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Petition to the FDA Requesting a Stronger Boxed Warning and New Restrictions on the Use of Varenicline (Chantix)

October 8, 2014

View the Petition as PDF.

View the Press Release as PDF.

December 16, 2016: View the Response Letter from the FDA.

Public Citizen joins four other organizations in petitioning the Food and Drug Administration (FDA) to require a more informative and comprehensive Black Box Warning for the smoking cessation drug varenicline (Chantix). The petition also asks that the FDA add restrictions to the Indications section of the product label warning against the drug’s use by individuals in sensitive or hazardous occupations, such as pilots, emergency medical workers, and others, in whom the neurological and psychiatric adverse effects of varenicline could pose a danger to themselves or others.

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