The U.S. Food and Drug Administration (FDA) has altered the label on the quit-smoking drug Chantix so it enhances awareness and addresses concerns over the drug's potential to lower one's alcohol tolerance level and that it might cause seizures.

This means the drug has received the FDA's strongest warning label since 2009. Chantix is an anti-smoking drug chemically known as verenicline. It was released in 2006.

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FDA warned Chantix might cause seizures and other psychiatric side effects. It also warned against mixing the drug with alcohol since it can cause aggression or cause persons to black out.

The warning was issued March 9 as a public notice after the FDA updated the drug's label in September. The cautionary advice was given so patients are aware of the changes and consider the new information before trying Chantix.

It became a big matter of concern after doctors noted increased level of drunkenness along with bizarre or aggressive behavior or loss of memory in certain individuals that drank alcohol during their treatment with Chantix.

The occurrence of seizures in some of the cases started within the first month of taking Chantix. The FDA said information about these risks was included in the Warnings and Precautions section of the drug label and in the patient Medication Guide.

In 2014, Pfizer sent a proposal to the FDA for the black-box warning to be removed. Pfizer's proposal was based on the company's own findings and other data, which seems to have concluded Chantix had no psychiatric side effects.

An FDA advisory committee denied the proposal in October. The FDA had taken the time to examine studies on Chantix, which include the studies and analyses made by Pfizer.

The Warnings and Precautions were further updated to include information like certain side effects on mood, behavior or thinking patterns under the influence of the drug.

According to the FDA, a big safety trial of Chantix is being conducted by Pfizer to gain deep insight into those risks and the results are likely to surface by the end of 2015.

TagsFDA Changes Label Anti-Smoking Drug Chantix, Chantix, FDA, Anti-Smoking Drug Chantix, Anti-Smoking Drug, Pfizer, seizure, psychiatric side effects, verenicline