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Ranexa (Ranolazine) & Seizure

Basic Details
Status
Complete
Last Updated
Thursday, January 3, 2019
Health Outcome(s)
seizure
Purpose
Drug and Outcome Analysis
Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
No
Study Summary

Combined with evidence from the Centers for Medicare & Medicaid Services, risk of seizure was determined to be driven primarily by underlying comorbidities. FDA decided that no action is necessary at this time, based on available information.

Analytic Code Link(s) (1)
Seizure Following Ranolazine Use
Result(s) (2)
Seizure Following Ranolazine Use Prevalent and Incident Dispensings of Ranolazine
Related Publication(s) and/or Presentation(s) (2)
Presentation: Integrating Sentinel into Routine Regulatory Drug Review: A Snapshot of the First Year Publication: Use of FDA’s Sentinel System to Quantify Seizure Risk Immediately Following New Ranolazine Exposure