Medical therapies for smoking cessation are limited, and the cardiovascular risk of varenicline is unresolved. This new analysis also increases existing concerns for psychiatric side effects with varenicline from the FDAs adverse event reporting system. Of all smoking cessation therapies (e.g. varenicline, buproprion, or nicotine therapies) 90% of depression/suicidality episodes were associated with varenicline; compared to nicotine replacement, varenicline had 8 times the odds of depression/suicidality. Ongoing concerns of serious side effects may limit the use of varenicline among some smokers (abstract)
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