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FDA Says Stop-Smoking Pill Increases Heart Problems

June 17, 2011

The Food and Drug Administration (FDA) said on Thursday that Pfizer’s drug to help smokers quit can lead to a small increase in heart problems in those who have cardiovascular disease.

The FDA is changing the Chantix label to identify the increased heart risk after reviewing the results of a clinical trial.

An independent randomized trial of 700 smokers with cardiovascular disease who were treated with Chantix or a placebo showed that the drug was effective in helping patients quit smoking for as long as one year.

However, patients who took Chantix were slightly more likely to have a heart attack than those who took the placebo.

In the FDA’s study, 2 percent of patents taking Chantix had non-fatal heart attacks compared with 0.9 percent in the placebo group.

Many smokers who try to quit do so to prevent the risk of heart attacks, which may now be associated with Chantix.

“The known benefits of Chantix should be weighed against its potential risks when deciding to use the drug in smokers with cardiovascular disease,” the FDA said in a statement.

The health regulators said it is also requiring Pfizer to evaluate the cardiovascular safety of Chantix by conducting a large, combined analysis of randomized, placebo-controlled trials.

Pfizer said in a statement it would discuss details of the analysis as well as the product’s label with the FDA.

Pfizer’s non-nicotine pill has found criticism for psychiatric side effects and prompted the FDA to issue a restrictive “black box” warning on the drug’s label.

Investors had high hopes for the drug when Pfizer for launched it, but reports of psychiatric side effects hampered strong sales growth.

About 1,200 plaintiffs filed lawsuits earlier this year claiming that Chantix causes depression or suicidal thoughts

Annual sales of Chantix are about $800 million, making the pill a moderate-sized product for the world’s biggest drug maker.

Chantix has been associated with agitation, depression and suicidal thoughts and was linked with nightmares.  Psychiatric symptoms have occurred in people without a history of mental illness and have worsened in people who already had mental illness.

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