Ranexa (Ranolazine) and Seizures

Project Title Ranexa (Ranolazine) and Seizures
Date Posted
Thursday, January 3, 2019
Status
Complete
Deliverables
Related Links
Description

Report 1: Ranexa and Seizures
Request ID: cder_mpl1r_wp033_nsdp_v01

​This report contains the estimated rates of seizures among indiviuals exposed to ranolazine alone, as well as individuals with concomitant use of ranolazine and either beta blockers, selected oral calcium channel blockers, or non-injectable nitrates. This request was distributed to 16 Data Partners on August 4, 2016. 

Report 2: Ranexa and Seizures, Self-Controlled Risk Interval (SCRI) Design
Request ID: cder_mpl2p_wp002_nsdp_v01

This report utilized a self-controlled risk interval study design to estimate the number of individuals exposed to ranolazine, or ranolazine and non-injectable nitrates, and among them, the number who had a seizure that occurred during specified risk and control windows. This request was distributed to 12 Data Partners on November 18, 2016. These data were presented at the 2017 ICPE Symposium: Integrating Sentinel into Routine Regulatory Drug Review: A Snapshot of the First Year. View more information here.

Report 3: Ranexa and Seizures, Self-Controlled Risk Interval (SCRI) Design
Request ID: cder_mpl2p_wp006_nsdp_v01

This report had two goals: 1) to compare the baseline characteristics of ranolazine and beta blockers users and 2) to utilize a self-controlled risk interval study design to estimate the risk of seizure events within specified risk and control windows for ranolazine users, and those with concomitant use of ranolazine and CYP3 inhibitors. This request was distributed to 14 Data Partners on November 9, 2017. 

The analytic packages associated with these reports can be found externally in Sentinel's Git Repository located here. The Git Repository serves as Sentinel's version control tracking system for analytic packages and technical documentation.

Medical Product
Ranexa
ranolazine
Health Outcome
seizure
Population / Cohort
All individuals
Time Period
2006-2017
Assessment Type
Safety Analyses
Study Type
Modular Program
Data Sources
Sentinel Distributed Database (SDD)
FDA Center
CDER