A Post-Authorization Safety Study of Quetiapine as Antidepressant Treatment in Sweden: Nested Case–Control Analyses of Select Outcomes

This post-authorization safety study (PASS) was a commitment to the European Medicines Agency. This PASS investigated quetiapine as antidepressant treatment in Swedish registers with regard to the risk for all-cause mortality, self-harm and suicide, acute myocardial infarction, stroke, diabetes mellitus, extrapyramidal disorders, and somnolence. Users of quetiapine and antidepressants (2011‒2014) who had changed treatment in the past year were...