Chantix® and Suicide Ideation
As a result of receiving numerous reports of suicidal thoughts and suicidal behavior associated with the use of Chantix®, the FDA ordered Pfizer, the manufacturer of Chantix®, to add a stronger warning to the Chantix® prescribing information and patient information sheet. The regulatory history related to this label change actually began in 2007.

On November 20, 2007, the FDA issued an “Early Communication About an Ongoing Safety Review of Varenicline (marketed as Chantix)”. In its “Early Communication,” the FDA stated:

“The manufacturer of Chantix, Pfizer, Inc., recently submitted to FDA postmarketing cases describing suicidal ideation and occasional suicidal behavior. FDA is currently reviewing these cases, along with a number of recent reports in the popular press and internet sites. 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 FDA recommended that healthcare professionals should monitor their patients who are taking Chantix® for mood and behavioral changes. It also urged Chantix® patients to contact their doctors if they experienced mood or behavioral changes and to use caution when driving or operating machinery.

            Following up on this “Early Communication,” on May 16, 2008 the FDA issued a public health advisory in which it announced that the Chantix® prescribing information (labeling) and patient information was being revised “to include warnings about the possibility of severe changes in mood and behavior in patients taking Chantix®. The FDA’s public health advisory included the following highlighted guidance:

• Patients should tell their doctor about any history of psychiatric illness prior to staring Chantix®
• Healthcare professionals, patients, patients’ families, and caregivers should be alert to and monitor for changes in mood and behavior in patients treated with Chantix®.
• Patients taking Chantix® should immediately report changes in mood and behavior to their doctor.
• Patients taking Chantix® may experience vivid, unusual, or strange dreams.
• Patients taking Chantix® may experience impairment of the ability to drive or operate heavy machinery.

Slightly over a year later, on July 1, 2009 the FDA announced “that it is requiring manufacturers to put a Boxed Warning on the prescribing information for the smoking cessation drugs Chantix (varenicline) and Zyban (buprpion). The warning will highlight the risk of serious mental health events including changes in behavior, depressed mood, hostility and suicidal thoughts when taking these drugs.” A Boxed Warning is the most serious form warning for prescription medications.

If you or a loved one have developed diabetes or pre-diabetes, or suffered physical self-harm after taking Chantix® and would like us to evaluate the situation, click HERE.

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