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Use of Valsartan, Angiotensin II Receptor Blockers (ARB), and Angiotensin-Converting Enzyme (ACE) Inhibitors

Basic Details
Date Posted
Status
Complete
Medical Product
angiotensin II receptor blocker (ARB)
angiotensin-converting enzyme (ACE) inhibitor
azilsartan medoxomil
candesartan
eprosartan
irbesartan
losartan
olmesartan
telmisartan
valsartan
Description

This analysis estimates the rates of valsartan (contaminated and uncontaminated with N-nitrosodimethylamine (NDMA) or N-nitrosodiethylamine (NDEA)), angiotensin II receptor blocker (ARB), and angiotensin-converting enzyme (ACE) inhibitor use in the Sentinel Distributed Database (SDD). Data from January 1, 2000 to June 30, 2018 from 17 Data Partners contributing to the SDD were included in this report. This request was distributed on October 30, 2018.

Deliverables (1)
Sentinel Modular Program Report: Use of Valsartan, Angiotensin II Receptor Blockers (ARB), and Angiotensin-Converting Enzyme (ACE) Inhibitors
Additional Details
FDA Center
CDER
Time Period
January 1, 2000 - June 30, 2018
Analysis Type
Descriptive
Population / Cohort
All individuals
Data Sources
Sentinel Distributed Database (SDD)
Related Links
2019 ICPE Poster: Exposure to N-nitrosodimethylamine (NDMA)/N-nitrosodiethylamine (NDEA)-contaminated Angiotensin-II Receptor Blockers Products in the United States
Sentinel Drug Analysis: Utilization of Valsartan: A Descriptive Analysis