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The FDA has notified the public that the smoking cessation aid Chantix (varenicline; Pfizer) may be associated with a small, increased risk of certain cardiovascular events in patients with cardiovascular disease.

The FDA has notified healthcare professionals and patients that it has required manufacturers of varenicline (Chantix, from Pfizer) and bupropion (Wellbutrin, Wellbutrin SR, Wellbutrin XL, and Zyban, from GlaxoSmithKline) to add new Boxed Warnings to the product labeling and develop patient Medication Guides highlighting the risk of serious neuropsychiatric symptoms.

The labeling for Chantix (varenicline tartrate, from Pfizer) has been updated with a warning to observe patients for serious neuropsychiatric symptoms, including changes in behavior, agitation, depressed mood, suicidal ideation and suicidal behavior.