The FDA announced that, because Pfizer’s Chantix quit-smoking drug was linked to seizures and alcohol risks, the black box label warning will remain. The label will also inform the patient that one can develop aggressive or suicidal behaviors from this treatment.
The Food and Drug Administration (FDA) stated in a press release that if patients have already experienced a lower than usual tolerance to alcohol, they need to cut back on alcohol consumption. FDA also warned patients who already experienced an epileptic episode while under Chantix treatment about the possibility of having to stop taking the medication and consult a health specialist.
The new warning label comes after Pfizer had presented all the necessary data and after FDA analyzed cases from the Adverse Event Reporting System database. From the database, FDA found seizure cases of people taking Chantix that had no history of epileptic disorders or had a seizure disorder that had been strictly monitored and well-controlled.
The Food and Drug Administration made the following statement:
“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.”
It seems a number of people under Chantix treatment experienced low levels of alcohol tolerance and erratic or aggressive behavior. Some even had memory loss episodes.
Therefore, additional warnings regarding changes in mood, behavior or thinking during the treatment were added to the label.
Although not all side effects had shown an increased risk during the study, the agency explained that “not all types of neuropsychiatric side effects were examined, and the studies had limitations that prevented the FDA from drawing reliable conclusions”.
Cautions about Chantix’s possible side-effects had also been released in the past- in 2009 and 2011. Six years ago, the FDA requested Pfizer to put a “black box warning” due to such side-effects as “hostility, agitation, depressed mood, and suicidal thoughts or actions.”
Recent research papers on the subject of Chantix treatment consequences on the patient’s body were analyzed during an FDA Advisory Committee meeting that took place in October of last year.
Pfizer is now conducting an extensive safety trial in order to examine all the side-effects that Chantix can produce. It is expected results will be available at the end of 2015.
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