Varenicline: quantifying the risk

The finding by Singh and colleagues that varenicline is associated with an increased risk of serious adverse cardiovascular events1 is not surprising because varenicline is frequently associated with hypertension.2^,3 An elevation in blood pressure, however small, increases the risk of adverse cardiovascular outcomes.4 Before approving varenicline, the US Food and Drug Administration (FDA) should have mandated that the manufacturer provide the FDA with data on cardiovascular safety.