FDA Warns Users of Anti-Smoking Drug Chantix it May Cause Seizures
The U.S. Food and Drug Administration is warning smokers who are trying to quit that they may have trouble tolerating alcohol if they are taking Chantix.
The medicine has been linked to seizures and since a revision of its drug's label done in September last year, FDA has cautioned that the users must familiarize themselves with the specific changes.
According to FDA, their warning on the black box which was issued three years after Chantix was approved is mostly for the very serious risks. It is a tablet that should be taken twice a day. Apparently, the label describes Chantix as one drug having numerous side effects the likes of serious hostility and violent bizarre besides harboring of suicidal thoughts.
The FDA advised Pfizer to conduct a larger, clearer safety study in late 2015 if they want a chance for the black box label to be removed.
The FDA says Chantix has been associated with seizures and some patients should cut back on their alcohol use while on the medication.
On its Chantix website, Pfizer echoes the FDA's advice to limit drinking until patients see how they tolerate alcohol while taking the smoking cessation drug. The company also acknowledges that Chantix users have "had changes in behavior, hostility, agitation, depressed mood, [and] suicidal thoughts or actions."
Chantix raked in $647 million in revenues last year. Pfizer also owns the most profitable drug, Lipitor, which brought in a whopping $12.9 billion in revenues.
Chantix was approved in 2006.