Practice Advisory: FDA Removal of Boxed Warning on Varenicline and Bupropion

In December 2016, the U.S. Food and Drug Administration (FDA) issued a FDA Drug Safety Communication revising the description of mental health side effects of medications used to assist individuals to stop smoking (1). This Safety Communication referred to varenicline and bupropion. In this Safety Communication, the FDA determined, based on a review of a large clinical trial, that the risk of serious side effects on mood, behavior, and thinking while using these medications was lower than previously suspected. The risk of mental health side effects, particularly in individuals also being treated for mental illness, is still present, but serious consequences, such as hospitalization, were very infrequent. As a result of this review, the FDA removed the Boxed Warning for serious mental health side effects from the labels on these medications.

The American College of Obstetricians and Gynecologists (ACOG) unquestionably recognizes the numerous adverse health effects of tobacco use and has numerous resources, including clinical guidance, toolkits, and patient education materials, to assist providers and patients with efforts to stop smoking. We recommend that obstetrician-gynecologists counsel women regarding the risks of smoking and the benefits of stopping smoking and discuss the resources available to assist in smoking cessation, which may involve use of these medications. If these medications are used, obstetrician-gynecologists should be aware of the benefits and risks associated with these medications, including the updated information based on the FDA Safety Communication.

This Practice Advisory serves as an interim update to all of ACOG’s smoking cessation materials regarding the removal of the Boxed Warning on these medications. ACOG will update the individual resources regarding the updated safety information as these resources undergo review and revision.

1. FDA Drug Safety Communication: FDA revises description of mental health side effects of the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) to reflect clinical trial findings. Available at: Accessed: November 4, 2017

For provider and patient resources on tobacco and smoking cessation, see ACOG’s Tobacco department page and Tobacco and Nicotine Cessation toolkit.

This Practice Advisory was developed by the American College of Obstetricians and Gynecologists in collaboration with Christopher M. Zahn, MD; Joseph R. Wax, MD; and Yasser Y. El-Sayed, MD.

A Practice Advisory is issued when information on an emergent clinical issue (eg, clinical study, scientific report, draft regulation) is released that requires an immediate or rapid response, particularly if it is anticipated that it will generate a multitude of inquiries. A Practice Advisory is a brief, focused statement issued within 24–48 hours of the release of this evolving information and constitutes ACOG clinical guidance. A Practice Advisory is issued only online for Fellows but may also be used by patients and the media. Practice Advisories are reviewed periodically for reaffirmation, revision, withdrawal, or incorporation into other ACOG guidelines.

This document reflects emerging clinical and scientific advances as of the date issued and is subject to change. The information should not be construed as dictating an exclusive course of treatment or procedure to be followed.

Publications of the American College of Obstetrician and Gynecologists are protected by copyright and all rights are reserved. The College's publications may not be reproduced in any form or by any means without written permission from the copyright owner. 

The American College of Obstetricians and Gynecologists (the College), a 501(c)(3) organization, is the nation's leading group of physicians providing health care for women. As a private, voluntary, nonprofit membership organization of more than 57,000 members, the College strongly advocates for quality health care for women, maintains the highest standards of clinical practice and continuing education of its members, promotes patient education, and increases awareness among its members and the public of the changing issues facing women’s health care. The American Congress of Obstetricians and Gynecologists (ACOG), a 501(c)(6) organization, is its companion organization.


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