June 16, 2011 – A new study linking the smoking cessation drug Chantix to heart attacks and other cardiovascular events has prompted the U.S. Food & Drug Administration (FDA) to strengthen the drug’s warning label and prescribing information. Additional side effects named in the Chantix warning include angina pectoris, nonfatal myocardial infarction, and the need for coronary revascularization. Doctors and patients are strongly advised to weigh the risks vs. benefits of Chantix before beginning a regimen.
What’s the problem?
The new prescribing information for Chantix will now include information about how the anti-smoking drug may be associated with an increased risk of the following cardiac events in individuals who have cardiovascular disease:
- heart attack
- angina pectoris
- nonfatal myocardial infarction
- need for coronary revascularization
- new diagnosis / treatment of peripheral vascular disease
The updated information will be added to the Warnings and Precautions section of the Chantix label and in the patient Medication Guide.
The move to enhance Chantix warning labels was prompted by the FDA’s review of a randomized, double-blind, placebo-controlled clinical trial of 700 smokers with cardiovascular disease who were treated with Chantix or a placebo. According to the results of the study, the side effects listed above were reported more frequently in patients who took Chantix than in those who took placebos. The administration is continuing to analyze the study’s findings, and is requiring Pfizer to conduct intensive additional research. FDA will continue to update the public as additional information becomes available.
“Healthcare professionals should be aware that smoking is an independent and major risk factor for cardiovascular disease, and smoking cessation is of particular importance in this patient population. The known benefits of Chantix should be weighed against its potential risks when deciding to use the drug in smokers with cardiovascular disease. Patients are encouraged to read the Medication Guide they receive along with their Chantix prescription.”
Side Effects of Chantix
Chantix (varenicline) was approved by the FDA in 2006 as a prescription treatment to help people quit smoking. The drug works by blocking receptors in the brain that are commonly stimulated by nicotine, thus reducing the positive feelings that come from cigarettes. However, reports of serious Chantix side effects began to surface shortly after it was introduced. In addition to the risk of heart attack and cardiovascular events, Chantix has also been associated with the following severe side effects:
- joint pain
- muscle pain
- suicidal thoughts
- psychotic behavior
- Stevens-Johnson Syndrome (SJS)
- liver failure
Sadly, reports of suicide linked to Chantix began to surface shortly after the drug hit the market. In November 2007, the FDA began reviewing reports of suicidal behavior associated with the drug, and in February 2008 the administration issued a press release highlighting changes made to the Chantix warning label about potential psychiatric side effects.The FDA indicated that their review of data indicates it is “increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.”
Between May 2006 and December 2007, the FDA received the following serious adverse event reports associated with the use of Chantix:
- 227 reports of suicidal acts, thoughts, or behavior
- 397 cases of possible psychosis
- 525 reports of hostility or aggression
To date, dozens of Chantix lawsuits have been filed against Pfizer in various state and federal courts around the country. The claims allege that Pfizer, who excluded individuals with depression or a history of mental illness from many clinical trials, failed to adequately research the adverse effects of their drug before marketing it heavily as an easy solution to help people stop smoking.