AUDIENCE: Family Medicine, Cardiology

 

ISSUE: FDA notified healthcare professionals and patients that the Prescribing Information for this drug product will be strengthened to inform the public that use of varenicline may be associated with a small, increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease. This safety information will be added to the Warnings and Precautions section and the patient Medication Guide.

 

BACKGROUND: FDA reviewed a randomized, double-blind, placebo-controlled clinical trial of 700 smokers with cardiovascular disease who were treated with Chantix or placebo. While cardiovascular adverse events were infrequent overall, certain events, including heart attack, were reported more frequently in patients treated with Chantix than in patients treated with placebo. The events included 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. FDA is continuing to evaluate the cardiovascular safety of Chantix and is requiring the manufacturer to conduct a large, combined analysis (meta-analysis) of randomized, placebo-controlled trials. FDA will update the public when additional information is available.

 

RECOMMENDATION: See the Data Summary section of the Drug Safety Communication for additional information.

 

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.

 

●编者提示：2011年6月16日，FDA发布有关戒烟药伐尼克兰（varenicline）的药品安全警告称，该药的处方信息将被修订以告知公众，在伴有心血管疾病的患者中使用该药可能会引起某些心血管不良事件风险的小幅度增加。这一安全信息将被加至处方信息中的“警告和注意事项”栏目和患者用药指南中。该药已在我国上市。