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Incidence and Prevalence of N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA) Contaminated Valsartan Use: A Descriptive Analysis

    Basic Details
    Date Posted
    Medical Product

    In this request, we examined the utilization of N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA) contaminated valsartan products, as well as angiotensin-converting enzyme (ACE) inhibitors (ACEI), other angiotensin II receptor blockers (ARBs) excluding valsartan, and calcium channel blockers (CCBs) in the Sentinel Distributed Database (SDD). This analysis includes two reports:

    • Report 1:  We investigated the utilization and switching patterns among prevalent users of NDMA and NDEA contaminated, uncontaminated, and recalled uncontaminated valsartan products.
    • Report 2: We investigated the utilization of incident NDMA and NDEA contaminated valsartan products, ACE inhibitors, ARBs, and CCBs users in the SDD.

    The study period includes data from January 1, 2010 to April 30, 2019. The request for Report 1 was distributed to 16 Sentinel Data Partners (DPs) on October 9, 2019. The request for Report 2 was distributed to 16 Sentinel Data Partners (DP) on October 14, 2019.

    Additional Details
    FDA Center
    Time Period
    January 1, 2010 - April 30, 2019
    Analysis Type
    Population / Cohort
    All individuals 18 years of age and older
    Data Sources
    Sentinel Distributed Database (SDD)