Details
Study Summary
Sentinel data was used to support decisions around potential labeling changes for antipsychotics and stroke risk. FDA decided that no action is necessary at this time, based on available information.
Analytic Code Link(s) (2)
Stroke Following Typical or Atypical Antipsychotic Use in Non-Elderly Patients: A Propensity Score Matched Analysis
Stroke Following Atypical Antipsychotic or Z-Hypnotic Use in Patients with Prior Use of Selective Serotonin Reuptake Inhibitors (SSRIs): A Propensity Score Matched Analysis
Result(s) (3)
Antipsychotics and Stroke
Stroke Following Typical or Atypical Antipsychotic Use in Non-Elderly Patients: A Propensity Score Matched Analysis
Stroke Following Atypical Antipsychotic or Z-Hypnotic Use in Patients with Prior Use of Selective Serotonin Reuptake Inhibitors (SSRIs): A Propensity Score Matched Analysis
Related Publication(s) and/or Presentation(s) (2)
Presentation: Integrating Sentinel into Routine Regulatory Drug Review: A Snapshot of the First Year
Publication: Antipsychotic Use and Stroke: A Retrospective Comparative Study in a Non-Elderly Population