The quit smoking drug Chantix will now feature a new label as per FDA directives. The change is being enforced to make the public aware of the unwanted side effects of the drugs which include lower tolerance of alcohol, unusual seizures and more.
The FDA has issued a caution for use of quit smoking drug Chantix which states, “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 new label has been incorporated on the basis of information proposed by Chantix manufacturer, Pfizer and so also on the cases in the FDA Adverse Event Reporting System database.
The latest warning comes after it was observed that some individuals who consumed alcohol while taking Chantix experienced increased levels of drunkenness as well as memory loss and increased unusual or aggressive behavior.
US FDA has stated that it has thoroughly examined the database and medical literature concerning the instances of seizures with the drug. It was revealed that some people had no prior history of seizures or undergone a seizure disorder that had been well controlled.
The FDA says, “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 latest addendum on the Warnings and Precautions section has been effected to include information such as certain side effects on mood, behavior or thinking pattern that has occurred under the influence of the drug.
FDA further added, “Not all types of neuropsychiatric side effects were examined, and the studies had limitations that prevented the FDA from drawing reliable conclusions.”