FDA updates Chantix label to include possible alcohol interaction

March 11, 2015

FDA has warned that the smoking cessation drug varenicline (Chantix) can interact with alcohol, resulting in some patients experiencing increased intoxicating effects of alcohol, sometimes associated with aggressive behavior and/or amnesia.

FDA has warned that the smoking cessation drug varenicline (Chantix) can interact with alcohol, resulting in some patients experiencing increased intoxicating effects of alcohol, sometimes associated with aggressive behavior and/or amnesia.

In addition, rare accounts of seizures in patients treated with Chantix have been reported. FDA has approved changes to the Chantix label to warn about these risks. (Refer to the Drug Safety Communication for a detailed data summary).

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.

Back in September, FDA approved updated label changes for Chantix that included data from a meta-analysis of 5 clinical trials that showed no increased risk in the incidence of suicidal ideation and/or behavior in patients taking Chantix versus a placebo. The warnings and precautions section also includes updates on alcohol use and seizures. Patients were instructed to reduce the amount of alcohol they consume until they know how Chantix affects their alcohol tolerance, according to the drug’s manufacturer Pfizer.

“Given the well-established health risk associated with smoking, Chantix has been a universally well-received therapeutic option to assist individuals in their smoking cessation efforts since its introduction to market almost 9 years ago,” said FormularyWatch Clinical Editor David Calabrese, RPh, MHP, vice president and chief pharmacy officer, Catamaran, a PBM headquartered in Schaumburg, Illinois.

“This latest warning from the FDA however further adds to the growing body of documented risks associated with the use of this product, and the need for greater diligence in patient risk assessment and education prior to the initiation of such therapy to ensure its safe and effective use,” Calabrese said.

Related: Medication therapy can increase long-term success for smokers who want to cut back first, study finds

FDA has recommended that healthcare professionals weigh the potential risk of seizures against the potential benefits before prescribing Chantix in patients with a history of seizures or other factors that can lower the seizure threshold. Advise patients to immediately stop taking Chantix if they develop agitation, hostility, aggressive behavior, depressed mood, or changes in behavior or thinking that are not typical for them, or if they develop suicidal ideation or behavior.

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.

Also refer to the Drug Safety Communication for more information for patients and healthcare professionals.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

·       Complete and submit the report Online

·       Download form or call (800) 332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to (800) FDA-0178

Read next: American Lung Association calls for halt of tobacco sales at pharmacies