In June 2011, the FDA issued a warning about the potential for serious adverse heart events in patients who use Chantix. The FDA noted at the time that a study of 700 smokers with cardiovascular disease who were given either Chantix or a placebo suggested a small but increased risk of cardiovascular adverse events.
"Cardiovascular events were infrequent overall, however, certain events, including heart attack, were reported more frequently in patients treated with Chantix than in patients treated with placebo," the FDA wrote. Information about the increased risk will be added to the Warnings and Precautions section of Chantix physician labeling and a warning will also be added to the medication guide.
Meanwhile, a study, published on July 4 by CMAJ (Canadian Medical Association Journal), found an increased risk of heart problems in patients who used Chantix, seemingly confirming the FDA's concerns. The study differed from the FDA, however, because it found the risk of heart problems increased in all patients who used Chantix, not just those with a prior history of heart problems.
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Researchers concluded that the study "raises safety concerns about the potential for an increased risk of serious adverse cardiovascular events associated with the use of varenicline [the generic form of Chantix] among tobacco users." They further noted that the initial safety information concerning potential heart problems linked to the use of Chantix was not adequately followed up with safety trials. This led them to conclude that until proper safety trials are conducted, physicians should weigh the risks of cardiovascular events and neuropsychiatric adverse events against the benefits of Chantix.