FDA Cites Suicide Ideation in Smokers Taking Varenicline (Chantix)


ROCKVILLE, Md., Nov. 20 -- The FDA said today it has received reports of suicidal thoughts and aggressive and erratic behavior among patients taking varenicline (Chantix) as an aid to quitting smoking.
In what it characterized as an early communication about an ongoing safety review, the agency it was reviewing recently submitted post-marketing reports of cases describing suicidal ideation and occasional suicidal behavior among patients taking varenicline, plus similar press reports and others on 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 FDA said.
"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."
The FDA also said it was 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."
In addition, the FDA said it was "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."
As a result, the FDA said health care professionals "should monitor patients taking Chantix for behavior and mood changes," patients taking varenicline should get in touch with their doctors if they experience behavior or mood changes, and "patients should use caution when driving or operating machinery until they know how quitting smoking with Chantix may affect them."
The FDA said it was "considering, but has not reached a conclusion about whether this information warrants any regulatory action."