Is Chantix Dangerous To Your Health?
Chantix is a prescription drug manufactured by Pfizer Inc. that is marketed as a smoking cessation drug. It contains an ingredient called varenicline. Chantix is a non-nicotine pill that works in two ways. It targets nicotine receptors in the brain, attaches to them, and thereby blocks nicotine from reaching those receptors. And, it reduces the release of a chemical in the brain called dopamine which controls mood and behavior: regulating the levels of dopamine released in the brain can remove some of the pleasure derived from smoking. Several years ago, the United States Food and Drug Administration required the manufacturer of Chantix to post additional safety information, warning its users that Chantix can cause changes in behavior, hostility, agitation, depressed mood, and suicidal thoughts or actions. Just recently, the FDA has notified the public that Chantix has an additional health risk.
On June 16, 2011, the FDA notified physicians and the public that Chantix may be associated with an increased risk of certain cardiovascular events in patients who have cardiovascular disease. The FDA has also required that new and additional safety information be added to the warnings and precautions associated with Chantix. The FDA reviewed a clinical study of over 8,000 smokers with cardiovascular disease who were treated with Chantix, and as a result is now requiring additional warnings that adverse cardiovascular events, including heart attack, have been reported by users of the drug.
The clinical study was performed by researchers and physicians at the Johns Hopkins University School of Medicine in Baltimore, Maryland. The researchers did a thorough search of medical articles and of literature gathered by the FDA and the European Medicines Agency (the equivalent of the FDA for the European Union). They also did a systemic review and analysis of what are known as randomized controlled trials, in order to ascertain the level of adverse cardiovascular effects in tobacco users who were given drugs containing varenicline as compared to tobacco users who were given placebos. The researchers concluded that certain adverse cardiovascular events were reported in more patients treated with Chantix then in patients that were treated with placebos. The adverse cardiovascular effects that were seen included angina pectoris, nonfatal myocardial infarction, the need for coronary revascularization, and heart attack. The researchers concluded that their analysis "showed a significantly increased risk of serious adverse cardiovascular events associated with varenicline," from which they concluded that there were safety concerns associated with the use of varenicline.
After its review of this study, the FDA issued a "Safety Announcement" notifying healthcare professionals and patients that Chantix may be associated with increased risk of adverse cardiovascular events, particularly those who have cardiovascular disease. The FDA is requiring that this safety information be added to the Warnings and Precautions section of the Chantix physician labels, and is also requiring that the Medication Guide for patients be revised to inform patients about the possible risk of adverse cardiovascular events.
It appears that Chantix can help people quit smoking, but can also lead to major cardiovascular difficulties such as heart attack. If you believe that your health has been effected by Chantix or another drug contain varenicline, please contact us to discuss your rights.