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

February 22, 2019

Media Inquiries

  Michael Felberbaum
  240-402-9548

“Tobacco products pose serious dangers to the health of teens and adolescents. Many methods that help adults quit smoking, including medications, have not been found to be effective for youth. 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,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “We’re confronting a deeply troubling public health problem with youth e-cigarette use that is threatening the progress we’ve made in reducing youth tobacco use. We recognize that this will require unique interventions to help America’s youth quit both combustible tobacco, e-cigarettes and other tobacco products. This is a cross-agency priority and the FDA is committed to exploring the possibility of and need for new or different potential drug therapies – as part of broader treatment strategies, including behavioral interventions – to support youth cessation of tobacco products, such as e-cigarettes, cigarettes, cigars or smokeless tobacco, and how we can support the development of such therapies.”

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.

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, angioedema and hypersensitivity reactions. Increased alcohol effects have been reported as well.

As part of continued efforts to protect youth from the dangers of tobacco use, the FDA held a public hearing in January to discuss the effort 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 the issues impacting the development of such therapies, as well as broader treatment strategies, including behavior interventions. 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.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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