In early 2008, the FDA issued a Public Health Advisory on the smoking cessation drug Chantix. Chantix, also known as varenicline, is manufactured by Pfizer. In late 2007, the FDA issued an Early Communication to the public and healthcare providers notifying that postmarketing adverse event reports were being evaluated. These reports related to changes in patients’ behavior, agitation, depressed mood, suicidal ideation, and actual suicidal behavior.
In the 2008 Advisory, new safety warnings were emphasized, emphasizing concern about worsening of current psychiatric illnesses or a depressed mood, and unusual behaviors.
Chantix was only approved by the FDA in May 2006 as a smoking cessation drug. It acts at sites in the brain affected by nicotine.