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Prospective Surveillance Pilot of Rivaroxaban Safety within the US Food and Drug Administration Sentinel System

Basic Details
Date
Type
Publication
Medical Product
rivaroxaban
warfarin
Health Outcome(s)
gastrointestinal (GI) bleed
intracranial hemorrhage
ischemic stroke
Description

The U.S. Food and Drug Administration's Sentinel System developed tools for sequential surveillance. This tool was used to sequentially compare outcomes for new users of rivaroxaban versus warfarin, employing propensity score matching and Cox regression. This study demonstrates the capability of Sentinel to conduct prospective safety monitoring and raises no new concerns about rivaroxaban safety.

Materials

Pharmacoepidemiology & Drug Safety, 2018; 1-9. DOI:10.1002/pds.4375

Information
Data Source(s)
Mini-Sentinel Distributed Database (MSDD)
Related Assessment(s)
PROMPT: Rivaroxaban Surveillance
2017 ICPE Presentation: Prospective Surveillance Pilot of Rivaroxaban Safety within the US Food and Drug Administration Sentinel System
Mini-Sentinel Drug Assessment: Xarelto (rivaroxaban) & Intracranial Hemorrhage, Gastrointestinal (GI) Bleed, and Ischemic Stroke
Author(s)

Elizabeth A. Chrischilles PhD, MS, Joshua J. Gagne PharmD, ScD, Bruce Fireman MA, Jennifer Nelson PhD, Sengwee Toh ScD, Azadeh Shoaibi PhD, MHS, Marsha E. Reichman PhD, Shirley Wang PhD, ScM, Michael Nguyen MD, Rongmei Zhang PhD, Rima Izem PhD, Margie R. Goulding PhD, Mary Ross Southworth PharmD, David J. Graham MD, MPH, Candace Fuller PhD, Hannah Katcoff MPH, Tiffany Woodworth MPH, Catherine Rogers MPH, Ryan Saliga BBA, Nancy D. Lin ScD, Cheryl N. McMahill-Walraven PhD, MSW, Vinit P. Nair BPharm, MS, RPh, Kevin Haynes PharmD, MSCE, Ryan M. Carnahan PharmD, MS, BCPP

Corresponding Author

E. Chrischilles, Department of Epidemiology, College of Public Health, University of Iowa, 145 N. Riverside Dr., Iowa City, IA 52242-2007, USA. Email: e-chrischilles@uiowa.edu