US Food and Drug Administration (FDA) has announced that alcohol and Chantix should not be mixed as the combination may result in seizures.
Chantix is a widely-used smoking cessation medicine, which was approved for use by the FDA in 2006. The FDA stated in 2013, that an estimated 1.2 million patients received a dispensed prescription for Chantix from outpatient retail pharmacies in the US.
In 2011, Pfizer announced that it was carrying an extensive study on the possible side-effects of its anti-smoking drug, but the preliminary results weren’t scheduled to be released until 2017. However, patients taking Chantix had experienced behavioral changes since 2007. This forced FDA to change the label of the medicine to reflect the risks associated with Chantix and consumption of alcohol.
FDA spokesperson said, “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.”
FDA has recommended that patients being treated with Chantix should reduce the amount of alcohol they consume until they know to what extent the medication affects their capacity to tolerate alcohol.
FDA has stated that the “Warnings and Precautions” section of the medicine’s label will now be updated to include information about these risks, along with additional information obtained from observational studies examining the risk of Chantix affecting patients’ mood and behavior.
Pfizer had conducted various studies to show that there is no difference in psychiatric problems in people consuming Chantix and people who are on other anti-smoking treatments. However, FDA stated that Pfizer’s studies lacked research on different types of psychiatric problems, which has prevented the regulator to remove the black box warning from the medicine’s packaging.
Pfizer on their part have stated that they are 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.