Varenicline, smoking cessation, and neuropsychiatric adverse events.

  title={Varenicline, smoking cessation, and neuropsychiatric adverse events.},
  author={Robert D. Gibbons and J. John Mann},
  journal={The American journal of psychiatry},
  volume={170 12},
OBJECTIVE In 2009, the U.S. Food and Drug Administration issued a black box warning for varenicline regarding neuropsychiatric events. The authors used data from randomized controlled trials and from a large Department of Defense (DOD) observational study to assess the efficacy and safety of varenicline. METHOD The authors reanalyzed data from the 17 placebo-controlled randomized controlled trials (N=8,027) of varenicline conducted by Pfizer, using complete intent-to-treat person-level… CONTINUE READING
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