The label on the quit-smoking drug Chantix has been changed by the FDA for creating awareness and apprehending the matter that it has the possibility of lowering one’s tolerance level on alcohol along with its association with an unusual risk of seizures.
FDA warns that “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.”
This new label has been developed on the basis of information proposed by Chantix maker Pfizer as well as on cases in the FDA Adverse Event Reporting System database.
It was found that certain individuals who consumed alcohol during their treatment with Chantix had heightened level of drunkenness along with unusual or aggressive behavior or had a loss of memory.
FDA has informed that it has examined the database and medical literature concerning cases of seizures with the drug and found that some people had no prior history of seizures or undergone a seizure disorder that had been well controlled.
“In most of these cases, the seizures occurred within the first month of starting Chantix. Information about these risks has been added to the Warnings and Precautions section of the drug label and to the patient Medication Guide,” the FDA says.
An update on the Warnings and Precautions section has been done for including information such as certain side effects on mood, behavior or thinking pattern that has occurred under the influence of the drug.
While the studies didn’t show an increased risk of such side effects, “not all types of neuropsychiatric side effects were examined, and the studies had limitations that prevented the FDA from drawing reliable conclusions,” FDA further adds.
In 2009 and 2011, FDA has alerted them about such potential side effects and in October 2014, in an FDA advisory meeting, recent studies on the possibilities of such side effects have been the main topic of concern.
The FDA began necessitating a “black box warning” on Chantix warning of behavior alterations such as “hostility, agitation, depressed mood, and suicidal thoughts or actions.”
The FDA says Pfizer is carrying out a big safety trial of Chantix to further look into these risks. The results of that study are being received by the end of 2015.
