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FDA Warning for Chantix Heart Attacks, Stroke, Death

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December 12, 2012 — Researchers have found a higher occurrence of heart problems among patients taking Chantix, an anti-smoking drug.

In response, the U.S. Food and Drug Administration (FDA) has published a Safety Communication to warn about the potential increased risk of heart attack, stroke, and death. However, the FDA cautions that “The increased risk was not statistically significant, which means it is uncertain whether the excess risk for the Chantix group was due to the drug or due to chance.”

Although the data is not statistically significant, the increased risk of heart problems is consistent with other large studies comparing Chantix to a placebo. After these studies were published, the FDA updated the warnings on Chantix, published a Safety Communication in July 2011, and required Pfizer to investigate the risk.

Pfizer conducted a meta-analysis, which is a study that takes data from many other studies and tries to find correlations regarding side effects. The researchers compiled data from 12 clinical studies, which involved 4,190 people who used Chantix and 2,812 people who used a placebo.

The researchers then investigated the risk of heart attack, stroke, and death due to heart problems within the first 30 days of quitting Chantix or a placebo. They found that 0.31% of Chantix patients suffered a cardiovascular problem, compared to 0.21% of patients who used a placebo.

In conclusion, the FDA wrote:

“Because the number of adverse cardiovascular events was small overall, the power for finding a statistically significant difference in a signal of this magnitude is low.”

The FDA also cautions that smoking cigarettes is also associated with an increased risk of cardiovascular events, lung diseases, and certain types of cancer. These risks decrease for people who successfully quit smoking. Therefore, patients should weigh the risks and benefits of using Chantix with their prescribing physician.

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