Details
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.
Analytic Code Link(s) (1)
Non-Melanoma Skin Cancer following Hydrochlorothiazide Use: A Propensity Score Matched Analysis
Result(s) (3)
Non-Melanoma Skin Cancer following Hydrochlorothiazide Use: A Propensity Score Matched Analysis
Duration of Use Among New Users of Hydrochlorothiazide (HCTZ), Angiotensin-Converting Enzyme Inhibitors (ACEIs), and Angiotensin II Receptor Blockers (ARBs)
Non-Melanoma Skin Cancer following Hydrochlorothiazide Use
Regulatory Link(s) (1)
FDA Labeling Change: Hydrochlorothiazide and Non-Melanoma Skin Cancer
Related Publication(s) and/or Presentation(s) (2)
Publication: Risk of Non-Melanoma Skin Cancer in Association with Use of Hydrochlorothiazide-Containing Products in the United States
Presentation: Risk of Non-Melanoma Skin Cancer Associated with Hydrochlorothiazide-Containing Products in the United States