The FDA has altered the label on the quit-smoking drug Chantix for creating awareness and address the concern over its potential to lower one’s tolerance level on alcohol and association with an annual risk of seizures.

The FDA warns, “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 information provided by Chantix maker Pfizer and cases in the FDA Adverse Event Reporting System database served the basis of developing the new label.

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

After doing meticulous examination of the database and medical literature concerning cases of seizures with the drug, the FDA concluded that some people had no prior history of seizures or undergone a seizure disorder that had been well controlled. The occurrence of seizures in some of the cases started within the first month of taking Chantix. The FDA said that information about these risks has been included in the Warnings and Precautions section of the drug label and in the patient Medication Guide.

The Warnings and Precautions has been further updated to include information, like certain side effects on mood, behavior or thinking pattern 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.