Varenicline (CHANTIX,CHAMPIX) Update
This aid to smoking cessation acquired a warning in July 2010 about increased risk of serious cardiovascular effects following two new studies. While the FDA declared the risks to be small, the adverse event data for the 4th quarter of 2010 suggest these studies may have underestimated the overall vascular adverse effects by limiting the focus to only the most serious events. We found seven additional potential vascular effects not included in these studies including hypertension, dizziness, visual and memory impairment and confusional state. All may be potentially linked to vasoconstriction or vasodilation, effects related to the nicotinic receptors that are bound by varenicline. Meanwhile, the Veterans Administration (VA) restricted the use of varenicline, citing risks of suicidal behavior and violence. The VA made varenicline a second-line drug to be used only if bupropion (ZYBAN) or nicotine patches had failed, and mandated a mental status exam to eliminate patients at greatest risk for psychiatric side effects.