Chantix Smoking Cessation Drug Linked to Increased Risk of Cardiovascular Events
Smoking and tobacco use is known to increase the risk of cardiovascular disease. Quitting smoking isn’t easy, but often can be helped with the use of certain medications. However, one of the more popular smoking cessation drugs, Chantix by Pfizer Inc, has now been found to also increase risk of cardiovascular problems such as heart attacks and peripheral artery disease.
Chantix was first approved in the United States in 2006. The drug is an oral nicotine-receptor blocker which works by blocking the pleasant effects of nicotine on the brain.
The Food and Drug Administration has announced that the Warnings and Precautions section of the label for Chantix (varenicline) must now carry safety information notifying the public that, based on data from a recent clinical trial, the drug may be associated with a small increased risk of certain cardiovascular adverse events, including heart attack, in patients who already have cardiovascular disease. The patient Medication Guide will also be revised to inform patients of the risk.
In the trial, 700 smokers aged 35 to 75 years with stable cardiovascular disease were treated with either Chantix or a placebo. The results did show that the drug (1 mg twice daily) was effective in helping patients to quit smoking and remain abstinent from smoking for as long as one year. However, events such as heart attack were reported in seven patients taking Chantix versus three patients on the placebo. The risk of angina pectoris and peripheral vascular disease was also higher.
In addition to the inclusion of a label warning, Pfizer Inc must also further evaluate the cardiovascular safety of Chantix.
Although the drug is also associated with psychiatric side effects such as depression and suicidal thoughts, Chantix is not being considered for market removal. Patients and physicians should weigh the known benefits of the drug against its potential risks when deciding to use Chantix in smokers with cardiovascular disease, says the FDA in their safety announcement.
Patients on Chantix should contact their healthcare professional if they experience new or worsening symptoms of cardiovascular disease such as shortness of breath or trouble breathing, new or worsening chest pain, or new or worsening pain in the legs when walking.