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In a new warning from the Food and Drug Administration (FDA), Chantix, a medication prescribed to help people stop smoking, could change the way the body responds to alcohol. The warning went on to say that in rare instances, the combination could result in seizures.
Two years ago, roughly 1.2 million people in the United States alone were prescribed Chantix. However, the manufacturer, Pfizer, provided the FDA with a case series where people reported adverse reactions to the drug.
Chantix first received FDA approval in 2006 after clinical trials showed that compared to a placebo, people stopped smoking for up to one year. However, among complaints of having vivid dreams and even nightmares, there were reported cases of people experiencing seizures.
Every year in the US, roughly 443,000 people die from direct smoking and an additional 49,000 from secondhand smoke. Because smoking is so dangerous for the development of cancer and cardiovascular disease, Chantix does offer some degree of protection but after the new report, the medication will be relabeled to advise patients of potential risks.
From the case series offered by Pfizer along with the FAERS database, experts with the FDA discovered that many of the adverse reactions, as well as seizures, involved people taking Chantix who also consumed alcohol. It appears that the drug somehow lowers tolerance for alcohol to include memory loss, uncharacteristic and even aggressive behavior, and a higher level of intoxication.
Of the people who suffered seizures while taking Chantix, none had a prior history of seizures or any kind of seizure disorder. Interestingly, the highest occurrence of seizures happened within the first month of being treated with Chantix.
Studies conducted by Pfizer were observational and data was from randomized controlled clinical trials. While specific risks were identified, higher risk of neuropsychiatric side effects was not noted.
Based on the new findings, the FDA is not suggesting that patients prescribed Chantix avoid or greatly reduce the amount of alcohol consumed. This warning will remain in effect until the full extent of the relationship between Chantix and alcohol tolerance can be determined.
The FDA also issued advice to patients to notify their physicians if they have a history of seizures, consume alcohol, or has a history of mental health prior to taking Chantix.
