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Title: FDA Reviewing Post-Marketing Cases Describing Suicidal Ideation and Occasional Suicidal Behavior With Chantix (Varenicline)

"FDA Reviewing Post-Marketing Cases Describing Suicidal Ideation and Occasional Suicidal Behavior With Chantix (Varenicline)"

BETHESDA, MD -- November 20, 2007 -- The U.S. Food and Drug Administration (FDA) informed healthcare professionals of reports of suicidal thoughts and aggressive and erratic behavior in patient who have taken Chantix (Varenicline), 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. SOURCE: U.S. Food & Drug Administration

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