FDA sees small but increased risk in patients taking the medicine
THURSDAY, June 16 (HealthDay News) -- The quit-smoking drug Chantix may lead to a small but increased risk of heart problems in people with cardiovascular disease, the U.S. Food and Drug Administration said Thursday.
In a study of 700 smokers with cardiovascular disease who were undergoing treatment with Chantix or a placebo, researchers saw a small but "statistically significant" greater risk of chest pain, non-fatal heart attacks and other cardiovascular problems in patients taking the quit-smoking drug, the FDA said.
Details of the new findings will be shared with doctors and will be included in the drug's medication guide to patients, the agency said.
In July 2009, the FDA mandated that Chantix (varenicline tartrate) and a second smoking-cessation drug, Zyban, carry a "black-box" warning about the potential risks of psychiatric problems, including depression and suicidal thoughts.
In its announcement Thursday, the FDA noted that smoking is a major contributor to cardiovascular disease, the number one killer of Americans. So doctors and their patients should weigh the "known benefits of Chantix against its potential risks when deciding to use the drug in smokers with cardiovascular disease," the agency said in a statement on its website.
Patients taking Chantix, which received FDA approval in 2006, should contact their health-care professional if they experience new or worsening symptoms of cardiovascular disease.
One heart expert agreed.
"In light of this study, any patient known to have cardiovascular disease who is taking Chantix or considering taking it, or health care provider considering prescribing it to a patient known to have cardiovascular disease must discuss the risks, benefits and alternatives in detail," said Dr. Jonathan Whiteson, director of the Cardiac and Pulmonary Wellness and Rehabilitation Program at NYU Langone Medical Center in New York City.
"It must be considered that there are options and that Wellbutrin has not been indicated in causing progression of cardiovascular disease in smokers with existing cardiovascular disease," Whiteson added. He said other smoking cessation aids, such as nicotine-replacement gums, patches or lozenges, as well as "adjunctive therapies such as aromatherapy, hypnosis and acupuncture" might also help smokers quit.
Whiteson stressed that the study only looked at Chantix users who were already diagnosed with heart disease before they started the drug, and "there is no evidence at present to suggest that Chantix leads to the new development of cardiovascular disease in people who are free of cardiovascular disease when they start the Chantix."
The FDA said it will continue to evaluate the risks and benefits associated with Chantix and is requiring the manufacturer -- Pfizer Inc. -- to conduct an analysis of all previous randomized, placebo-controlled trials of the drug. The agency said it will release those findings to the public when they become available.
In a statement, Pfizer pointed out that smoking is a key risk factor for heart disease, and quitting the habit brings heart benefits that are "immediate and substantial," the Wall Street Journal reported. Pfizer agreed that patients should talk to their doctors to "determine what medications are right for them."
For more on how to quit smoking, visit the U.S. Centers for Disease Control and Prevention (http://www.cdc.gov/tobacco/quit_smoking/how_to_quit/index.htm ).
SOURCES: Jonathan Whiteson, M.D., director, Cardiac and Pulmonary Wellness and Rehabilitation Program, NYU Langone Medical Center, New York City; U.S. Food and Drug Administration, June 16, 2011; Wall Street Journal