17-Apr-15 11:00 AM  CST

New Warnings from FDA Link Increased Seizure Risk to Chantix

Each year millions of Americans resolve to end unhealthy habits, and one of the most common is smoking. Smoking cessation products are a billion dollar business in the United States. Everything from nicotine gums, to lozenges to patches has hit the U.S. market over the last 2 decades. Perhaps of the most controversial smoking cessation treatment to be marketed in the U.S. in recent years is the drug known commercially as Chantix.

Chantix, whose generic name is varenicline tartrate is considered to be widely effective for those wishing to stop smoking, but has been laden with controversy from its first day on the market. Known to cause wild and often disturbing dreams which have been christened by those taking the drug as “Chantix Dreams”, Chantix has also been shown to increase the risk of suicidal tendencies, depressed mood, and atypical behavior, earning it a “blackbox” warning from the FDA. The warnings about Chantix have been so disconcerting that the Federal Aviation Association forbids the use of the drug in pilots and air traffic controllers.

The latest warnings from the FDA have forced Pfizer, who manufactures Chantix to change the labeling on the drug to include a warning concerning the risk of alcohol use when taking Chantix that may lead to an increased risk for seizure. Pfizer must effectively state that patients taking Chantix should decrease their alcohol intake for a specified period of time until they know how they respond to the drug.

Pfizer, because of the increasing controversy and risk demonstrated by Chantix, has been involved with a safety study of the drug since 2009 when the FDA began requiring a “blackbox” warning for the drug. Results from Pfizer’s safety study are expected to be release later in the 2015.






Cassels, C., (2015), “FDA Warns of Seizure, Alcohol Risk with Chantix”, WebMD, http://www.webmd.com/smoking-cessation/news/20150310/chantix-alcohol-seizures, retrieved, 3. April 2015


Vivanco, L., (2008), “Chantix Controversy”, Chicago Tribune, http://articles.chicagotribune.com/2008-06-09/news/0806090246_1_chantix-drug-s-risks-and-benefits-fda, retrieved, 3. April 2015

For additional information on this article, please contact:
Kelley Simmons
Source: Sandy Andrews, CPhT, BLS  

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