The Chantix label will be updated to include information on the efficacy and safety in patients with cardiovascular disease and with chronic obstructive pulmonary disease, reported the U.S. Food & Drug Administration (FDA).
The updated label includes information gathered from a randomized clinical trial of 700 smokers with cardiovascular disease. The trial revealed Chantix was effective in assisting patients with cardiovascular disease stop smoking, but it also demonstrated the smoking cessation drug is associated with a small, increased risk of certain cardiovascular adverse events.
The FDA advised health care professionals to weight the benefits of Chantix prior to using the drug in patients with cardiovascular disease.
The label will also include information from a trial evaluating the safety of Chantix in patients with mild-to-moderate chronic obstructive pulmonary disease. The results showed that the drug helped patients quit and refrain from smoking for as long as year. According to the FDA, adverse events in the trial were similar to those in a study conducted for Chantix’s 2006 approval.
On June 16, the FDA released a safety communication saying Chantix may cause a small, increased risk of heart problems in patients with cardiovascular disease. The agency reviewed study results from a randomized clinical trial which showed infrequent events of heart attack in those using Chantix versus patients taking the placebo.
Researchers found the drug helped patients quit smoking for more than a year, but results revealed a small but “statistically significant” increased risk of chest pain, non-fatal heart attacks and other cardiovascular problems patients using Chantix.
Since its approval in 2006, Chantix has faced controversy over the reported side effects associated with the drug.
In July 2009, the FDA issued a “black-box” warning about the effects of the drug after hundreds of patients reported the drug caused them to suffer from various psychiatric side effects including depression, rage and suicidal thoughts.
