  |
Chantix (varenicline): Drug Safety Communication - FDA Updates Label to Include Potential Alcohol Interaction
AUDIENCE: Family Practice, Patient, Pulmonology
ISSUE: FDA is warning that the prescription smoking cessation medicine Chantix (varenicline) can change the way people react to alcohol. Interactions between alcohol and Chantix have resulted 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.
BACKGROUND: Chantix is a prescription medicine that is FDA-approved to help adults quit smoking.
RECOMMENDATION: Healthcare professionals should 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: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch Safety Alert, including links to the Press Release at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm437415.htm
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your email address to log in. If you have questions or problems with the subscription service, please visit subscriberhelp.govdelivery.com.
This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
| This email was sent to list-fda@xxxxxxxxxxx using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 |  |
