FDA in Brief: FDA Updates Label for Chantix with Data Underscoring it’s not Effective in Children 16
Tuesday, March 19, 2019
Posted by: Natalia Gromov
FDA, February 22, 2019
“Today, the U.S. Food and Drug Administration approved changes to the prescribing information for Chantix (varenicline), specifying that the drug is not recommended for pediatric patients 16 years of age or younger because its efficacy in this population has not been demonstrated. Chantix was originally approved in 2006 for use in adults as an aid to smoking cessation treatment, and safety and efficacy in pediatric patients had not been established at that time.
Under the Pediatric Research Equity Act, the sponsor was required to study the drug in appropriate pediatric patients. A placebo-controlled study that 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) found that use of varenicline did not significantly increase abstinence rates. While the pediatric population was defined as ages 16 and under at the time the studies were required, young adults ages 17-19 were permitted to participate; however, the study was not powered to evaluate an effect in the young adults…”
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