Researchers warn of hazards of smoking and need for wider use of varenicline to quit
In 2006, varenicline was approved as a safe and effective means to quit smoking and achieved permanent quit rates of approximately 25 percent. In 2009, however, varenicline received a black box warning by the FDA based on their adverse event reports of neuropsychiatric symptoms like depression and thoughts of suicide. There were plausible alternative explanations including that nearly half of the subjects had psychiatric histories, 42 percent were taking psychotropic drugs and about 42 percent were suffering from depression. Nonetheless, since then, there has been a 76 percent decline in the number of prescriptions dispensed from a peak of about 2 million in the last quarter of 2007 to about 531,000 in the first quarter of 2014. In their commentary, the FAU researchers emphasize that, until recently, the totality of randomized evidence on varenicline had been restricted to eight small trials, which did not demonstrate a hazard. The researchers caution that the reliable detectio...