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The safety of varenicline for smoking cessation continues to generate controversy. In a recent systematic review and meta-analysis, investigators analyzed data from 14 trials and found a significantly increased risk for cardiovascular events with varenicline. Now, a group that includes some of the same authors has evaluated data from the FDA's Adverse Event Reporting System (AERS) to compare the neuropsychiatric safety profiles of three smoking-cessation treatments: varenicline, bupropion, and nicotine-replacement products.
The AERS consists of case reports about serious adverse events that are sent to drug manufacturers or directly to the FDA. From 13,243 case reports on the three products, the investigators identified 3249 events described…