A new analysis by the US Food and Drug Administration (FDA) downplays the psychiatric risks of the smoking cessation drug varenicline, but an independent analysis of the agency's adverse event reports suggests the drug dramatically increases the risk of suicide and suicide-related behavior compared with other cessation medications.
Reports of an array of serious adverse events, including suicide, other violence, cardiac problems, and crashes, have dogged varenicline for several years. Such reports led the FDA in 2009 to require that the drug's label carry a black box warning of the risk of severe neuropsychiatric adverse events in patients taking the drug and earlier this year to update the drug's label to warn of increased risk of cardiac adverse events in patients with cardiovascular disease. Now the new analysis from the FDA concludes that varenicline does not increase the risk of hospitalization for psychiatric problems. Meanwhile, though, the independent analysis found an alarmingly high rate of suicide-related adverse events—predominantly events that would not involve hospitalization.
Kuehn BM. New Reports Examine Psychiatric Risks of Varenicline for Smoking Cessation. JAMA. 2012;307(2):129-130. doi:10.1001/jama.2011.1924