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Heart risk in anti-smoking drug seen

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This FDA image released on June 21, 2011 shows one of the new proposed cigarette warning labels. Beginning September 2012, FDA will require larger, more prominent cigarette health warnings on all cigarette packaging and advertisements in the United States. These warnings mark the first change in cigarette warnings in more than 25 years and are a significant advancement in communicating the dangers of smoking. UPI/FDA 
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Published: July 5, 2011 at 12:26 PM

BALTIMORE, July 5 (UPI) -- The popular anti-smoking drug Chantix increases the risk for a heart attack or other heart problems in healthy, middle-aged smokers, a U.S. researcher says.

Dr. Sonal Singh of Johns Hopkins, the lead author of a new study, says warnings on the drug should be stronger than those currently required by the Food and Drug Administration, The Baltimore Sun reported Monday.

"People want to quit smoking to reduce the risk of cardiovascular disease, but in this case they're taking a drug that increases the risk for the very problems they're trying to avoid," Singh said.

Singh, who reviewed 14 clinical trials, said the risk increased by 72 percent for healthy, middle-aged smokers.

That is significantly higher than the FDA indicated in mid-June when it warned about a small increase in cardiovascular impacts for those on the drug, Singh said.

In a statement, FDA officials said more analysis was needed before the agency would change its position.

The drug's maker, Pfizer, issued a statement saying the company "strongly believes in and supports Chantix as an important treatment option" and that it disagrees with Singh's interpretation of the trial data.

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