Medication Monitor

Generic Name (Trade Name—Company)
June 16, 2011


New cardiovascular warning

According to FDA, new safety information will be added to Warnings and Precautions section of the varenicline label describing a small, increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease. In addition, the patient Medication Guide will be revised to inform patients about this possible risk. A review of data from a randomized, controlled trial involving 700 patients showed that more patients treated with varenicline compared with placebo had events such as 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.