Volume 177 , 1 August 2017, Pages 187-193 Trends in utilization of smoking cessation agents before and after the passage of FDA boxed warning in the United States Author links open overlay panel DrishtiShaha The FDA issued a black box warning (BBW) on bupropion and varenicline in 2009. We examined the trends in use of bupropion and varenicline before and after the BBW. We observed a significant decline in the use of varenicline after the passage of BBW. The BBW was not associated with decline in the use of bupropion. Passage of BBW may have a substantial impact on the utilization of certain medications. 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. 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.
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