review: Varenicline (marketed as Chantix) - FDA][November 2007 - Prescribing Information - Pfizer] :”

“This information reflects FDA’s current analysis of available data concerning these drugs. Posting this information does not mean that FDA has concluded there is a causal relationship between the drug products and the emerging safety issue. Nor does it mean that FDA is advising health care professionals to discontinue prescribing these products. FDA is considering, but has not reached a conclusion about whether this information warrants any regulatory action. FDA intends to update this document when additional information or analyses become available.
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.
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 “
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About the Author


MA, MAppSci, PhD

Dr. Jonathan Foulds is an expert in the field of tobacco addiction.

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