(RxWiki News) Some people turn to medications like varenicline (brand name Chantix) to help quitting smoking. Chantix can be helpful, but it comes with a few warnings.
The US Food and Drug Administration (FDA) has issued a warning regarding combining Chantix with alcohol. Some patients who took Chantix and drank alcohol became aggressive or experienced amnesia. In a few cases, patients have had seizures.
"Patients should speak to their pharmacists about the safety and side effects of Chantix," said James H. Dykes, RPh, owner of Cullen Care Pharmacy in Houston, TX, in an interview with dailyRx News. "Chantix can be a great smoking-cessation tool, but it must be used safely."
Chantix is a prescription drug used to help people stop smoking. Chantix keeps a smoker from feeling the pleasant effects of nicotine by binding to nicotine receptors in the brain.
Most patients take Chantix for about 12 weeks. The FDA notes that clinical trials have found Chantix to be effective in helping patients quit smoking.
The FDA reviewed literature from Pfizer, the manufacturer of Chantix, as well as data from the FDA’s own database for reporting adverse drug events. Called the FDA Adverse Event Reporting System (FAERS), this database is used by health care professionals who want to report side effects or other problems tied to the use of a medication.
According to the reports from these sources, some patients became overly intoxicated when they combined Chantix and alcohol. Others became aggressive or displayed strange behavior.
Some people developed amnesia and had no memory of what happened.
Also, the FDA looked at reports of patients developing seizures when they drank while taking Chantix. The FDA noted that seizures tended to occur within the first month of taking the Pfizer drug.
Patients who had seizures when they combined alcohol and Chantix either had no history of seizures or had a seizure disorder that was well-controlled.
Based on this information, the FDA updated the warning label for Chantix.
The new label says that people who take Chantix should decrease the amount of alcohol they drink. Each person should determine how Chantix affects his or her ability to tolerate alcohol.
If patients who are taking Chantix should have a seizure, the FDA says they should stop taking the medication immediately and notify the doctor who prescribed it.
The FDA also reviewed recent studies that investigated how Chantix may affect patients’ moods, behavior and ability to think. The FDA had previously posted a warning about possible side effects in this area but did not draw any new conclusions from the new research.
The FDA noted that Pfizer is conducting a large clinical safety trial of Chantix at this time.
Results from this trial are expected to be available in late 2015. The FDA plans to update the public when the study results become available.
The FDA is not suggesting that patients should not take Chantix. However, it does recommend that each patient and doctor should discuss the risks and benefits of the medication.