FDA Modifies Chantix Label for Heart, COPD Patients

The <"http://www.yourlawyer.com/topics/overview/chantix_side_effects">Chantix label has been updated with new information regarding the safety and efficacy of the smoking cessation medication, according to an announcement from the U.S. Food & Drug Administration (FDA). The modifications to the Chantix label apply to patients with pre-existing heart disease and chronic obstructive pulmonary disease (COPD).

The new Chantix label will now include information from a randomized clinical trial of 700 smokers with cardiovascular disease. According to the FDA, while the study found that Chantix was effective at helping such patients stop smoking, it also demonstrated that Chantix may be associated with a small, increased risk of certain cardiovascular adverse events in these patients. Information regarding the heart events seen in the trial was added to the “Warnings and Precautions” section of the Chantix label last month. Healthcare professionals should always weigh the potential benefits of Chantix against its potential risks when deciding to use the drug in patients with heart disease, the FDA said.

The label modification also includes the addition of a study that 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, the FDA said.

Finally, new directions have been added to the label for patients who select a quit smoking date after they have already started taking Chantix. According to the FDA, the new label states that such patients should start taking Chantix seven days before their quit date or, alternatively, begin the drug and then quit smoking between day eight and day 35 of treatment.

Since being approved by the FDA in 2006, Chantix has been prescribed to 13 million people. The drug has long been controversial because of its association with psychiatric side effects, including suicidal thoughts and behavior. In 2009, the FDA announced that a Boxed Warning would be added to the Chantix label because of such problems. The drug has since been named in numerous personal injury lawsuits.

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