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Researchers Find Smoking Cessation Drug Varenicline Does Not Increase Suicide Risk

September 13, 2013

 Contact:         Dacia Morris


(212) 543-5421





(New York, NY—September 13, 2013)—An analysis of 17 placebo-controlled randomized trials found that varenicline, a medication FDA-approved for smoking cessation, was not associated with suicide risk. The results, published online in the American Journal of Psychiatry on September 13, 2013, are striking in light of the FDA’s 2009 black-box warning for varenicline stating its possible link to depression and suicide.


To assess varenicline’s safety as a smoking-cessation treatment —as well as any associated risk of increased suicidal thoughts and behavior, depression, aggression/agitation, and nausea—J. John Mann, MD, Paul Janssen Professor of Translational Neuroscience at Columbia University Medical Center, and his co-author, Robert Gibbons from the University of Chicago, reanalyzed data of more than 8,027 patients from Pfizer-run trials, both those with (n=1,004) and without (n=7,023) psychiatric disorders. Their analyses included a new group of subjects, not previously reported upon, who had a psychiatric disorder, as they were potentially at greater risk of psychiatric symptoms or side effects. They also analyzed a Department of Defense (DoD) dataset of 35,800 patients who received varenicline or nicotine-replacement therapy, to compare rates of neuropsychiatric side effects and to “assess reports of anxiety, mood and psychotic symptoms and disorders, other mental disorders, and suicide attempt.”


The results showed that “Varenicline is more effective than we thought for smoking cessation and safer than we thought,” said Dr. Mann. He added, “The specific concern that it may increase the risk for suicidal behavior is not supported by the results of this study. This should encourage smokers to try a smoking-cessation program. Moreover, since smoking rates are higher with some psychiatric disorders, this is even better news for such patients in terms of the safety of a smoking-cessation program that includes the use of varenicline”.


Patients who took varenicline were significantly more likely to remain abstinent. Additionally, the drug did not increase rates of suicidal events, depression, or aggression/agitation. The DoD study results showed that patients who took varenicline were not at greater risk for developing a neuropsychiatric disorder. In fact, rates were significantly lower for patients who received varenicline than those who received nicotine replacement therapy.


Funding for this research study was provided by National Institute of Mental Health grants MH062185 (Dr. Mann) and MH8012201 (Dr. Gibbons).


Conflict of interest disclosures:  Dr. Gibbons has served as an expert witness for Pfizer on a case related to varenicline and neuropsychiatric adverse events and on cases related to gabapentin and suicide; for Wyeth on cases related to antidepressants and suicide; and for the U.S. Department of Justice. Dr. Mann has received research support from GlaxoSmithKline and Novartis and receives royalties for the Columbia Suicide Severity Rating Scale from the Foundation for Mental Health. Data for the randomized controlled trials were supplied by Pfizer. Pfizer had no involvement in the analysis of these data or the writing of the paper. Pfizer reviewed the final manuscript to ensure accuracy of the study descriptions and to ensure against inadvertent disclosure of confidential information or unprotected inventions. Pfizer did not provide any comments except minor corrections to Table 1.





Columbia University Department of Psychiatry & NYS Psychiatric Institute

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