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Hydrochlorothiazide & Non-Melanoma Skin Cancer

    Basic Details
    Last Updated
    Wednesday, September 30, 2020
    Health Outcome(s)
    non-melanoma skin cancer
    Drug and Outcome Analysis
    Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
    Regulatory Determination / Use

    In response to observational studies showing an elevated risk of non-melanoma skin cancer associated with hydrochlorothiazide (HCTZ) use, FDA assessed the risk of non-melanoma skin cancer for patients treated with HCTZ-containing products compared to non-HCTZ angiotensin-converting-enzyme inhibitor (ACEI)-containing products in the Sentinel System. FDA found HCTZ is associated with an increased risk of non-melanoma skin cancer. In the Sentinel study, increased risk was predominantly for squamous cell carcinoma and in white patients taking large cumulative doses. These findings informed additions to the Adverse Reactions and Information for Patients sections of the label.