Cited by 142Smoking Behavior and CessationPharmacovigilance and Adverse Drug ReactionsSubstance Abuse Treatment and Outcomes

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Varenicline, Smoking Cessation, and Neuropsychiatric Adverse Events

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Gibbons, Robert D., Mann, J. John·2013·American Journal of Psychiatry

DOI 10.1176/appi.ajp.2013.12121599PMC PMC4238282

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Abstract

OBJECTIVE: In 2009, the U.S. Food and Drug Administration issued a black box warning for varenicline regarding neuropsychiatric events. The authors used data from randomized controlled trials and from a large Department of Defense (DOD) observational study to assess the efficacy and safety of varenicline. METHOD: The authors reanalyzed data from the 17 placebo-controlled randomized controlled trials (N=8,027) of varenicline conducted by Pfizer, using complete intent-to-treat person-level longitudinal data to assess smoking abstinence and reports of suicidal thoughts and behavior, depression, aggression/agitation, and nausea and to compare effects in patients with (N=1,004) and without (N=7,023) psychiatric disorders. The authors also analyzed a large DOD data set to compare acute (30-day and 60-day) rates of neuropsychiatric adverse events in patients receiving varenicline or nicotine replacement therapy (N=35,800) and to assess reports of anxiety, mood, and psychotic symptoms and disorders, other mental disorders, and suicide attempt. RESULTS: In the randomized controlled trials, varenicline increased the risk of nausea (odds ratio=3.69, 95% CI=3.03-4.48) but not rates of suicidal events, depression, or aggression/agitation. It significantly increased the abstinence rate, by 124% compared with placebo and 22% compared with bupropion. Having a current or past psychiatric illness increased the risk of neuropsychiatric events equally in treated and placebo patients. In the DOD study, after propensity score matching, the overall rate of neuropsychiatric disorders was significantly lower for varenicline than for nicotine replacement therapy (2.28% compared with 3.16%). CONCLUSIONS: This analysis revealed no evidence that varenicline is associated with adverse neuropsychiatric events. The evidence supports the superior efficacy of varenicline relative to both placebo and bupropion, indicating considerable benefit without evidence of risk of serious neuropsychiatric adverse events, in individuals with and without a recent history of a psychiatric disorder.

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Authors: Gibbons, R. D., & Mann, J. J.
Affiliations: University of Chicago (US)
ORCID: Gibbons, Robert D.
Mann, J. John
Venue: American Journal of Psychiatry
Publisher: American Psychiatric Association Publishing
Published: 2013-12
Volume: 170
Issue: 12
Pages: 1460-1467
ISSN: 0002-953X (ISSN-L)
1535-7228
DOI: 10.1176/appi.ajp.2013.12121599
PMC: PMC4238282
OpenAlex: W2101931786
Cited by: 142
References: 17
Citations by year: 2026: 3 · 2024: 2 · 2023: 6 · 2021: 29 · 2020: 10 · 2019: 4 · 2018: 7 · 2017: 10 · 2016: 23 · 2015: 28 · 2014: 16 · 2013: 3
FWCI: 16.25
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Locations: American Journal of Psychiatry (publishedVersion)
PubMed (publishedVersion)
Europe PMC (PubMed Central) (acceptedVersion)
PubMed Central (acceptedVersion)
Funders: U.S. Department of Justice
Pfizer
National Institute of Mental Health (MH8012201, MH-062185, P50MH062185)
Topics: Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Smoking Behavior and Cessation
Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
Keywords: varenicline, smoking cessation, neuropsychiatric adverse effects, black box warning, nicotine replacement therapy, bupropion, smoking abstinence, suicidal ideation, depression, aggression, nausea, mental illness, military personnel, drug safety
MeSH terms: Varenicline, Adult, Aggression, Mental Disorders, Benzazepines, Depression, Female, Humans, Male, Nausea, Psychomotor Agitation, Quinoxalines, Risk Factors, Suicide, Attempted, Randomized Controlled Trials as Topic, Smoking Cessation, Bupropion, Treatment Outcome, Akathisia, Drug-Induced, Suicidal Ideation, Tobacco Use Cessation Devices, Observational Studies as Topic

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