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Chantix Recall Urged After Study Finds Significant Heart Risks

Jul 5, 2011 | Parker Waichman LLP

A Chantix researcher is calling on the U.S. Food & Drug Administration (FDA) to pull the controversial stop-smoking drug from the market after a study he co-authored showed that taking Chantix increased the risk of heart attacks, strokes and other cardiovascular events by as much as 72 percent.

"The sum of all serious adverse effects of Chantix clearly outweighs the most positive effect of the drug," Dr. Curt D. Furberg, a Wake Forest medical professor, said according to The Wall Street Journal.

In a separate interview with The New York Times, Furberg said there are better ways to quit, and said Chantix should be recalled.

“It piles up,” he said. “I don’t see how the FDA can leave Chantix on the market.”

The new study, which Dr. Furberg co-authored with Dr. Sonal Singh, assistant professor of medicine at Johns Hopkins University, appears in the Canadian Medical Journal.   It involved a meta-analysis of 14 earlier Chantix trials that included more than 8,200 patients (4,908 people on varenicline and 3,308 taking placebos).  Only one of the studies included in the meta-analysis involved patients with pre-existing heart problems.

The study authors concluded that doctors could expect to get one extra cardiac event associated with Chantix for every 28 smokers they treated with the drug.  The study also found that people with no signs of heart problems possibly face the highest risks from Chantix.

This isn't the first time Chantix has been linked to heart problems.  Just last month, the FDA added new warnings to its label after a different study found it could raise heart risks in people with pre-existing cardiac problems.

According to Dr.  Singh, however, Chantix heart problems were known long before that.

“The FDA should have already put it on their warning label,” Dr. Singh told The New York Times. “The risk is substantial, the risk is present in smokers without heart disease, and Pfizer knew about this for five years.”

Since being approved by the FDA, Chantix has been prescribed to 13 million people, making it the best-selling smoking cessation drug on the market.  But it has long been plagued by controversy because of its association with psychiatric side effects, including suicidal thoughts and behavior.  In 2009, the FDA announced that a Boxed Warning would be added to the Chantix label because of such problems.   The drug has since been named in numerous personal injury lawsuits.




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