FDA Approves Label Change for Chantix

The FDA has recently approved updated label changes for the drug, Chantix, otherwise known as varenicline. The anti-smoking drug’s new label now contains information about the efficacy and safety of its use for two particular groups of patients — those with cardiovascular disease and those with chronic obstructive pulmonary disease. The new label also includes updated directions for patients to use when selecting a quit-smoking date.

The FDA requested the label change following its review of a double-blind clinical trial consisting of 700 smokers with cardiovascular disease who were treated with either Chantix or a placebo. The study revealed that cardiovascular-based adverse events were reported with greater frequency from the patients being treated with Chantix than from those taking a placebo. The FDA will continue to evaluate the safety of Chantix and is also requesting that the drug’s maker conduct additional placebo-controlled trials in order to better identify and understand the risks associated with using the medication.

For now, it is clear that the known benefits associated with using Chantix should be heavily weighed against its potential risks for serious side effects.

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