The U.S.? Food and Drug Administration (FDA) has issued a public advisory about the smoking cessation drug, Chantix (varenicline tartrate), saying that? for people who already suffer from heart disease,? Chantix may pose a slight increase in risk for? "certain adverse cardiovascular events".
FDA Advisory
This safety precaution will be added to the Warnings and Precautions section of physician labeling and the Patient Medication Guide for the drug.
The advisory is based on a review of a randomized, double-blind, placebo-controlled clinical trial that looked at the effectiveness and safety of Chantix.? The study followed 700 patients between the ages of 35 and 75 with cardiovascular disease for a year.? For the first 12 weeks, patients received either 1 mg of Chantix twice a day or a placebo.? Drug treatment stopped at the end of 12 weeks and study participants were followed for the next 40 weeks.?? Smoking cessation counseling was also provided throughout the year.
The Good News
Between weeks 9 and 52,? the Chantix group were able were able to maintain abstinence from tobacco at a rate of 19% compared with 7% of those in the placebo group.
The Bad News
Adverse cardiovascular events, including angina pectoris, nonfatal myocardial infarction, need for coronary revascularization, and new diagnosis of peripheral vascular disease or admission for a procedure for the treatment of peripheral vascular disease appeared to occur at a slightly increased rate for the Chantix group over the placebo group.
Like all medications that require a prescription, there are risks associated with Chantix.? It is not suitable for everyone, but can be an effective quit aid for some.? If you have heart disease and are on Chantix currently, talk to your doctor about how to proceed.
Chantix Patient Information
How Chantix Works as a Quit Aid
Chantix Side Effects:? Is Chantix Safe to Use?
View the original article here