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Postmarketing reports linking varenicline to suicidality, depression, and psychosis led to an FDA black-box warning that has not been lifted even though multiple studies failed to show these associations. Now, researchers have analyzed observational data from the entire Swedish population and used a more powerful within-subject design that controls for unmeasured confounders (69,757 individuals with varenicline prescriptions). Registry data covered medical-visit diagnoses, crimes, emergency visits, deaths, and traffic offenses.
The analysis uncovered no link between varenicline and crime, suicide, accidents, or psychosis. However, varenicline was associated with a small increased risk for new anxiety and mood conditions (hazard ratios, 1.27 …