FDA Warns of Possible Chantix Heart Risks

The smoking-cessation drug Chantix may carry a slightly higher risk for heart problems, according to the Food and Drug Administration (FDA).

The finding was announced by the FDA as a result of a large combined analysis of clinical trials for the drug. The meta-analysis studied data for 7,002 patients, some of whom received Chantix (varenicline) while the others received a placebo. The analysis established that the probability of a major adverse heart event including nonfatal heart attack, nonfatal stroke, or cardiovascular-related death is slightly greater for Chantix users as compared to those on a placebo.

The FDA pointed out that the risk was not considered statistically significant, which means it is uncertain whether the higher risk for the Chantix group was due to the drug or due to chance.

However, the trial data was analyzed in different ways and it was found that serious heart problems occurred more in patients using Chantix as compared to non-users. Thus the FDA report notes that it seems more likely that it is not purely a chance finding.

Due to the greater probability of adverse cardiovascular events, the FDA says the Chantix label has been updated to include the results of the meta-analysis. The Chantix label already carries a warning that the drug may raise the risk of suicide.

From September 2011 to September 2012, approximately 2.3 million Chantix prescriptions were dispensed and approximately 1.26 million patients received the drug from U.S. outpatient retail pharmacies.

If you or a loved one has been harmed by a dangerous drug, contact Sokolove Law today for a free legal consultation and to find out if a dangerous drugs lawyer may be able to help you.

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