Observational studyDrug and alcohol dependence2017
Trends in utilization of smoking cessation agents before and after the passage of FDA boxed warning in the United States.
Observational study in Drug and alcohol dependence, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
11 citing papers in PubMed, 15 citations in OpenAlex.
- Can We Predict Who Will Experience Adverse Events While Using Smoking Cessation Pharmacotherapy? A Secondary Analysis of the EAGLES Clinical Trial.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2025Trial
- Withdrawal Symptom, Treatment Mechanism, and/or Side Effect? Developing an Explicit Measurement Model for Smoking Cessation Research.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2020Trial
- Placebo-controlled randomized clinical trial testing the efficacy and safety of varenicline for smokers with HIV.Drug and alcohol dependence · 2019Trial
- Changes in the Use of Montelukast for Asthma After a US Food and Drug Administration Boxed Warning.JAMA network open · 2026Article
- Smoking Cessation Medication Prescribing for Smokers With and Without Mental Illness.Psychiatric services (Washington, D.C.) · 2023Article
- Characterising the use of varenicline: an analysis of the Australian dispensing claims data.Addiction (Abingdon, England) · 2022Article
- Trends in Incident Varenicline Prescribing Among Veterans Following the US Food and Drug Administration Drug Safety Warnings.The Journal of clinical psychiatry · 2021Article
- Looking Back and Going Forward: Roles of Varenicline and Electronic Cigarettes in Smoking Cessation.Cureus · 2021Review
- Provider and clinical setting characteristics associated with tobacco pharmacotherapy dispensed in the Veterans Health Administration.Tobacco induced diseases · 2021Article
- Population-level predictors of changes in success rates of smoking quit attempts in England: a time series analysis.Addiction (Abingdon, England) · 2020Article
- Varenicline and Nicotine Replacement Use Associated With US Food and Drug Administration Drug Safety Communications.JAMA network open · 2019Observational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 1 institution in 1 country.
Funding
Abstract
backgroundIn 2009, the FDA required a black box warning (BBW) on bupropion and varenicline, the two commonly prescribed smoking cessation agents due to reports of adverse neuropsychiatric events. We investigated if there was a decline in use of bupropion and varenicline after the BBW by comparing the percent using these medications before and after BBW.
methodsWe conducted a retrospective observational study using data from the Medical Expenditure Panel Survey from 2007 to 2014. The study sample consisted of adult smokers, who were advised by their physicians to quit smoking. We divided the time period into "pre-warning", "post-warning: immediate", and "post-warning: late." Unadjusted analysis using chi-square tests and adjusted analyses using logistic regressions were conducted to evaluate the change in bupropion and varenicline use before and after the BBW. Secondary analyses using piecewise regression were also conducted.
resultsOn an average, 49.04% of smokers were advised by their physicians to quit smoking. We observed a statistically significant decline in varenicline use from 22.1% in year 2007 to 9.23% in 2014 (p value<0.001). In the logistic (Adjusted Odds Ratio=0.36, 95% CI=0.22-0.58) and piecewise regressions (Odds Ratio=0.64, 95% CI=0.41-0.99) smokers who were advised to quit smoking by their physicians were less likely to use varenicline in the immediate post-BBW period as compared to pre-BBW period. While the use of varenicline continued to be significantly low in the late post-BBW period (AOR=0.45, 95% CI=0.31-0.64) as compared to the pre-BBW period, the trend in use as seen in piecewise regression remained stable (OR=0.90, 95% CI=0.75-1.06). We did not observe significant differences in bupropion use between the pre- and post-BBW periods.
conclusionThe passage of the FDA boxed warning was associated with a significant decline in the use of varenicline, but not in the use of bupropion.
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Registered trials
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