Chantix Suicide Risk

January 2008 - Pfizer Updates Chantix Warning Label

Neuropsychiatric Symptoms

Serious neuropsychiatric symptoms have occurred in patients being treated with CHANTIX. Some cases may have been complicated by the symptoms of Nicotine withdrawal in patients who stopped smoking; however, some of these symptoms have occurred in patients who continued to smoke. All patients being treated with CHANTIX should be observed for neuropsychiatric symptoms including changes in behavior, agitation, depressed mood, suicidal ideation and suicidal behavior. These symptoms, as well as worsening of pre-existing psychiatric illness, have been reported in patients attempting to quit smoking while taking CHANTIX in the post-marketing experience. Patients with serious psychiatric illness such as schizophrenia, bipolar disorder, and major depressive disorder did not participate in the pre-marketing studies of CHANTIX and the safety and efficacy of CHANTIX in such patients has not been established. Patients attempting to quit smoking with CHANTIX and their families and caregivers should be alerted about the need to monitor for these symptoms and to report such symptoms immediately to the patient's healthcare provider.

Novevember 2007 - FDA Release

FDA has received reports of suicidal thoughts and aggressive and erratic behavior in patients who have taken Chantix, a smoking cessation product.

Suicidal Thoughts

The manufacturer of Chantix, Pfizer, Inc., recently submitted to FDA postmarketing cases describing suicidal ideation and occasional suicidal behavior. FDA currently is 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 role of Chantix in these cases is not clear because smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illness. However, not all patients described in these cases had pre-existing psychiatric illness and not all had discontinued smoking.

Aggressive and Erratic Behavior

FDA is aware of a highly-publicized case of erratic behavior leading to the death of a patient using Chantix to attempt to quit smoking. Although other factors, including alcohol consumption, appear to have played a part in this specific case, FDA asked Pfizer for additional cases that might be similar. We are currently evaluating the material Pfizer submitted in response to our request.

Legal Rights for Chantix Injury Victims

If you or a loved one injured themselves while taking Chantix you may have valuable legal rights. Mark & Associates, P.C. offers a free case consultation to all Chantix users and their families. To learn about your legal rights, please call 1-866-507-4448 or submit an evaluation form on the right side of this page.