SAFETY ALERT: Chantix Labeling Updated to Include Cardiovascular Risk Data

The FDA has approved updated labeling for Chantix (varenicline tablets; Pfizer) to include information about the efficacy and safety of the drug in patients with cardiovascular (CV) disease and those with chronic obstructive pulmonary disease (COPD). In a randomized placebo-controlled clinical trial of 700 smokers with CV disease, data showed that Chantix was effective in helping patients with CV disease quit smoking, and more than doubled the chance that patients remained abstinent from smoking for as long as one year compared with patients treated with placebo. The study, however, also demonstrated that use of varenicline may be associated with a small, increased risk of certain CV adverse events in patients who have CV disease.

In a second randomized clinical trial evaluating Chantix in 460 patients ≥35 years of age who had mild-to-moderate COPD, data showed that Chantix was more effective in helping COPD patients quit smoking and remain abstinent from smoking for as long as one year compared with placebo. Adverse events in this clinical trial were similar to those seen in studies that were conducted for Chantix's initial approval in 2006, and no new safety concerns were identified.

The Chantix label now also includes alternative directions for patients to select a quit-smoking date, stating that patients should start taking Chantix seven days before their quit date or alternatively, begin Chantix dosing and then quit smoking between Days 8 and 35 of treatment.

For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm259469.htm.