Chantix, a smoking-cessation drug made by Pfizer, Inc., may cause seizures, according to a report by the U.S. Food and Drug Administration (FDA). The FDA also states that Chantix may contribute to people becoming aggressive and could cause them to pass out if they take the drug while drinking alcohol.
The FDA issued their warning to the public on Monday. They changed Chantix’s label to reflect the agency’s concerns that the smoking-cessation drug lowers an individual’s tolerance to alcohol, as well as increasing the risk of seizures for some people.
A quote from the FDA news release is as follows.
“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.”
Chantix is also referred to as varenicline, a chemical and prescription medication that treats nicotine addiction by stimulating nicotinic receptors in the human body at a much weaker rate than tobacco products that provide higher amounts of nicotine.
According to WebMD, the FDA issued this latest warning after obtaining information Pfizer submitted to the FDA Adverse Event Reporting System database. The records suggest some people who drank alcohol while taking Chantix lost their memory, acted unusual, became aggressive, and built up a tolerance to alcohol.
Here is an excerpt from the FDA Chantix warning.
“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 did not base their decision to add the warning about Chantix entirely on Pfizer’s cases; the regulatory agency combed through medical literature, as well. They found cases where people who had no history of seizures were having seizures after they started taking Pfizer’s smoking-cessation medication.
The potential side effects of Chantix include uncharacteristic changes in behavior or thinking. In addition, individuals who take Chantix and drink alcohol should consider reducing the amount of alcohol he or she consumes.
The FDA offers this message to the public and healthcare professionals.
“We urge health care professionals and patients to report side effects involving Chantix to the FDA MedWatch program.”
According to Reuters, in 2014, Chantix sales were close to $647 million. To determine the health risks of the smoking-cessation drug, Pfizer said they would conduct larger safety trials on Chantix, with results expected later this year.
[Featured image courtesy of Justin Sullivan/Getty Images]