The U.S. Food and Drug Administration (FDA) has issued a safety announcement confirming that alcohol and Chantix should not be mixed as the combination may result in seizures.
Chantix is a smoking cessation medicine developed by Pfizer. The medicine is usually prescribed twice a day to people who want to quit smoking. However, the drug may alter the way an individual's reaction to alcohol.
On Monday, March 9, the FDA released a safety announcement, which suggests that people on Chantix prescription should reduce alcohol intake as in some rare cases the mix can cause seizures. The FDA has also changed the label of the medicine to reflect the risks associated with Chantix and consumption of alcohol.
"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," per the FDA safety announcement.
Chantix is used by thousands of Americans as an effective way of quitting smoking. However, the packaging of the drug has the most severe warning label, which is also referred as the black box. Previous studies have reported that the use of Chantix can increase depression, aggression and suicidal tendencies.
The drug was originally approved by the FDA in 2006 but the warning label started appearing on the package since 2008. Pfizer had a blow in 2009 when FDA asked the drug maker to include the warning label in a black box.
The latest safety announcement from FDA also revealed that the agency has examined various studies and an analysis provided by Pfizer supports that there is no difference in psychiatric problems in people consuming Chantix and people who are on other anti-smoking treatments. However, the FDA also revealed that Pfizer's study lacks research on different types of psychiatric problems, which has prevented the regulator to remove the black box warning from the medicine's packaging.
Pfizer is conducting further studies to confirm that Chantix have similar effects on people who use other anti-smoking aids. FDA will be analyzing Pfizer's claim in late 2015 before taking any action to remove the warning label from the medicine's packaging.
The potential side effects of Chantix have also made the Federal Aviation Administration ban air traffic controller and pilots from consuming the medicine.
In 2014, Pfizer reported $647 million as revenue from the sale of Chantix.
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