TY - JOUR
T1 - Trends in utilization of smoking cessation agents before and after the passage of FDA boxed warning in the United States
AU - Shah, Drishti
AU - Shah, Anuj
AU - Tan, Xi
AU - Sambamoorthi, Usha
N1 - Publisher Copyright:
© 2017 Elsevier B.V.
PY - 2017/8/1
Y1 - 2017/8/1
N2 - Background In 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. Methods We 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. Results On 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. Conclusion The passage of the FDA boxed warning was associated with a significant decline in the use of varenicline, but not in the use of bupropion.
AB - Background In 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. Methods We 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. Results On 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. Conclusion The passage of the FDA boxed warning was associated with a significant decline in the use of varenicline, but not in the use of bupropion.
KW - Boxed warning
KW - Bupropion
KW - Neuropsychiatric adverse events
KW - Smoking cessation agents
KW - Trends
KW - Varenicline
UR - http://www.scopus.com/inward/record.url?scp=85020305573&partnerID=8YFLogxK
U2 - 10.1016/j.drugalcdep.2017.03.021
DO - 10.1016/j.drugalcdep.2017.03.021
M3 - Article
C2 - 28605678
AN - SCOPUS:85020305573
SN - 0376-8716
VL - 177
SP - 187
EP - 193
JO - Drug and Alcohol Dependence
JF - Drug and Alcohol Dependence
ER -