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The FDA recorded 48 cases of adverse events involving decreased tolerance to alcohol or aggressive behavior in patients who drank alcohol while taking varenicline since varenicline was approved in 2006. Many of those people also reported “no memory or impaired memory of their experience.” In addition, the FDA identified 64 cases of seizures, usually in the first month of using the drug. More than half of those patients had no prior history of seizures, said the agency.
Previously, concerns were raised about neuropsychiatric effects of the drug on mood, behavior, and risk of suicidality. The FDA’s updated review of randomized, controlled studies and observational studies found no difference in neuropsychiatric side effects between varenicline and placebo or nicotine replacement therapy. However, the agency did note limitations in the studies that “may underestimate the actual incidence of neuropsychiatric adverse events and restrict our ability to predict the direction of the relative risk associated with Chantix.” The agency kept the black-box warning on the label regarding the risk of suicidality and suicidal ideation but said that a postmarketing trial due from Pfizer later this year may clarify these risks.
“Until patients know how Chantix affects their ability to tolerate alcohol, they should decrease the amount of alcohol they drink,” the FDA concluded. “Patients who have a seizure while taking Chantix should stop the medicine and seek medical attention immediately.”
For more in Psychiatric News about smoking cessation treatment and varenicline, see “Smoking Cessation for Patients Called an Urgent Priority.”
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