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Use of Hydrochlorothiazide in the United States Following Label Update About Skin Cancer Risk

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    Description

    On August 20, 2020, the United States (U.S.) Food and Drug Administration (FDA) issued a Drug Safety Communication (DSC) along with labeling updates to inform the public about a small increased risk of non-melanoma skin cancer (NMSC) associated with hydrochlorothiazide (HCTZ) use. This study aims to assess whether the DSC impacted HCTZ use in the U.S. We conducted a trend analysis in the Sentinel Distributed Database using national healthcare administrative data from January 2017 to November 2022. We identified two cohorts each month: An overall cohort of all enrollees and a skin cancer cohort of those with a history of NMSC.

    Author(s)

    Cheng Chen, Efe Eworuke, Ashish Rai, Laura Hou, Jenice S. Ko, Mary Ross Southworth, José J. Hernández-Muñoz, Mingfeng Zhang

    Corresponding Author

    Mingfeng Zhang; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration

    Email: mingfeng.zhang@fda.hhs.gov