FDA Issues New Warning Label for Chantix
We’re all hoping for that miracle pill. You know, the pill that will make us thinner without having to diet or workout, the pill that will get rid of fine lines and wrinkles, or the pill that will help us quit smoking. Unfortunately, there is no such thing as a miracle pill.
Sure, some prescription drugs are helpful and can give us a better quality of life, if used correctly. But some prescription drugs have proven to be dangerous to our health, reducing our overall quality of life.
One such dangerous pill is Chantix (generic name Varenicline), touted by major pharmaceutical company Pfizer as the pill that would help people quit smoking. The Food & Drug Administration (FDA) approved the drug in 2006 to help people quit smoking. But recent studies suggest that Chantix may put its patients at an increased risk of a heart attack, even if a patient has never had prior heart problems or cardiovascular disease. These results have prompted the FDA to include a warning on the box regarding potential cardiovascular-related health effects.
In 14 studies conducted over the past five years, researchers found that 72 percent of the more than 8,000 patients studied had an increased risk of being hospitalized with a heart attack or serious heart problem, compared to those taking a placebo. Smokers taking Chantix who had never had heart disease were at a 150 percent increased risk of experiencing an adverse heart event.
These results are troubling to many doctors, especially since Chantix is supposed to help reduce the risk of heart attack that comes from smoking. Researchers now believe the drug is doing exactly what it’s trying to prevent.
Some doctors have had concerns about the drug dating back to its release on the market in 2006. Dr. John Spangler, a co-author of the new research findings, says he raised concerns about the drug and its effect on the heart in 2006 during the drug’s approval process, but that his warnings were ignored by both the FDA and Pfizer, meaning neither patients nor physicians were warned of the risk at the time.
When asked why the FDA did not see fit to warn doctors and patients about the drug's risks in 2006, it responded that the data at the time was too inconsistent for a warning label. Since its approval, Chantix has been the subject of several FDA safety reviews, including one for depression and suicide. In 2009, the FDA issued a black box warning, the strongest warning issued by the FDA, regarding the risk of depression and suicide for patients taking Chantix.
Only recently has the FDA seen fit to issue a new warning, after findings from a 2010 study conducted by Dr. Nancy Rigotti, a professor at Harvard Medical School and the director of Mass General’s Tobacco Research & Treatment Unit, found that there is an increased risk of adverse cardiovascular events in patients taking the drug.
Sales of Chantix topped $755 million in 2010, putting 13 million people worldwide and seven million in the United States alone at risk for depression, an adverse cardiac event, or even a loss of consciousness, visual disturbances, violent outbursts, or a worsening of diabetes.
With the new warning, doctors are limiting or discontinuing the use of Chantix by their patients. Dr. Jay Cohn of the Rasmussen Center for Cardiovascular Disease Prevention at the University of Minnesota is in favor of the FDA’s new warning, saying “[t]he data . . . justify a black box warning on Chantix labeling about cardiovascular risk.”
Pfizer disagrees with the results of the studies relied upon by the FDA, but must turnover all of its data regarding adverse cardiovascular events to the FDA. Chantix serves as a reminder that a pill cannot cure everything.
