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New Warnings Added to Chantix FDA Label

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Brian Finehout-Henry3 years ago

The Food and Drug Administration has warned that Chantix has been associated with lowered tolerence to aclohol and an increased risk of seizures, according to Fox News.

What is Chantix?

Chantix, active chemical ingredient varenicline, is made by Pfizer and won FDA approval in 2006.

Chantix is intended to help people quit smoking by binding to nicotine receptors in the brain.

An article in the Journal of Medicinal Chemistry explains that Chantix binds to and partially activates these nicotine receptors causing a reduction in nicotine withdrawal symptoms and blocking nicotine from binding to these receptors.

FDA Warns of Seizures and Increased Effect of Alcohol with Chantix

The FDA added the warnings for seizures and alcohol intake to the Chantix label in September 2014, but did not issue a public warning till March 2015, which is unusual because the agency routinely issues a public warning announcement along with a label change, according to Newsmax.

In-PharmaTechnologist reports that Chantix can change the way a person responds to alcohol, leading to decreased tolerance, unusual behavior and aggressiveness, and black outs.

The FDA warning notes that the FDA has received numerous adverse event reports involving people drinking their usual amount of alcohol but experiencing heighten effects; resulting in injuries, motor vehicle accidents, and arrests. The FDA has also warned that Chantix has been associated with seizures in people with no history of seizures and in people with well-controlled seizure disorders.

The LA Times reports that in many adverse event reports linking Chantix with seizures, Chantix was the only identified risk factor for seizures. The FDA also added information from studies investigating the neuropsychiatric side effects, including changes in mood, behavior, and thinking in people taking Chantix, according to PharmacyTimes.

Other Safety Issues with Chantix

FiercePharma reports that in 2009 a black box warning was added to the label of Chantix to warn of the increased risk of suicidal ideation and action. Black box warnings are the most serious warning the FDA issues and only warn of the most serious adverse effects, according to Newsmax.

Al Jazeera America reports that FDA adverse event reports have linked Chantix to 544 suicides and over 1800 suicide attempts during the last five years. Australian Doctor reports Chantix tops the list of drugs linked to suicidal and homicidal thoughts. The Wall Street Journal reports that Pfizer has spent hundreds of millions of dollars to settle thousands of lawsuits regarding the suicide risk associated with Chantix.

Al Jazeera America also reports that Chantix is the prescription drug with the most adverse event reports to the FDA. The Federal Aviation Administration has banned the use of Chantix in pilots and air traffic controllers because of the association with neuropsychiatric side effects, according to the Wall Street Journal.

The Wall Street Journal also reports that a drug safety watchdog group has raised safety questions about Chantix and reports of movement disorders and muscle spasms, heart arrhythmias, and blood sugar and diabetes problems.


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