(RxWiki News) U.S. Food and Drug Administration officials recently warned smokers with a history of heart disease that taking smoking cessation drug varenicline (Chantix) could could put them at added risk for a heart attack or peripheral vascular disease.
Officials said taking the medication may be associated with a small increased risk of adverse heart events in patients with previous cardiovascular disease such as heart attacks and strokes. Another label will be added to the warnings and precautions section, as well as the patient medication guide.
"Talk to your doctor about whether continuing to take Chantix is in your best interest."
The FDA continues to evaluate the safety of the drug and is requiring the manufacturer to conduct a meta-analysis of all randomized placebo-controlled trials. The public will be updated when more information is made available.
Before issuing the stronger warning, the FDA had conducted a double-blind placebo-controlled clinical trial of 700 smokers with heart disease who were treated with either Chantix or the placebo. Incidents were infrequent but a higher rate of heart attacks were reported in patients taking Chantix.
The clinical trial revealed a small increase in the likelihood of 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.
Doctors are being asked to weigh the known benefits of Chantix with the potential risks of continuing to smoke when deciding whether to use the drug in smokers with heart disease. Chantix is manufactured by Pfizer.
The FDA is asking doctors and patients to report adverse effects, or product quality problems to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online at www.fda.gov/MedWatch/report.htm. A form that can be mailed or faxed is available by calling (800) 332-1088.