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Medication Safety Alert

November 20, 2007

ISSUE:Reports of suicidal thoughts, aggressive and erratic behavior in patients taking medication
MEDICATION:Varenicline (Chantix®), 0.5mg and 1mg oral tablets

The following was posted on FDA Med Watch alert website dated November 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."

An excerpt of the FDA’s "Early Communication of an Ongoing Safety Review" is provided below:
"FDA has received reports of suicidal thoughts and aggressive and erratic behavior in patients who have taken Chantix."

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.

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."