Brain & Drugs
  • 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 smoking.

    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 medicine

      • You are viewing the Brain Drugs at Alpha Online. Understanding the human brain is essential to become a well-informed, modern citizen. Responsible adults need to become better informed about prescription drugs and exercise constraint when seeking and accepting prescriptions that alter brain function. The topics online are from the book, Human Brain, by Stephen Gislason MD, a physician-writer who is good at making complex subjects more understandable.

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