TY  - JOUR
T1  - NEw reports examine psychiatric risks of varenicline for smoking cessation
AU  - Kuehn BM
Y1  - 2012/01/11
N1  - 10.1001/jama.2011.1924
JO  - JAMA
SP  - 129
EP  - 130
VL  - 307
IS  - 2
N2  - 
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.

SN  - 0098-7484
M3  - doi: 10.1001/jama.2011.1924
UR  - http://dx.doi.org/10.1001/jama.2011.1924
ER  -