Smoking cessation drug varenicline (Chantix) is not recommended for youths 16 years and under as it has not been proven effective, federal health officials said Monday.
The Food and Drug Administration (FDA) is changing the label for the drug to reflect the recommendation.
“Many methods that help adults quit smoking, including medications, have not been found to be effective for youth,” Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “Today’s labeling changes for one such drug intended to help adult smokers quit cigarettes underscores the finding that current drug therapies for smoking cessation that work for adults may not be effective and appropriate for youth.”
Chantix was approved for adult use in 2006 and recently underwent a study in which teens received treatment for 12 weeks and then were followed for 40 weeks. The drug did not significantly help teens stop smoking.
The findings come on the heels of news that teen tobacco use is rising due to the popularity of e-cigarettes. Tobacco use by high school students increased 38% from 2017 to 2018, and middle school student use increased 29%.
Dr. Woodcock called the trend “a deeply troubling public health problem” and said the FDA has made it a priority to explore new drug therapies to complement behavioral interventions.
In the updated policy E-Cigarettes and Similar Devices, the AAP said pediatricians need to screen youths for use. It also called for bans on sales to those under 21, internet sales, all flavors including menthol and advertising accessible to youths.
