FDA Warns, Pfizer’s Chantix Associated With Seizures and Lower Alcohol Tolerance

By Rheingold Giuffra Ruffo & Plotkin LLP

On March 9 2014, the U.S Food and Drug Administration announced a safety warning that Chantix, an anti-smoking drug by Pfizer has been associated with seizures when mixed with alcohol consumption, in addition to causing a decreased tolerance to alcohol.

Chantix (Varenicline) is a drug prescribed to people who wish to quit smoking. It was approved by the FDA in 2006. The FDA updated the label to include a boxed warning, reserved for the most serious risks from drugs. The warning included neuropsychiatric side effects, suicidal thoughts, hostility and agitation.

Pfeizer recently requested FDA to remove the boxed warning by suggesting that their own research and studies show no such association of risks with the drug. However, the new labeling is based on a new case series submitted by Pfeizer and the FDA Adverse Reporting System. The data shows that patients who consumed alcohol while on Chantix continue to have suicidal, self-injury or homicidal thoughts, in addition to sudden blackouts, seizures, impaired vision and lower tolerance to alcohol consumption.

FDA recommends consumers being treated on Chantix to reduce their alcohol intake until the extent of the side effects from the drug are known. “Until patients know how Chantix affects their ability to tolerate alcohol, they should decrease the amount of alcohol they drink. Patients who have a seizure while taking Chantix should stop the medicine and seek medical attention immediately,” the FDA warned in a release.

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