Varenicline May Raise CV Events in CVD Patients: FDA

Disclosures

June 16, 2011

June 16, 2011 (Rockville, Maryland) — The smoking-cessation drug varenicline (Chantix, Pfizer) may be associated with a small increased risk of cardiovascular events in patients with cardiovascular disease, according to the Food and Drug Administration (FDA) [1].

The new safety communication, which will be added to the warnings and precautions section of the drug's label, states that physicians need to balance the known benefits of varenicline--a drug effective in helping patients quit smoking--with the potential risks when deciding to use the drug in patients with cardiovascular disease.

In a review of a randomized, double-blind, placebo-controlled study of 700 patients treated with varenicline for smoking cessation, there was an increased risk of nonfatal MI, revascularization, angina pectoris, and peripheral vascular disease when compared with patients treated with placebo. Although the study was not designed to detect a statistical difference in the clinical end points, cardiovascular events were numerically higher among the 353 patients treated with varenicline.

The FDA states that physicians should speak with patients about seeking medical attention if they experience new or worsening symptoms of cardiovascular disease while taking varenicline.

In July 2009, the FDA required a new boxed warning for varenicline, stating that the drug has been associated with serious mental-health events. Reported symptoms include changes in behavior, hostility, agitation, depressed mood, suicide ideation, and attempted suicide.

Varenicline, an oral nicotine-receptor blocker, was approved by the FDA in May 2006 under the agency's priority-review program.

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