FDA In Brief > FDA in Brief: FDA updates label for Chantix with data underscoring it’s not effective in children 16 and younger

FDA In Brief > FDA in Brief: FDA updates label for Chantix with data underscoring it’s not effective in children 16 and younger

Today the U.S. Food and Drug Administration (FDA) approved changes to the prescribing information for varenicline (Chantix). These changes specify that the drug is not recommended for pediatric patients 16 years of age or younger because its efficacy in this population was not demonstrated. Chantix is a nicotinic receptor partial agonist indicated for use as an aid to smoking cessation treatment. It was originally approved by the FDA in 2006 for adult use. At that time, safety and efficacy in pediatric patients had not been established, although a single-dose pharmacokinetic and safety study patients age 12 to 16 years was included in the application and described in labeling.  Based upon the Pediatric Research Equity Act (PREA) requirement to study appropriate pediatric populations, the sponsor conducted two studies of varenicline in adolescent patients: a multiple-dose pharmacokinetic and safety study and a placebo-controlled study that evaluated efficacy and safety for smoking cessation (abstinence). The placebo-controlled study examined two weight-adjusted doses of varenicline in pediatric patients, age 12 to 16 years (some patients age 17-19 years were also included in this study). Patients received treatment for 12 weeks followed by a non-treatment follow-up period of 40 weeks. This study found that use of varenicline did not significantly increase abstinence rates in this population.  As part of this supplement approval, the drug’s labeling will be updated to include these study findings and will state that varenicline is not recommended for use in pediatric patients 16 years of age and younger because its efficacy in this population was not demonstrated.   The most common adverse reactions associated with Chantix are nausea, sleep disturbance, constipation, flatulence and vomiting. Other adverse reactions have been identified during post-approval use of Chantix and are included in the label: neuropsychiatric adverse events, seizures, accidental injury, cardiovascular events, somnambulism (sleepwalking), angioedema (swelling beneath the skin) and hypersensitivity reactions. Increased alcohol effects have been reported as well. More information on smoking cessation for teenagers is available online. As part of continued efforts to protect youth from the dangers of tobacco use, the FDA held a public hearing in January to discuss ways to eliminate youth e-cigarette use as well as other tobacco product use, with a focus on the potential role of drug therapies to support cessation and issues impacting the development of such therapies. Despite concerns about youth use of e-cigarettes and other tobacco products, research on youth tobacco product cessation is limited and focused on smoking cessation. To address that gap, the agency has expanded its scientific priority areas to include support for research on these topics through new funding opportunities.  Additional information on FDA’s Youth Tobacco Prevention Plan can be found on our website.