FDA Drug Safety Communication: Chantix (varenicline) drug label now contains updated efficacy and safety information

The FDA has issued new information about this safety issue, see the FDA Drug Safety Communication issued on 12-12-2012.

The following announcement is related to planned labeling changes that were described in the recent FDA Drug Safety Communication on Chantix (varenicline) issued on 6/16/2011.

[7-22-2011] The U.S. Food and Drug Administration (FDA) has approved an updated drug label for the smoking cessation aid Chantix (varenicline) to include information about the efficacy and safety of the drug in two patient populations who may benefit greatly from giving up smoking—those with cardiovascular disease and those with chronic obstructive pulmonary disease (COPD). The updated label now also includes alternative directions for patients to select a quit smoking date.

Updated information on the use of Chantix in patients with stable cardiovascular disease

FDA reviewed a randomized clinical trial of 700 smokers with cardiovascular disease. Patients received either Chantix 1 mg twice daily or placebo for 12 weeks and were followed for an additional 40 weeks. The clinical trial showed that Chantix was effective in helping patients with cardiovascular disease quit smoking, and more than doubled the chance that patients remain abstinent from smoking for as long as one year compared to patients treated with placebo. This information has now been added to the Chantix label. Because smoking is an independent and major risk factor for cardiovascular disease, smoking cessation is of particular importance in this patient population.

This trial also demonstrated that Chantix may be associated with a small, increased risk of certain cardiovascular adverse events in these patients—FDA communicated about this potential risk and labeling update in the June 16, 2011 Drug Safety Communication. The absolute risk of cardiovascular adverse events with Chantix, in relation to its efficacy, is small.

However, healthcare professionals should always weigh the potential benefits of Chantix against its potential risks when deciding to use the drug in patients with cardiovascular disease.

Information on the use of Chantix in patients with COPD

FDA reviewed a randomized clinical trial evaluating the efficacy and safety of Chantix in 460 patients at least 35 years of age who had mild-to-moderate COPD. Patients received either Chantix 1 mg twice daily or placebo for 12 weeks and were followed for an additional 40 weeks. The results showed that Chantix was more effective in helping COPD patients quit smoking and remain abstinent from smoking for as long as one year compared to 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.

Alternative directions for patients to select a quit smoking date after they have already started taking Chantix

Previously, the Chantix drug label only included instructions for patients to first select a quit date, and then to start taking Chantix 7 days before their quit date. FDA reviewed a randomized clinical trial in a general, otherwise healthy population of smokers who were instructed to begin taking Chantix, and then select a target quit date between Day 8 and Day 35 of treatment. Patients received either Chantix 1 mg twice daily or placebo for 12 weeks and were followed for an additional 12 weeks. The results showed that Chantix was more effective in helping patients quit smoking and remain abstinent from smoking for as long as 24 weeks compared to 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 updated label states that patients should start taking Chantix 7 days before their quit date or alternatively, begin Chantix dosing and then quit smoking between Days 8 and 35 of treatment.

Information from the three clinical trials has been added to the Dosage and Administration, Warnings and Precautions, Adverse Reactions, Clinical Studies, and Patient Counseling Information sections of the Chantix physician label. The patient Medication Guide has also been updated to include information about cardiovascular adverse events and alternative directions to select a quit date.

Healthcare professionals and patients can access the latest drug label for Chantix here.

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