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Antipsychotic Agents (Including Haloperidol Injection) & Stroke

Basic Details
Status
Complete
Last Updated
Friday, December 8, 2017
Health Outcome(s)
stroke
Purpose
Drug and Outcome Analysis
Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
No
Regulatory Determination / Use

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