Ranexa (Ranolazine) and Seizures

Project Title Ranexa (Ranolazine) and Seizures
Date Posted
Monday, February 5, 2018
Project ID
cder_mpl1r_wp033_nsdp_v01, cder_mpl2p_wp002_nsdp_v01
Status
Complete
Deliverables
Related Links
Description

These reports contain 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. The query was run against the Sentinel Distributed Database for the time period of January 1, 2006 to September 30, 2015. The request was distributed to 16 data partners on August 4, 2016. 

Medical Product
Ranexa
ranolazine
Health Outcome
seizure
Population / Cohort
All individuals
Time Period
2006-2015
Assessment Type
Safety Analyses
Study Type
Modular Program
Data Sources
Sentinel Distributed Database (SDD)
FDA Center
CDER