Varenicline (Chantix) and Buproprion (Zyban): Update and Revision on Mental Health Side Effects
January 4, 2017
The FDA recently completed a review of a large clinical trial that assessed the risk of serious side effects associated with the 2 smoking cessation agents, varenicline and bupropion. The trial reported a much lower risk of adverse effects related to behavior, mood, and altered thinking than expected. There is still some risk of these adverse events, particularly in patients with underlying mental illness or who have been treated for mental illness in the past. The majority of these reactions did not result in serious outcomes (eg, hospitalization). The FDA concurred with the authors’ findings and as a result, removed the black-box warnings from both bupropion and varenicline that had initially been required starting 2009. Labeling for bupropion products will still contain a black-box warning related to suicidality with antidepressant medications. Medication guides will still be provided to the patients receiving varenicline or bupropion prescriptions, warning of the adverse effects. However, the risk evaluation and mitigation strategy (REMS) will be removed that officially required medication guides be provided. These actions are in line with external recommendations presented at the FDA Advisory Committee meeting held in September 2016.
The FDA found varenicline, bupropion, and nicotine replacement patches to be more effective than placebo at aiding patients in smoking cessation upon review of the clinical literature. These therapies were efficacious in patients with or without mental illness. The benefits of their use for smoking cessation outweigh the potential risks.
Health care professionals should continue to counsel patients on smoking cessation. This includes addressing pros and cons of including medications in their treatment regimen. Counsel patients to stop taking varenicline or bupropion if adverse effects are noted with regards to mood, abnormal thinking, or behavioral changes.
Additional information is available at the following links:
- FDA MedWatch Alert – December 16, 2016
- FDA Drug Safety Communication – December 16, 2016
January 4, 2017; University of Utah, Drug Information Service. Copyright 2017, Drug Information Service, University of Utah, Salt Lake City, UT.