On February 1, 2008, the Food and Drug Administration (FDA) issued a Public Health Advisory detailing new safety warnings concerning Pfizer’s smoking cessation drug Chantix. The advisory arrives in the aftermath of 491 reports of suicidal thoughts and 37 reports of suicide in Chantix patients worldwide, received through the FDA’s adverse event reporting system.

In November of 2007, the FDA began investigating the association between Chantix use and neuropsychiatric symptoms evidenced in adverse event reports such as changes in behavior, agitation, depressed mood, suicidal ideation, and actual suicidal behavior. As the agency’s investigation continues, the FDA has requested that Pfizer make the warnings and precautions on Chantix labels more noticeable.

Approved by the FDA in 2006, Chantix is a smoking cessation drug that works by acting at sites in the brain affected by nicotine. The Public Health Advisory and Health Care Professional Sheet issued by the FDA emphasizes the following safety information for patients and health care professionals:

• Patients should inform their health care provider about any history of psychiatric illness prior to starting Chantix.
• Chantix patients should be aware of and monitor any changes in mood and behavior.
• Patients should immediately report changes in mood and behavior to their doctor.
• Vivid, unusual, or strange dreams may occur while taking Chantix.
• Impairment of the ability to drive or operate heavy machinery may be experienced by Chantix patients.

Sources: “FDA issues public health advisory on Chantix,” Food and Drug Administration Press Release, February 1, 2008; Matthew Perrone, “FDA: Chantix may pose psychiatric risks,” Kansas City Star, February 1, 2008 (http://www.kansascity.com/438/story/471379.html).