Chantix Reports of Suicidal Thoughts and Aggressive and Erratic Behavior..

November 21, 2007 - CHANTIX™ (also Champix) (varenicline) is non-nicotine prescription medicine specifically developed to help adults quit smoking. CHANTIX contains no nicotine, but it targets the same receptors that nicotine does. CHANTIX is believed to block nicotine from these receptors. Studies show: At the end of 12 weeks of CHANTIX, 44% were able to quit smoking. It also helped reduce the urge to smoke. (From According to boasts by Pfizer, the drug's maker, "approximately one-in-five" users quit smoking for a year.) Posted 11/20/2007 - FDA informed healthcare professionals of reports of suicidal thoughts and aggressive and erratic behavior in patient who have taken Chantix. 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. The FDA recommends that healthcare professionals 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.