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(EMAILWIRE.COM, July 12, 2011 ) WASHINGTON, D.C. -- In June 2011, the U.S. Food and Drug Administration announced a warning afor those taking the anti-smoking drug, Chantix. According to the FDA, those taking this stop-smoking drug could be at higher risk for heart attacks and other health problems. Chantix has already been linked to other health problems, including suicide attempts and Stevens-Johnson Syndrome, a rare but life-threatening skin disorder.
In a recent drug safety communication, the FDA said that the warnings about the potential risk of heart problems will be added to the Chantix label and medication guide. According to federal regulators, those with pre-existing cardiovascular disease may face an increased risk of various cardiovascular events such as: heart attack, angina pectoris, coronary revascularization, or peripheral vascular disease.
After reviewing data from a clinical trial involving 700 smokers, half of whom were given Chantix instead of a placebo to help them quit smoking, the announcement was made. The researchers of the clinical trial found that two percent of the users of Chantix suffered a heart attack within a year, twice as many as smokers given a placebo. Coupled with other statistical factors, the researchers reported that Chantix can result in a 72 percent risk increase of heart problems among patients with exisiting cardiovascular disease.
In addition to updating warning labels, Pfizer, the maker of the drug, is required to perform a large, combined meta-analysis of clinical trial data to further evaluate risks of heart problems.
Three years ago, the Institute for Safe Medicine Practices first raised concerns about the drug. During the first 18 months the drug was on the market, the group identified 224 reports of Chantix heart problems among adverse events reported to the FDA between May 2006 and December 2007. These adverse events included events such as: cardiac rhythm disturbances, heart attacks and other cardiac problems. The Institute for Safe Medicine Practices monitors the potential for unsafe drugs.
The FDA will continue to review and evaluate the risk of Chantix side effects and will provide further information when it is made available. In the meantime, the FDA is recommending that physicians weigh the benefits of Chantix in helping people quit smoking against the potential risk of heart problems when deciding whether to use the drug among smokers with cardiovascular disease.
When Chantix was first released, the drug maker had high hopes that it would be huge seller. However, growing concerns about the potential side effects have made it a medium-sized seller with approximately $800 million in sales. Concerns over the Chantix heart attack risk is likely to continue to lessen the number of patients who turn to this drug over other methods.
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Source: EmailWire.com
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