Varenicline

Brand name: Chantix

Public Citizen has been assessing the quality and efficacy of drugs and devices since its founding in 1971. We use the law, petitions, and letters to monitor the FDA and coax the agency into action. Our actions have contributed to many drugs being pulled off the market. Public Citizen has also been instrumental in getting “black box” and other warnings on drugs. Our advocacy work on this drug is available below.

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More information on varenicline (Chantix)

• Press Release: FDA Wrong to Remove Chantix’s Black Box Warning Based on One Flawed Study, Sets Dangerous Precedent for Future Medication Safety, December 19, 2016
• Testimony Before the FDA’s Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee Regarding the Black Box Warning on the Smoking Cessation Drug Varenicline (Chantix), September 14, 2016
• Petition to the FDA Requesting a Stronger Boxed Warning and New Restrictions on the Use of Varenicline (Chantix), April 28, 2011