The new warning label is designed to clarify the risks, including the safety and effcacy for patients with heart disease or Chronic Obstructive Pulmonary Disease -- two patient populations that would most benefit from quitting smoking.
"Talk to your doctor about whether Chantix is appropriate."
The updated label also will include alternative directions to aid patients in selecting a stop smoking date.
The new label is designed to better inform consumers about a small increased risk of cardiovascular events such as a heart attack in patients with preexisting heart disease. That information will be added to the warnings and precautions section of the patient medication guide.
The FDA had reviewed a randomized study of 700 smokers with heart disease who received either Chantix or a placebo. Adverse events were uncommon, however, smokers taking Chantix more frequently reported cardiovascular events such as heart attack, angina, new diagnosis of peripheral vascular disease, or hospital admission for peripheral vascular disease treatment. Peripheral vascular disease occurs when arteries leading to the legs and feet narrow and harden.
The new labels also provide information for COPD patients. A study of 460 COPD patients showed that Chantix was more effective in helping patients quit, and was not associated with an increased risk of adverse events.
Another label change will state that patients should begin taking Chantix seven days before their desired quit smoking date, or begin the medication and them stop smoking between day 8 and day 35 of treatment.
FDA officials are still working to evaluate the cardiovascular safety of the drug. Drug manufacturer Pfizer is required to conduct a large analysis of randomized placebo-controlled trials.