FDA Removing Black Box Warnings on Smoking Cessation Drugs

Varenicline and bupropion pose a lower risk of serious mental health side effects than was previously thought.
Varenicline and bupropion pose a lower risk of serious mental health side effects than was previously thought.

Following a required clinical trial review1, the US Food and Drug Administration (FDA) has determined that 2 smoking cessation drugs, varenicline(Chantix®, Pfizer)  and bupropion (Zyban®, GlaxoSmithKline), are associated with a  lower risk of serious neuropsychiatric adverse side effects in behavior, mood, and thinking than was previously suspected.2

The phase 4, randomized, double blind EAGLES trial (Study Evaluating The Safety And Efficacy Of Varenicline and Bupropion For Smoking Cessation In Subjects With And Without A History Of Psychiatric Disorders, ClinicalTrials.gov Identifier: NCT01456936)was designed to detect the occurrence of at least one treatment emergent adverse event associated with anxiety, depression, or hostility with either Chantix or Zyban.

The results of the trial also confirmed that the benefits of smoking cessation generally outweigh the risk of these medications. The FDA, however, cautioned that the risk of mental health side effects remains present in those who use these medications, particularly in patients concurrently being treated for depression, anxiety disorders, or schizophrenia, as well as those who had been treated for mental illnesses in the past.

The FDA will remove the existing black box warnings from Chantix and Zyban drug labels and will update the existing warning section in both labels. Additionally, the risk evaluation and mitigation strategy (REMS), formally requiring a patient Medication Guide explaining the risks associated with using the medicines, will be removed. The clinical trial review also confirmed that Chantix, Zyban, and nicotine replacement patches were all more effective for achieving smoking cessation than treatment with placebo.

These decisions are consistent with the recommendations of outside experts at a 2016 FDA Advisory Committee meeting.

The FDA maintained that any patients and healthcare professionals should report any side effects involving Chantix, Zyban, or other medicines to the FDA's MedWatch program.

References

1. Anthenelli RM, Benowitz NL, West R, St Aubin L, McRae T, Lawrence D, et al. Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine patch in smokers with and without psychiatric disorders (EAGLES): a double-blind, randomised, placebo-controlled clinical trial. Lancet 2016;387:2507-20.

2. 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 [news release]. Silver Spring, MD: US Food and Drug Administration; December 16, 2016. http://www.fda.gov/Drugs/DrugSafety/ucm532221.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed December 19, 2016. 


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