TY - JOUR T1 - VArenicline gets stronger warnings about psychiatric problems, vehicle crashes AU - Kuehn BM Y1 - 2009/08/26 N1 - 10.1001/jama.2009.1153 JO - JAMA SP - 834 EP - 834 VL - 302 IS - 8 N2 - The FDA's decision to require its strongest type of warning on labeling for varenicline comes after several efforts by the agency since 2007 to alert physicians and patients to psychiatric risks associated with the widely prescribed drug. The new labeling will prominently warn of the risk of behavioral changes, depression, hostility, aggression, suicidal thoughts, and suicide in patients taking the drug. A similar warning is also being added to the label of bupropion, an antidepressant and smoking cessation therapy that already carried a warning about suicidality in patients treated with the drug for depression. SN - 0098-7484 M3 - doi: 10.1001/jama.2009.1153 UR - http://dx.doi.org/10.1001/jama.2009.1153 ER -