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news.The US Food and Drug Administration (FDA) has asked Pfizer to conduct large and combined analysis of Chantix (varenicline tablets) to assess the cardiovascular safety of the drug in smokers.
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Chantix is used as a smoking cessation medicine which works in the brain to block the pleasurable effects of smoking.
The results from a randomized trial involving 700 smokers who had cardiovascular disease demonstrated that the drug was effective for the patients for quitting cigarette smoking for around one year, Reuters reported.
However, the drug has increased the incidence of fatal heart attacks compared placebo group.
Reuters quoted FDA as saying that the known benefits of Chantix should be weighed against its potential risks when deciding to use the drug in smokers with cardiovascular disease.
Further, the FDA has decided to change the label of Chantix for identifying the increased heart risk following reviewing the results of the clinical trial.