Assessments

This webpage provides access to Sentinel assessments that have been conducted by U.S. FDA’s Center for Drug Evaluation and Research (CDER).  The search options below can be used to find materials based on medical product, safety outcome, and the following study types:

  • Exploratory Analyses characterize the rates of health outcomes, examine medical product use, and explore the feasibility of more detailed evaluations. 
  • Safety Analyses build on exploratory work and formally evaluate medical product-outcome associations using more advanced study designs and statistical methods to control for confounding. 

Search results provide a listing of assessments, reported results, related links to publications, and FDA Drug Safety Communications. If you wish to search for information on other types of projects, a comprehensive listing of all Sentinel projects, including all assessments, data, surveillance tools, methods, and communication materials can be accessed using the Report Finder.

Disclaimer
The information contained on this website is provided as part of FDA's commitment to place knowledge acquired from Sentinel in the public domain as soon as possible. Please read the disclaimer.

Most Recent Drug Assessments

TitleDate Posted
Sentinel Summary Table Report: Brintellix/Brilinta04/25/2017
Sentinel Summary Table Report: 2011 NMEs Incident Use04/24/2017
Sentinel Summary Table Report: 2011 NMEs Prevalent Use04/24/2017
Sentinel Summary Table Report: 2011 NMEs HCPCS04/24/2017
Sentinel Summary Table Report: 2012 NMEs Incident Use04/24/2017
Sentinel Summary Table Report: 2012 NMEs Prevalent Use04/24/2017
Sentinel Summary Table Report: 2012 NMEs HCPCS04/24/2017
Sentinel Summary Table Report: 2013 NMEs Incident Use03/22/2017
Sentinel Summary Table Report: 2013 NMEs Prevalent Use03/22/2017
Sentinel Summary Table Report: 2014 NMEs Incident Use03/22/2017
Sentinel Summary Table Report: 2014 NMEs Prevalent Use03/22/2017
Sentinel Summary Table Report: 2013 NMEs HCPCS03/22/2017
Sentinel Summary Table Report: 2014 NMEs HCPCS03/22/2017
Sentinel Modular Program Report: Influenza Antiviral Drug Use 2010-201510/30/2016
Sentinel Modular Program Report: ADHD Medications and Heart Failure10/25/2016
Mini-Sentinel Prospective Surveillance Plan: Prospective Routine Observational Monitoring of Mirabegron 09/22/2016
Mini-Sentinel Modular Program Report - Mirabegron, AMI, and stroke09/22/2016
Mini-Sentinel Modular Program Report: Dronedarone and electrocardiograms08/17/2016
Protocol: Parenteral Iron and Anaphylactoid Reactions v2.007/22/2016
Report: Parenteral Iron and Anaphylactoid Reactions07/22/2016
Mini-Sentinel Modular Program Report: Dabigatran and warfarin use among members with atrial fibrillation and other pre-existing 07/21/2016