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In 2009, the FDA required black-box warnings for the smoking cessation medications varenicline (Chantix) and bupropion (Zyban) stating that they might cause serious neuropsychiatric adverse events; the drugs' manufacturers were required to assess this risk in a randomized controlled trial. More than 8000 motivated adult smokers (82% with at least 1 attempt to quit; mean cigarettes daily, ≥10) were randomized to receive varenicline, bupropion, transdermal nicotine patch, or placebo for 12 weeks. All patients received counseling and agreed to stop smoking within 1 week of randomization; patients were followed for 12 weeks after treatment ended. Half the participants met DSM-IV-TR criteria for psychiatric disorders but were clinically stable; …