Warnings: Chantix (varenicline)
In March 2015 the U.S. Food and Drug Administration (FDA) expanded its
warnings of adverse effects of the "smoking cessation" drug Chantix (varenicline). Chantix is a prescription medicine that is FDA-approved to help adults quit
The FDA bulletin stated: "We reviewed the case series submitted by Pfizer,
the manufacturer of Chantix, as well as the cases in the FDA Adverse Event
Reporting System (FAERS) database describing patients who drank alcohol during
treatment with Chantix and experienced adverse reactions. Some patients
experienced decreased tolerance to alcohol, including increased drunkenness,
unusual or aggressive behavior, or they had no memory of things that happened.
We also reviewed FAERS and the medical literature for cases of
seizures with Chantix and identified cases in which the patients who had
seizures while taking Chantix either had no history of seizures or had a seizure
disorder that had been well-controlled. In most of these cases, the seizures
occurred within the first month of starting Chantix. We updated the Warnings
and Precautions section of the Chantrix label to include information about
several studies that investigated the risk of neuropsychiatric side effects on
mood, behavior, or thinking occurring with Chantix. "
In a 2016 Revision of recommendations, the FDA removed the boxed warnings and
suggested that the negative effects of Chantix were less than previously
reported. The FDA wrote:"
Patients should stop taking Chantix or Zyban and call their health care
professionals right away if they notice any side effects on mood, behavior, or
thinking. Patients should also talk to their health care professionals for help
and information about stopping smoking, including about whether stop-smoking
medicines may help or if they have any questions or concerns about taking a
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