Chantix (varenicline tartrate) is a prescription medication sold by Pfizer to help people quit smoking. Since it was introduced in May 2006, a number of serious and potentially life-threatening side effects of Chantix have raised concerns about whether the risks associated with the medication may outweigh the benefits over other methods of quitting smoking.
On June 16, 2011, the FDA announced that new warnings about the potential risk of heart attacks from Chantix will be added to the Warnings and Precautions section of the patient Medication Guide.
The new Chantix heart warnings indicate that use of the drug may be associated with an increased risk of heart problems among individuals with pre-existing cardiovascular disease. However, other studies suggest that all users may face an increased risk of heart problems from Chantix, including heart attacks, strokes and congestive heart failure.
The warnings were issued after the FDA reviewed data from a clinical trial involving 700 smokers with cardiovascular disease who were treated with Chantix or a placebo. An increased number of cardiac events were found among those treated with Chantix, including:
- Non-Fatal Myocardial Infarction
- Angina Pectoris
- Need for Coronary Revascularization
- New Diagnosis of Peripheral Vascular Disease
- Admission for Treatment of Peripheral Vascular Disease
As a result of Pfizer’s failure to adequately research and explore the potential risk of heart side effects from Chantix, the FDA is now requiring the drug maker to conduct a large, combined analysis of prior clinical trial data to better assess the potential Chantix heart risks.
In July 2011, a study published by the Canadian Medical Association Journal found that smokers who took Chantix may face a 72% increase in the risk of suffering a serious cardiovascular event, including a heart attack or stroke. This study suggests that even individuals without pre-existing heart disease may face a substantial risk of a heart attack or stroke from Chantix.
Information signaling a potential risk of heart attacks and other heart problems from Chantix has been available to the manufacturer for some time. In May 2008, the non-profit consumer watchdog Institute for Safe Medication Practices released a report that identified at least 224 reports of Chantix heart problems received by the FDA during the first 18 months the drug was on the market. These adverse event reports received by the FDA only represent a small fraction of the total number of Chantix heart attacks and cardiac problems experienced by users.
The law firm of Saiontz & Kirk, P.A. previously evaluated the potential for Chantix heart attack lawsuits, but new cases are no longer being accepted. Several thousand lawsuits over Chantix were filed against Pfizer, primarily involving individuals who committed suicide, attempted suicide or suffered other psychiatric side effects of the medication. Those complaints alleged that Pfizer failed to adequately warn about the risk of these problems prior to July 2009. Most of those lawsuits settled in 2013 and Saiontz & Kirk, P.A. is no longer accepting new clients involving injuries associated with the use of Chantix.