Chantix (varenicline): FDA Issues Drug Safety Communication Regarding Update to Label

On March 9, 2015, the FDA updated the safety label for Chantix to include how the drug (1) could change the way users react to alcohol and (2) be associated with seizures.

Chantix (varenicline) is an FDA-approved prescription drug manufactured by Pfizer, used to help adults quit smoking.  Chantix works by reducing cravings for and decreasing the pleasurable effects of cigarettes and other tobacco products.

Chantix: Seizures, and increased intoxication with, decreased tolerance to alcohol

The Safety Communication states that patients, while on Chantix, experienced increased intoxicating effects of alcohol.  Patients reported decreased tolerance to alcohol along with increased drunkenness, unusual or aggressive behavior, and amnesia.

Regarding seizures, the FDA stated that 64 cases of seizures by patients taking Chantix have been reported.  In 37 of the cases, the patients had no prior history of seizures.  In ten of the cases, the only contributing factor seemed to be the use of Chantix

The FDA concluded that:

Although the findings of the observational studies appear reassuring, they do not completely evaluate the effect of Chantix on neuropsychiatric adverse events and cannot be interpreted to mean that there is no risk of neuropsychiatric events with Chantix.

This safety communication follows previous safety communications from the FDA regarding neuropsychiatric side effects associated with Chantix in 2009 and 2011.

Contact the attorneys of Harman Law

If you have experienced serious side effects or know someone who has suffered serious side effects or died after taking the smoking cessation medicine Chantix, contact the dangerous drug attorneys at Harman Law LLC to learn your legal rights and eligibility for compensation.

We offer a no cost, no obligation initial consultation to patients and families of patients. Call 1-888-55-HARMAN or fill out the “Quick Connect” form at the top right of this page.

Links

Chantix Safety Communication, U.S. Food and Drug Administration, March 9, 2015: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm437415.htm

FDA Warns of Seizure, Alcohol Risks With Chantix, Medscape WebMD, March 10, 2015: http://www.webmd.com/smoking-cessation/news/20150310/chantix-alcohol-seizures

Varenicline, U.S. National Library of Medicine   (does not include latest warning): http://www.nlm.nih.gov/medlineplus/druginfo/meds/a606024.html

http://en.wikipedia.org/wiki/Varenicline