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N‐nitrosodimethylamine (NDMA)‐Contaminated and Non‐NDMA‐Contaminated Valsartan Use: A Descriptive Analysis

Basic Details
Date Posted
Status
Complete
Medical Product
valsartan
Description

In this report we examined counts of individuals with N-nitrosodimethylamine (NDMA)-contaminated and non-NDMA-contaminated valsartan use in the Sentinel Distributed Database (SDD), and assessed the duration of database enrollment following the first eligible dispensing. The study period includes data from May 1, 2011 to October 31, 2020. We distributed this request to seven Sentinel Data Partners on December 18, 2020.

Deliverables (1)
Sentinel Modular Program Report: N‐nitrosodimethylamine (NDMA)‐Contaminated and Non‐NDMA‐Contaminated Valsartan Use: A Descriptive Analysis
Additional Details
FDA Center
CDER
Time Period
May 1, 2011 - October 31, 2020
Analysis Type
Descriptive
Population / Cohort
Individuals aged 18 and older
Data Sources
Sentinel Distributed Database (SDD)
Related Links
Sentinel Drug Analysis: Incidence and Prevalence of N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA) Contaminated Valsartan Use: A Descriptive Analysis
Sentinel Drug Analysis: Utilization of Valsartan: A Descriptive Analysis
Sentinel Drug Study: Valsartan and Non-Valsartan Angiotensin Receptor Blocker Utilization in the United States Following Recalls Due to Nitrosamine Impurities: A Descriptive Analysis