Varenicline (Chantix)

Food & Drug Administration 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 Food & Drug Administration postmarketing cases describing suicidal ideation and occasional suicidal behavior. Food & Drug Administration 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.

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Aggressive and Erratic Behavior
Food & Drug Administration 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, Food & Drug Administration asked Pfizer for additional cases that might be similar. We are currently evaluating the material Pfizer submitted in response to our request.

Drowsiness
Food & Drug Administration 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.

Food & Drug Administration 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 Food & Drug Administration’s commitment to inform the public about its ongoing safety reviews of drugs. Food & Drug Administration 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. Food & Drug Administration is working to complete the analysis of the materials submitted by Pfizer. As soon as this analysis is completed, Food & Drug Administration will communicate its conclusions and recommendations to the public.

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Pfizer Strengthens Suicide Warning On Chantix Label
Drugmaker updates the label to reflect ongoing concern that the anti-smoking drug is connected to suicidal thoughts and behavior.

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• January 19, 2008 | Pharmalot

You may call last November, the FDA began reviewing cases of suicidal thoughts and aggressive and erratic behavior in Chantix patients that were received from Pfizer, along with a number of reports from the media and internet sites. At the time, the agency wrote on its web site that “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 taking Chantix.”

And so today Pfizer says its updated label includes a warning “that patients who are attempting to quit smoking with Chantix should be observed for serious neuropsychiatric symptoms, including changes in behavior, agitation, depressed mood, suicidal ideation and suicidal behavior.” No figures were immediately available on cases reported.

A notable example, however, that drew national attention to Chantix was the case of Carter Albrecht. While in a drunken rage, the Texas musician banged on the door of a homeowner, who feared an intruder, and shot and killed the young man. Although Albrecht was later found to have tested for a high level of alcohol, he’d also begun taking Chantix, the smoking-cessation drug, a week earlier and complained of vivid dreams. Hallucinations are noted as only a rare psychiatric disorder, but “Chantix dreams” were cited by Albrecht’s family and girlfriend as possibly contributing to his outburst.

The FDA, meanwhile, had asked Pfizer for on additional cases that may be similar. The agency is “currently evaluating the material Pfizer submitted in response” as well reports of drowsiness in people taking Chantix who had difficulty driving or operating machinery. We are awaiting an update from Pfizer concerning the info provided to the agency.